Bethesda, Md., July, 16 2014 – The Parenteral Drug Association (PDA) has confirmed FDA’s Stephen Ostroff, M.D., Acting Chief Scientist in the Office of the Commissioner will present “FDA’s Views on Scientific Advances and their Impact on Manufacturing of the Future” on September 8, 2014 in at the opening plenary session of the 2014 PDA/FDA Joint Regulatory Conference in Washington, DC at the Renaissance Hotel. The Conference dates are September 8-10, 2014, and the theme is “Connecting Regulatory, Quality, Science & Compliance: Assuring Customer-Focused Outcomes throughout the Product Lifecycle”
“Participation of the Agency’s Chief Scientist in a session on the future of manufacturing shows that the PDA/FDA Joint Regulatory Conference offers a wider range of information beyond just regulatory information,” said PDA President Richard Johnson. “The agenda includes many presentations that are science and technology oriented, with a slant towards the Agency’s regulatory role and activities in the various product areas.”
Ostroff is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership and support for FDA’s regulatory science and innovation initiatives.
These initiatives include the Advancing Regulatory Science Initiative, the Critical Path Initiative, scientific professional development, scientific integrity, and the Medical Countermeasure initiative (MCMi).
Ostroff joined FDA in 2013 as Chief Medical Officer in the Center for Food Safety and Applied Nutrition and Senior Public Health Advisor to FDA’s Office of Foods and Veterinary Medicine. Prior to that he served as Deputy Director of National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC), where he was also Acting Director of CDC’s Select Agent Program. He retired from the Commissioned Corps of the U.S. Public Health Service at the rank of Rear Admiral (Assistant Surgeon General).
Ostroff joins 27 other confirmed FDA officials speaking at the conference, including Center for Drug Evaluation and Research Director Janet Woodcock, M.D.
Dr. Janet Woodcock is confirmed to provide remarks addressing “The Cost of Poor Quality” on Tuesday, September 9, 2014
Allergy Laboratories’ Susan Schniepp and FDA/Office of Regulatory Affair’s (ORA) Monica Caphart are co-chairing this event. Other confirmed senior FDA officials include: CBER’s Dr. Karen Midthun and Mary Malarkey; CVM’s Dr. Bernadette Dunham and Dr. Martine Hartogensis; CDER’s Ilisa Bernstein; CDRH’s Steve Silverman; ORA’s Dr. Steven Solomon and Douglas Stearn as well as a host of senior staff scientists and pharmaceutical manufacturing scientists.
To review the entire program and register, please see: http://www.pda.org/2014pdafda.
The Conference is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.