APEC Harmonization Center Biosimilar Workshop, January 2010

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APEC Harmonization Center Biosimilar Workshop, January 2010

Publication Number

APEC#210-CT-04.2

Published Date

January 2010

Type of Publication

Proceedings

Publications Under

CTI Sub-Fora & Industry Dialogues Groups, Life Sciences Innovation Forum(LSIF)

Accessed

2421

Pages

171

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Description

The main objectives of the workshop were: 1) to educate and engage participants in an interactive discussion on the specific harmonization issue of multi-regional clinical trials, demonstrating the complexity of the issue and the importance of a coordinated and collaborative approach; and 2) to place the specialized training in the regulatory issues of multi-regional clinical trials within the broader context of the harmonization of standards and regulatory procedures in life science products in order to show how such harmonization responds to APEC's goal of effective facilitation and liberalization of trade and investment among the APEC economies.

  • Executive Summary
  • Proceedings of APEC Harmonization Center Biosimilar Workshop
  • Annexes