Co-development of targeted therapeutics

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 personalised 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 finalise 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 We will discuss both the impact of the proposed draft guidance issued by the FDA and the expected major changes surrounding companion diagnostic regulation to occur in the EU, in order to give companies a clearer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 personalised 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.. At Voisin Consulting, she is in charge of the design and implementation of global regulatory strategies for the development of IVDs, and in particular CDx in co-development with medicinal products.

Date: 18 September 2012
Time: 10:00 - 11:00
Venue: Online Training, Wilmington
Cost: $245.00

More info:

Online Training