Axon Seminar In Vitro Diagnostics Wednesday 12 September 2012
Bringing an in vitro diagnostic product to the market is challenging and complex. Rules at the EU and national level are constantly changing, while regulatory policy is developing to get to grips with new products. A robust and scientifically supported regulatory and legal strategy is therefore key to successful market access.
Speakers and their presentations:
Sabine Ohse, Head Medical Devices Certification at BSI Group Regulatory strategy for in vitro diagnostics in the EU
Henk Vietor, CEO at Skyline Diagnostics Company experience with regulatory issues and how to deal with them
Erik Vollebregt, Partner at Axon Lawyers IVD Capita Exotica
Carine van den Brink, Partner at Axon Lawyers Promotion and sale of IVDs in EU