1 Hour and 25 Minute Video | Erik Vollebregt, Axon Lawyers
In order to best protect patients and healthcare providers within the European Union, and with a focus on creating a unified system for regulatory oversight of medical devices, EU policy makers have proposed and enacted a variety of new regulatory oversights of these innovative and important products. Understanding the methods by which decisions are made and new regulations are enacted is critical as medical device manufacturers look for a compliant and clear path for moving forward. Through an in-depth analysis of the European regulation of medical devices, and recent cases impacting the regulatory environment, participants will have a clearer understanding of the current regulations as well as projections into the new year.
- Key players and responsibilities: Council, ENVI committee, notified bodies, competent authorities
- Timescales and impacts on innovation: Upcoming proposals, debates, votes and implementation
- Analysis of Lycocentre case and effects on harmonization
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Legal Counsel
- Quality Assurance
Lawyer and Founding Partner
Erik Vollebregt, Lawyer and Founding Partner, Axon Lawyers
Erik is a lawyer specialised in EU legal issues relating to medical devices. He has wide experience in life sciences legislation and regulatory, at EU and Dutch level. Erik was trained as intellectual property and competition lawyer. He has gained experience in contentious matters, commercial contracts, and transactional work at the Directorate-General for Competition of the European Commission.