Recorded Webinar: Current Companion Diagnostic Regulatory Framework in the EU & US

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Webinar Duration: 60 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Sylvie Le Glédic

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 We will discuss both the impact of the proposed draft guidance issued by the FDA and the expected major changes surrounding companion diagnostic regulation to occur in the EU.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- FDA draft guidance on CDx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

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.
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