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Marketing Authorisation in Europe 2009

06-17-2008 10:16 AM CET | Health & Medicine

Press release from: FORUM Institute of Management

2007/2008 have brought many changes in the field of regulatory affairs. 2009 casts its shadow ahead.
- What kind of changes does the revision of the EU guidance on the SmPC bring?
- What is the current status of the new variation regulation?
- The paperless eCTD - is it a reality coming soon?
- Sunset clause - are all questions answered?

FORUM Institute fuer Management, one of the leading professional seminar and conference providers in Europe, offers an international conference for the pharmaceutical industry on 4 September 2008 in Cologne.

Use the opportunity to speak with experts from 5 European national authorities:

- Dr. Eric Abadie, Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSaPS), FRANCE
- Dr. Peter Bachmann, Federal Institute for Drugs and Medical Devices (BfArM), GERMANY
- Dr. Christer Backman, Medical Products Agency, SWEDEN
- Dr. Daniel Brasseur, Federal Agency for Medicines and Medicinal Products, BELGIUM
- Dr. Patrick Salmon, Irish Medicines Board, IRELAND

Further information on the conference and the company you will find under:

Dr. Henriette Wolf-Klein
Department head pharma
FORUM Institut fuer Management GmbH, Heidelberg
Vangerowstraße 18
69115 Heidelberg
Tel. 0049 6221 500 680
Fax. 0049 6221 500 618

FORUM Institute is very active and acknowledged in the field of educational seminars and conferences for the pharmaceutical industry. In several areas FORUM has the leading market position. Especially the close co-operation with the regulatory authorities assures the outstanding quality and up-to-dateness of the trainings. Each novel important guideline from the national authorities or the EMEA/CHMP results in a seminar within a short period of time to insure that pharmaceutical industry personnel receives the proper information and training. The speakers are experts from the pharmaceutical industry, service provider, lawyers and national / international authorities.

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