Bridging the Gap: Co-Development of Targeted Therapeutics and Companion diagnostics in the US and EU

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Bridging the Gap: Co-Development of Targeted Therapeutics and Companion diagnostics in the US and EU - Webinar By GlobalCompliancePanel

Website http://bit.ly/14pLzcj | Edit Freely

Category Medical Device, Pharma, Biotech, Clinical, Drug, Food Safety, Heath,FDA

Deadline: April 24, 2013 | Date: April 24, 2013

Venue/Country: California, U.S.A

Updated: 2013-04-08 17:37:09 (GMT+9)

Call For Papers - CFP

Overview: This presentation will focus on the major regulatory issues that concern diagnostic and pharmaceutical partners during co-development of a targeted therapeutic and companion diagnostic including, current development trends related to companion diagnostics, coordination of clinical trials, and the regulatory review of both products in the US and EU.

After months of discussions on personalized medicine and the use of companion diagnostics with targeted therapeutics, the much anticipated draft FDA guidance document on in vitro companion diagnostics was finally released by the agency for comments. In contrast, the EU has yet to release any specific guidance on companion diagnostic development and/or finalize changes in the regulatory framework. We will discuss both the impact of the proposed draft guidance issued by the FDA and the expected major changes surrounding companion diagnostic regulation to occur in the EU, in order to give companies a clearer perspective on how to shape their internal company practices to be aligned with the latest thought process of regulators in both the US and EU.

Why should you attend: This presentation will help the audience, both pharmaceutical and diagnostic companies, understand the regulatory hurdles when developing a target therapeutic and a companion diagnostic. The audience will learn how to shape their internal company practices to be aligned with the latest thought process of regulators in both the US and EU.

Areas Covered in the Session:

Current Trends in Personalized Medicine and Companion Diagnostics

Coordination of Clinical Trials

Joint meeting with Agencies

Regulatory Review Process including submissions

Anticipated changes in EU regulations

Agency expectations

Who Will Benefit:

Regulatory Affairs

Business Development

Top Management

Research and Development

Preclinical and Clinical Development

Sylvie Le Glédic is Director, IVD's ? Medical devices at Voisin Consulting Life Sciences (VCLS), France. Sylvie Le Glédic brings over two decades of experience in the regulatory field of in vitro diagnostic (IVD) medical devices, including biochemistry, haematology, immunology, blood gas and molecular biology products, under Annex II List A and List B.

Price: $225.00

GlobalCompliancePanel

NetZealous LLC,

161 Mission Falls Lane,

Suite 216, Fremont, CA 94539, USA

USA Phone:800-447-9407

Fax: 302-288-6884

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http://www.globalcompliancepanel.com

http://bit.ly/14pLzcj

Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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