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MedTech Summit

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Hybrid Event, 20 - 24 June 2022
In-Person: Clayton Hotel Burlington Road, Dublin, IrelandDigital Experience: One track will be live-streamed each day in BST time zone, with on-demand recording access for all other tracks made available from the afternoon of the following day. Learn more on the Digital Experience page.

Sabina Hoekstra-van den Bosch, PharmD FRAPS
Regulatory Strategy Principal at TÜV SÜD

Profile

Sabina is Regulatory Strategy Principal at Notified Body TÜV SÜD and acts as representative of TÜV SÜD and Notified Bodies at European level.  She is Chair of NBCG-Med, the EU Commission’s working 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, serving subsequently in the Medicines Evaluation Board, the Ministry of Health and the governmental organization for clinical investigations in the Netherlands.

She has worked in medtech industry as Lead for European Regulation in Philips, where she acted as leader and expert in European Medical Device and Pharmaceutical Regulations on corporate level 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 was co-founder and Chair of the RAPS Netherlands Chapter. She is Fellow of RAPS since 2015 and serves in RAPS Global Board of Directors since 2020.

Sabina holds a PharmD from Leiden University, the Netherlands.

Agenda Sessions

  • Experiences and Lessons Learnt from Virtual Audits

    09:40
  • Notified Body Perspective

    14:35
  • Multi-Stakeholder Panel: Borderline and Classification of Medical Devices under the EU MDR

    15:50