EUCRAF is pleased to announce the names of the speakers of Seminar 7. This seminar provides information about the roles of supervising authorities and the essential characteristics of quality systems.

Dr. Susanne Keitel from EDQM is the Course Leader of Seminar 7. She introduces the EDQM, the European Directorate for the Quality of Medicine and Healthcare, its role, structure, activities and certificate of suitabilty. Furthermore together with Thomas Hecker, also from EDQM she speaks about Agency´s batch release, OMCL network, the Official Control Authority Batch release (OCABR) procedure and CAP testing. They also introducs PICS and WHO, their role, activities, WHO certificates and transatlantic simplification of administration procedures.  

Dr. Andrea Hauser from the University Hospital Regensburg, formerly Inspector RP bavaria discusses the questions: which quality management systems apply in the EU and how they are regulated and who is supervising the companies in the EU and in third countries and how this supervision is supervised. Moreover she gives a talk on the structure and role of the supervising authorities, especially the European Medicines Agency (EMA). Together with Dr. Gabriele Dallmann from EUCRAF she presents the topic: the Regulatory Affairs Department at the interphase. Furtmer she speaks about the principles of GMP, the company`s responsibilty in batch release and The Qualified person, the principles of GDP, the Rapid Alert System, product defects and recalls.

Dr. Wiebke Siegel a former Inspector at RP Darmstadt gives a talk on the special GMP considerations for biopharmaceuticals including advanced therapies.

Dr. Georges France from Pfizer gives an insight into the compliance and steady optimisation of production and processes.

Dr. Ralf Hess from PAREXEL gives a talk on the principles of GLP.

Dr. Bernd Raffelsberger from Pfizer speaks on the experience with inspections conducted by the different inspectorates from Europe, US and Japan and how an inspection is performed.

Dr. Dagmar Chase from Clinrex GmbH gives a talk on the principles of GCP, including the responsibilities of sponsors and investigators; serious GCP breaches and their impact on the amketing authorization and GCP inspections triggered during marketing authorization assessment.