Navigation Links
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. 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
408-773-6258
sophie(dot)mccallum(at)clinovo(dot)com

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.
http://www.clinovo.com

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 http://www.prweb.com/releases/2012/6/prweb9624815.htm.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:7/24/2017)... ... July 24, 2017 , ... Each year, Inavero’s Best ... proven their superior service quality as rated by hiring professionals and job candidates. ... based on service quality ratings from their placed talent. , Fewer than 2% ...
(Date:7/20/2017)... ... July 20, 2017 , ... Resoundant, Inc. is ... imaging centers around the U.S. that offer MR Elastography for liver fibrosis staging. ... needle biopsy for staging liver fibrosis assessment. , “MRE:connect was created in response ...
(Date:7/20/2017)... ... July 20, 2017 , ... VIC Technology Venture ... the company’s board of directors. This addition continues to strengthen and diversify VIC’s ... Goforth, CEO and Chairman. “He is a highly accomplished business executive with a broad ...
(Date:7/20/2017)... , ... July 20, 2017 , ... Corporate Directors Forum ... its 27th annual Director of the Year Awards. , The awards will be presented ... This annual event celebrates directors who have made significantly positive contributions in the ...
Breaking Biology Technology:
(Date:4/19/2017)... April 19, 2017 The global ... landscape is marked by the presence of several large ... held by five major players - 3M Cogent, NEC ... accounted for nearly 61% of the global military biometric ... in the global military biometrics market boast global presence, ...
(Date:4/11/2017)... GARDENS, Fla. , April 11, 2017 /PRNewswire/ ... management and secure authentication solutions, today announced that ... by Intelligence Advanced Research Projects Activity (IARPA) to ... IARPA,s Thor program. "Innovation has been ... and IARPA,s Thor program will allow us to ...
(Date:4/5/2017)...  The Allen Institute for Cell Science today announces ... portal and dynamic digital window into the human cell. ... application of deep learning to create predictive models of ... a growing suite of powerful tools. The Allen Cell ... publicly available resources created and shared by the Allen ...
Breaking Biology News(10 mins):