ECMDR is the first integrated European Diploma Course of Medical Device Regulation on the ECPM Training Platform at the University of Basel. It incorporates all essential aspects of medical device technology and their regulation in Europe and internationally.
Mission
EMCDR was created to provide a training platform in Europe to enhance the knowledge, expertise and skills needed to accompany and support:
- certified and comprehensive education on integrated cutting-edge concepts and best practices leading to appropriate use of medical devices and their combinations, e.g. pharmaceuticals as well as in vitro diagnostics and companion diagnostics
- development, manufacture, installation and post-production vigilance as set out and regulated by medical device legislation,
- implementation of administrative guidelines and other guidance applicable in Europe
- integrated product development which is science-based, efficient, economical and of high quality
Title and Credit Points
The ECMDR is presented as a self-standing programme of 6 Modules of 4 days each to obtain the Diploma in Medical Device Regulation offered by the European Center of Pharmaceutical Medicine (ECPM) and is accredited with 30 ECTS by the University of Basel in collaboration with the European So-ciety of Medical Device Regulation (ESMDR), DIA Europe and the Regulatory Affairs Professionals Society (RAPS).
Six mandatory Modules, 5 ECTS each
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June 6-9, 2011
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Introduction to Medical Device Regulation
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September 12-15, 2011
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Medical Device Development
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February 13-16, 2012
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Medical Device Development
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June 4-7, 2012
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Specific Requirements for Combination Products
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September 10-13, 2012
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International Regulatory Systems
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February 2013
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Regulatory Strategy and Project Management
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Registration and Fees
Please register via our homepage www.ecmdr.eu or send an email to gisela.gautschi@unibas.ch. The fee for the entire course amounts to EUR 9’600, special academic fees on request.
Venue
Pharmacenter Basel, University of Basel, Switzerland
