Module 3 Presentations

07/05/2024

Point of Care (POC) Manufacturing • P roducts manufactured at the point where a patient receives care.

E.g. ATMPs, cell and gene therapy

POC manufacturing = many manufacturing sites

Current regulatory processes not designed for this type of product

The Organisation for Professionals in Regulatory Affairs

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In this presentation we covered

• Knowledge of the applicable laws for clinical trials • Understanding of Good Manufacturing Practices (GMPs) for Investigational Medicinal Products (IMPs) • Specific requirements for IMPs, including blinding & labelling • Release / QP batch certification of IMPs • Impact of Brexit • What’s new

The Organisation for Professionals in Regulatory Affairs

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