Module 5 Presentations

18/07/2024

Module 5 Regulatory Control of Clinical Operations

Venkat Reddy Sunkara, MSc, MRSC Senior Director, Regulatory Affairs, CMC Icon Clinical Research UK Ltd

The Organisation for Professionals in Regulatory Affairs

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Agenda and Learning Outcomes:

• The role of the Qualified Person • The role of the IMP QP • History of Legislation • Manufacturing and importation requirements • Regulatory framework under which clinical trials are managed • Issues related to manufacture, packaging and distribution of clinical supplies

The Organisation for Professionals in Regulatory Affairs

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