Meet Our Speakers

Edward Ball

Manager, Intelligence and Strategic Execution at RQM+, UK

Ed Ball is part of RQM+’s Intelligence & Innovation team. He is a Chartered Engineer (CEng) and holds a MSc… READ MORE

Hannah Bowden

AI Airlock Programme Manager, MHRA, UK

Hannah Bowden is the AI Airlock Programme Manager at the Medicines and Healthcare products Regulatory Agency (MHRA), a role she… READ MORE

Carlos Galamba

CEO, MDx CRO, UK

Carlos Galamba is the CEO and Head of IVD at MDx, a leading EU-based CRO and regulatory consulting firm specializing… READ MORE

Sharmila Gardner

Technical Documentation Manager & Head of UK Approved Body Intertek Medical Notified Body, UK

Sharmila has a dual role at Intertek as the Technical Documentation Manager – managing the TD assessment process, the technical… READ MORE

Danielle Giroud

CEO, MD-Clinicals, Switzerland

With over 30 years of experience within the medical device industry, Ms. Danielle Giroud is founder of MD-Clinicals ( https://www.md-clinicals.com), a… READ MORE

Hugh Harvey

Managing Director, Hardian Health, UK

Dr Harvey is an experienced clinician and health technology advisor, with a focus on leveraging big data and artificial intelligence.… READ MORE

Simon Lidgate

Technical Team Manager, AIMD Clinical, BSI, UK

I hold a doctorate in the numerical modelling of electromagnetics. After various roles involving the numerical modelling of electromagnetic and… READ MORE

Tom Melvin

Associate Professor of Medical Device Regulatory Science, University of Galway, Chair of the Regulatory Affairs Committee, Biomedical Alliance in Europe, Ireland

Tom Melvin is Associate Professor of Medical Device Regulatory Science at the University of Galway. Tom is Chair of the… READ MORE

Natasha Motsi

AI Airlock Technical Programme Manager, MHRA, UK

Natasha Motsi is a Technical Programme Manager at the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), where she leads the… READ MORE

Elisabeth Oltmanns

Managing Partner, Escentia, Germany

Elisabeth Oltmanns is a PhD candidate in Medicine at the University of Galway, where her research focuses on the… READ MORE

James Pink

Director of Research and Development @ RegNav, UK

Since starting his healthcare career in medical physics and clinical technology in the late 1990s, James Pink has become a… READ MORE

Hatem Rabeh

Clinical Evaluation Expert for Medical Devices, Founder, Clinical Evaluation Navigator, France

Hatem Rabeh, MD, MSc, is a clinical evaluation expert specializing in helping Medical device companies meet MDR requirements with clarity and… READ MORE

Sally Sennitt

Director at Elsmere Enterprises, Belgium

EU physician and MedTech Regulatory Affairs professional. At my best with clinical strategy, CER, PMCF, Notified Body responses for any… READ MORE

Nebojsa Serafimovic

Assessor Medical Devices, Senior Expert, Austrian Agency for Health and Food Safety (AGES), Austria

Nebojsa Serafimovic is a Senior Assessor for clinical investigations with medical devices and performance studies with in vitro diagnostics at… READ MORE

Monica Tocchi

Founder & CEO, Meditrial USA Inc.

Dr. Monica Tocchi is the CEO and Founder of Meditrial, a global contract research organization driving innovation in complex medical… READ MORE

Cécile van der Heijden

Advocaat / Attorney at law, Axon Lawyers, Netherlands

Cécile van der Heijden is an Amsterdam-based attorney-at-law, specialising in regulatory strategy, data governance, and innovation in the life sciences sector,… READ MORE

Tom Willshare

Co-founder and CTO of Spotlight Health, UK

Tom is Co-founder and CTO of Spotlight Health, a women’s health startup developing AI-powered tools to support earlier diagnosis of… READ MORE

Sarina Zillikens

Clinical Affairs Specialist, Escentia, Germany

Sarina Zillikens is a Clinical Affairs Specialist at Escentia GmbH, where she leads clinical evaluations in compliance with MDR for… READ MORE