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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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

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Webcast series "From Lab to Launch: Technical CMC and Non-Clinical Development of RNA/DNA-based drugs"

RNA-/DNA-based drugs: gain a solid understanding of the complexities involved in the development and regulatory approval of RNA-based drugs and oligonucleotides. Meet outstanding and longtermin experienced experts in the field of research.

online 11/09/-11/12/2024
Toxicology and beyond: Safety assessment in drug development

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online 17-18/09/2024
online 17-18/02/2025
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online 12-26/11/2024