EU Biosimilar Registration and Marketing Requirements 2014

04-05 Feb 2014

Radisson Blu Edwardian Grafton Hotel, London, United Kingdom

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Key Topics

EMA guidance on immunogenicity assessment of biotechnology derived therapeutic proteins
Regulatory requirements for the registration of Biosimilars
Risk benefit conclusions and relevancy to clinical practice
How to Prepare Module 3 of the Common Technical Document: Special issues for Biosimilars

Who should Attend

Attendees working in departments such as:

Portfolio and Project Management
Biogenerics/Biosimilars/ follow on Biologics/Biotechnology
R&D
Clinical Development
Process Development
Product safety and Quality Management
Regulatory Affairs and compliance
Corporate Strategy
Legal Affairs

From Pharmaceutical, Biotechnology, CRO and Generic companies.

Past Events

EU Biosimilar Registration and Marketing Requirements 2014 - 04-05 Feb 2014, Radisson Blu Edwardian Grafton Hotel, London, United Kingdom (40949)

EU Biosimilar Registration and Marketing Requirements May 2011 - 24-25 May 2011, MWB Victoria, London, United Kingdom (13756)

EU Biosimilar Registration and Marketing Requirements 2011 - 08-09 Feb 2011, MWB Victoria, London, United Kingdom (10892)

EU Biosimilar Registration and Marketing Requirements 2026

Important

Please, check "EU Biosimilar Registration and Marketing Requirements" official website for possible changes, before making any traveling arrangements

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Health & Medicine: Pharma

Technology: Biotechnology

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