MDR/IVDR 2.0: Towards a Resilient & Persistent Europe

 Dr. Christophe Lahorte, PhD. performed academic research for 6 years at the Gent University. Since 2004 he has been actively involved within the R&D department of Belgian agency for medicines and health products (FAMHP) in the quality assessment of CTA’s and PIP’s. In 2009, Dr. Lahorte was appointed as head of the FAMHP’s Unit for National Scientific-Technical Advice & Knowledge Management. In 2017, he became the Head of the FAMHP’s National Innovation Office which aims to support and guide all types of innovators developing new innovative drug products and medical technologies in Belgium and Europe. In addition, he is actively involved in several European projects coordinated by the EMA and European Commission including the ACT EU. 

Carine Cochereau holds a Pharmacist PHD and a MBA in Industry management. Further to 3 years of pharmaceutical and clinical activities in hospitals located in Paris, Carine started her professional career in medical device industries within Johnson & Johnson for a period of 12 years followed by 2 years within Cardinal Health and Biom’up playing different roles in Quality, Regulatory and Clinical affairs activities. Since October of 2019, Carine has been part of Integra LifeSciences as VP International Regulatory Affairs.

Since 2014, Carine has been chairing the Clinical Investigation taskforce in Medtech Europe and an active member of different groups such as the MDR, Eudamed.

 Maddalena is a regulatory affairs leader with extensive experience in the medical device industry and at BSI. With a Master’s Degree in Medical Biotechnology, she has built a strong career at the intersection of science, regulation, and strategic leadership. She has led global regulatory strategies, translating complex requirements into clear, actionable guidance that supported product development, compliance, and market access. As Head of the Notified Body – Medical Devices at BSI, she oversees strategic and operational activities, shapes regulatory policy, and drives process optimisation. Her leadership is instrumental in upholding BSI’s reputation for excellence in regulatory compliance and conformity assessment. 

 Megha is a seasoned Regulatory Affairs professional with extensive experience in the Life Sciences, Medical Devices, and In Vitro Diagnostic devices industry. She has successfully led global teams with diverse portfolios and collaborated with regulatory authorities to shape new policies and regulations. Currently, Megha serves as the Director of Global Strategic Regulatory Affairs at Thermo Fisher Scientific, responsible for regulatory intelligence, policy, and advocacy across the organization’s varied business segments. Megha is the Vice-Chair of ABHI’s IVD Regulatory Affairs Committee and holds a leadership position in MedTech Europe. She has been recently honoured with the Fellow designation by the Regulatory Affairs Professional Society (RAPS) in recognition of her significant global volunteering contributions both within and outside RAPS. 

 Erik specialises in EU legal and regulatory frameworks for medical devices, digital health technologies, pharmaceuticals, and life sciences, with distinctive expertise in AI, software, in vitro diagnostics and personal data protection. As a multilingual legal expert with extensive experience at the European Commission and several leading international law firms, he provides strategic counsel on complex regulatory and legal matters. His clients include the largest medical technology manufacturers and pharmaceutical companies in the world to start-ups as well as EU institutions, national governments and industry associations. Erik embodies that CE for the life sciences industry means "Call Erik".