ABSTRACT
This presentation will provide an update on the work of the EMA GMDP IWG moving toward a modern, risk-based, GMP framework, with particular emphasis on innovation, supply chain resilience, quality system effectiveness, stakeholder consultation, and international collaboration.
The role of the EMA GMDP IWG with respect to safeguarding quality and supply chain resilience.
An update on the revision of the EU GMP Guidelines.
An update on modernisation of EudraGMDP Database and GDP activities.
A look at how the GMDP IWG supports the implementation of new pharmaceutical legislation.
A look at how the GMDP IWG engages with stakeholders.
LED BY
Brendan joined the European Medicines Agency in October 2002. He was Head of the Manufacturing and Quality Compliance Service at the Agency from 2014 – 2020. He is currently the Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP IWG).