CDER Director Woodcock, 27 U.S. FDA Speakers Confirmed for 2014 PDA/FDA Joint Regulatory Conference
BETHESDA, Md., June 18, 2014 /PRNewswire-USNewswire/ — The Parenteral Drug Association has confirmed the participation of 27 officials from the U.S. FDA, including CDER Director Janet Woodcock, MD, as speakers at the 2014 PDA/FDA Joint Regulatory Conference. Besides the Office for Drug Evaluation and Research (CDER), the FDA Centers for Biologics Evaluation and Research (CBER), Devices and Radiological Health (CDRH), and Veterinary Medicine (CVM), along with the Office of Regulatory Affairs (ORA), will be represented on the podium during the conference.
“PDA membership works in a wide range of industries, so it is important they hear the viewpoints from officials in the various centers,” said PDA President Richard Johnson. “It is also critical that our members understand the latest Agency initiatives in order to be able to perform effectively for their companies, and have the opportunity to interact with key regulators to ask questions and understand the background and various perspectives.”
The following is a list of the confirmed FDA speakers, alphabetically listed with their center/office indicated:
Jeffrey Baker, CDER Rapti Madurawe, PhD, CDER Kimberly Benton, PhD, CBER Mary Malarkey, CBER Ilisa Bernstein, CDER Karen Midthun, PhD, CBER Monica Caphart, ORA Ann Marie Montemurro, ORA David Cummings, CDER Alicia Mozzachio, CDER Gerald Dal Pan, CDER Laurie Norwood, CBER Bernadette Dunham, D.V.M, PhD, CVM Thomas O'Connor, PhD, CDER Carl Fischer, CDRH Mahesh Ramanadham, CDER Richard Friedman, CDER Carol Rehkopf, CBER Martine Hartogensis, CVM Steven Silverman, CDRH Mai Huynh, CVM Steven Solomon, ORA Robert Iser, CDER Douglas Stearn, ORA Valerie Jensen, R. Ph, CDER Janet Woodcock, MD, CDER Steve Kozlowski, MD, CDER
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SOURCE Parenteral Drug Association