1st CMC Forum in Japan: Challenges for Quality Improvement in Asia

Venue: Nakano Sun Plaza

Location: Tokyo, Japan

Event Date/Time: Jun 11, 2012 End Date/Time: Jun 11, 2012
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Discuss Challenges Facing Drug and Drug Substance Development, Generics, OTCs, and the Pharmaceutical Trade

Global pharmaceutical companies regularly import pharmaceutical products and/or drug substances that are manufactured around the world—making supply chain integrity of utmost importance. Although, ICH has created several guidelines on CMC harmonization, interpretation of these guidelines are different in each country. And there are some variations in GMP regulation in each country that sometimes result in reduced quality of imported/exported pharmaceutical products and drug substance. With Japan prepared to join the PIC/S in the near future, adherence to a global quality standard is paramount. This forum will explore ways to harmonize quality around the world, especially Asian countries.

Simultaneous Translation Available
Event Code:12304