Bethesda, Md., February 8, 2017 – The Parenteral Drug Association (PDA) today announced that five U.S. FDA experts are confirmed speakers at the 2017 PDA Pharmaceutical Quality Metrics and Culture Conference at the Bethesda North Marriott & Conference Center, Feb. 21-22.
The five speakers are:
- Tara Gooen Bizjak, Senior Science Policy Advisor for Pharmaceutical Quality, CDER, FDA
- Seyoum Senay, MS, Lead Informatics Platform - EDM, OBI, FDA
- Jeffrey C. Baker, PhD, Deputy Director, Office of Biotechnology Products, CDER, FDA
- Mary Malarkey, Director, CBER, FDA
- William MacFarland, MS, MBA, Supervisory Biomedical Engineer, FDA
PDA is working with FDA to confirm the participation of several other CDER officials and with the UK’s Medicines and Healthcare Products Regulatory Agency to confirm one of their officials. The conference also will have broad industry and academia participation, including speakers from Amgen, Johnson and Johnson, Sanofi Pasteur, Hovione, the University of St. Gallen, and many others.
The meeting is the first chance for industry representatives to hear from and interact with FDA officials following the Agency’s publication of a revised draft of Submission of Quality Metrics Data Guidance for Industry. Public comments on the document were originally due in January, but FDA recently announced an extension of the public commenting period to March 27. The extension of the commenting period signals FDA's desire for as much inclusive feedback as possible, and its participation in this meeting is perfectly timed for receiving that input and having a direct dialog on the draft.
Members of the press can request passes using the online Press Pass Request Form.