European GMPs and the Role of the Qualified Person (QP) 08-09 July 2014, Jersey City, NJ (New York City Metro Area) The Impact of EU Directives and Guidelines on the Supply Chain - A conference organised by the ECA Academy and the European QP Association

Speakers Richard M. Bonner, Chairman of ECA and European QP Association Dr Susanne Ding, Boehringer Ingelheim, Germany Dr Rainer Gnibl, EU-GMP Inspectorate, Germany Tor Gråberg, Medical Products Agency, Sweden Dr Bernd Renger, Immediate Past Chair of the European QP Association, Germany FDA Speaker, (invited) Mark Tucker, Ph.D, form. FDA Investigator and Compliance Officer, USA Highlights Understand European GMPs The European Pharmaceutical Legislation EU GMP Update Import/ Export EU PQR versus US APR The US Quality Unit versus the EU QP Understand the Role of the QP Duties and Responsibilities The EU Discretion Paper and the Release of Batches Supply Chain and Supplier Qualification Clinical Trial Supplies: IMP Handling in Europe and the Role of the QP Plus: The Role of PIC/S in globalising World The View of the FDA Welcome The Pharmaceutical Industry is becoming more global due to international collaborations, mergers and acquisitions and more complex supply chains requiring 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 European Compliance Academy ECA and the European QP Association, recognising this need for further professional knowledge development, intend to support the pharmaceutical industry outside Europe in understanding the European 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. Representatives from the authorities as well as QPs and well-known experts will talk about the current issues and share their point of view. Various case studies will be presented and discussed to come up with possible solutions. Make use of this event by exchanging experiences with your colleagues and by establishing informal contact and networking. I would like to invite you to this unique opportunity, and I look forward to meeting you. Best regards, Richard M. Bonner Chairman of the Qualified Person Association Objectives 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. Target Audience 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. Media Partners:            >> Here you get to the programme and the registration