Biosimilars 2011

Current activities of the Biosimilar Working Party - the upcoming guideline of monoclonals as biosimilars

Essential clinical & non-clinical studies - study design, endpoints, immunogenicity

Your Speakers:

Dr. Dr. Michel Mikhail: Expert in Pharmacology & Toxicology, GERMANY
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Gareth Morgan: DLA Piper UK LLP, Intellectual Property and Technology Group, London, UNITED KINGDOM
Link: www.taylorwessing.com

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Cecil Nick: PAREXEL Consulting Uxbridge, UNITED KINGDOM
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Dr. Christian Schneider: Paul-Ehrlich-Institut (PEI), Langen, GERMANY
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Dr. Martina Weise: Federal Institute for Drugs and Medical Devices (BfArM), Bonn, GERMANY
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Register

Your Contact: Dr. Henriette Wolf-Klein
Bereichsleiterin Pharma
E-Mail

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Venue:

Bonn: Hilton Hotel
Berliner Freiheit 2
53111 Bonn

Tel. +49 228 7269-0
Fax +49 228 7269-700

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Fee:

890,- EUR zzgl. MwSt.

Further Information

Aims and Objectives: Several biosimilar marketing authorisations have been granted, the first launches have taken place, but there are still several questions to be answered:

How similar does a biosimilar really need to be?
How will the "biosimilar philosophy" expand to more complex biologics such as monoclonals according to the upcoming guideline?
Which non-clinical and clinical study data are really essential for a successful marketing authorisation?
What are the current developments with regard to intellectual property issues?

May I invite you to discuss these and many more topics with our experts from the industry and the CHMP Biosimilar Working Party?

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Biosimilars Seminar - benefit: Several biosimilar marketing authorisations have been granted, the first launches have taken place, but there are still several questions to be answered. Get the answers at our seminar Biosimilars 2011.
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