Overall Programme

48th EMWA Conference - Vienna

7-11 May 2019

See Fees and Registration for details of fees and waiting list procedures for events (including EPDP workshops).  

 

EPDP workshops

If you attend an EPDP workshop and successfully complete the pre- and post-workshop assignments you can gain an EPDP credit (2 for a double workshop), which can allow you to apply for an EMWA certificate of professional development. See the EPDP brochure for details. However, you are welcome to attend workshops without doing them for credit. 

 

When you have registered for a workshop, download the pre-workshop assignment using the link on the right hand side of the workshop listing. 

 

 

 

 

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Tuesday 7 May

16:00
to
20:00

Registration

Content

Welcome from the EMWA President and Conference Director, presentation of awards, a cultural talk and a lecture on patient groups by Otto Spranger

Changes in the health-care landscape placing the patients first
How were the health care conditions for patients some 100 years ago? What is happening today, and where are we heading tomorrow? What part do patients play for the pharmaceutical industry and doctors? What role do patient lobby groups and other relevant patient-level organisations have in today’s politics. How can best available health care and health practices be ensured? What is the attitude of the patient and the patient representative groups to individual patient data sharing?
These are some of the topics that will be presented. Emphasis will be on some of the well-known and perhaps not so well known medical achievement that originated in Austria and affected world-wide the general medicine practices and doctor-patient relationships. Personal experiences will be shared with regard to patient needs for those affected by asthma and chronic obstructive pulmonary disease (COPD). The future goals and visions for these patients will also be described.

Moby-Dick: An SOP for Whaling?
Art Gertel
Reading Herman Melville’s classic American novel of Man’s battle with his inner demons, embodied by Captain Ahab in pursuit of the White Whale, Moby-Dick, may come away wondering why all the attention paid to the mechanics of finding, pursuing, killing, and processing these leviathans!
This year is the bicentennial of Melville’s birth, and it is only fitting to pay tribute to this monumental tale by examining it, not as a mere novel, but a work that embodies a “user’s guide” to whaling – a Standard Operating Procedure (SOP), if you will. In addition to identifying characteristics of SOPs, we will also thrill to the adventure that served as Melville’s inspiration – the saga of the
Whaleship Essex!
Join Art Gertel, yarn-spinner of last year’s
Shackleton’s Ghost Writer adventure, as he takes you on another tale of our indominable will, or foolishness.


Schnitzel, Waltz & Paranoia - The ‘Heart of Europe’ between appearances and reality 
Sandra Goetsch-Schmidt
Georg Schmidt
19:00
to
20:45

Networking Reception
Social

Wednesday 8 May

07:00
to
07:30

Easy Morning Yoga Session
Drop-in Session

Participant Profile

This is one of a series of occasional short seminars begun at the Barcelona conference.

Drop in on this interactive short seminar for a quick ‘English’ fix looking at major and minor issues with the use of English in our context to set you up for the day. Come with questions if you want, but remember we have only 40 minutes. Or send them to me upfront:
alistair.reeves@t-online.de.

Content

Topics today are:
Use and misuse of ‘respectively’
American vs. British English
Myths about starting sentences
Use of ‘both’
Your questions

Participant Profile

This workshop is for medical writers at different stages of their career. There is no prerequisite in order to participate but a basic knowledge of clinical trial documents is expected.

Objectives

The EMA Policy 0070 requires public disclosure of clinical trial (CT) documents. The EU General Data Protection Regulations (GDPR) requires that personal data in these documents be protected. Though divergent at first glance, these new requirements actually are aligned to benefit patients. As medical writers, we need to find the right balance between disclosure and data protection while maintaining the scientific utility of the documents we write.
The objective of this workshop is to help medical writers deal with different CT documents impacted by the EMA Policy 0070 and the GDPR. The participant will gain knowledge in identifying critical patient data and the “risk areas” of a CT document or project, and in mitigating risks to confidentiality and of non-compliance.

Content

The workshop will cover:
· a short introduction to CT transparency and disclosure, the key regulations (i.e., EMA Policy 0070, GDPR), and definitions of key terms
· benefits, challenges, and risks of disclosure
· CT documents impacted, with focus on the study protocol and the clinical study report
· personal data pseudonymisation (“redaction-friendly”) techniques at the document level
· working with other functional groups to ensure patient data protection in CT documents

Hands-on exercises will be provided on
· identifying data protection risks
· pseudonymisation strategies to mitigate risks to patient confidentiality.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:30hrs

08:45
to
11:45

MSF6

Participant Profile

Participants should, ideally, have already completed Introduction to Pharmacokinetics (DDF7) and Pharmacology for Medical Writers: Part 1 – The Basics (MSF1), or have equivalent experience or knowledge.

Objectives

This workshop is designed to explain the reasons behind the commonest types of adverse effects of drugs and medicines. This is intended to enable participants to understand and often predict adverse effects of new drugs and medicines. This will make it easier for participants to write accurately and effectively about the adverse effects of the drugs and medicines they will meet in their work.

Content

All effective drugs (and hence the medicines that contain them) have adverse effects. To be useful, therefore, the effective (i.e. therapeutic) dose of a drug or medicine must produce only acceptable adverse effects. Adverse effects can arise in several ways, and this workshop seeks to describe these in a systematic way. The mechanisms can be broadly summarised as follows:
(1) Extended normal pharmacology
(2) Parallel pharmacology
(3) Idiosyncratic reaction
(4) Pharmaceutical
(5) Pharmacokinetic interaction
(6) Pharmacological interaction
(7) Chemical interaction

Each of these mechanisms will be described with suitable examples, and the clinical significance of the different types of interaction will be discussed. Because of its largely factual content, the workshop will be mainly didactic. However, attendees will be expected to participate by answering questions as the presenter develops the explanations.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

DDA31
Orphan Medicinal Drug Products
Drug Development - Advanced

Participant Profile

This workshop will benefit medical writers who have an interest in the clinical development of orphan medicinal products, and who are familiar with the European Medicines Agency marketing authorisation application (MAA) procedures. Prior attendance to DDF13 Basic Concepts of Study Design in Clinical Development would be helpful but is not essential.

Objectives

To provide participants with an understanding of how to prepare the scientific part of an orphan designation application and to recognise strategies used in clinical development of an orphan medicinal product.

Content

Orphan medicinal products are intended to treat rare diseases, and the pharmaceutical industry are eligible for a number of incentives if they develop these products. However, a medicinal product cannot be granted orphan designation unless orphan designation is approved by the European Commission, and an approval of orphan designation is not a guarantee for a successful marketing authorisation. Clinical development of orphan medicinal products is often complex because rare diseases are poorly characterised and under-researched at the time of development, and only affect a small percentage of the population. This workshop will provide an overview of orphan medicinal products, rare diseases and incentives; provide an overview of the orphan designation procedure; provide guidance on how to prepare a comprehensive orphan designation application (scientific part); and provide strategies for clinical development in orphan medicinal products. As protocol assistance is an incentive granted for orphan designation, an overview of the procedure will also be covered.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

PTA6

Participant Profile

Medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers. The workshop will meet the needs of writers often working to tight protocol and study report writing timelines because of inadequate scheduling of the processes leading up to and driving preparation of these documents. This is an ideal forum for writers whose organisations or clients have scope to improve their analysis and reporting processes and procedures.

Objectives

Protocol writing heralds the start of the trial documentation and reporting process; the study report is often the final document prepared by medical writers. Exacting and sometimes unrealistic timelines for deliverable preparation are often agreed without consultation with the medical writer. The workshop discusses the stages before and during preparation of these documents to show how achievable timelines may be scheduled, thereby facilitating good proposal writing. After completing the workshop, participants will understand the stages involved so they can make a valuable contribution to their organisation’s or client’s process improvement activities and are better equipped to manage client expectations with regard to efficient, effective and realistic proposal writing and project scheduling.

Content

• Bidding and project award process
• First steps on contract win and allocation of study
• Contract review and confirmation of scope
• Communication with client and functional groups
• Scheduling
• Study protocol: stages of preparation
• Clinical study report: stages of preparation
• Proposal writing
• Business advantages of effective scheduling, influencing the process, and managing expectations

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

MCF8a
From Clinical Study Report to Manuscript
Medical Communication - Foundation

Participant Profile

Medical writers who write or expect to write manuscripts based on Clinical Study Reports (CSRs). Participants ideally should have already attended the EMWA workshops on ‘Writing a Clinical Study Report Using ICH E3’ and ‘Writing a Manuscript for Publication’, or should have equivalent experience in at least one of these areas of medical writing.

Objectives

To acquire effective strategies and techniques to write a manuscript for publication based on a CSR.

Content

· Examine differences between CSRs and manuscripts (pre-workshop assignment)
· Prepare a document checklist for writing a manuscript from a CSR
· Determine which sections of a CSR (ICH E3) are relevant for a manuscript
· Establish guidelines for writing a manuscript based on a CSR
· Determine how to use the tables and figures from a CSR
· Analyse examples of CSR text, figures and tables and convert to manuscript format (post-workshop assignment)

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

Participant Profile

The Investigational Medicinal Product Dossier (IMPD) is an important part of the clinical trial application (CTA) which is submitted to the EMA for approval of clinical trials of investigational medicinal products (IMPs) in the EU. Those who stand to benefit from this workshop are regulatory personnel and medical writers in the pharmaceutical industry, CROs, and medical writing agencies who are involved in preparing regulatory documentation – especially documents pertaining to the chemistry, manufacturing, and quality control (CMC) of IMPs.

Participants of this workshop will be expected to have experience/knowledge of the drug development and approval process, especially in the US and the EU as well as familiarity with various components of the eCTD.

Objectives

Participants of this workshop will get an overview on the individual parts of the IMPD, as well as details of the relevant source documents and submission requirements and the medical writer’s role in the preparation of the dossier.

Content

The IMPD includes summaries of information related to the quality, manufacture and control of the IMP, data from non-clinical studies and from its clinical use. An overall risk-benefit assessment, critical analyses of the non-clinical and clinical data in relation to the potential risks and benefits of the proposed study also have to be part of the IMPD.

The main focus of the workshop will be to clarify the medical writer’s role in the selection, assembly, and summary of relevant source documents for drafting a full or simplified IMPD for medicinal drug products, with a strong emphasis on the
chemistry, manufacturing, and quality control (CMC) components of these.

The workshop is planned to be interactive and will include discussion of participants’ questions submitted in their pre-workshop assignments, where relevant. There will also be a handful of exercises carried out during the workshop to encourage overall participation.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:30hrs

08:45
to
12:15

MCA8
The Value Story and the Global Value Dossier
Medical Communication - Advanced

Participant Profile

Anyone who wants to learn more about value messages and writing value dossiers, whether they are new to these topics or have some experience with them. The workshop will not assume any prior knowledge of value dossiers or market access, but will assume a basic familiarity with drug development and clinical data.

Objectives

After completing the workshop, you should understand the concept of ‘value’ and be able to construct a value story and value messages for a pharmaceutical product or medical device. You will be familiar with the structure of a typical value dossier and have an understanding of what information is required in each section. You will understand what a value dossier is used for and how to make sure it fulfils users’ needs.

Content

Obtaining marketing authorisation is no longer the final step in a drug’s journey to market. Manufacturers must also persuade budget-holders (payers) in each country to pay for it. The global value dossier (also known as core value dossier) is a key resource for pharmaceutical company market access teams. The workshop explain the concept of ‘value’ as it applies to pharmaceutical market access. It will emphasise the importance of the ‘value story’, and participants will learn how to create evidence-based ‘value messages’ (i.e. the claims that are used to show the product’s clinical, humanistic and economic value). The workshop will then describe the structure of a typical value dossier and guide participants through the information that goes into each section, and where to find it. The emphasis throughout will be on ensuring that the document meets the needs of its end-users.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:30hrs

08:45
to
12:15

DDA5
The CTD Clinical Overview
Drug Development - Advanced

Participant Profile

This workshop is aimed at writers with experience in writing study reports but who are new to writing Clinical Overviews for the Common Technical Document (CTD).

Objectives

The purpose of this workshop is to look at creating the optimal CTD Clinical Overview that achieves its purpose. On completion of the workshop package, participants should be able to approach writing a CTD Clinical Overview with a better understanding of the expectations of a Regulatory Authority Assessor.

Content

The workshop will begin with a brief presentation on what a Clinical Overview is and how it fits into the dossier as a whole. This will then be followed by an overview of the Clinical Overview structure and the important points within each section. Finally there will be some pointers about what a regulatory reviewer wants from a Clinical Overview. Participants will then have the opportunity to take part in a group exercise drafting a Product Development Rationale section based on information provided in the workshop.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

MDA2
Writing Clinical Evaluation Reports
Medical Devices - Advanced

Participant Profile

Medical writers with experience in regulatory writing for medicinal products or medical devices. Participants should have attended the workshop ‘Introduction to Writing for Medical Devices’ or should have a basic knowledge of the market approval process for medical devices.

Objectives

To provide guidance and insight into the clinical evaluation process and report writing for medium- and high-risk medical devices.

Content

Main elements of the workshop are:
• A brief overview of the market approval process and the role of the clinical evaluation
• The Clinical Evaluation Plan
• The Clinical Evaluation Report (CER): content and data/documents to be used for its preparation
o Pre-clinical and clinical data
o Risk management documents
o Post-market surveillance documents
o Claims
o Device information provided by the manufacturer to the user
o State-of–the-Art analysis
o Benefit/risk assessment

The workshop will include group exercises and discussions as well as evaluations of anonymised documents.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

Participant Profile

This course is intended for medical writers with no or little experience of writing clinical study reports (CSRs).

Objectives

The objective of this workshop is to equip you with the essential skills required for the management and preparation of high-quality CSRs. This includes in-depth sessions on both the writing of CSRs as well as their project management. The workshop will include group exercises and discussions so that participants can develop new skills attained and learn from each other’s experiences.

This double workshop brings together different aspects of knowledge and medical writing skills required (covered in depth in other workshops) for the production of CSRs.

Content

The course will cover:
• CSR project preparation and timelines
• Writing a CSR according to International Conference on Harmonisation (ICH) E3 guidelines and CORE reference
• Writing the methods sections: brief overview and advice
• Interpreting data, describing results: demography and baseline characteristics
• Interpreting data, describing results: efficacy; using the statistical report
• Interpreting data, describing results: safety and safety narratives
• Different types of CSRs: abbreviated CSR, full CSR, post-marketing reports, medical device reports
• CSR review and quality control
• Appendices: an overview

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

Content

See the Expert Seminar Series page for further details
10:15
to
11:00

Refreshments available
12:00
to
13:30

Lunch
12:30
to
13:15

Predatory Journals
Not for credit

Content

See the Expert Seminar Series page for further details
13:30
to
17:00

PTA14
Building Medical Writing Teams
Professional Techniques - Advanced

Participant Profile

Managers of writing teams (in-house or freelance), experienced writers looking for a career path into management, freelancers working working in networks or in a team, and those who are interested in building network-teams. The workshop mainly focuses and draws examples from regulatory writing teams.


Complementary workshops: PTF8–Cross-cultural communication, PTA11–Strategies for Improving Document Quality, PTA12–Interpersonal Skills for Medical Writers, PTA13–The Art of Mentoring.

Objectives

Participants should have a greater understanding of the unique and varied composition of medical writing teams and the strategies and skills that can be used to build, manage and expand dynamic teams of writers in any writing environment.

Content

We will discuss how team leaders and managers can use a variety of strategies and skills to build, manage and expand teams of writers, and how they can harness each members’ skills, knowledge and expertise to ensure production of high quality work within budgeted hours and timelines. We will also cover establishing a team atmosphere to provide an encouraging environment for learning, developing and sharing writing skills at the level, need and desire of each team member.

The workshop will cover:

· What a real team looks like
· How a real team functions and develops
· How experienced writers benefit from the team model
· Freelancers as part of the team
· Global teams – team cohesion, distance communication
· Expanding the team
· Retention strategy and succession planning

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:30hrs

Participant Profile

This basic workshop is intended for participants directly or indirectly involved in the planning, analysis and/or reporting of clinical trials, or in the design of clinical development programs, or those with little or no background in this area who are interested in learning the basics.
Previous experience or background knowledge of clinical trial disclosure is not required.
This workshop will benefit newcomers to the topic, but also those simply wishing to update their knowledge of this topic.

Objectives

Attending this workshop will help participants to understand the regulatory requirements (e.g., EMA Policies 043 and 070) and industry commitments for clinical trial disclosure, understand how patients and investigational sites may benefit from this disclosure, be introduced to the new documents required due to the disclosure (EMA Policy 070 anonymisation report, lay summaries, etc.), be aware of the challenges created by clinical trial disclosure for when drafting clinical documents (e.g., protocols, clinical study reports), understand what is company confidential information, personal protected information, and data privacy, and understand how data privacy and confidential information is protected (e.g., using anonymization or redaction).

Attending this basic workshop before attending one of the above specialist workshops will enable participants to gain the most benefit from the advanced workshops.

Content

This will be an interactive workshop combining classical presentations with quizzes and exercises to introduce the topic. The aspects of clinical trial disclosure most relevant for medical writers, including potential new deliverables and challenges during protocol and CSR writing, will be highlighted. This workshop will enable attendees to embark upon workshops covering specialized topics such as the drafting of lay summaries, trial registration and results reporting in EudraCT/clinicaltrials.gov, and the protection of protected personal data and commercially confidential data.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 1:00hrs

13:30
to
17:00

DDF11a
Subject Narratives for Clinical Study Reports
Drug Development - Foundation

Participant Profile

This workshop is intended for medical writers who are familiar with the clinical development process but have no or limited experience in writing subject narratives for clinical study reports.

Objectives

Participants will acquire knowledge of the requirements and criteria for writing subject narratives within the framework of relevant ICH guidelines. They will obtain an understanding of the narrative writing process, including sources of data, presentation of information, important functional groups contributing to the narratives, and techniques for narrative generation. This will enable the writer to prepare high-quality narratives and optimise narrative writing activities.

Content

The following topics will be discussed during the first part of the workshop:
• Relevant sections of the ICH guidelines, emphasising the purpose of narratives
• Definition of narrative criteria and categories
• Content, including sources of information and data, the role of clinical trial and pharmacovigilance databases, recycling of information from CIOMS forms
• The narrative writing process, including formats, templates, use of programmed data, coordination with other functional groups, quality control, tips for handling narratives in large studies

During the second part of the workshop participants will be divided into groups and asked to write a simple narrative based on tables and listings.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

LWF15

Participant Profile

This workshop is for medical writers interested in exploring the use of readability tools to help them produce more readable biomedical research text. Participants should have some experience of writing and editing scientific research texts, but do not need specialised knowledge.

Objectives

This workshop explores ‘readability’, focusing on how formulas, formula-derived statistics and other tools can help writers edit biomedical research articles. After this workshop, participants should be able to:
· Understand what determines the readability of a document
· Appreciate what readability formulas measure (usually sentence length and word difficulty) and what formula-derived statistics mean
· Recognise the pros/cons and realistic place of readability statistics, particularly when applying them to biomedical research texts
· Use readability statistics and other tools to screen biomedical texts and help improve text readability.

Content

In this workshop, we will:
· Define ‘readability’ and consider what influences readability
· Consider the importance of readability, particularly of biomedical research articles
· Review commonly-used readability formulas
· Consider the readability of biomedical research articles
· Critically assess the use of readability statistics
· Review other tools available to analyse text and improve readability
· Consider a Readability Screening Checklist.

Practical elements of the workshop will include:
· Comparison of two texts for readability: initial impression and later in-depth comparison using readability statistics and web-based tools
· Analysis of participants’ own writing using readability statistics
· Exercises illustrating important determinants of sentence length and therefore readability: the active/passive voice, nominalisation and joining words to improve sentence flow.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

PTA12
Interpersonal Skills for Medical Writers
Professional Techniques - Advanced

Participant Profile

Anyone who wants to explore effective and diplomatic ways of overcoming common interpersonal hurdles that arise in the course of every day life as a medical writer.

Objectives

To think about the role of the medical writer as a team mediator and to learn how to solve common interpersonal problems, either by avoiding them in advance or by understanding the issues that need to be addressed once they have occurred.

Content

As medical writers, we deal with many different people (some with very large egos and very little diplomacy) to prepare the documentation we are expected to write. This workshop will present and discuss the basic philosophy of the role of a medical writer in the social context. We will look at our role on a project team in terms of team dynamics as well as how we interact with people on a one-on-one basis. Real-life examples (good and bad) and hands-on exercises followed by discussion will demonstrate how to use different approaches in different contexts to minimize interpersonal conflicts and overcome those that occur.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

PTA2

Participant Profile

Delegates should include medical writers, particularly those who work within, or for, pharmaceutical companies; project managers (whether by actual title or function); and others with responsibility for overseeing and coordinating multifunctional projects. Participants should have at least 1 year’s experience working within a matrix environment.

Objectives

• Acquire understanding of basic project management theory
• Apply project management theory to multifunctional projects
• Broaden context beyond medical writing
• Add team-building strategies

Content

Discussion will include project management theory and practical applications, both within the context of a matrix organisation, and as an independent providing services to clients. A medical writing group may also adopt these practices to better control their own destiny.
This workshop will be a combination of lecture and in-class exercise, and will include discussions based on analysis of the scenarios presented in the homework. While the majority of the presentation will be didactic, there will be opportunity for attendees to share their experiences and ask questions throughout the presentation.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
17:00

MCF16
Publication Ethics
Medical Communication - Foundation

Participant Profile

This workshop is intended for all medical and scientific writers who are involved with the preparation of medical publications

Objectives

The purpose of this workshop is to introduce medical and scientific writers to current ethical controversies in biomedical publication and the guidelines that have been developed to help avoid such ethical issues.

Content

The workshop will cover ethical issues that may be encountered when publishing biomedical research. Plagiarism, authorship, ghost writing, prior publication, over- and under-reporting, conflicts of interest and the role of industry, are amongst the topics that will be examined. The guidelines that impact upon medical writing and their practical application will be explored. Participants will discuss recent examples that highlight ethical dilemmas. The two presenters will provide an author and journal perspective.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
17:00

LWA12
Master Class: Taxonomic Analysis of Medical Writing
Language and Writing - Advanced

Participant Profile

Experienced medical writers.

Objectives

To enhance the identification, analysis, and revision of writing distractions.

Content

Do you want to gain insight into your medical writing syntactic distractions—insight that will enhance your syntactic fluency?
If so, the following 3 levels of activities may be for you.
1. Preworkshop: Revise the distractions in a set of 5 sentences and prepare to discuss your reasons for revision.
2. Workshop: From a compilation of all the submitted anonymous revisions, you (along with a workshop partner) will analyse and vote for the clearest and most succinct, then enter a discussion with all registrants and the workshop leader as to the reasons for the selection.
3. Postworkshop: Respond to the workshop-identified distractions in your 5-revised sentences.

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

13:30
to
17:00

MDA1
Literature Reviews for Medical Devices
Medical Devices - Advanced

Participant Profile

This workshop is intended for medical writers who are either interested in working with medical devices or who already work with medical devices and are involved in preparing literature reviews for clinical evaluation reports (CERs). Familiarity with European medical device regulations and the CER writing guideline MEDDEV 2.7/1 rev. 4 is desirable. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.

Objectives

The aim of this workshop is to understand how to write a literature review as part of a CER. Participants will learn how to prepare a literature review to current MEDDEV 2.7/1 rev. 4 requirements.

Content

The workshop will explain the following:
· the role of the literature review in the clinical evaluation of a medical device;
· the scope of the literature review;
· developing literature search strategies for the subject device and state of the art (current knowledge);
· writing the state of the art section;
· screening and appraising the literature for the subject device;
· data extraction;
· analysing and presenting the literature in the CER;
· literature disposition;
· citing references and listing excluded references.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs

15:00
to
15:45

Refreshments available

Content

See the Expert Seminar Series page for further details
17:15
to
18:15

Annual Meeting

Content

Please view Social Programme page for further details

Thursday 9 May

07:00
to
07:30

Easy Morning Yoga Session
Drop-in Session
07:45
to
08:25

Participant Profile

This is one of a series of occasional short seminars begun at the Barcelona conference.

Drop in on this interactive short seminar for a quick ‘English’ fix looking at major and minor issues with the use of English in our context to set you up for the day. Come with questions if you want, but remember we have only 40 minutes. Or send them to me upfront:
alistair.reeves@t-online.de.

Content

Topics today are:
Order of words and ideas in simple sentences
Words that don’t exist in English
‘Following’ and ‘after’, ‘prior to’ and ‘before’
‘We’ in scientific texts
Your questions
08:45
to
12:15

DDF41
Writing a Clinical Study Protocol
Drug Development - Foundation

Participant Profile

This workshop is aimed at new medical writers and experienced writers who are new to writing clinical study protocols. Other relevant workshops are “The Clinical Study Protocol: Content and Structure”, “Basic Concepts of Study Design in Clinical Development” and “Managing the Clinical Study Protocol Writing Process”.

Objectives

The purpose of this workshop is to introduce medical writers to the components and concepts of a protocol, and to provide instruction on protocol writing. On completion of the workshop package, participants should feel confident about how to develop and write a protocol and how to manage the process.

Content

The workshop will explain how to develop a protocol with practical examples and exercises. Participants will be introduced to the role of the study team in protocol writing. An outline will be given of regulations, guidelines, and sources of information. The pre-workshop assignment will be reviewed and used to build up a picture of the study. The influence of the study design on the protocol will be discussed. Development of the protocol synopsis will then be examined in detail, including discussion of study design and the relationship of the protocol with the Case Report Form.

The workshop will then focus on the body of the protocol, i.e. filling in the details, including how to ensure that the study will be conducted as intended. This will be supplemented by the interactive workshop exercises, which are designed to get participants thinking in logical, practical sequence. The last part of the workshop will describe the ‘standard’ and administrative sections, appendices, and the ‘When, Why and How?’ of protocol amendments.

Pre-Workshop Assignment Length: 3:00hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

DDA32a
Writing Development Safety Update Reports
Drug Development - Advanced

Participant Profile

This workshop is aimed at medical writers who would like to obtain knowledge about the Development Safety Update Report (DSUR). Participants should have some experience of collection and analysis of safety data, and an understanding of safety monitoring during clinical trials. Participants without this knowledge or without experience in safety/pharmacovigilance writing should in advance attend the course DDF32.

Objectives

This workshop will provide participants with a comprehensive overview and the knowledge needed to write a DSUR. Starting with the DSUR’s regulatory background, purpose, and goal, the workshop will guide participants through the DSUR requirements, document content, the preparation and writing process.

Content

Since 2011, DSURs are required throughout the ICH region for all marketed drugs or drugs under development for which clinical trials are ongoing. The aim of this workshop is to explain what the DSUR is, when it needs to be written (and when possibly not), which data and information need to be included and how to present them. It also provides guidance on the writing and project management process, taking into account that the DSUR is a document that requires an interdisciplinary and well-organised team effort within challenging timelines. Concise as per guidance, with a clear and logical structure, the DSUR nevertheless has some pitfalls in store that are also discussed in this workshop. To bring life and colour to the theory, all of this is illustrated with examples from the daily practice of preparing, writing, and submitting DSURs.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

MCA3a
Systematic Reviews
Medical Communication - Advanced

Participant Profile

The workshop was developed for medical writers with little or no experience in preparing systematic literature reviews of clinical studies. Participants should have a good understanding of study design in clinical research as well as of analysis and presentation of data from clinical studies.

Objectives

The objective of the workshop is to give an overview of the purpose of systematic reviews of clinical studies and of the methods and processes used to develop these reviews. After the workshop, participants will be familiar with the requirements for publication of systematic reviews and will understand how to evaluate the quality of systematic literature reviews of clinical research.

Content

The workshop will discuss the following topics:
• Purpose of systematic literature reviews of clinical studies
• Definition and characteristics of systematic reviews
• Methods of developing a review
• Writing a publication on a systematic review

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
17:00

LWF13+14
Editing and Proofreading Essentials (Double Workshop)
Language and Writing - Foundation

Participant Profile

The workshop is intended for medical writers who edit or proofread their own work or that of their colleagues. It is not intended for people who specialise in medical editing. Previous attendance at another workshop is not required.

Objectives

This workshop aims to give an overview of editing and proofreading. After completing this workshop, participants should be able to:
• Appreciate how editing and proofreading contribute to document quality
• Identify and correct substantive and technical errors
• Proofread and clearly show changes that need to be made
• Compile style guides and editing checklists

Content

In this workshop, we will:
• Review the need for both editing and proofreading
• Focus on substantive editing: reorganising and editing to ensure that the correct message is delivered effectively and specifications are met
• Discuss how to work effectively with the author
• Focus on technical editing: getting down to the detail, including checking for format and consistency
• Look at proofreading, to give a ‘final polish’
• Consider tools to help the editor

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 4:00hrs

09:00
to
13:00

Getting into Medical Writing

Content

See the Symposium page for full details
10:15
to
11:00

Refreshments available
12:00
to
13:30

Lunch
12:45
to
13:15

Content

Abstracts accepted for poster presentation will be presented by authors in the Ballroom Foyer between 12:45-13:30

Participant Profile

Silver Corporate Partner Session - AstraZeneca

Join us for an educational workshop to explore how the changing oncology landscape and rise of biomarker testing help to address some of the most pressing issues in cancer treatment. This interactive session brings together leading external experts to look at how we can identify opportunities to deliver better patient outcomes based on biomarker information.
13:00
to
13:30

Regulatory Public Disclosure SIG update
Seminar - Not for credit

Content

Come along to the Regulatory Public Disclosure Special Interest Group (RPD SIG) lunchtime session. This will be an opportunity to hear from the RPD SIG members and what they have been doing, to find out what resources are available to support your RPD needs, an opportunity to hear about hot topics and what the SIG is planning over the coming year. The RPD SIG would also  like to hear EMWA member questions and what else members would like from the RPD SIG.
13:30
to
16:30

PTF30a
Basics of Medical Statistics for Medical Writers Part 1
Professional Techniques - Foundation

Participant Profile

This workshop is aimed at medical writers who would like to improve their understanding of statistics. No previous knowledge of statistics is assumed, but a basic familiarity with what clinical trials are (eg experience with writing CSRs or publications of clinical trial results) would be helpful. Please note that this workshop is at a basic level and medical writers who are already experienced and confident in writing about statistical techniques may not benefit from it.

Objectives

To help medical writers to understand the basic principles behind statistical analysis as used in clinical research (both in clinical trials and epidemiological research).

This workshop was first run at the EMWA conference in Warsaw in November 2018. It has the same content, except for a few topics that have been moved to a new, part 2, workshop which will also include some new topics. We plan to run part 2 at the November 2019 conference.

Content

· Types of data
· The normal distribution and other distributions
· Hypothesis testing and P-values
· Estimation and confidence intervals
· Measures of variability: standard deviations and standard errors
· Some common statistical tests
· Parametric and non-parametric tests

The workshop will focus on what medical writers need to know about statistics to be able to present them in reports and publications, and not on mathematical details.

This workshop is aimed at making sure medical writers who are not experienced with using statistics have a good understanding of the basics. The companion workshop "Basics of medical statistics for medical writers part 2" will cover some more advanced concepts.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00-3:00hrs

Participant Profile

This workshop is intended for medical writers who wish to learn more about the global regulatory environment for pharmaceuticals.

Objectives

The purpose of this workshop is to introduce medical writers to the regulatory and cultural underpinnings of differing processes applied to the preparation, submission, review, and approval of regulatory submissions for pharmaceuticals to EU and US licensing authorities. On completion of the workshop, attendees should better understand the way the agencies operate and the requirements (as stated in the regulations and implicit in past practice) for preparing a successful dossier.

Content

There is an internationally agreed format for the presentation of an application dossier for a marketing authorisation for a pharmaceutical product: the Common Technical Document (CTD). It is accepted by all ICH member countries; however, this does not mean that the way in which reviewers approach the assessment is the same or that the processes for submission, review, and approval are identical. In particular, there are significant differences between the way data are summarised and the approach taken by European reviewers compared to that taken by their counterparts in the USA. While some of these differences may ultimately evolve to a state of commonality, others likely never will.
Participants will be introduced to the origins of drug regulations, and will review some of the labyrinthine procedures associated with preparing, filing, and defending a licensing application. Cultural and practice differences and similarities between the EU and the USA will be explored. This workshop does not cover the regulatory requirements for medical devices or vaccines.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
17:00

MDF2
Going from Pharma to Medical Devices
Medical Devices - Foundation

Participant Profile

This workshop is primarily intended for medical writers who have some knowledge of regulatory guidance and are interested in working with medical devices. Prior attendance at the Introduction to Writing for Medical Devices workshop would be helpful but is not essential.

Objectives

The aim of this workshop is to understand the EU regulatory pathways, to become familiar with the documents used for medical devices to see these in the light of those used for pharma, and to identify transferable skills between pharma and medical devices.

Content

The workshop will explain the following:
· Definition of Terms: Pharma vs Medical Devices;
· The EU Regulatory Pathway: Pharma vs Medical Devices;
o Product development steps;
o Regulations and guidelines;
· The Documents: Pharma vs Medical Devices;
· Transferable Skills;
· Case Studies.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

15:00
to
15:45

Refreshments available
17:15
to
18:45

EMWA Editorial Board Meeting
Editorial Board Meeting
17:15
to
19:00

Freelance Business Forum
Discussion Forum
19:00
to
22:00

Social events
Social

Friday 10 May

07:00
to
07:30

Easy Morning Yoga Session
Drop-in Session
07:45
to
08:25

Participant Profile

This is one of a series of occasional short seminars begun at the Barcelona conference.

Drop in on this interactive short seminar for a quick ‘English’ fix looking at major and minor issues with the use of English in our context to set you up for the day. Come with questions if you want, but remember we have only 40 minutes. Or send them to me upfront:
alistair.reeves@t-online.de.

Content

Topics today are:
Misuse of ‘and/or’
‘Which’ or ‘that’?
‘Either/or‘, ‘neither/nor, and ‘nor’’
Colons and capital letters
Your questions

Participant Profile

We are delighted to offer another opportunity for EMWA members to learn from each other.
People who work from home often find that they miss the support of an IT department and office colleagues who can answer a quick question on how to do something, or show them a useful shortcut. Solutions to problems can often be shown quickly compared with the hours that can be spent using internet searches, help lines etc. Useful tips on making the most of software can be demonstrated in a moment. It is also easy for freelancers and other home workers to miss out on new software and Apps that could be very useful tools. So, in the EMWA spirit of sharing what we know, why not come along to this informal session of demonstrations and mini master classes. The precise content will depend on who takes part but will include social media, other Apps that can be particularly useful for medical writers, and ‘work horse’ software such as Word.

Content

The ShowIT ShareIT Rise and Shine session on Friday 4th May at 8 am will include:
·         Perfectic editing software with Anne McDonough
·         Backups-dropbox with Adam Jacobs
·         Adobe Indesign with Mariella Franker
·         Readability software- hemingway app with Somsuvro Basu
·         Illustrator with Gabi Plucinska
08:45
to
11:45

DDF39
An Overview of Healthy Volunteer Studies
Drug Development - Foundation

Participant Profile

This workshop is for medical writers who would like to gain insight into the unique aspects of clinical trials conducted with healthy volunteers rather than patients (such as Phase 1, thorough QT, and bioequivalence studies).

Objectives

Healthy volunteer studies make up a large proportion of studies in most clinical development programmes. Medical writers working on documents for these studies need to understand how they differ from clinical trials in patients. After attending this workshop, the participant will understand the design issues and data collected in healthy volunteer studies.

Content

This workshop will cover the following topics for healthy volunteer studies:
· Key regulatory guidance documents
· Populations studied
· Study designs and objectives
· Types of assessments

Note: Phase I studies in patients will not be covered.

Note: Content in this workshop was previously included in Workshop DDA18. (Medical Writing for Healthy Volunteer Studies)

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 1:00hrs

08:45
to
11:45

MSF3

Participant Profile

Medical writers with basic knowledge of descriptive statistics who want to gain insight into the usefulness of epidemiological principles for medical writing.

Objectives

This workshop is designed for medical writers with little to no experience with epidemiology and its applications in the pharmaceutical business and public health. Participants will be provided with a general overview of relevant applications of epidemiology for medical writers. The scope and relevance of contemporary epidemiology for medical writers will be discussed using examples from clinical medicine, public health and pharmacoepidemiology. In addition, commonly used measures of disease occurrence – incidence and prevalence - and their use in research designs will be reviewed. The class format combines lectures with group exercises.

The main objectives are:
• Provide an overview of the applications of epidemiology in the business of medical writing
• Explain the use, significance and pitfalls of commonly used disease frequency indicators: prevalence and incidence

Content

Three major topics will be covered:
• Scope of contemporary epidemiology for medical writers
• Relevance of contemporary epidemiology for medical writers
• Basic measures of epidemiology for medical writers: prevalence and incidence

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 1:00hrs

08:45
to
11:45

DDF7
Introduction to Pharmacokinetics
Drug Development - Foundation

Participant Profile

This workshop is aimed at medical writers, both new and experienced, who need to understand the basics of pharmacokinetics. Participants will normally have had little if any previous formal instruction in pharmacokinetics, or may not have understood what instruction they have received (or may even have received such instruction before they realised they would need it).

Objectives

The objective of this workshop is to demystify pharmacokinetics for those who are terrified of mathematics. On completing the workshop participants should understand the meanings of some of the key terms and symbols used in pharmacokinetics, have some understanding of what the different terms tell us about the properties of drugs and be able to write competently about basic pharmacokinetics.

Content

Participants will be given straightforward explanations and derivations of the key pharmacokinetic principles and equations. These explanations will be largely conceptual rather than mathematical, with worrisome mathematical terms and techniques explained in simple terms.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
11:45

LWF9
Summarising
Language and Writing - Foundation

Participant Profile

This workshop is intended for medical writers who work mostly on regulatory documents. Participants should have a basic knowledge of the most common regulatory documents (e.g. clinical study reports, protocols, and investigator’s brochures).

Objectives

Medical writers spend most of their time summarising information. The purpose of the workshop is to provide a structured approach to identifying key information so that they can prepare a summary of any regulatory document that meets the needs of the reader and includes appropriate information.

Content

The workshop will start by clarifying what is meant by summarising and the summary documents that we produce. Identifying key messages will be discussed and this will help us to decide what to leave out. Some general guidance will be given on concise writing and on planning the document. The importance of review and revision will be described and discussed, and we will work on reducing the number of words needed to express a point. Workshop exercises will be used to illustrate the points raised and to give participants the opportunity to practise the methods suggested during the workshop.

Pre-Workshop Assignment Length: 0:30hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
11:45

MCF7c
Targeting your Audience
Medical Communication - Foundation

Participant Profile

Anyone who wants to develop their fundamental writing skills by building on the philosophy of writing and the writer’s role in expressing an idea in many ways. Anyone interested in gaining some practical insight into areas of writing (from public relations to regulatory) they may not encounter on a daily basis.

Objectives

The primary goal of writing is to convey information to a target audience. This workshop will explore the fundamental concepts of how a writer can express the same story to vastly varied audiences. The workshop and the post-workshop assignment will introduce, actively explore and exercise the different writing styles commonly used in medical writing, emphasising which style is most effective for each audience, and why. Participants will learn and develop one of the fundamental principles of good writing: recognise who you are writing for and write for them.

Content

The basic philosophy of considering the purpose of a document will be presented and discussed. Real-life examples (good and bad) and hands-on writing with discussion will demonstrate how to use different writing styles in different contexts, from manuscripts to marketing information.

Pre-Workshop Assignment Length: Nonehrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

LWF8
Sharpen Up Your Writing Skills
Language and writing - Foundation

Participant Profile

This workshop will be useful for anyone who wants to make their writing more effective. It will be particularly useful for those who have come into medical writing without receiving any training in writing skills.

Objectives

The objective of the course is to help participants write clear, professional text that communicates effectively with their target audience. We will focus on writing for STM (scientific/technical/medical) audiences and for patients and the general public, but the skills taught are applicable to all types of written communication.

Content

If we do not persuade our audience to start and then continue reading, our effort as writers is wasted. It is also wasted if readers fail to understand the intended message, or if we lose credibility through poor presentation. The workshop looks at the principles of effective writing, and how to use them to achieve your communication goals. Topics covered include:
• Structure and style: the do’s and dont’s of effective writing
• Achieving clarity without ‘dumbing down’
• Common style traps in STM writing
• Writing for patients and the public
• Writing to persuade: make your writing powerful
• Say it concisely: tips for reducing word count
The course contains interactive class exercises, and learning points are illustrated using real examples of good and bad medical writing.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 1:00hrs

08:45
to
12:15

DDF38a

Participant Profile

Regulatory medical writers working in the contract research organisation or pharmaceutical company environment, as either employees or as freelancers, who write or review clinical study reports (CSRs). The workshop will meet the needs of writers and reviewers in interpreting existing International Council for Harmonisation (ICH) guidelines that drive preparation of CSRs, and in ensuring that CSRs are written in accordance with the principles of responsible clinical trial data sharing. Participants must have written at least one CSR or reviewed several, and have working knowledge of International Council for Harmonisation (ICH) reporting guidelines.

Objectives

The current ICH guidance on CSR authoring is ICH E3 (1995) and the 2012 Questions and Answers (Q & A) Revision document. Inconsistencies in interpretation require clarification, and indeed this is recognised specifically for ICH E3 in the 2012 Q & A document. CORE Reference (see http://www.core-reference.org/) launched on 03 May 2016, provides interpretational guidance on CSR authoring that incorporates regional (EU and US) and real-world insights. These include guidance on writing CSRs that share clinical trial data responsibly, and in accordance with current public disclosure requirements. Participants will acquire the knowledge and skills required to author or review fit-for-purpose CSRs that belong in the modern drug development arena.

Content

· Background to CORE Reference· Description of CORE Reference complete web-based resource
· Common inconsistencies in ICH guideline interpretation and how CORE Reference addresses these issues
· Background to transparency and public disclosure requirements
· How CORE Reference deals with the challenges of responsible clinical trial data sharing.

Pre-Workshop Assignment Length: 3:00hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

DDA30
Addressing Safety in Clinical Study Protocols
Drug Development - Advanced

Participant Profile

This workshop is for medical writers who would like to learn more about how to address safety sections in the clinical study protocols conducted with healthy volunteers as well as patients (including bioequivalence studies in healthy volunteers and efficacy/safety studies in patients). Participants should have basic knowledge of the clinical study protocol content and structure and a basic understanding of clinical development process for drugs and biologics. Participants who do not have this knowledge should first take Workshop DDF12 “The Clinical Study Protocol: content and structure”.

Objectives

Study protocols of certain drugs, whether in healthy volunteers or in patients, demand critical discussion of safety aspects. Participants should become confident in drafting the relevant sections of study protocols for such drugs and biologics.

Content

This workshop will cover preparation of the safety section of protocols in: •phase I, II, III and IV clinical trials for new drugs •bioequivalence studies in healthy volunteers for long acting release drugs and narrow therapeutic index drugs •pharmacokinetic studies in patients for cytotoxic drugs and anti-psychotic drugs •PK/PD and clinical studies for liposomal drug products, peptides and biologics.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

DDA10a

Participant Profile

Medical writers with a working knowledge of clinical drug development and some insight into CMC and nonclinical development. Experience writing IBs or IMPDs would be relevant.

Objectives

The workshop will familiarise participants with the EMA’s guidance on the Paediatric Investigation Plan (PIP) Application, providing a foundation that will be helpful for writing PIPs.

Content

The PIP is an EMA requirement designed to encourage and regulate the specific development of medicinal products for use in children. The main elements of the workshop will be:
• Background information on the challenges associated with conducting paediatric development programmes and the need for specific regulation
• Objectives of the EMA regulation
• Overview of the format and content of the documentation required for the PIP application.

The workshop will include a discussion of hands-on experience with preparing PIP applications, illustrating some of the logistical challenges involved in obtaining the information needed from teams that often have little or no previous experience with this type of document. Participants will be encouraged to share any experience they may have had with organising or writing PIPs.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 2:00hrs

Participant Profile

This workshop is for medical writers who want to engage in the writing of lay summaries of study results as mandated by the EU regulation. Participants should already have an understanding of CSR structure (ICH E3) and should know the basics of clinical research (trial design, efficacy and safety analysis, basic statistics).

Objectives

Writing lay summaries is a difficult and challenging task. Medical writers with an interest in lay writing are well suited for this new and upcoming activity. However, the provision of lay summaries requires a lot more than good lay language writing. The workshop will introduce the many different aspects of providing lay summaries: the available regulatory guidance, the positions of various stake holders (pharma and patient organisations), the intricacies of the actual writing of lay summaries, and considerations for appropriate distribution of the lay summaries.

Content

The workshop will introduce the requirements for lay language summaries of study results according to the EU regulation. The various guidance documents from stakeholders (HRA, TransCelerate, MRCT, European Commission) will be reviewed, appraised, and discussed. The content requirements for lay summary will be presented and possible solutions will be discussed. As lay language writing is difficult and complex, only the basic principles of plain language writing will be covered. To appreciate the complexity of lay language writing in a confined context, the workshop will have a practical exercise as participants will be asked to write a short paragraph of a lay summary. In addition the various distribution options for lay summaries and the issue of translations will be discussed.

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 3:00hrs

Content

See the Expert Seminar Series page for further details
09:00
to
17:00

Executive Committee Meeting
Committee Meeting
10:15
to
11:00

Refreshments available
12:00
to
13:30

Lunch

Content

This is a brief guide on the essential concepts, main processes, and the latest important updates affecting Clinical Trial Disclosure and Transparency. The presentation is meant for those who need a quick clarification or reassurance about this topic as well as those who are vaguely aware but not sure about the current status.
For most clinical trials, several documents that are prepared by
medical writers, data managers, and statisticians are now required to be disclosed in public databases and repositories. Such documents include the clinical trial protocol (and all of its amendments), statistical analysis plan (and all of its amendments), along with the summary results that is based on the clinical trial report. Thus, for these stakeholders it is essential to be well informed and up-to-date about the impact that these documents carry through the mandatory and legally-binding public disclosure and transparency activities.
The following topics will be covered:
·
Interrelations between the legal requirements in the EU/EEA, based on the
Regulation EU 536/2014 (and the obligation to prepare a Plain Language Summary for each clinical trial), EMA Policy 0070, EMA Policy 0043.
· Requirements for the disclosure of information for
applicable clinical trials, as defined by the USA law FDAAA 801/Final Rule.
· Status of the
ICMJE requirements: Data Sharing Statements, for published papers based on results from clinical trials and Data Sharing Plan, for newly registered clinical trials in the public databases.
·
Trial trackers, to illustrate the ease with which disclosure compliance can be monitored and measured (…by the public, health authorities, investigative journalists, patient lobby groups).
·
Future requirements for disclosure and transparency, their impact, and how standardization of all documents relevant to a clinical trial could be established.
13:30
to
16:30

PTF4

Participant Profile

The workshop is aimed towards medical writers at all levels of experience, and whether working in a freelance capacity, or within a CRO environment, or for a pharmaceutical company. It will be an ideal forum for those who either have no quality control (QC) system in place, or are looking to develop one, whilst those with experience of working with, or implementing QC systems will be able to explore and share best practice. It is not necessary to have attended any other workshops.

Objectives

For a medical writer the correct application of a QC process minimises errors in the factual presentation of data, rectifies spelling mistakes and ensures accurate document structure. At the end of the workshop, participants should have an understanding of why it is important to have a QC procedure in place for written documents including clinical study reports, when in the writing process QC should be implemented, and how to document the results.

Content

The importance of QC in medical writing will be covered. The consequences of not implementing and following a QC process will be discussed. QC requirements, who should perform the task, and how to carry it out will all be addressed. The workshop is designed to both inform and share experiences; therefore interaction of participants will be actively encouraged. Although the workshop is applicable to other types of medical writing it will primarily use clinical study reports as working examples.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
16:30

MCF12
Grant Writing
Medical Communication - Foundation

Participant Profile

Researchers who wish to improve the likelihood of getting funds by increasing the quality of their grant applications, and medical writers who would like to assist researchers in writing and improving such applications.

Objectives

To increase understanding of grant-provider expectations and priorities, and learn how to translate ideas into strictly defined quantifiable projects.

Content

Competition for research funding is increasing, and well-written grant applications can open or close doors for research careers. An important workshop topic is matching research ideas with funders’ objectives. For EU applications equal emphasis is placed on a project’s scientific and technical quality, possibility of implementation and expected impact. Being most interested in the science, researchers tend to underestimate the importance of the last two points, which constitute two thirds of the evaluation criteria. The workshop will address these issues.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
16:30

MCF3
Creating an Impact with Posters
Medical Communication - Foundation

Participant Profile

This workshop is aimed at writers who already write posters, and would like to make their posters more interesting or those individuals who want to learn how to approach poster writing.

Objectives

• To discuss practical ways of improving poster writing
• To suggest ways of improving poster appearance

Content

The workshop will consider both good and bad posters from a content and layout viewpoint. The exercise will allow participants to convert a bad poster into an effective one.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs

13:30
to
16:30

DDF32b
Introduction to Pharmacovigilance Writing
Drug Development - Foundation

Participant Profile

Writers who want to better understand the different types of pharmacovigilance (PV) documents, when and why they are needed and how they interact with each other. It is recommended that this workshop is completed before attending the advanced workshops for writing Risk Management Plans (RMP), Development Safety Update Reports (DSUR), and Periodic Benefit-Risk Evaluation Reports (PBRER).

Objectives

After completing this workshop, participants will have basic understanding of the different PV documents required by the regulatory authorities both prior to marketing and post-marketing. They will understand the purpose of the documents, when they are required, how they interact and overlap with each other and what guidance is available to help in preparation of them. In addition, they will be introduced to the difference of the safety data collected in clinical trials and post-marketing.

Content

In depth document content and format is covered in other document-specific workshops. This workshop will provide a basic overview of RMP, DSUR and PBRER, and explain the standard terms and definitions routinely used in PV documents. It will discuss overlaps and links between these documents, available guidance, when and why the documents are needed, who uses them, and what the roles medical writers in clinical development and PV have in developing the documents.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

13:30
to
16:45

Expert Seminar Series Session 5
Expert Seminar Series

Content

See the Expert Seminar Series page for further details

Participant Profile

This workshop is at an advanced level, but is accessible to all medical writers interested in the journal article.

Objectives

This workshop is designed to enhance understanding the writing distractions pertinent to conceptual components of the journal article. The distractions are syntactic (structure, order, number, grammar, punctuation, paragraph) of words, phrases, and clauses.

Content

Do you want to gain insight into your medical writing distractions that are specific for the conceptual components of the journal article? If so, the following 3-levels of activities may be for you.
(1) Pre-workshop: Revise the distractions in a set of 5 sentences specific for a conceptual component (e.g., research problem in the Introduction section). Be prepared to discuss the justification for each revision.
(2) Workshop: From a compilation of all the submitted revisions, you (along with a workshop partner) will analyse and vote for the clearest, and then enter a discussion with all registrants as to their decisions. The workshop leader will then justify his decision in terms of an analysis of syntactic distractions for all the revisions. The vote tally monitor will then reveal the votes about which more discussion will be open.
(3) Post-workshop: You will comment on the distractions that may have surfaced in your revisions.
The workshop is a complement to LWA12
Taxonomic Analysis of Medical Writing

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

13:30
to
17:00

DDF35
Introduction to Writing about Efficacy
Drug Development - Foundation

Participant Profile

This workshop is aimed at medical writers with little or no experience of writing about efficacy in clinical and regulatory documents. Basic knowledge of the clinical development process is expected.

Objectives

The workshop aims to give participants a basic understanding of the general principles by which efficacy is evaluated in clinical trials. Participants will gain a broad awareness of the different kinds of efficacy endpoints and statistical analyses they are likely to encounter. The focus is not on detailed statistical theory, but on practical approaches to understanding efficacy analyses and reporting their results in a clinical study report, regardless of clinical indication. The workshop includes exercises designed to give participants hands-on practice at using statistical analysis plans to understand and describe efficacy analyses, and at interpreting data tables for efficacy. After completing the workshop, participants should be better equipped to write the efficacy sections of clinical documents.

Content

The workshop will cover: Introduction to efficacy • How is efficacy evaluated? The relationship between study objectives, endpoints, and assessments • How are efficacy endpoints chosen? • Different categories of efficacy endpoint and associated data • How are efficacy endpoints analyzed? • Writing efficacy methodology sections • Reporting efficacy results

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 2:30hrs

13:30
to
17:00

DDA29

Participant Profile

This workshop addresses writers dealing with or interested in documents for non-interventional (observational) studies for epidemiology, real life safety and efficacy, health economics, and quality of life. This is a development of the DDA 9 workshop with an emphasis on the new opportunities to design studies using existing clinical databases. Participants should have at least 2 years of medical writing experience with study related documents (e.g. protocol, CSR, scientific publication).

Objectives

This workshop provides you with the definition of non-interventional studies, how they differ from randomized controlled clinical trials (RCT) and what is the regulatory background for these differences. The diversity of types of non-interventional studies will be explained, with special emphasis on recent study designs using existing clinical databases instead of study specific databases. It will be explained how documents for non-interventional studies are prepared by medical writers (in particular protocols and study reports), in particular how writing will differ from RCTs.

Content

What is non-interventional research. Definition of non-interventional studies. Scientific Goals of Non-Interventional Studies. Different Designs of Non-interventional Studies. Use of Databases in Non-interventional Studies. Are Non-Interventional Studies Scientifically Valid? Documents for Non-interventional Studies, similarities and differences to RCT documents (SAP, Protocols, ICF, Reports, Publications, Transparency Reporting). Specific ways to describe Non-interventional Study design and study results. Differences in discussion and interpretation of the data compared to RCTs.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: hrs

Participant Profile

The course is intended for medical writers with little or no experience of writing clinical submission dossiers although participants should be familiar with the clinical development process and have had some experience of writing clinical study reports.

Objectives

• To introduce participants to the preparation of clinical submission dossiers according to the CTD
• To convey general principles and process of summary writing
• To facilitate understanding of the limits of the available regulatory guidance

Content

• Development and background of the CTD
• Purpose and types of clinical summary documents
• CTD Module 2.5 (Clinical Overview)
• CTD Module 2.7 (Clinical Summary)
• Integrated summaries of efficacy and safety for the USA

Pre-Workshop Assignment Length: 4:00hrs

Post-Workshop Assignment Length: 4:00hrs

13:30
to
17:00

MCF17a
Using Writing Guidelines
Medical Communication - Foundation

Participant Profile

As professional medical writers should be reporting guideline champions, this workshop is propaedeutic for any workshops on scientific journals or congresses publishing.

Objectives

The growing availability of guidelines and checklists makes identification and use of the most appropriate guideline for any specific disclosure more difficult. This workshop will help the writer to identify what is available and understand how to choose and use the most appropriate guidelines for their purpose.

Content

The Consolidated Standards of Reporting Trials (CONSORT) statement, issued in 2001, was the first example of a comprehensive and structured guideline on how to communicate the results of randomised clinical trials. In addition, different guidelines and checklists to use for the results of observational, health outcome, quality of life, mixed-method, and many other types of studies have been published. To complement all of these, pharmaceutical companies have developed Good Publication Practice, individual editors have developed their own guidelines, and most journals have their own instructions for authors. In this workshop, we will review the main guidelines to identify when and how they can be used by medical writers to improve the productivity and quality of their job.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

Content

This is your chance to meet the EMWA Professional Development Committee (EPDC). We will be holding an open session where you can find out what is involved in leading a workshop or webinar and talk to us about the education programme. This will be followed by a session for current workshop leaders.
15:00
to
15:45

Refreshments available
17:15
to
18:15

Content

(formerly called Working in and on Your Business)
This seminar is free-of-charge and is primarily for freelance medical writers who have to juggle client demands with those of their business. Many freelancers struggle to find time to manage their personal and business needs whilst meeting client demands and deadlines. This seminar will introduce and explore the concepts of working ‘on your business’ as well as ‘in your business’, describing processes, systems and practices which may be implemented to help freelancers manage their business more efficiently while managing their clients more effectively.
19:00
to
22:00

Social events
Social

Saturday 11 May

08:30
to
12:45

EPDC Meeting
Committee Meeting

Participant Profile

EPDC Committee Members only.

Participant Profile

Mindfulness is a way of paying attention, on purpose and non-judgementally, to what goes on in the present moment in our bodies, our minds, and in the world around us. Mindfulness-Based Stress Reduction (MBSR) is the largest and best-known stress reduction programme in the world which has been embraced by many large corporations and educational institutions. MBSR is recommended by the National Institute for Health and Clinical Excellence in the UK and has been shown to be effective treatment for a wide range of medical disorders, as well as improving quality of life in healthy individuals. Recent studies have shown that taking time to do mindfulness meditation at work can improve concentration and productivity.

There are many techniques that can help us to learn to be mindful. These include ‘meditating’ (i.e. focusing) on the breath, our body, or on any activity that we are doing. We will practice a few simple techniques during the seminar so that participants can experience how it feels to be mindful.

We will encourage the participants to share their experiences, challenges, and stresses of working as medical writers. We will then investigate how mindfulness techniques could help in these situations so that work becomes more enjoyable even when deadlines are looming.

Numerous clinical trials have been performed on the effects of mindfulness in healthy volunteers and on various diseases. The seminar will include an up-to-date literature review of the scientific evidence for the positive effects of mindfulness on our physical and mental health.
08:45
to
11:45

PTF19
An Introduction to Marketing for Medical Writers
Professional Techniques - Foundation

Participant Profile

Anyone who wants to gain a better understanding of the basic concepts and theories of marketing.

Objectives

Participants will gain insights into how pervasive and persuasive marketing is, and how attention to detail can help them to improve both their own and their firm’s image. By demystifying marketing, workshop participants can both identify and implement simple techniques in many elements of their daily work. Participants will have to bring their own marketing examples to the workshop for discussion. This thought-provoking workshop will lead you to view the process of marketing in a new light. (Please note that the main workshop focus is on general marketing theories and real-life examples drawn from different industries).

Content

Topics covered include the marketing concept, the marketing mix, buyer behaviour, the promotional mix, and strategic analysis. The workshop includes a mixture of lecturing, real-life examples, group activities and discussion.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
11:45

DDF2a
The Investigator’s Brochure
Drug Development - Foundation

Participant Profile

Medical writers with at least 1 year of experience in the pharmaceutical industry.

Objectives

• Learn what the ICH and regulatory guidelines say about the Investigator’s Brochure (IB)
• Learn useful tools and advice for the actual writing, compiling, and managing of an IB project
• Experience the dynamics of team writing and editing as it pertains to an IB

Content

The IB is definitely the poor cousin in the pharmaceutical industry document family, as it rarely gets the resources and time required to do it properly. It can also be the bane of the freelancer’s life, as ‘quick update’ projects often turn out to involve excruciating re-formatting and consistency checks. In the first part of the course, participants will learn the ‘theory’ of IB writing, i.e. what the ICH and regulatory guidelines say, as well as tools to be used in successful IB writing gleaned from the extensive experience of the workshop leader. In the second part of the course, participants will work in teams to prepare a mini-brochure based on actual data and compare their results to those of the other teams.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
11:45

PTF13
Critical Appraisal of Medical Literature
Professional Techniques - Foundation

Participant Profile

This workshop will be of use to all medical writers who need to read published medical papers and interpret their findings. Participants should have a basic grasp of trial design (parallel groups, crossovers, etc.) and recognition of (but not necessarily practical experience of using) common statistical tests (e.g. chi-squared, t-test).

Objectives

After attending this workshop, participants should be able to assess the strengths and weaknesses of papers they read in the medical literature and be able to judge whether the published conclusions of the paper are valid.

Content

The workshop will explain what to look for when reading published papers, with emphasis on assessing strengths and weaknesses of the research described. This will include considerations of study design, sources of potential bias, use of appropriate statistical methods, choice of endpoints, and generalisability. The workshop will include practical exercises in critiquing papers in a group discussion format.

Pre-Workshop Assignment Length: 2:00hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

MSF12

Participant Profile

Experienced regulatory writers with little or no experience of the clinical development of antibiotics.

Objectives

Provide an introduction to bacterial infections and their development so that the regulatory writer feels confident in discussing the development of documents.

Content

Starting work in a new therapeutic area is always a challenge but several factors make infection/antibiotics particularly difficult. This interactive workshop aims to demystify some of the daunting complexities that regulatory medical writers will encounter when starting out in this fascinating field. As background, the workshop will cover nomenclature and classifications, the incidence of common bacterial diseases, modes of action for common drug classes and the main mechanisms of bacterial resistance. After covering these basics, attendees will explore the practicalities of measuring resistance and then look at the key considerations for study design, conduct and reporting. Throughout, the emphasis will be on equipping the regulatory medical writer with the knowledge needed to contribute meaningfully to the development of clinical study documents.

Pre-Workshop Assignment Length: 1:30hrs

Post-Workshop Assignment Length: 0:30hrs

Participant Profile

This workshop is intended for all medical writers, both native English speakers and those for whom English is a second language, who edit the work of authors who are not native speakers of English. The workshop will be of interest both to those who edit occasionally for colleagues as well as people who edit extensively.

Objectives

Editing the work of others is a common component of medical writing. This activity can be especially challenging if the original author was not a native speaker of English and problems of poor writing skills are compounded by lack of fluency in the language. This workshop will give medical writers training and feedback in this sensitive task.

Content

This workshop will take the form of a master class. The workshop leader sees herself primarily as a facilitator and guide in achieving results. That is to say there will be almost no lecture content. Based on examples provided by the workshop leader, participants will work together in small groups to improve a text after which feedback will be provided all together. This workshop demands team work and your active participation. Obviously, therefore, it is necessary that you yourself are a confident speaker of English. Depending on availability it is hoped that other experienced editors will join the class as facilitators. At the end there will be a discussion session on providing feedback to the original author. The emphasis will be on generating texts that communicate clearly rather than reviewing grammar rules.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 2:00hrs

08:45
to
12:15

MSF7
Fundamentals of Immunology
Medical Science - Foundation

Participant Profile

This workshop is intended for medical writers with little or no background in immunology or those who are interested in refreshing their knowledge on the basic principles of immunology

Objectives

The purpose of this workshop is to introduce medical writers (irrespective of their area of specialisation or the nature of documents they work on) to the basic principles of immunology. The ultimate aim of the workshop is to enable medical writers to better understand fundamental immunological concepts which in turn helps to better interpret the meaning of the results of clinical trials.

Content

The workshop will cover the following aspects: structure and functioning of the immune system, types of immunity and interactions, and immune system related disorders.

Based on the preworkshop assignment, two different group activities will take place to co-create a glossary of specific terminology/concepts in immunology.

Pre-Workshop Assignment Length: 1:00hrs

Post-Workshop Assignment Length: 3:00hrs

08:45
to
12:15

DDA24a
Clinical Study Reports in Oncology
Drug Development - Advanced

Participant Profile

This workshop is intended for medical writers who have already some experience in the writing of clinical study reports (CSRs) but no experience in oncology. Participants should have a general understanding of clinical study designs, of the guidance provided by ICH E3, and should be familiar with statistics, in particular with time-to-event analysis.

Objectives

This workshop aims to provide a systematic overview of what is different about oncology CSRs. Having attended the workshop, Medical Writers should have an understanding of key oncology concepts and should be able to apply these to the writing of the different report sections.

Content

The workshop will introduce key oncology concepts and will outline how these concepts inform the writing of the CSR. We will go through the report sections (following ICH E3). Topics discussed along the way will include:
- Patients with cancer: diagnosis, treatment modalities, disease progression
- Clinical studies in oncology: study design; interim vs. final analysis; trial committees (Data Monitoring Committee, Central Independent Review)
- Drugs in oncology: principles of dose finding, treatment schedules, dose reduction / escalation, management of side effects
- Efficacy: assessment of tumour response – RECIST; central independent review vs. investigator assessment of tumour imaging; time-dependent endpoints, especially progression-free survival, time to progression, overall survival; importance of censoring rules
- Safety: CTCAE grading system, Dose Limiting Toxicities and Maximum Tolerated Dose, MedDRA and Standard MedDRA Query, the concept of "adverse events of special interest"

Pre-Workshop Assignment Length: 2:30hrs

Post-Workshop Assignment Length: 3:00hrs

09:00
to
12:00

Introduction to Medical Writing
Seminar - Not for credit

Participant Profile

This seminar is provided free-of-charge and is aimed at those considering a career in medical writing. It is open to conference delegates and members of the general public. It will also be interesting to those who have recently joined the profession who would like to know more.

Content

In addition to giving a presentation covering all aspects of medical writing, the seminar leader will act as a facilitator to optimise exchange of experience between participants, as well as providing insight based on her expertise in this area.

The aim is to provide information on the following:

• Definition of medical writing and its different categories
• Role of the medical writer throughout the life-cycle of a pharmaceutical product
• Explanation of the different types of documents that we write with detailed information on some of the most common (e.g. clinical study protocols and reports, investigator brochures, CTDs, manuscripts, posters)
• Timelines and project management
• Finding a job as a medical writer (qualities and qualifications required), types of companies that employ medical writers, recruitment process, working as a freelancer
• Training and networking for medical writers

Members of the public who wish to attend the seminar should approach the EMWA Staff at the Conference registration desk who will issue them with a temporary badge and direct them to the seminar room.
10:15
to
11:00

Refreshments available
12:00
to
13:30

Lunch
13:30
to
13:30

Content

The conference closes at 13:30 on Saturday 11 November