White paper

MA and lifecycle management in Japan

MA and lifecycle management in Japan

Additions and differences to ICH requirements
Author: Dr. Christina Juli

This white paper describes the principles of post-approval change management protocols (PACMP) and the related guideline documents. It includes the description of the process and the impact on timelines.

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White paper

MA and lifecycle management in Japan

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Your pre-meeting: Be prepared for your event

Attend one of our free pre-meetings to familiarise yourself with the Learning Space and the various ways in which you can interact during the event

Webcast: Prior Use before The UPC, The EPO, German, Chinese And U.S. Courts

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The online seminar with details on development, quality, CMC, approval and market access (including an update on the upcoming EU HTA) for advanced therapy medicinal products. Qualifiy now!

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