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1 MED
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3D Communications
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Abbott
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Accestra Consulting Company
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Wang, April
Regulatory Affairs Manager
Accestra Consulting Company
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Accumulus Synergy
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CV
Vinces, Cesar
Director, Regulatory Innovation & International Policy Lead
Accumulus Synergy
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Aetion
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Aignostics
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Alexion Astra Zeneca Rare Diseases
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Caturla Goni, Merce
Head of Product Cluster, Regulatory Affairs Marketed Products Strategy
Alexion Astra Zeneca Rare Diseases
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Argenx
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Arriello
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Asher Biotherapeutics, Inc.
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Cross, James
Senior Vice President, Regulatory Affairs
Asher Biotherapeutics, Inc.
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Axon Lawyers
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Bayer Plc
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Benefits Regulatory Consulting
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BioNTech SE
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BioSciPons
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Boston Scientific
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Bristows LLP
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BSI
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BSI Group
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Bsi Group The Netherlands
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Pérez Ruiz, Inma
Artificial Intelligence Regulatory Lead
Bsi Group The Netherlands
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CAI
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CAMD
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Celegence
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Certara
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China Med Device, LLC
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Cisema
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Complear
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Compliance and risks
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Corcym
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Danish Medicines Agency
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Dedalus
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DIN e.V.
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DIN Media (formerly Beuth Verlag)
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Bergander, Sven
Head of department platforms & processes
DIN Media (formerly Beuth Verlag)
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DLRC
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DQS Medizinprodukte GmbH
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Kurdyn, Szymon
Head of Notified Body (non-active medical devices)
DQS Medizinprodukte GmbH
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Dutch Health and Youth Care Inspectorate
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Edwards Lifesciences
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EFPIA
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ekwithree GmbH
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Elekta
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Elemed
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Else Kröner Fresenius Center for Digital Health
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Gilbert, Stephen
Professor of Medical Device Regulatory Science
Else Kröner Fresenius Center for Digital Health
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EMA
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Dias, Monica
Head of Supply and Availability of medicines and medical devices
EMA
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Entourage GmbH
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Neff, Jennifer
Principal Consultant & Head of Medical Devices
Entourage GmbH
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Erasmus MC
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Escentia GmbH
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Essenvia
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Roy, Dhriti
Vice President of Regulatory Affairs Transformation
Essenvia
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European Commission
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European Commission - Directorate-General for Health and Food Safety
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PP
Piscoi, Paul
Policy Officer - Unit D.3: Medical Devices
European Commission - Directorate-General for Health and Food Safety
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European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
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Tkachenko, Olga
Policy Officer
European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
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European Medicines Agency
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Berntgen, Michael
Head of Scientific Evidence Generation Department
European Medicines Agency
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Ganan, Alberto
Head of Committees and Quality Assurance Department
European Medicines Agency
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European Patients' Forum
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EXTEDO GmbH
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F. Hoffmann-La Roche Ltd
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Gass, Nathalie
Regulatory Senior Program Director
F. Hoffmann-La Roche Ltd
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F.Hoffmann-La Roche, Ltd.
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Federal Ministry of Health Germany
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OS
Schulte, Ortwin
Head of Unit 124 – Medical Devices Safety
Federal Ministry of Health Germany
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Fortrea
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Jain, Sanjay
Senior Director, Global Regulatory Strategy
Fortrea
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Foundation of Borys the Hero
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Founder of Waypoint Consulting
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Klasen, Eric
RA & Quality consultant in Life Sciences
Founder of Waypoint Consulting
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Fraunhofer IMTE
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Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE
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Aykurt, Ozan
Research Scientist in Regulatory Affairs for (AI/ML-enabled) Digital Health Solutions
Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE
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Fresenius Kabi Deutschland GmbH
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Kuhtz, Juliane
Manager Regulatory Affairs
Fresenius Kabi Deutschland GmbH
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FSQ Experts
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G&L Healthcare Advisors
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Kuiken, Paul
Vice President Advisory Services
G&L Healthcare Advisors
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Gilead
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GMED
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GMED SAS
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Greenlight Guru
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Hyman, Phelps & McNamara, P.C.
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Lenz, Adrienne
Principal Medical Device Regulatory Expert
Hyman, Phelps & McNamara, P.C.
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IBEC
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SK
Keogh, Sinead
Head of Sectors Ibec, Director Irish MedTech Association,incoming Director BioPharmaChemical Ireland
IBEC
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Immunotech SAS (Beckman Coulter)
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International Pharmaceutical Quality (IPQ) Publications (formerly MHRA)
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JJ
Jamieson, Janine
European Editor
International Pharmaceutical Quality (IPQ) Publications (formerly MHRA)
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International Porphyria Patient Network (IPPN)
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IQVIA
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J&J
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Johner Institut GmbH
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Johnson & Johnson MedTech
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khhconsulting
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Kiwa
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Kiwa Dare
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Mason Hayes & Curran LLP
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MBM Future Health, AMNOG Advisory Services
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MCRA
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Conway, Erica
Vice President, IVD Regulatory Affairs - Europe
MCRA
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MD-CLINICALS SA
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MedBoard
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MED-EL
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MedEnvoy Global
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Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH
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Panten, Sarah
Co-Founder / Speaker of the Board / Co-Founder & Managing Partner
Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH
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Medical Device Project B.V.
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MEDIcept, Inc.
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MedSec LLC
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MedTech Europe
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Merative
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mi-CE consultancy
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Namsa
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National Institute for Health and Care Excellence
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Cresswell, Katharine
Scientific Advisor - Science Policy and Research Programme
National Institute for Health and Care Excellence
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NBCG-Med - Notified Body Coordination Group
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Patten, Tom
Executive Committee -Secretary
NBCG-Med - Notified Body Coordination Group
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nexialist
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Northeastern University
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Notified Body (BSI)
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Novartis
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Olympus Surgical Technologies Europe
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Huebner, Stephanie
Manager Third Party (OEM) Therapeutic Solutions Division, Regulatory Affairs
Olympus Surgical Technologies Europe
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Oxford Endovascular Ltd
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Parexel
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Parexel International India Safety Services Private Limited
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Chakrabarti, Sarbajit
Regulatory Affairs Associate
Parexel International India Safety Services Private Limited
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Pearl Pathways
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Pharmaceutcial
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Liu, Yingying
Global Regulatory Affairs, Associate Director
Pharmaceutcial
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PharmaLex
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PL
Larcier, Patrick
Senior Director, Strategy Product Development Solutions
PharmaLex
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Philips
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Cobbaert, Koen
Senior Manager - Quality, Standards & Regulations
Philips
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Phortas GmbH
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Precision for Medicine
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Ansari, Maham
Senior Director, IVD Regulatory Affairs
Precision for Medicine
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PRO-LIANCE GLOBAL SOLUTIONS GmbH
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Bajagic, Milica
Scientific and Software Expert
PRO-LIANCE GLOBAL SOLUTIONS GmbH
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Rohrberg, Julia
Regulatory and Clinical Expert
PRO-LIANCE GLOBAL SOLUTIONS GmbH
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Purdie Pascoe
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Qarad
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QARALOGIC
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Qserve
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Qserve Group
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QServe Group B.V.
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QUESTALPHA GmbH & Co. KG
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von Rüden, Martin
Regulatory Affairs Manager / Director Research
QUESTALPHA GmbH & Co. KG
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RAPS
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RAPS BoD
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RAPS Germany
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RegDesk, Inc.
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Regulatory Affairs and IP Director
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Vider Cohen, Taly
Regulatory Affairs and IP Director
Regulatory Affairs and IP Director
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Regulatory Affairs Professionals Society
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RM
Matthews, Renee
Senior Editor, Features
Regulatory Affairs Professionals Society
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Rimsys
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Price, Adam
Director of Regulatory and Technical Programs
Rimsys
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Roche Diagnostics GmbH
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Scheib, Stefan
Global Head of Regulatory Affairs, Core Lab
Roche Diagnostics GmbH
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RoX Health GmbH
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Kassner, Anja
Regulatory Affairs and Project Manager
RoX Health GmbH
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Royal Philips
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RQM+
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Ball, Ed
Manager, Intelligence and Strategic Execution
RQM+
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Sandoz
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Sanofi
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Schrack & Partner
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self employed
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self-employed
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SGS Notified Body, 1639
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Siemens Healthineers
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Johri, Abhineet
Senior Key expert AI and Regulatory affairs Manager
Siemens Healthineers
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SLG Prüf- und Zertifizierungs GmbH
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Richter, Tina
Clinical Evaluation Expert / Auditor
SLG Prüf- und Zertifizierungs GmbH
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Smith+Nephew
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Starodub BV
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TÜV NORD CERT
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TÜV NORD CERT GmbH
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TÜV SÜD
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Burde, Stefan
Director Global Strategic business Development IVD
TÜV SÜD
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TÜV SÜD Medical & Health Services
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Witte, Martin
Senior Director Strategic Business Development
TÜV SÜD Medical & Health Services
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TÜV SÜD Medical Health Service
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TÜV Verband
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Technische Hochschule Lübeck Fachbereich Angewandte Naturwissenschaften
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Spitzenberger, Folker
Professor for Regulatory Affairs
Technische Hochschule Lübeck Fachbereich Angewandte Naturwissenschaften
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Teleflex Medical
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Ryan, Caroline
Clinical Manager Global Scientific Affairs
Teleflex Medical
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Teva Pharmaceuticals
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Trinity College Dublin
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Melvin, Tom
Associate Professor of Medical Device Regulatory Affairs
Trinity College Dublin
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TUV SUD
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TUV Sud GmbH
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TUV SUD Product Services
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von Hahn, Royth P.
Senior Vice President of Medical Health Services (global)
TUV SUD Product Services
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UCB
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Unilabs
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Veeva Systems
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Racic, Amra
Sr. Director Global Government Affairs
Veeva Systems
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Vita Green Group
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von basum consulting
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W. L Gore & Associates
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Ypsomed AG
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