2009 PDA Press Releases
7/10/2009 07-10-2009-Perspective on Regulations from an Insider to Close the 2009 PDA/FDA Meeting
Something unique to the long-running PDA/FDA Joint Regulatory Conference will occur this year. Not only will the meeting delve deeply into the most pressing regulatory issues of the day, but its closing day will include a powerful reality check when regulatory affairs professional and breast cancer survivor Amy Giertych provides her unique perspective as both an insider and a patient.
6/30/2009 06-30-2009-SIFDS/PDA Shanghai Joint Development Center Unveils Office
Officials from the Shanghai Institute of Food and Drug Safety (SIFDS), a branch of the Shanghai Municipal Food and Drug Administration (SHFDA), and the Parenteral Drug Association, Inc. (PDA) celebrated the grand opening of a new office for the SIFDS/PDA Joint Development Center (SHJDC).
5/21/2009 05-21-2009-PDA Israel Chapter to host two PDA TRI courses in July
The Parenteral Drug Association Training and Research Institute (PDA TRI) and the PDA Israel Chapter are teaming up this July to bring the Institute’s world-class training for the pharmaceutical/biopharmaceutical industry to Israel, with two courses covering regulatory hot topics.
3/23/2009 PDA Comments on the U.S. FDA’s Draft Guidance on Process Validation
The public comment period for the U.S. FDA’s draft guidance on process validation generated more activity from PDA members since the Agency published its aseptic guidance for comment earlier in the decade. More than 400 comments were submitted to PDA, which established an online tool to collect the comments.
2/1/2009 02-01-2009-PDA Names Robert L. Dana Sr. Vice President for Regulatory Affairs and PDA TRI
In January 2009, Robert L. Dana, a long time PDA member, assumed new responsibilities within PDA. In his new role as Senior Vice President, Regulatory Affairs and Training and Research Institute, he will report to Bob Myers, President of PDA, and will also maintain a dotted line relationship to Rich Levy, PhD, Sr. VP, Scientific and Regulatory Affairs, PDA and will continue to serve as PDA’s regulatory authority.