3rd Annual Biosimilars Summit

February 2017



Hotel Riu Plaza Berlin

Martin-Luther-Straße 1, 10777

About Summit

This 3rd Annual Summit brings together industry experts to explore strategies and gain insight into designing new biosimilar development programmes and analysis methods, clinical advancement, and new solutions for successful implementation in the market.

Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders and Managers specialising in:

  • Biologics/Biotechnology/ Biogenerics
  • Legal Affairs
  • Pricing and Reimbursement
  • Regulatory Compliance
  • Preclinical and Clinical Development
  • Quality Affairs/ Quality Control
  • Biopharmaceuticals
  • Intellectual property
  • Clinical Immunology
  • R&D
  • New Product Development
  • Pharmacovigilance

From Industries Including:

  • Clinical Immunology
  • Immunology
  • Drug Safety
  • Preclinical Development
  • Therapeutic Areas
  • Business Development
  • Vaccines Development
  • Scientific Affairs
  • Validation
  • Analytical Characterization
  • Antibody Discovery
  • Oncology
  • Infection and Immunity
  • Risk Management
  • Clinical Program
  • Personalized Medicine
  • Portfolio Planning
  • Regulatory Affairs
  • Pharmacovigilance
  • Global Strategy
  • Antibody Engineering
Key Practical Learning Points of the Summit

The global regulatory landscape for biosimilars’ approval
The latest achievements of biosimilars in therapeutic areas
Bioanalytics for biosimilars
Extrapolation and Interchangeability
Pharmacovigilance issues
Developments in the biosimilar guideline framework
Drug safety factors
Legal considerations for biosimilars
Successful implementation of biosimilars in the market
Caroline Bouilliat

Commercial Lead (Biosimilars)

Amgen, Switzerland

Bernd Liedert

Senior Director, Clinical Development Biosimilars

Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Dr. Steinar Madsen

Medical Director

Norwegian Medicines Agency

Dr. Uwe Gudat

Head of Safety Biosimilars

Merck, Switzerland

Matthew Turner

Global Medical Director Biosimilars

Merck, Switzerland

Scott Davis

Senior Director Therapeutic Science & Strategy

QuintilesIMS, UK



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