Presented by Helen Colquhoun,
CEO, Pleiad Devices
Topics covered:
- Regulatory issues re: Pharma vs. MD&D
- Risk-based regulatory burden
- Regulating approval in the EU
- Human factors testing for the FDA
- Japan – different or more of the same
Thursday, March 24th 2011
8:30am Breakfast and Networking
9:00am – 11:00am Presentation and Discussion
DoubleTree Guest Suites Philadelphia West
640 W Germantown Pike, Plymouth Meeting, PA, 19462
(866) 539-0036
Register by March 10th and be entered to win a $50 American Express gift card!
Questions about the event or trouble registering? Contact Bob Muzerall at bmuzerall@fxtrans.com or call 518.433.5481
About the speaker:
Helen Colquhoun, MD, holds degrees in Genetics and Medicine from the University of Edinburgh and spent several years practicing clinical medicine before entering the life science industry in 1988. Helen spent seven years working with a major pharmaceutical company before setting up as an independent consultant in 1995. Since that time she has spent increasingly more time working with medical device and drug delivery companies.
In 2000 she co-founded the Pleiad group of companies and is currently CEO of Pleiad Devices, a clinical research organization based in the USA and Europe that specializes in clinical research and regulatory support for medical device companies. Helen runs Pleiad's North American operation and is based in Cambridge, Massachusetts.