CRED 8 Presentations

01/07/2024

Main tasks of the CAT

• Prepare a draft opinion on each advanced therapy medicinal product (ATMP) application before the CHMP adopts a final opinion • Upon request, opinion on any scientific matter relating to ATMPs • Participate in procedures for ATMP classification and certification • Contribute to other procedures and activities as needed (e.g. scientific advice for ATMPs)

25

The Organisation for Professionals in Regulatory Affairs

25

Main tasks of COMP

• Delivering opinions on orphan drug designation applications

• Providing advice to EU Commission on policy on orphan medicines and assists in drafting detailed guidelines

• Assisting in international co-operation

• Link with patients’ associations

26

The Organisation for Professionals in Regulatory Affairs

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