Clinical Affairs Spotlight
Drawing on themes from leading conferences and industry forums, it explores evolving perspectives on clinical evidence generation, post-market clinical follow-up, real-world data, and regulatory expectations. The course supports continuous professional development by keeping participants aligned with the latest thinking, key challenges, and practical strategies.
Online
October 2026
6 months
10 sessions
Why you should join this course
You will learn to
What can you expect?
Meet the Speakers
Michael D'Agosto
University teacher | Edvance scientific board member
Michael D’Agosto is Professor and Dean of Studies M.Sc. Medical Devices - Regulatory Affairs at Hochschule Furtwangen University. He is a medical doctor (MD) and medical engineer by training and worked in the medical device industry prior to his academic career. Michael is also Scientific Expert and Partner at Escentia GmbH. Michael has been part of Edvance MedTech from the very beginning, sharing his expertise and experience. He is essential for our progression with his ability to explain complex issues in a comprehensible way and for his openness to support everyone.
Cécile van der Heijden
Attorney-at-law | Senior Legal Counsel at Axon Lawyers
Cécile van der Heijden is an attorney-at-law at Axon Lawyers and strategist in European life sciences regulation, with expertise spanning MedTech, AI, data, biotech and health law. Her special interest lies with cross-legislation and FemTech. Recognised for her cross-legislation expertise, she brings coherence to complex regulatory frameworks. She is a frequent speaker at international conferences and has published on medical devices, data governance, and health law, as well as on history, combining professional practice with academic inquiry.
Elisabeth Oltmanns
Managing partner at escentia
Elisabeth Oltmanns is a PhD student and her research focuses on the integration of clinical and non-clinical data (eclipse-md.com). With a background in Biomedical Engineering and an MSc in Regulatory Affairs, she combines technical expertise with regulatory insight. Alongside her academic work, she consults through Escentia, a boutique clinical affairs consultancy supporting medium-risk medical devices. Passionate about advancing medical device development, she is dedicated to transforming clinical evaluations from a regulatory requirement into a strategic advantage.
Amie Smirthwaite
founder of salvae medical
Yu Jin
Yu Jin is a clinical and regulatory affairs specialist with an MD and PhD in cardiology and cardiovascular epidemiology. With over 15 years of experience across clinical practice, research, the medical device industry, and regulatory sectors, Dr. Jin has developed a comprehensive understanding of both the clinical and scientific aspects of medical device development and evaluation.
Currently a consultant, her career has included leadership roles in clinical and regulatory strategy, particularly in the areas of EU MDR clinical evaluations and clinical investigations. Dr. Jin has extensive expertise in the Notified Body conformity assessment process, including Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) studies, and clinical investigations.An author of over 50 peer-reviewed scientific publications, Dr. Jin is also recognized for her deep clinical expertise in cardiovascular devices.
Marcus Torr
Marcus is a Post Market Survey expert with over seven years of experience in real-world evidence generation for the medical device and IVD industries. He joined Purdie Pascoe in 2015 after completing a First Class MSci in Natural Sciences (Chemistry with Pharmacology) at the University of Bath.
After nearly five years in primary market research, Markus transitioned into leading the Post Market Survey team in 2019. In this role, he has grown the team to 15+ specialists and overseen the delivery of more than 500 surveys across PMCF (EU-MDR), PMPF (EU-IVDR), and broader real-world data programs. His work spans a wide range of device types, including both general (Level 8) and case-specific (Level 4) surveys, many of which have been approved by leading Notified Bodies.
Tom Melvin
UNIVERSITY TEACHER | EDVANCE SCIENTIFIC BOARD MEMBER
Tom Melvin is Associate Professor of Medical Device Regulatory Science at the University of Galway. Tom is Chair of the Biomedical Alliance Regulatory Affairs Committee and a member of the European Medicines Agency Expert Panels for medical devices, the European Society of Cardiology Regulatory Affairs Committee and the National Research Ethics Committee for Medical Devices. Tom previously worked at Trinity College Dublin and was a senior medical officer for medical devices at the Health Products Regulatory Authority and Co-Chair of the MDCG CIE working group. Tom has been part of Edvance MedTech from the very beginning, contributing invaluable knowledge and insight, while also keeping the founding team grounded and focused when our ideas risked running too wild.
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