Dr. Fatima Bennai-Sanfourche currently serves as the Global Senior Director of QA&RA Compliance for Medical Devices, Combination Products, and eHealth at Bayer AG. In this role, she ensures regulatory compliance and high product quality across Bayer’s medical device and eHealth portfolio. She also oversees the compliant use of medical devices and software tools in clinical investigations and trials, adhering to Good Clinical Practice.

She has a rich background in the medical field, with over 20 years of experience in quality management, regulatory affairs, and the development of medical devices, including software, in vitro diagnostics, and combination products. Her career at Bayer began in the medical affairs and pharmacovigilance department, where she served as the Director of Medical Device Safety and Global Pharmacovigilance/Medical Device Safety Officer.

Her academic journey started with a focus on Biology, specialising in Biochemistry, Immunology, and Pharmacology. She earned her PhD in Pharmacology and Pharmacochemistry from Strasbourg, France. Dr. Fatima-Bennai-Sanfourche early professional life was dedicated to research and development in France, Sweden, and Germany, focusing on cerebrovascular diseases, hypertension regulation, and immunoassay development.

In addition to her current responsibilities, Dr. Fatima-Bennai-Sanfourche leads the implementation of the Medical Device Regulation (MDR) for PH-Bayer AG. She has been recognised for her expertise and contributions to the field, being nominated by the European Commission in 2019 as an EFPIA observer for the Post-Market Surveillance and Vigilance (PMSV) subgroup (GROW.D4). Since July 2021, she has been a member of the European Commission Post-Market Surveillance (PMS) task force, contributing to the preparation of MDR PMS guidance according to Article 83.

Dr. Fatima Bennai-Sanfourche is actively involved in several professional groups and initiatives, including:

• Member of the Regulatory group of the EFPIA for medical devices.
• Member of the EU Commission group for Clinical Investigation and Evaluation of medical devices (MDCG CIE).
• Chair of the In vitro Diagnostic group at Medtech and Pharma Platform (MPP).
• Member of the European Acceleration Clinical Trials (ACT EU) initiative chaired by the EMA.
• Member of the ACT EU Multi-stakeholder Platform Advisory ad-hoc Group.
• Member of the RWD used in pragmatic trial group at TransCelerate.

Her extensive experience and leadership in the pharmaceutical, medical device, and regulatory fields make her a pivotal figure in the Medtech and pharma regulatory landscape in Europe.

Dragan Jovic is a military telecommunication engineer with expertise in military telecommunications, cybersecurity, and operational planning who transitioned to the Medical Device field.

He is currently employed as the Director of Quality and IT at a Danish medical device manufacturer, while also working as a regulatory consultant. With 9+ years of regulatory experience, he specialises in CE Marking, Software as a Medical Device, Risk Management, and Post-Market Surveillance. He has worked on cybersecurity in medical devices, ensuring compliance with ISO/IEC 27001 and Medical Device Regulation (MDR) cybersecurity requirements.

As a lead auditor (ISO 13485, ISO/IEC 27001), MDSAP auditor, and technical documentation assessor, he supports certification processes. He has extensive experience in health informatics, AI-driven medical solutions, and telecom-based telehealth systems.

Dragan lectures at the Serbian Institute for Standardisation, speaks at EMWA conferences, and has worked globally, including direct client projects in Denmark. His expertise includes FDA pre-market submissions (510k), software development (IEC 62304), and cybersecurity risk management.

Anne Paulussen is a seasoned regulatory affairs expert with over a decade of experience spanning in vitro diagnostics (IVDs), combination products, and biotechnology. She specializes in strategic regulatory guidance for combined submissions of investigational drugs with investigational devices, with a strong focus on Companion Diagnostics (CDx) under the EU In Vitro Diagnostic Regulation (IVDR).

Anne has successfully guided start-ups bringing their IVDs to the EU market, and advised major pharmaceutical and diagnostic companies on Annex XIV IVDR applications. Her expertise extends to global regulatory strategy, FDA engagement, and clinical trial compliance and she is also an experienced speaker and trainer at industry conferences such as EMWA, RAPS and Healixia Clinical Trial conference.

Currently, Anne serves as Quality, Regulatory, and Clinical Affairs Director at Flen Health, overseeing a team navigating global regulatory challenges. As co-chair of RAPS Belgium LNG and a member of EMWA’s Medical Device SIG, she actively contributes to the regulatory community.

With a passion for knowledge-sharing and regulatory excellence, Anne is dedicated to helping companies bring innovative combination products and diagnostics to market while ensuring compliance with evolving regulations.