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Regulatory Affairs for Biotech

Course Objectives

The process of drug development is changing rapidly as biotech techniques are becoming more mainstream, and more and more biotech based drugs are coming to market. Regulation of biotech products is fundamentally different from that of NCEs.

Are you fully aware of the extent of these differences and are you confident you have the knowledge you need to work in this field?

This course addresses the issues of real and perceived risks associated with biotech products, and the way the regulatory agencies are dealing with this based on the trainers’ own experiences. This course assumes some knowledge of the science behind biotech.

Who Should Attend

  • Regulatory affairs
  • Registration
  • Compliance
  • QA/QC
  • Manufacturing/Production
  • Product Validation
  • Process Validation

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(updated 22 May 2012)

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Dates and Venues

17 Jul 2012 - 18 Jul 2012

Regus Boston Independence Wharf, Boston, USA

27 Nov 2012 - 28 Nov 2012

Regus Mission Valley, San Diego, California, USA

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