David Cockburn, form. European Medicines Agency (EMA)
Dr Susanne Ding, Boehringer Ingelheim
Dr Rainer Gnibl, EU-GMP Inspectorate
Dr Ulrich Kissel, European QP Association
This event is designed by QPs and international Experts as a forum with focus on sharing information and experience and on discussing the critical areas of European GMPs and the QP’s daily work.
The Pharmaceutical Industry has become more global due to international collaborations, mergers and acquisitions and more complex supply chains require companies to have a greater understanding of pharmaceutical legislation throughout the world. This is becoming increasingly evident by the number of non-EU professionals contacting the European Compliance Academy and the Qualified Persons Association asking for more and more detailed information about the European GMPs and the unique role and responsibility of the EU QP.
The ECA Academy and the European QP Association, recognising this need for further professional knowledge development, intend to support the pharmaceutical industry outside Europe in understanding the EU approach and legal framework in this respect. Therefore, the QP Association has set up the programme at hand on European GMP requirements and the role of the QP.
In light of the establishment of a Mutual Recognition Agreement between US and EU and the parallel move out of Great Britain from the EU, representatives from the authorities as well as QPs and well-known experts will talk about the current issues and share their point of view.
The Conference has been designed for non-EU QA and QCU personnel, upper management functions and authority representatives who want to be informed about European GMPs and the duties and responsibilities of Qualified Persons.
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Clinical Trial Supplies: IMP Handling in Europe and the Role of the QP
- Current and future EU-GMP and QP requirements
- Certification and release of Investigational Medicinal Products (IMPs) for studies in the EU
- Specific aspects of IMP supply chains
- GMP-GCP Interface
- QP oversight and being a QP in a global environment