Sponsored by 
Date: Wednesday 28 October 2026
Time: 14:00 - 15:00 GMT
What you'll learn
By attending, you'll gain:
- Understand why FDA or NMPA approval does not automatically translate into EU readiness.
- Identify where regulatory and clinical expectations differ in Europe and how this impacts timelines and risk.
- Learn how an integrated regulatory and clinical strategy enables more predictable EU market entry.
Who should attend
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CEO, COO, Founder, Managing Director
- Head of Regulatory Affairs, Director of Regulatory Affairs, Regulatory Affairs Manager
- Head of Clinical Affairs, Director of Clinical Affairs, Clinical Operations Manager
- Head of Quality, Quality Director, Quality Assurance Manager
- Head of Research and Development, R&D Director, Head of Product Development
- Program Manager, Senior Project Manager
- Head of Product, VP Product
- Head of Market Access, Market Access Director
- Head of Business Development, Strategy Director
- EU Expansion Lead, International Expansion Manager
- Medical Advisors, investigators
Webinar host & presenters
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Presenter: Anne-Sophie Grell
Business Unit Manager Regulatory Affairs Medical Device, QbD group
PhD in Physics with a background in MRI research at a cancer hospital, followed by a Master’s in Medical Physics focused on quality control in imaging and radiotherapy. In 2010, I moved to the private sector as Quality and Regulatory Affairs Manager at IBA. Since then, I have held various roles in Regulatory and QA at IBA, Philips, and for nearly five years at QbD. This experience has enabled collaboration with competent authorities and notified bodies worldwide. I now support clients in defining effective regulatory strategies for medical device market access in Europe, the US, and Asia.
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Presenter: Petra De Geest
Clinical Evidence & Safety Lead, QbD Group
I hold a Master’s degree in Sports Physiotherapy and worked for 10 years in clinical practice with both professional and non-professional athletes. I then transitioned into Clinical Research, where I held roles in Clinical Operations and Safety Management, and later served as Clinical Evaluation Lead for a medical imaging device manufacturer. At QbD, I combine my experience as a Clinical Safety Lead with supporting companies in building the clinical evidence required to bring their products to the EU market.
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Pricing
| Standard webinar registration fees |
| Webinar Registration Type |
Price (GBP) |
Standard Price
TOPRA Member |
FREE |
Standard Price
Non-member |
FREE |
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