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look back at 2009
  • 130+ participants
  • In excess of 75 individual organisations represented
  • 33 hours of presentations
  • Over 10 hours of networking
  • 91% of our attendees ranked the congress as good or excellent
  • 30 different countries

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conference details
Conference:
Pre-conference workshop
23 Feb 9am - 5pm
Day 1
24 Feb 8.30am - 6:00pm
Day 2
25 Feb 8.30am - 5:30pm
Post-conference workshop
26 Feb 9am - 5pm
 
Venue:
The Royal Horseguards Hotel, London, United Kingdom

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Cecil Nick,
Vice President
PAREXEL Consulting

Cecil is a regulatory professional with over 25 years experience specializing in biological and biotech products. Cecil joined PAREXEL in 2001 from Novo Nordisk Ltd. where he gained considerable experience in the development and registration of biotechnological products and NCE’s.
Appearing:
Post-conference workshop - Fri 26 Feb 2010
1pm

Biosimilars - Important Concepts for Regulatory Approval

  • Global challenges
  • Demonstrating physico-chemical comparability
  • The importance and challenges of biological testing
  • How valuable is non -clinical testing?
  • The role of PK and PD data
  • Key considerations for demonstrating therapeutic equivalence?
  • How much clinical safety data?
Cecil Nick,
Vice President,
PAREXEL Consulting
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our speakers
Speaker photo
Robert Wessman
Executive Chairman
Alvogen
Speaker photo
Petra Danielsohn-Weil
European President, Established Brands
Pfizer
Speaker photo
Satish Reddy
Chief Operating Officer & Managing Director
Dr Reddy's Laboratories
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Gerard van Odijk
President & Chief Executive Officer
Teva Pharmaceuticals Europe
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Honorable Henry A Waxman
Member of Congress
United States of Americas
 
 
 


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