APEC Publications | APEC Harmonization Center Biosimilar Workshop, January 2010

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APEC Harmonization Center Biosimilar Workshop, January 2010

APEC Harmonization Center Biosimilar Workshop, January 2010

PUBLICATION NUMBER
APEC#210-CT-04.2
YEAR
2010
PUBLISHED DATE
January 2010
TYPE OF PUBLICATION
Proceedings
PAGES
171
ACCESSED
2329

 

Individual Files

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



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.




Download

File size: 7752.68KB



INDIVIDUAL FILES

Individual Files

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


DESCRIPTIONS

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.

DOWNLOAD

Download

File size: 7752.68KB


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Life Sciences Innovation Forum