Module 3 Presentations

07/05/2024

Lecture 4: CMC Project Management

Christian Maasch Head of Quality Regulatory Compliance, Change Control Mgmt & Deputy Quality Systems

Takeda GmbH, Oranienburg, Germany May 15 th ,2024

Disclaimer: Confidential. For internal use only. The opinions expressed in this presentation and on the following slides are solely those of the presenter and not necessarily those of Takeda. Takeda does not guarantee the accuracy or reliability of the information provided herein.”

The Organisation for Professionals in Regulatory Affairs

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Learning Outcomes

1. The “y2024 Framework” for Project Managers 2. Definition and Challenges of CMC Project Management 3. Project Management Approaches and Tools 4. Bridging PM and RA - Putting Dossier Development in Context

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

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