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Clinovo Hosted the Fourth Silicon Valley BioTalks on June 6th, 2012
Date:6/21/2012

Sunnyvale, CA (PRWEB) June 21, 2012

Over fifty healthcare industry professionals attended the fourth session of the Silicon Valley BioTalks, a panel discussion co-sponsored by Clinovo and CapGemini. The event took place on June 6th, 2012 in CapGemini South San Francisco offices and addressed how to lead a successful FDA submission.

For this fourth session “FDA Submission: The new rules”, a panel of regulatory experts shared best practices on communication the Food and Drug Administration (FDA) representatives, clinical standards, and guidelines implemented by the newly appointed FDA commissioner Margaret Hamburg. “The Silicon Valley BioTalks is a great forum to hear some very experienced clinical trial professionals", states one of the attendees.

The panel was composed of industry experts with up to 20 years experience in regulatory affairs: Dr. Urte Gayko (Nodality, VP of Regulatory and Clinical Affairs), Dr. Christine Conroy (Affymax, VP of Regulatory Affairs and GCP Compliance) and Dr. Sandra Nino-Siddens (Geron Corporation, Executive Director of Regulatory Affairs). The panel was moderated by Dr. Anne-Marie Duliege (Affymax, Chief Medical Officer). The Silicon Valley BioTalks also included a networking session to allow attendees to discuss about the latest trends and challenges in the healthcare industry with fellow life science professionals.

Clinical trial professionals attended the event to increase their knowledge on Food and Drug Administration (FDA) evolving guidelines and learn best practices for FDA submissions. ”There is a growing necessity for sponsors to submit data in standards that are recognized and easily reviewable by the FDA”, pointed out Dr. Conroy, VP of Regulatory Affairs and GCP compliance at Affymax.

Source: PRWeb
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