Final ProgramCPSA 2012
Transforming Drug Discovery & Development Through Innovation:
Past, Present and Future
October 1 - 4, 2012
Sheraton Bucks County Hotel
Langhorne, PA
Session Synopsis
Monday, 10:00 am - 11:30 am
Colloquium: Regulatory Issues and Industrial Workflows
"Regulatory Compliance Can be a Real Drag, like Being Married for 22 Years!?"
Discussion Leaders: Chad Briscoe, PRA International and Robyn Rourick, Genentech
It's been 34 years since the first instigation of the GLP Regulations in 1978 and 22 years since the first Crystal City meeting in 1990. That's a long time for an ever evolving and maturing field of pharmaceutical development. With that thought in mind regulatory compliance can be like an old, tired marriage. There may be lots of love and understanding, but it's not as exciting as it maybe once was. The last few years have brought new excitement in bioanalysis with a renewed focus on various scientific advances such as dried blood spots and protein LC/MS analysis. In addition, the FDA has initiated comment on whether to modernize the regulations governing GLPs to be more aligned with current practice for sponsors, test facilities and test sites. This session will freshen up the regulatory perspectives with something old, something new, something borrowed and something blue. Industry veteran Ken Dammers will provide a historical overview of the GLPs with a focus on his experience through various companies and roles. This will be followed by Eric Woolf who will speak to the new challenge many of us are dealing with which is consolidating, globalizing and harmonizing processes in organizations formed through various mergers and acquisitions. Edwin Hooijschuur will follow with a European perspective to "borrowing" global regulations and various client procedures in order to lead a European CRO that best meets the expectations of global stake-holders. Finally, after hearing from the perspective of Chongwoo Yu, an FDA Reviewer and former industry scientist, we should all be feeling a bit more or less blue.
Presenters:
Eric Woolf, Merck
Edwin Hooijschuur, PRA International
Chongwoo Yu, Food & Drug Administration
Ken Dammers, Celgene Corporation
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