Programma

27 How to ensure Compliance with EU GMP and the Marketing Authorisation in a Global Environment
Trix Tuin, QP, EMEA Affiliates, Kyowa Kirin Holdings B.V.
03 november 2022 10:00 - 11:15

Legislations: The performance of a medicinal product over its lifetime, its safety, quality and efficacy, lies with the MAH. While certain activities of an MAH may be delegated to a manufacturer or other party, the MAH retains the responsibilities. There is no difference in the responsibilities that apply to the MAH in this situation relative to when the MAH and the manufacturer are from related companies or from separate/unrelated companies. The Qualified Person (QP) is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP).)

In this presentation/workshop the following topics will provide briefly an overview focussing on:

  • MAH responsibilities
  • Qualified Person and the MAH
  • Global Manufacturing
  • Compliance Challenge Examples

The above with interactive discussion on real life situations.