Biosimilars Global Congress 2014 Europe
17th-19th September 2014
Hilton London Kensington, London UK

Paradigm Global Events are once again proud to present the annual
Biosimilars Global Congress 2014 Europe

Pre-Conference Workshops covers:

Morning- Biosimilar Monoclonal Antibodies: from theory in Guidelines to reality after approval
Afternoon- Clinical development of Biosimilars

The two - day Congress will provide and interactive discussion and networking format led by key industry expert speakers with intimate knowledge in the industry. Gain practical strategies and best practices on challenges, innovations, technologies and concepts surrounding biosimilars.

Day one topics will focus on:
 Global Regulatory Perspective
 Current Regulations and future Challenges for the development of Biosimilars in Europe & US
 Regulatory Strategies in the Emerging Markets
 Harmonization
 Global Commercialization & Reimbursement
 Clinical & Non-Clinical
 Impact of Healthcare system on Biosimilars
 Patients perspective on Biosimilars
 Scientific and Clinical Considerations for Biologics and Biosimilars
 Harmonization to ensure patient safety
 Global Strategic Collaboration
 Including two interactive panel discussion on:

Day two topics will focus on:
 Update on FDA Development for Biosimilars
 Interchangeability – Guidelines
 Preparing for U.S. Market entry – strategy consideration in view of BPCIA
 Key Regulatory aspects for development and approval of Monoclonal Antibodies
 Manufacturing & development process considerations of Biosimilars  Substitution and Interchangeability
 Challenges & Obstacles in Conducting Clinical Trials
 CMC requirement s for Biosimilars Product Development / Manufacturing

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