Date: 10/06/2025
Time: 12:00 - 13:00 GMT / 13:00 - 14:00 CET

Duration: 1 hour

Suitable for

TOPRA members (and non-members) and TOPRA International Groups (IN) interested in:

       - Market Access to Europe
       - Understanding what HTAR is
       - Gathering additional insights on key HTAR concepts

Benefits for participants

As a regulatory professional you will get an understanding what HTAR means and how regulatory affairs will play a role in HTAR.

 In this webinar, we will specifically cover:

       - The historic European and local HTA process in Belgium and the Netherlands
       - What HTAR is, why and when it is important and what the timelines are for implementation
       - What will change under the HTAR
       - Key definitions and insights on Joint Clinical Assessment, PICOs and Joint Scientific Consultation

Presenter(s)


Wim Neckebroeck, Regulatory Affairs Director, Kintiga
Wim brings over 16 years of experience in the pharmaceutical industry. During the first decade of his career, he worked in various pharmaceutical companies, including Novo Nordisk, Abbott and Viatris, where he held various regulatory affairs roles. After 10 years, Wim transitioned to consulting where he acquired experience in leading major outsourcing projects across Europe. Currently he supports clients by navigating the complex regulatory landscape at both Benelux and EU levels.



Sam Bryant, Regulatory Affairs Manager, Kintiga
Sam has over 20 years of experience of drug development in the biotechnology and pharmaceutical sector, with 12 years of experience in regulatory affairs. Sam has a track record of successfully leading regulatory interactions in support of clinical development of innovative products, including most recently for a biotech developing cell therapy ATMP for rare disease . Sam has in-depth knowledge of European Clinical Trial Regulation, FDA, ICH and GMP requirements. As an EMA CTIS Master Trainer, Sam has been responsible for process implementation at a top 5 CRO for the conduct of clinical trials under the EU CTR.

The main webinar presentation will run for 45 minutes and will then be followed by a Q&A session.

Pricing
TOPRA Member: Free
Non-member: £45