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 Kimberly Benton, PhD, CBER Ilisa Bernstein, CDER Monica Caphart, ORA David Cummings, CDER Gerald Dal Pan, CDER Bernadette Dunham, D.V.M, PhD, CVM Carl Fischer, CDRH Richard Friedman, CDER Martine Hartogensis, CVM Mai Huynh, CVM Robert Iser, CDER Valerie Jensen, R. Ph, CDER Steve Kozlowski, MD, CDER | Rapti Madurawe, PhD, CDER Mary Malarkey, CBER Karen Midthun, PhD, CBER Ann Marie Montemurro, ORA Alicia Mozzachio, CDER Laurie Norwood, CBER Thomas O’Connor, PhD, CDER Mahesh Ramanadham, CDER Carol Rehkopf, CBER Steven Silverman, CDRH Steven Solomon, ORA Douglas Stearn, ORA Janet Woodcock, MD, CDER |
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The Parenteral Drug Association (PDA) is the leading global provider of science, technology and regulatory information and education for the pharmaceutical and biopharmaceutical community. Founded in 1946 as a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 9,500 members worldwide. Go to http://www.pda.org/footer/about-pda to learn more.
Media Inquiries: Walt Morris, 301-656-5900, x. 148; morris@pda.org
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SOURCE Parenteral Drug Association
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