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RAI Center

Mar 04, 2013 9:00 AM - Mar 04, 2013 12:30 PM

Europaplein, 1078 GZ Amsterdam, Netherlands

Tutorial 04: Introduction to Medical Device Regulation

Speakers

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

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

Regulatory Strategy Principal , 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.

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