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Step by step through Medical Device Law

Requirements for Germany and Europe
Wann 11.07.2011
von 09:00 bis 17:00
Veranstaltungsort Hilton Hotel
Stadt Bonn
Kontakttelefon 06221 500-685
Zielgruppe This seminar will be of benefit to all co-workers of the pharmaceutical and
medical device industry, especially from the following departments:
- Legal
- Regulatory Affairs
- Clinical Research
- Quality Management
- Marketing
This seminar will be addressed to new staff members in these fields of work but it is also a very good refresher course for co-operators with first experiences.
Termin übernehmen vCal

This intensive course explains in an understandable way the legal framework of the development and marketing of medical devices for non legal practitioners. You will be familiar with the determining factors for the entire product lifecycle of a medical device: Which laws apply to a clinical trial? Which forms of advertising are permitted? Under which circumstances is the manu- facturer liable? And when is the user? Moreover, two experts will give you advice on the legal innovations of the 4th German Medical Device Act (MPG) and the asso- ciated new requirements for manufacturers in Europe. Furthermore you will be provided with information on the broader significance of the German Federal Institute for Drugs and Medical Devices (BfArM) as the authority for medical devices in Germany. Topics: - European and German framework in Medical Device Law - Clinical investigation and clinical trial - Marketing and distribution of medical devices - Rights and duties of the competent authorities - Liability and compliance


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