Pharmaceutical Quality and Continuous Improvement during a Drug Product’s Lifecycle – A Regulatory Perspective from FDA/CDER’s Office of Pharmaceutical Quality (OPQ)
Susan Rosencrance, Ph.D. (Director, FDA/CDER/OPQ/OLDP)
This presentation will provide an overview of FDA/CDER’s Office of Pharmaceutical Quality (OPQ) and its role in assuring quality medicines are available to the American public. There will be a discussion on how the Office of Pharmaceutical Quality provides opportunities for building and using an integrated knowledge base that allows for quick informed regulatory decisions during all stages of a product’s lifecycle. The presentation will emphasize how good lifecycle management with effective leveraging of the knowledge base streamlines the assessment of post-approval changes, enhances regulatory flexibility and promotes continuous improvement.
Date and Location
Thurs Sept 14th, 2017
Registration: 5:30 PM
About the speaker
Dr. Susan Rosencrance currently serves as the Director for the Office of Lifecycle Drug Products in the Office of Pharmaceutical Quality (OPQ). In this capacity, she directs procedures and processes for evaluating and assessing drug product quality during the lifecycle of both brand name and generic drug products. Prior to joining the FDA, Susan worked at Merck & Co.'s R&D Laboratories in Rahway, New Jersey. She joined the Office of Generic Drugs (OGD) in 1991 and spent the majority of her tenure in CDER working on generic drug products. She held various roles within OGD including senior chemistry reviewer, team leader, deputy division director, and OGD Deputy Director for Chemistry. Susan also served as the Deputy Director for Generic Drug Chemistry in the Office of Pharmaceutical Science prior to the formation of OPQ. Susan holds a Ph.D. in Chemistry from American University and completed her dissertation research at the NIH Laboratory of Biophysical Chemistry conducting a molecular dynamics study on hydrophobic interactions in alpha-helical coiled coils found in proteins. She received her bachelor’s degree in Biochemistry from Hood College and also completed studies at the University of Strasbourg in Strasbourg, France in the Institute Internationale D’Etudes Française – Université Louis-Pasteur.
Registered and paid online: $50.00
Between-positions, Retirees & Students (WITH ADVANCE REGISTRATION ONLY): $45.00
ADVANCE REGISTRATION WILL END AT 5:00 PM ON TUESDAY SEPT 12th; AFTER THAT YOU MUST PAY AT THE DOOR.