An update on regulatory public disclosure - news, initiatives, and changes to regulations - Christopher Marshallsay
3:45 PM - 4:20 PM
Regulatory public disclosure (RPD) is a rapidly evolving discipline. Key areas include the pending “go live” of the EU Clinical Trial Regulation; the May 2018 implementation of the EU General Data Protection Regulation; and ongoing discussion of the EMA policy 0070 requirements.
This ESS update on RPD will summarise changes to the relevant regulations and will share recent relevant news. Updates will be provided about various initiatives, including the EU and US initiatives to enforce clinical trial registration and results reporting in web-based registries; the Health Canada data transparency initiative; various data transparency monitoring initiatives; and the impact of Brexit on public disclosure.