Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

CCH - Congress Center Hamburg

Apr 06, 2016 9:00 AM - Apr 06, 2016 12:30 PM

Am Dammtor / Marseiller Str., 20355 Hamburg, Germany

TUT01: Introduction to the Regulation of Medical Devices and Medical Software

Instructors

Sabina  Hoekstra-van den Bosch, PharmD, MSc, RPh

Sabina Hoekstra-van den Bosch, PharmD, MSc, RPh

Global Director Regulatory Strategy, Tüv Süd, Netherlands

- >20 years experience as pharmaceutical and medical device regulator in the Dutch government, successively in Medicines Evaluation Board, Ministry of Health and CCMO (governmental organization for clinical investigations) - Lead for European Regulation in Philips (global medtech company), co-leading Philips’ EU MDR/IVDR Implementation Program - Currently Regulatory Strategy Principal in Notified Body TÜV SÜD - Chair of NB-MED (formal EU Commission’s working group of Notified Bodies and Vice-President of Team-NB (association of EU Notified Bodies) - Long track record in global professional organizations DIA and RAPS - Regular speaker and faculty member in educational conferences on regulatory topics - Holding PharmD of Leiden Univer

Erik  Vollebregt, JD, LLM

Erik Vollebregt, JD, LLM

Partner, AXON Lawyers, Netherlands

Erik's practice focuses on (medical) technology, pharmaceuticals, healthcare and life sciences in regulatory matters and he is active in litigation, commercial and transactional work in all of these fields.

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.