As a Senior Consultant and Vice-President at confinis, Mr. Viky Verna currently assists medical device and pharmaceutical companies with regulatory affairs challenges. His qualifications are firstly supported by his education; specifically, a BS and a MS in Biomedical Engineering from the University of Miami, a MS in Pharmacy and a Drug Regulatory Affairs Certificate from the University of Florida, and a Global Regulatory Affairs Certification (RAC) from Regulatory Affairs Professional Society (RAPS). Mr. Verna’s experience with Combination Products started at the US Food and Drug Administration (FDA) as an investigator. Later, at the Center for Devices and Radiological Health (CDRH) of the FDA, Mr. Verna held several positions including (Acting) Branch Chief of the Respiratory, ENT, General Hospital, and Ophthalmic (REGO) devices branch which handles the compliance activities of combination products among others, including drug delivery systems. During his time at CDRH, he also served as:
- a Subject Mater Expert (SME) reviewer in the quality system working group of the Office of Compliance, where he generated and reviewed the regulatory case reports (establishment inspection report review memos) for regulatory decisions and legal compliance actions; and,
- a combination product branch lead of the REGO branch. In this position, his responsibilities included training and reviewing the work of the team, as well as developing reviewing processes and techniques to be used by the office.
After joining confinis, Mr. Verna has helped several companies of all sizes successfully comprehend, navigate around, and comply with the US regulatory requirements for medical devices and combination products including those involving drug delivery systems. By being an expert member of the ISO technical committee (TC 84), Mr. Verna has also been leveraging his expertise and experience to help develop international standards for injection and respiratory products, infusion pumps, needles, catheters, and the likes.