2012 - Current Companion Diagnostic Regulatory Framework in the EU & US -Webinar By GlobalCompliancePanel

Overview: This presentation will focus on the major regulatory issues that concerns diagnostic and pharmaceutical partners during co-development of a targeted therapeutic and companion diagnostic.

This will include 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 We will discuss both the impact of the proposed draft guidance issued by the FDA and the expected major changes surrounding companion diagnostic regulation to occur in the EU.

Why should you attend: This presentation will help the audience to understand the regulatory hurdles to be considered when developing a target therapeutic and a companion diagnostic. This audience will gain a clear 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.

Areas Covered in the Session:
Current trends in personalized medicine
Coordination of clinical trials during co-development
FDA draft guidance on CDx
CDx/IVD regulatory framework and anticipated changes in EU
Proposed interactions with the regulatory agencies
Regulatory review process
Case studies

Who Will Benefit:
Regulatory Affairs
Business Development
Top Management
Research and Development
Preclinical and Clinical Development

Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884