Speakers

Nataliya Deych

Vice President Regulatory Affairs EMEA, Latam, Canada

Edwards Lifesciences

Abhineet Johri

Regulatory Affairs Manager & Senior Key Expert-AI

Siemens Healthineers

Andreas Stange

Senior Vice President MHS Regulatory & Quality

TÜV SÜD

Paul Piscoi

Policy Officer, Directorate-General Health & Food Safety, Unit D.3 Medical Devices

European Commission

Crystal D’Silva

Associate Director, Material Characterization and Assessment

Baxter

Jeppe Larsen

Director of Medical Devices

Danish Medicines Agency

Erik Vollebregt

Partner

Axon Lawyers

Mahua Yasmin

Manager Regulatory Affairs EME

Johnson & Johnson

Adam Kleinman

Associate Director, Medical & Scientific Writing

Philips

Menna Bahr

Regional Regulatory Affairs GCC

Medtronic

Monica Shah

Sr. Director, Clinical Affairs

Intuitive

Taylor Builee

Senior Principal Toxicology Specialist

Solventum

Tonia Jeiter

Senior Manager Clinical Evaluation and Clinical Lifecycle Management

Alcon

Vera Dowling

Senior Principal Biocompatibility Manager

Cardinal Health

Marta Carnielli

Head of Certification IVD

TÜV SÜD

Ron Brown

Toxicologist

Risk Science Consortium

Susan Partridge

Clinical Regulatory Lead

BSI

Milos Stojkovic

Safety Process Director

Roche

Petr Brat'ka

Preclinical Evaluation Manager

Czech Metrology Institute

Abigail Loneker

Senior Biological Safety Engineer

Philips

Alejandro Frangi

Bicentenary Turing Chair in Computational Medicine / UK CEiRSI Executive Director

University of Manchester

Alina Martirosyan

Senior Scientific Manager Toxicology

B Braun

Alison Dennis

Partner

Winston Taylor

Alyse Andre

Account Executive

Rematiq

Amanda Chancellor

Senior Manager, Global Sustainability

ResMed

Amber Harrison-Crudge

EUDAMED Lead

Johnson & Johnson

Dr Andriani Daskalaki

Clinical Expert/Regulatory

mdc medical device certification GmbH

André Breisinger

Expert Medical Devices Regulation

Swissmedic

Anna Amich

Director Device & Digital Safety

AstraZeneca

Arne Sunaert

Medical Device Software Coordinator

FAMHP

Barbara Fink

Associate Director of Clinical Affairs

Heartstream

Bassil Akra

CEO

AKRA TEAM

Beau Rollins

Principal Consultant

Intrinsic Medical Group

Bianca Lutters

Head of Clinical Affairs and Principal Consultant

Qserve Group

Boopathy Dhanapal

Convener of ISO/TC 194 WG 18

Independent Consultant

Chaojun Li

Senior Director, Global Head of Sustainability

WSA

Christophe Giradey

Managing Director

wega Informatik

Cécile van der Heijden

Senior Attorney-at-Law

Axon Lawyers

Damien Matak

CEO

EBI

Danielle Giroud

Convener

TC 194 WG4 for the ISO 14155

Danny Sun

Director of WuXi AppTec Medical Device Testing Center

Wuxi AppTec

Denver Faulk

Director of Biocompatibility, Sleep & Respiratory Care

Philips

Dilsat Pinar Pergjetani

Chief Quality & Regulatory Affairs Officer

Human Care Group

Ebube Ogbuagu

Medical Doctor

Royal Derby Hospital, NHS/ Committee Expert AI Airlock, MRHA

Ed Woo

Regulatory Consultant

Independent

Eljar Amini-Nejad

Client Solutions Senior Consultant EMEA

NSF

Ella Helgeman

Senior Regulatory Director

Radiometer

Esmeralda Megally

CEO & Co-Founder

Xsensio

Fabian Kriegel

Head of Material Development & Biocompatibility

Carl Zeiss Meditec

Felicity Ellis

Head of Legal and Compliance

Scarlet

Flora Wegener

Lead Scientific Expert Toxicology

Merz Aesthetics

Folker Spitzenberger

Professor for Regulatory Affairs for medical devices

Unversity of Applied Sciences Lübeck

Frank Trautwein

Director Clinical Strategy, MedTech EU

Veeva

Frédéric Courivaud

Senior Principle Researcher

DNV / Chief Editor of prEN 18228

Gary Saner

Senior Regulatory Solutions Architect

Lexis Nexis

Gavin Quigley

Director & Medical Safety Officer

Johnson & Johnson

Gert Bos

Executive Director & Partner

Qserve Group

Giacomo Cargnello

Head of Quality Assurance & Regulatory Affairs, C&C Solutions

Varex Imaging

Hans-Peter Meulekamp

Director of Sales, Europe

DistillerSR

Helena Ziert

Account Manager Medical & Health Services

TÜV SÜD

Jack Wong

CEO and Founder

Asia Regulatory Professionals Association (ARPA)

James Shearn

Director, Regulatory Intelligence & Policy

Steris

Jamie Gallagher

Partner

Mason Hayes & Curran

Jan-Oliver Hollnagel

Senior Clinical Evaluator

BIOTRONIK

Jessica Auton

Regulatory Affairs Policy & Intelligence Manager

B.Braun

Jincy Robin

AI Airlock Programme Officer

MHRA

Josep Pané

Head of Device and Digital Vigilance and Safety

UCB

Kaitlin Dailey

Senior Conference Producer

Informa Connect

Leon Doorn

Chair Medical Device / AI Working Group

NEN (Dutch Standardisation Institute)

Lorenz Strehl

Head of Enterprise Business

Flinn.ai

Malene Nielsen

Senior Biocompatibility Specialist

3Shape

Mariana Reis

Regulatory Affairs & Quality Assurance

C-mo Medical Solutions

Marina Daineko

Biocompatibility Consultant

Intrinsic Medical Group

Mark Grumbridge

Head of Clinical Investigations

MHRA

Matthew Jorgensen

Toxicologist, Global Biocompatibility

Teleflex

Maximilian Reuter

Senior Director Systems Solutions Data Program Management, Regulatory Affairs Operations, Person Responsible for Regulatory Compliance

Olympus Europa

Michael King

Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect)

IQVIA

Miriana Jlenia Quattromani

Senior Scientific Manager

3Shape

Nebojsa Serafimovic

Assessor for Clinical Investigations

Austrian Medicines and Medical Device Agency, Austrian Federal Office for Safety in Health Care

Peter Chen

Senior Principal Scientist, Biocompatibility | Medical Devices

Medical Device Testing Center, WuXi AppTec

Philippe Hasgall

Research Associate Director, Biological Evaluation

Zimmer Biomet

Pinalee Nanda

RA/QA Manager - Digital Health & AI Regulatory Lead

NEC OncoImmunity

Priscilla Lemes

Regulatory Affairs Specialist - Product Life Cycle EMEACLA

Edwards Lifesciences

Rebecca Mathias

Research Associate, Medical Device Regulatory Science Group

Else Kröner Fresenius Center for Digital Health

Rene Zoelfl

Senior Director, Global Industry Advisor Life Science

PTC

Roshni Kasturi

Clinical Lead, MDR/IVDR

Ascensia Diabetes Care

Sasikala Thangavelu

Vice President

SOCIETY OF MEDICAL AND BIOLOGICAL ENGINEERING MALAYSIA (MSMBE)

Shreya Sridhar

Principal Systems Engineer and Technical Lead

Medtronic

Silke De Zolt

Section Manager IVD Devices

TÜV Rheinland

Stephanie Berger

Director Global PMS

Philips

Stephen Gilbert

Professor of Medical Device Regulatory Science

Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden

Steve Weber

Assistant Professor

The Johns Hopkins School of Medicine

Stuart Angell

Chair of Regulatory Affairs Working Party & Member of the Executive Board

BIVDA

Svetlana Bykanova

Chief Quality Officer

HOYA Vision Care

Tatsiana Ripich

Head of Regulatory Affairs

enmodes GmbH

Tom Kokhuis

Clinical Development Scientist

Philips

Vanda Almeida

Responsible AI Clinical Lead

Philips

Vaso Basinou

Freelance Consultant

Zena

Vicky Valla

Regulatory Compliance Lead

Evnia ApS

Vivian Sáenz MacAdden

Director, Industry Stakeholder Programs

DistillerSR

Yu Jin

Clinical Expert at Notified Body

Freelance Professional

Zaynab Khalid Zia

AI Airlock Regulations Specialist

MHRA