With optional Post-Conference Sessions on June 9, 2011.
Over the past few years the role and duties of the Qualified Person keep increasing in significance and scope. Being the key person in the quality function of a pharmaceutical company, the QP has to consider many issues to fulfil the responsibilities and to comply with the European legislation.
This Conference 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 Conference has been designed for non-European QA and QCU personnel, upper management functions and authority representatives who want to be informed about the latest development regarding European GMPs and the duties and responsibilities of Qualified Persons.
Speakers:
- Richard M. Bonner, Qualified Person, Formerly with Eli Lilly and Company Ltd., UK
- Dr Christopher Burgess, Qualified Person, Burgess Analytical Consultancy, UK
- Dr Dimitrios Catsoulacos, European Medicines Agency, EMA
- Dr Bernd Renger, Qualified Person, Chairman, European QP Association
- Dr Janice Soreth, FDA, Office of International Programs at EMA
- Martine Tratsaert, Qualified Person, Johnson & Johnson, Belgium
- Mark Tucker, Ph.D., Genentech Inc./Roche Group, USA
Highlights
Understand European GMPs
- The European Pharmaceutical Legislation
- Import/ Export, CEPs and GMP Certificates
- EU Product Quality Review Requirements versus US Annual Report Requirements
Understand the Role of the QP
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- The Legal and Professional Duties of the Qualified Person
- EU Inspections in the U.S. and the Involvement of the QP
- The EU Discretion Paper and the Release of Batches by the QP
- The Role of the QP in Contract Manufacturing
- The role of the QP in the Supply Chain and Supplier Qualification
- The US Quality Unit versus the EU QP
The view of FDA and EMA
With optional Post-Conference Sessions on June 9, 2011
- Session 1: Case studies: Certification by a QP and Batch Release
- Session 2: Clinical Trial Supplies: IMP Handling in Europe and the Role of the QP
For further information and registration, please visit:
http://www.gmp-compliance.org/qpag_forum_5.html