Navigation Links
Clinovo Hosted the Fourth Silicon Valley BioTalks on June 6th, 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. The abstracts of the discussion can be found on the Clinovo website.

Clinovo has direct experience with the Food and Drug Administration (FDA) and supported two FDA advisory panels for world's leading life sciences companies. Clinovo’s experts presented the conclusions of their work to FDA reviewers and convincingly answered their questions. Four companies were FDA approved following their collaboration with Clinovo.

The Silicon Valley BioTalks is a premier venue for pharmaceutical and medical device professionals to build their knowledge and expertise. Since its launch in June 2011, the Silicon Valley BioTalks gathered over 200 clinical trials professionals from the Bay Area and beyond. Clinovo and the co-organizers invited 15 influent industry experts from leading life science companies including Roche, Abbott, Affymax, Theravance and Jazz Pharmaceuticals. The next session will take place in September 2012.

Contact information
Sophie McCallum
Marketing Manager at Clinovo

About Clinovo
Clinovo partners with life science companies to streamline their clinical trials, leveraging years of expertise in systems integration, open source technology and industry standards. Clinovo provides Staffing Solutions, eClinical Systems and Biometrics Services including Clinical Data Management, Electronic Data Capture, CDISC mapping and SAS Programming.

About the Silicon Valley BioTalks
Silicon Valley BioTalks is a series of quarterly networking and expert discussion events. Top-tier panelists from leading pharmaceutical, biotechnology and medical device companies share their expertise and best practices on specific industry challenges. The previous sessions of the Silicon Valley BioTalks addressed the following topics: Implementing Adaptive Clinical Trials, Run Efficient Clinical Trials With Open Source Technologies and How CDISC standards streamline clinical trials.

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. SeraCare Reports Fiscal Year 2011 and Fourth Quarter Financial Results
2. Biodel Reports Fourth Quarter Fiscal Year 2011 Financial Results
3. BioMed Realty Trust Declares Fourth Quarter 2011 Common Stock and Preferred Stock Dividends
4. InterMune to Report Unaudited Fourth Quarter Esbriet® Revenue and Business Update on January 5
5. Luminex Corporation Fourth Quarter and Full Year 2011 Earnings Release Scheduled for February 6, 2012
6. Quest Diagnostics Reports Fourth Quarter 2011 Financial Results; Provides Guidance for 2012
7. Amgen Announces Webcast of 2011 Fourth Quarter and Full Year Financial Results
8. Covance Reports Fourth Quarter Revenue of $532M, GAAP EPS of $0.35, Pro Forma EPS of $0.73, and Adjusted Net Orders of $759M
9. Cepheid Reports Fourth Quarter and Full Year 2011 Results
10. BioMed Realty Trust to Report 2011 Fourth Quarter and Year End Results
11. Sangamo BioSciences Announces Fourth Quarter and Full Year 2011 Conference Call and Webcast
Post Your Comments:
(Date:10/11/2017)... NJ (PRWEB) , ... October 11, 2017 , ... Personal eye wash is a basic ... one eye at a time. So which eye do you rinse first if a dangerous ... have Plum Duo Eye Wash with its unique dual eye piece. , “Whether ...
(Date:10/11/2017)... ... October 11, 2017 , ... Proscia Inc ... hosting a Webinar titled, “Pathology is going digital. Is your lab ready?” with ... adoption best practices and how Proscia improves lab economics and realizes an increase ...
(Date:10/11/2017)... and LAGUNA HILLS, Calif. , Oct. ... Cancer Research, London (ICR) and University ... SKY92, SkylineDx,s prognostic tool to risk-stratify patients with multiple myeloma ... MUK nine . The University of Leeds ... partly funded by Myeloma UK, and ICR will perform the ...
(Date:10/11/2017)... ... October 11, 2017 , ... A new ... rates in frozen and fresh in vitro fertilization (IVF) transfer cycles. ... to IVF success. , After comparing the results from the fresh and frozen ...
Breaking Biology Technology:
(Date:4/24/2017)... April 24, 2017 Janice Kephart ... with  Identity Strategy Partners, LLP (IdSP) , today ... without President Trump,s March 6, 2017 Executive ... , refugee vetting can be instilled with greater confidence, ... now, all refugee applications are suspended by until ...
(Date:4/13/2017)... , April 13, 2017 UBM,s Advanced ... will feature emerging and evolving technology through ... Innovation Summits will run alongside the expo portion of ... sessions, panels and demonstrations focused on trending topics within ... advanced design and manufacturing event will take place June ...
(Date:4/11/2017)... 11, 2017 No two people are ... the New York University Tandon School of Engineering ... found that partial similarities between prints are common ... mobile phones and other electronic devices can be ... vulnerability lies in the fact that fingerprint-based authentication ...
Breaking Biology News(10 mins):