Viky Verna, MS, RAC Confinis AG

As a Senior Consultant at confinis ag, 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 in 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 such as syringes. During his time at CDRH, he also served as a: A 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, A combination product branch lead of the REGO branch. 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 understand, navigate around, and comply with the US regulatory requirements for combination products and medical devices including drug delivery systems. By being an expert member of the ISO technical committee, Mr. Verna has also been leveraging his expertise and experience to help develop international standards for injection and respiratory products, infusion pumps, needles and catheters.