Invited Speakers

Philipp Hohenbrink - Conference Committee

Director of International Operations, MDSS, Germany

Philipp will celebrate his 10-years anniversary in Regulatory Affairs at the RMD 2025. He is currently supervising various representative services across… READ MORE

Bassil Akra

CEO and President of AKRA TEAM, Germany

Dr. Bassil Akra is CEO and President of AKRA TEAM in Germany (GmbH) and the USA (Inc), a globally acting… READ MORE

Nada Alkhayat

Policy Officer at European Commission, Belgium

Nada Alkhayat is a Policy Officer at the European Commision’s unit for Medical Devices in the Directorate General for Health… READ MORE

Koen Cobbaert

Senior Manager – Quality, Standards and Regulations at Philips, Belgium

Koen Cobbaert is a Philips Regulatory Science and Policy expert specialized on EU MDR, Data Act and AI Act. In… READ MORE

Maria Donawa, M.D.

President, Donawa Lifescience Consulting, Italy

Maria E. Donawa, MD is President, Donawa Lifescience, headquartered in Rome, Italy, with over 30 years’ regulatory experience, including six… READ MORE

Sandra Ferretti - Conference Committee

Obelis Chief Compliance Officer & Public Affairs Director, Belgium

Sandra Ferretti is the EAAR liaison officer and Chief Compliance Officer and Public Affairs Director at Obelis, a leading authorized… READ MORE

Giulia Girola

Regulatory Affairs Specialist, Materialise, Belgium

Giulia Girola is a Regulatory Affairs Specialist at Materialise in Leuven, Belgium, focusing on the orthopedic portfolio. She ensures regulatory… READ MORE

Daphne Hessels

Project Manager IVD and Medical Devices, DEKRA Certification, Netherlands

Daphne Hessels joined DEKRA Certification B.V over 4 years ago, where she is a Project Manager, Lead Auditor and Technical… READ MORE

Hasmik Kirakosyan

Consultant, MDSS, Germany

Hasmik Kirakosyan is the Lead of Regulatory Affairs and Operations – CH-REP Service at MDSS CH GmbH and a Regulatory… READ MORE

Volker Lücker

Editor, Deutscher Apotheker Verlag, Germany

Ajda Mihelcic - Chair of Conference Committee

Regulatory Intelligence & Innovation, Obelis, Belgium

Ajda holds a law degree and is heading the Regulatory Intelligence & Innovation department at Obelis, a leading authorized representative… READ MORE

Ludger Möller

EAAR Chairman, President, MDSS GmbH, Germany

Ludger Möller, Dipl. Ing. ▪ Owner MDSS GmbH ▪ Founder MDSS Consulting GmbH, ITN Holding GmbH, MDSS-UK RP Ltd, MDSS… READ MORE

Mika Reinikainen

UKRPA Chairman, Managing Director, Abnovo, UK

Mika Reinikainen is a founder and past Chairman of the European Association of Authorised Representatives (EAAR) and the current Chairman… READ MORE

Albert Roossien

Regulatory Lead at Medical Devices Notified Body BSI Group The Netherlands

Bert holds a MSc degree in Medical Biology and a PhD Degree from the Medical Department of the University of… READ MORE

Marcel Schijf

Medical Technology Health and Youth Care Inspectorate, Ministry of Health, Welfare and Sport, Netherlands

Marcel Schijf is an Inspector Materiovigilance at the Dutch Competent Authority (CA) for medical devices, the Health and Youth Care… READ MORE

Virginie Siloret

Global Medical Devices Certification Manager, SGS, France

Virginie Siloret is the Global Medical Device Certification Manager of the Notified Body Belgium NB1639 and was previously the Global… READ MORE

Olga Tkachenko

Policy Officer, European Commission, Belgium

Olga Tkachenko graduated with an MSci and BA in Natural Sciences (Biochemistry) from the University of Cambridge in 2013 and… READ MORE

Søren Underbjerg

Team Lead Clinical Development and Market Access, Qmed, Denmark

Søren Underbjerg has a bachelor’s degree in medicine and a master’s in medical Market Access from Aalborg University and have… READ MORE

Kirsten Van Garsse

Regulatory Affairs Manager & Director Authorized Representative Operations, Qarad, Belgium

Kirsten Van Garsse holds a master’s degree in biomedical sciences from the Vrije Universiteit Brussel (VUB), obtained in 2002. With… READ MORE

Annette J. van Raamsdonk - Conference Committee

Lead Quality & Regulatory Affairs Consultant, Emergo by UL, Netherlands

Annette van Raamsdonk, LL.M. is the Lead Quality & Regulatory Affairs Consultant at Emergo’s office in The Netherlands. She gained… READ MORE

Ilinca Visanoiu

Regulatory Affairs Manager MRC Holland, Netherlands

Ilinca Visanoiu is the Regulatory Affairs Manager at Amsterdam-based MRC Holland, inventor and manufacturer of SALSA® MLPA®, the gold standard… READ MORE

Erik Vollebregt

Partner, Axon Lawyers, The Netherlands

Erik specialises in EU and national legal and regulatory issues relating to medical devices, including AI, batteries, REACH and protection… READ MORE

European Commission

Petra Zoellner

Regulatory Affairs (IVDR & MDR) Director, MedTech Europe, Belgium

Petra directs MedTech Europe’s team focusing on implementation of the EU regulatory systems for medical devices and in vitro diagnostic… READ MORE