Viky Verna
the University of Miami, USA
Biography
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 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
Abstract
Abstract : Combination Products – Global Regulatory Landscape