Speaker List

Clinical Evaluation Specialist
BioSciPons

Corporate Director, Regulatory Affairs
MED-EL

Consultant
khhconsulting

Senior Consultant IVD - Regulatory Affairs
Qarad

Head of Unit
European Commission

Clinical Evaluation Lead
Dedalus

IVD Manager Device Compliance & Performance Evaluation Studies
Qarad

In-house clinician
SGS Notified Body, 1639

Policy Officer
European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6

Director IVDR-MDR
MedTech Europe

Chief QA/RA Officer
QARALOGIC

Sr. Transparency Specialist
Certara

Professor
Northeastern University

Regulatory Affairs Manager
Accestra Consulting Company

CEO and Founder
nexialist

EMEA Regulatory Affairs
W. L Gore & Associates

Regulatory Intelligence Director
nexialist

Senior Regulatory Consultant, IVD
Namsa

Director RWE MD&D
Aetion

IVD Department Manager
GMED

Senior Manger
SANOFI

Europe Regulatory Experts Head
Sanofi

Quality and Regulatory Affairs Senior Manager
Immunotech SAS (Beckman Coulter)

Risk Management Expert
Escentia GmbH

Research Scientist in Regulatory Affairs for (AI/ML-enabled) Digital Health Solutions
Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE

Scientific and Software Expert
PRO-LIANCE GLOBAL SOLUTIONS GmbH

Head of department platforms & processes
DIN Media (formerly Beuth Verlag)

German HTA Expert
MBM Future Health, AMNOG Advisory Services

Head of Certification IVD
TUV Sud GmbH

Regulatory Affairs Manager
Fraunhofer IMTE

Senior Business Consultant
EXTEDO GmbH

Global Regulatory Intelligence & Policy Lead
UCB

Director
BioNTech SE

Professor of Medical Device Regulatory Science
Else Kröner Fresenius Center for Digital Health

Principal Consultant IVD
Entourage GmbH

Principal Management Consultant
ENTOURAGE GmbH

Head of IVD and Principal Consultant
Entourage GmbH

Manager Third Party (OEM) Therapeutic Solutions Division, Regulatory Affairs
Olympus Surgical Technologies Europe

Regulatory Affairs and Project Manager
RoX Health GmbH

Partner
Schrack & Partner

Head of Digital Infrastructure & IT-Services (CIO)
DIN e.V.

Head of Notified Body (non-active medical devices)
DQS Medizinprodukte GmbH

Board Member
RAPS Germany

Principal Consultant & Head of Medical Devices
Entourage GmbH

Vice President
EXTEDO GmbH

Co-Founder / Speaker of the Board / Co-Founder & Managing Partner
Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH

Associate Director/Principal Scientist
Argenx

Clinical Evaluation Expert / Auditor
SLG Prüf- und Zertifizierungs GmbH

Founder and Managing Director
Phortas GmbH

Consultant
Benefits Regulatory Consulting

Technical Manager, Medical Device International
TÜV NORD CERT

Professor for Regulatory Affairs
Technische Hochschule Lübeck Fachbereich Angewandte Naturwissenschaften

Project Manager IVD Medical Device Testing
TÜV SÜD

Managing Director
PRO-LIANCE GLOBAL SOLUTIONS GmbH

Senior Director Strategic Business Development
TÜV SÜD Medical & Health Services

CEO
Cisema

Regulatory Affairs Associate
Parexel International India Safety Services Private Limited

Regulatory Compliance Consultant
Compliance and risks

Partner
Mason Hayes & Curran LLP

Associate Director Regulatory Affairs
CAI

Executive Committee -Secretary
NBCG-Med - Notified Body Coordination Group

Senior Quality Manager, Global Digital Health
Boston Scientific

Regulatory Affairs and IP Director
Regulatory Affairs and IP Director

Head of Clinical, Quality and Regulatory
Corcym

Internal Clinical Expert – Kiwa Cermet Italia NB 0476
Kiwa

Regulatory Lead
BSI

Executive Director & Partner
QServe Group B.V.

Senior Regulatory Affairs Specialist
EMA

Clinical Product Reviewer
Kiwa Dare

Head of Scientific Advice
European Medicines Agency

Principal Scientific Administrator
European Medicines Agency

Director Product Security
Royal Philips

Regulatory Strategy Principal
TÜV SÜD Medical Health Service

Director Governmental Affairs EU
Elekta

Regulatory Affairs Manager
Starodub BV

Head of IVD Notified Body
BSI

Head of Clinical Operations
QServe Group

Consultant
Qserve

Consultant / Clinical writer
Qserve

Principal Consultant
Medical Device Project B.V.

Teammanager Innovation Support Office Medical Technology
Erasmus MC

Senior Consultant QA/RA
Medical Device Project B.V.

Sr. Global Regulatory Intelligence & Advocacy Manager
Boston Scientific

CEO / senior consultant
mi-CE consultancy

Head of Product Cluster, Regulatory Affairs Marketed Products Strategy
Alexion Astra Zeneca Rare Diseases

Principal Consultant
Arriello

Group IVDR Manager
Unilabs

Director Regulatory + Quality Intelligence
Ypsomed AG

Patient Advocate
International Porphyria Patient Network (IPPN)

Regulatory Senior Program Director
F. Hoffmann-La Roche Ltd

Founder and CEO
MD-CLINICALS SA

RA & Quality consultant in Life Sciences
Founder of Waypoint Consulting

Global Regulatory Affairs, Associate Director
Pharmaceutcial

Director, Global Post-Market Surveillance
Smith+Nephew

Vice President Regulatory Affairs
Teva Pharmaceuticals

Manager, Intelligence and Strategic Execution
RQM+

Director, Clinical Trials Regulatory
IQVIA

Principal Regulatory Consultant
DLRC

PMCF Manager
Purdie Pascoe

Vice President, IVD Regulatory Affairs - Europe
MCRA

Scientific Advisor - Science Policy and Research Programme
National Institute for Health and Care Excellence

Director, Regulatory Affairs UK
Edwards Lifesciences

Director Regulatory Strategy
Veeva Systems

VP Regulatory
BSI

Global Head, IVD
BSI

EU Regulatory Policy Lead
Gilead

Senior Director, Global Regulatory Strategy
Fortrea

Senior Manager, Regulatory and Quality
NAMSA

Global Head, Medicinal & Biologics Team
BSI Group

Regulatory Director & Head of Medical Devices Notified Body
BSI

Technical Specialist & Scheme Manager
BSI

Vice President Advisory Services
G&L Healthcare Advisors

CEO & Founder
Elemed

Head of Regulatory Science & Policy EU/AMEE
Sanofi

Principal Regulatory Consultant
NAMSA

Clinical Regulatory Lead
BSI

Regulatory Intelligence Lead EU
UCB

Head of Approved Body
TUV SUD

Principal Regulatory Consultant
NAMSA

Vice President Technical
Parexel

Director, Regulatory Affairs
Smith+Nephew

Head of the UK Approved Body
BSI

PMCF / MDR Lead
Purdie Pascoe

Senior Director, IVD Regulatory Affairs
Precision for Medicine

Sr. Regulatory Affairs Specialist
Aignostics

Regulatory Services Manager
Certara

Director, IVD Global Regulatory Affairs
RQM+

Director Global Strategic business Development IVD
TÜV SÜD

Senior Manager - Quality, Standards & Regulations
Philips

Senior Vice President, Regulatory Affairs
Asher Biotherapeutics, Inc.

Partner
Bristows LLP

Vice President, Regulatory Affairs
Boston Scientific

Regulatory Lead
BSI

Principal
China Med Device, LLC

Global Heal of Clinical Compliance
Notified Body (BSI)

Principal Consultant
Qserve Group

Clinical Compliance Manager
BSI

Senior Key expert AI and Regulatory affairs Manager
Siemens Healthineers

CEO
MedSec LLC

Head of Sectors Ibec, Director Irish MedTech Association,incoming Director BioPharmaChemical Ireland
IBEC

Senior Director, Strategy Product Development Solutions
PharmaLex

Global Head of HTA Strategy
Sanofi

Principal Medical Device Regulatory Expert
Hyman, Phelps & McNamara, P.C.

CEO & Founder
Essenvia

Regulatory Lead
BSI

Senior Editor, Features
Regulatory Affairs Professionals Society

Regulatory Affairs Specialist
Merative

Director of Credentialing
RAPS

Director of Regulatory and Technical Programs
Rimsys

Sr. Director Global Government Affairs
Veeva Systems

Senior Science Lead
3D Communications

Regulatory and Clinical Expert
PRO-LIANCE GLOBAL SOLUTIONS GmbH

Vice President of Regulatory Affairs Transformation
Essenvia

Global Head of Regulatory Affairs, Core Lab
Roche Diagnostics GmbH

Chief Regulatory Innovation Officer
Accumulus Synergy

Expert
RAPS BoD

Sr. Software Quality Engineer
MEDIcept, Inc.

Senior Associate
Axon Lawyers

Director, Regulatory Innovation & International Policy Lead
Accumulus Synergy

Partner
Axon Lawyers

Senior Vice President of Medical Health Services (global)
TUV SUD Product Services

Regulatory Affairs consultant
self employed

Medical Device Consultant
FSQ Experts