Annabelle Bruyndonckx

Partner at Simmons & Simmons LLP

Speaker

Annabelle Bruyndonckx is a seasoned Healthcare & Life Sciences attorney with over 25 years' experience in the healthcare and life sciences sector, offering legal support in French, Dutch, and English. My practice is deeply rooted in the EU regulatory framework, focusing on clinical trial/investigation agreements, promotion, and distribution of pharmaceuticals/medical devices and compliance. I also navigate public tender laws in healthcare, address challenges with borderline products (medicine-food/cosmetics/devices) & qualification of products, and tackle early market access issues. Over the last years I've broadened my expertise to support the HLS and MedTech sectors with the AI Act and digital health within the EU, ensuring technologies comply with the applicable regulations. My work extends to advising on marketing, labeling, and advertising of foodstuffs and cosmetics, aligning products with EU regulatory standards. A significant part of my role involves coordinating multijurisdictional advice, ensuring a harmonized approach across different EU member states.

She is a member of the board of Healixia and the President of the Regulatory Affairs Education Group of Healixia. She is also a member of the European Pharmaceutical Law Association (EPLA) and the European Food Law Association (EFLA).