Global Director Regulatory Strategy
TÜV SÜD
Sabina Hoekstra-van den Bosch, PharmD FRAPS
Sabina is Global Director Regulatory Strategy at Notified Body TÜV SÜD and represents of TÜV SÜD and Notified Bodies at European level. She acts as Chair of NBCG-Med, the EU Commission’s formal coordination group of Notified Bodies, and Vice-President of Team-NB, the EU Notified Bodies’ association.
Sabina has 20 years of experience as pharmaceutical and medical device regulator and legislator in the Dutch government, serving subsequently in the Medicines Evaluation Board, Ministry of Health and the governmental organization for clinical investigations CCMO.
She has worked as Lead for European Regulation in Philips, where she acted as leader and expert in EU medical device and pharmaceutical regulations and was involved in EU MDR/IVDR implementation.
Sabina has a long track record as volunteer in global professional organizations (DIA and RAPS). She is a regular speaker and faculty member in educational conferences on regulatory topics.
She is Fellow of RAPS and serves in the RAPS Global Board of Directors.
Sabina is trained as pharmacist and holds a PharmD from Leiden University.
Disclosure information not submitted.
EU-MDR Implementation: Latest News
Wednesday, October 4, 2023
8:00 AM – 9:15 AM EDT
RAPS BOD Roundtable: I Am Regulatory
Wednesday, October 4, 2023
11:45 AM – 12:15 PM EDT
RAPS BOD Roundtable: Volunteering
Wednesday, October 4, 2023
12:00 PM – 1:00 PM EDT
Wednesday, October 4, 2023
2:00 PM – 3:00 PM EDT
Wednesday, October 4, 2023
3:30 PM – 4:30 PM EDT
Conversations That Matter - Interactions with Health Authorities: Medical Devices and IVDs
Thursday, October 5, 2023
8:00 AM – 9:15 AM EDT
Solutions Circle: EU/MDR State of Play
Thursday, October 5, 2023
10:45 AM – 11:15 AM EDT
Will EU IVDR implementation benefit from MDCG 2022-14 and if so, HOW?
Thursday, October 5, 2023
2:00 PM – 3:00 PM EDT
Companion Diagnostics: Overview of the IVDR Requirements and the EMA Consultation Process
Thursday, October 5, 2023
4:45 PM – 5:45 PM EDT