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

(prHWY.com) August 24, 2012 - Wilmington, DE -- GlobalCompliancePanel to organize RAPS pre-approved webinar on "Bridging the Gap: Co-Development of Targeted Therapeutics and Companion diagnostics in the US and EU"

Description:Pharmaceutical and diagnostic companies that co-develop Targeted Therapeutics and Companion diagnostics need to be aware of the intricate details of regulation in this industry, whether they are partnering each other or are working in isolation. Regulationfor coordinating clinical trials is very stringent and requires exactness of the highest standards. Companies need to be aware of these, as well as current trends.
This webinar will focus on regulatory reviews in the US and the EU. While the US FDA released a draft guidance document on in-vitro companion diagnostics for review after a long and heated debate; the EU is still yet to do the same. It has not yet come up with any specific guidance on companion diagnostic development, nor has it finalized changes in the regulatory framework.
This webinar will take up the draft regulation from the US FDA for discussion. It will analyze the impact this draft regulation from the US FDA could have on American and EU markets, and will analyze the possible content and implications of the impending EU draft. Attending this webinar will give participants an idea of how to shape their practices in alignment with both the US and EU requirements.
Areas Covered in the Session:
o Current Trends in Personalized Medicine and Companion Diagnostics
o Coordination of Clinical Trials
o Joint meeting with Agencies
o Regulatory Review Process including submissions
o Anticipated changes in EU regulations
o Agency expectations
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When: September 18, 10:00 AM PDT | 01:00 PM EDT
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By whom:
Sylvie Le GlÃ©dic is Director, IVD's - Medical devices at Voisin Consulting Life Sciences (VCLS), France. Sylvie Le GlÃ©dic brings over two decades of experience in the regulatory field of in vitro diagnostic (IVD) medical devices, including biochemistry, hematology, 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.

Sylvie collaborates with Companion Diagnostic developers and Pharmaceutical companies in defining and establishing industry best practices in relation to Personalized Medicine. Sylvie is based in VCLS' Paris office.
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For whom:
The webinar will benefit those in
o Regulatory Affairs
o Business Development
o Top Management
o Research and Development
o Preclinical and Clinical Development
----------------------------------------------------------------------------------------------------------------
Duration: 60 minutes
-----------------------------------------------------------------------------------------------------------------
TDescription:Pharmaceutical and diagnostic companies that co-develop Targeted Therapeutics and Companion diagnostics need to be aware of the intricate details of regulation in this industry, whether they are partnering each other or are working in isolation. Regulationfor coordinating clinical trials is very stringent and requires exactness of the highest standards. Companies need to be aware of these, as well as current trends.
This webinar will focus on regulatory reviews in the US and the EU. While the US FDA released a draft guidance document on in-vitro companion diagnostics for review after a long and heated debate; the EU is still yet to do the same. It has not yet come up with any specific guidance on companion diagnostic development, nor has it finalized changes in the regulatory framework.
This webinar will take up the draft regulation from the US FDA for discussion. It will analyze the impact this draft regulation from the US FDA could have on American and EU markets, and will analyze the possible content and implications of the impending EU draft. Attending this webinar will give participants an idea of how to shape their practices in alignment with both the US and EU requirements.
Areas Covered in the Session:
o Current Trends in Personalized Medicine and Companion Diagnostics
o Coordination of Clinical Trials
o Joint meeting with Agencies
o Regulatory Review Process including submissions
o Anticipated changes in EU regulations
o Agency expectations
-----------------------------------------------------------------------------------------------------------------
When: September 18, 10:00 AM PDT | 01:00 PM EDT
-----------------------------------------------------------------------------------------------------------------
By whom:
Sylvie Le GlÃ©dic is Director, IVD's - Medical devices at Voisin Consulting Life Sciences (VCLS), France. Sylvie Le GlÃ©dic brings over two decades of experience in the regulatory field of in vitro diagnostic (IVD) medical devices, including biochemistry, hematology, 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.

Sylvie collaborates with Companion Diagnostic developers and Pharmaceutical companies in defining and establishing industry best practices in relation to Personalized Medicine. Sylvie is based in VCLS' Paris office.
-----------------------------------------------------------------------------------------------------------------
For whom:
The webinar will benefit those in
o Regulatory Affairs
o Business Development
o Top Management
o Research and Development
o Preclinical and Clinical Development
----------------------------------------------------------------------------------------------------------------
Duration: 60 minutes
-----------------------------------------------------------------------------------------------------------------
To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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