Aimed at professional with a working knowledge of regulatory affairs, this advanced course will provide a road map to support your transition from the current regulatory system based on directives to the new requirements established by the regulation. The course will include comprehensive sessions on; technical documentation, the vigilance system, the regulatory hierarchy in the EU, labelling, clinical evaluations and investigations, EUDAMED, post-market surveillance and post-market clinical follow-up studies.
Delegates will be able to cement this knowledge through case studies and practical exercises, with additional time on the course provided to discuss the implications of Brexit and future challenges for industry.
Mika has a Master’s degree in Law from the University of Nice and later gained a Master’s in Business Administration from the Wharton School.
He has more than 30 years of experience managing European medical regulatory affairs in industry, as a healthcare legal counsel and as a regulatory consultant. He has also been involved directly in the development of the Medical Devices Directives and of technical standards since the 1990s.
He founded the medical device consulting company Abnovo Ltd in 2007 to provide a wide variety of networked services to the medical device industry worldwide.
He is currently a member of various medical device expert working groups of the European Commission and is Chairman of the European Association of Authorised Representatives (EAAR).
This course will provide experienced professionals with the regulatory knowledge to practically apply life-cycle management in an MDR environment, particularly to those who play a key role in transitioning their products to the MDR.