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Inaugural Improving Comparator Studies

Learn from industry experience on how to save money, increase efficiency and ensure compliance of your comparator studies

Key benefits of attending:

  • Learn from an Ethics Committees perspective what they look for when reviewing comparator studies
  • Discuss your regulatory questions with an MHRA representative in an interactive panel discussion
  • Listen to 8 industry case studies bringing you practical advice when conducting your comparator studies
  • Network with high level industry professionals from across the comparator studies and clinical trials supplies field at this co-located conference
  • Explore the analytical approach to blinding strategies and stability testing for comparator products, include the use of over-encapsulation
  • Find out how companies are implementing successfully comparator sourcing strategies

2011 Conference Highlights

Exciting topics for 2011 include:

  • Hear the latest regulatory expectations and perspectives from the MHRA

  • Discover the expectations of an Ethics Committees from the managing physician of an Ethics Commission

  • Learn from Boehringer Ingelheim, Pfizer and GlaxoSmithKline how they overcame the challenges faced in this area including the chance to discuss Central sourcing versus Local sourcing

  • Understand the role and requirements of a Qualified Person from Baxter and ensuring compliance to Good Manufacturing Practice

  • Gain a new perspective – hear from the experiences of a clinical investigator

  • Explore the essential analytical methods for blinding strategies and stability testing, including the use of over-encapsulation

  • Network with high level industry professionals from across the comparator studies and clinical trials supplies

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Sponsors

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Media Partners

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Increased Networking Opportunities: This conference is co-located with

Expert Speaker Pannel

Expert Speaker Pannel

Prof. Malcolm Lader Emeritus Professor of Clinical Psychopharmacology, Institute of Psychiatry King’s College London

Ute Buhler GMP analytics Pfizer UK

  • Peter Feldschreiber, Barrister, Four New Square, Lincolns Inn London, Senior Medical Assessor, MHRA
  • Peter Orosz, Head of Clinical Supply Chain Management, Oncology, Boehringer Ingelheim
  • Jeroze Dalal, Clinical Operations, GlaxoSmithKline
  • Kati Mortier, Global Qualified Person,Johnson & Johnson PRD
  • Denise Hager, Comparative Agent Development, Pfizer Inc.
  • Niklas Mattsson, Independent Consultant
  • Albert Chau, Data and Statistical Science Consultant, in2phase Limited

Don't miss our must-attend pre-workshop

Pre-Conference Workshop W - Monday 10 October

EMA, FDA and Clinical Supply Chain Management

Led by: Patti Seymour, BioProcess Technology Consultants, Inc.

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Dates and Venues

11 Oct 2011 - 12 Oct 2011

Ramada Plaza Basel Conference Center

Speaking opportunities still available

Please contact:

 

Michael Combellack

Conference Producer
Informa Life Sciences

Tel: +44 (0) 20 7017 5031

Email: michael.combellack@informa.com

Connect with me on LinkedIn!
http://www.linkedin.com/pub/michael-combellack/2a/ab1/90b

Who Should Attend?

Heads of Department, Directors, Managers, Team Leaders, Associates, Consultants and Coordinators from:

  • Clinical Supplies
  • Sourcing
  • Clinical Development
  • Analytical Development
  • CMC and Analytical Chemistry
  • Regulatory Affairs
  • Clinical Operations

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