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1MED SA
-
-
Abbott
-
Martins, Joao
Director of Regulatory Affairs
Abbott
Amadora, Lisboa, Portugal
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ACT-IVD
-
Meurant, Robyn
Founder, Principal Consultant
ACT-IVD
Bougival, Ile-de-France, France
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Aesculap AG
-
-
Agency for Medicinal Products and Medical Devices (HALMED)
-
IM
Malnar, Ivica
Agency for Medicinal Products and Medical Devices (HALMED)
-
AKRA Team GmbH
-
-
Alexion/AstraZeneca
-
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ANDO Portugal - National Association for Skeletal Dysplasias
-
Alves, Inês
School of Health and Human Development - University of Évora
ANDO Portugal - National Association for Skeletal Dysplasias
Portugal
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Artos AI
-
JK
Kim, Josh
CEO
Artos AI
San Francisco, California
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Astellas
-
-
AstraZeneca
-
-
AstraZeneca
-
-
AstraZeneca
-
Lenic, Ines
Regulatory Affairs Director - EU
AstraZeneca
-
avasis solutions GmbH / Medical Device Knowledge Unit e.V.
-
Panten, Sarah
Co-Founder & Managing Partner / Board Member
avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Hamburg, Hamburg
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Axon Lawyers
-
-
-
Bausch + Lomb
-
Conardy, Brandi
Manager of Regulatory Affairs - Medical Devices
Bausch + Lomb
Saint Charles, Missouri
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Benefits Regulatory Consulting
-
Schmidt, Beate R.
Consultant
Benefits Regulatory Consulting
Mannheim, Baden-Wurttemberg, Germany
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Be-on-Quality GmbH
-
LS
Schälter, Lisa
Business Area Lead for IVD & Combination, Tissue and Substance-Based Medical Devices
Be-on-Quality GmbH
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Beyond Conception
-
-
Biochemical Systems International S.p.A.
-
Cipolleschi, Luigi
Quality Manager / RA Specialist
Biochemical Systems International S.p.A.
Arezzo, Toscana, Italy
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Biologics Consulting Group, Inc.
-
-
BioSciPons
-
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Brainlab SE
-
Kowalski, Dominik
R&D Project Manager / Regulatory Compliance
Brainlab SE
Ebersberg, Bayern, Germany
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Brooke & Associates
-
-
Brunel University of London
-
-
BSI
-
Halliday, Suzanne
VP Regulatory, Global Regulatory Compliance
BSI
Milton Keynes, England, United Kingdom
-
-
Jeary, Theresa
Global Head, Medicinal & Biologics Team
BSI
Milton Keynes, England, United Kingdom
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-
-
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O'Callaghan, Sean
IVD Technical Specialist and Scheme Manager
BSI
Milton Keynes, United Kingdom
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Palm, Sofia
Regulatory Lead
BSI
Milton Keynes, England, United Kingdom
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-
-
BSI Group
-
-
Fabi, Sara
Regulatory Lead
BSI group
Rome, Lazio, Italy
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BSI Notified Body
-
Pinsi, Maddalena
Associate Head of Medical Devices Notified Body
BSI Notified Body
Milano, Lombardia, Italy
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Carl Zeiss Vision International GmbH
-
-
Carthera
-
-
CCMO
-
-
Celegence
-
-
Cencora
-
-
-
Centre for Medical Devices Certification, Czech Metrology Institute
-
PB
Bratka, Petr (he/him/his)
Head of Preclinical Evaluation Dept., Product Reviewer
Centre for Medical Devices Certification, Czech Metrology Institute
Praha 4, Hlavni mesto Praha, Czech Republic
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CEROM - https://www.irst.emr.it/it/ricerca-e-innovazione/comitato-etico-della-romagna
-
RC
Camillini, Roberto
Ethical Committee member (IT)
CEROM - https://www.irst.emr.it/it/ricerca-e-innovazione/comitato-etico-della-romagna
Italy
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CertHub GmbH
-
-
China Med Device
-
-
Cisema
-
-
Complear
-
MA
Amador, Miguel
Partner and Chief Technology and Innovation Officer
Complear
-
-
Compliance-Connextions Limited
-
Spencer, Sue
Director
Compliance-Connextions Limited
Farnborough, England, United Kingdom
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confinis
-
-
Curiolis, Inc.
-
-
Danish Medicines Agency (DKMA)
-
-
Dedalus
-
-
-
Dedalus Italia
-
-
DEKRA Certification B.V.
-
-
McKenzie, Jean
Cluster Manager: Cardiovascular
DEKRA Certification B.V.
-
Department of Applied Economics, University of Granada, Spain
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-
Ecker + Ecker GmbH
-
-
Edwards Lifesciences Sarl
-
-
EFPIA
-
-
EFPIA ERAO and Device Group
-
TM
Møller, Thomas Wejs
Senior Director, Global Regulatory Affairs, Novo Nordisk
EFPIA ERAO and Device Group
SØBORG, Denmark
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Elemed
-
-
Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
-
Gilbert, Stephen (he/him/his)
Professor of Medical Device Regulatory Science
Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Dresden
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Else Kröner Fresenius Center for Digital Health, TU Dresden
-
-
Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology
-
CW
Welzel, Cindy
PostDoc
Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology
Germany
-
Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
-
Freyer, Oscar (he/him/his)
Research Associate
Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Dresden, Sachsen, Germany
-
Ostermann, Max
Research Associate
Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Dresden, Germany
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EMA
-
-
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Ennov
-
-
European Medicines Agency
-
-
-
Ganan, Alberto
Head of Committees and Quality Assurance Department
European Medicines Agency
-
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KI
Immonen, Kaisa
Patient and Consumer Liaison
European Medicines Agency
Netherlands
-
-
-
Scanlan, Elizabeth
Scientific Communication Officer
European Medicines Agency
1083 HS Amsterdam, Netherlands
-
Segec, Andrej (he/him/his)
Scientific administrator, DARWIN EU® Studies Coordinator
European Medicines Agency
Amsterdam, Noord-Holland, Netherlands
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European Medicines Agency (EMA)
-
-
-
-
-
-
-
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Flok Health
-
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Fraunhofer IPA
-
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Fresenius Medical Care Deutschland GmbH
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Genedrive Diagnostics
-
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GlobalVision
-
-
GMED
-
-
-
GMED, France
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-
GMP Advisory Services
-
SC
Clerkin, Seb
Director of Operations and Principle Consultant
GMP Advisory Services
Cork, Cork, Ireland
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GSK
-
-
Heraeus Medical GmbH
-
Hirte, Sonja
Clinical Evaluation Manager
Heraeus Medical GmbH
-
-
HMC-regulation
-
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HOYA SURGICAL OPTICS
-
-
IGES Institut GmbH
-
-
Immatics
-
Batty, Natalie
Senior Regulatory Affairs Specialist
Immatics
Bonn, Nordrhein-Westfalen, Germany
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INFARMED
-
-
INFARMED – National Authority of Medicines and Health Products, I.P.
-
MM
Marcelino, Marta
INFARMED – National Authority of Medicines and Health Products, I.P.
-
RS
Santos Ivo, Rui
President / Chair, Management Board EMA
INFARMED – National Authority of Medicines and Health Products, I.P.
-
BS
Sepodes, Bruno
INFARMED – National Authority of Medicines and Health Products, I.P.
-
Institute for Clinical Trials, University of Galway
-
TM
Melvin, Tom
Associate Professor in Medical Device Regulatory Science
Institute for Clinical Trials, University of Galway
Ireland
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Johner Institut GmbH
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LH
Holub, Leon
Product Owner Regulatory Radar
Johner Institut GmbH
-
-
Johnson & Johnson
-
-
-
KD&A
-
-
Kenvue
-
-
Kiwa Assurance
-
Cuper, Natascha J.
Product Reviewer / Internal Clinician
Kiwa Assurance
Woerden, Utrecht, Netherlands
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Kiwa Cermet Italia
-
-
Komorebi Ltd
-
Slater, Katy
Regulatory Director
Komorebi Ltd
Selby, England, United Kingdom
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Lucendra SA
-
-
MDSS GmbH
-
-
MDx CRO
-
-
MED-EL
-
-
MedEnvoy Global BV
-
-
Medical Device Project B.V.
-
van Boxtel, Robert A.
Principal Consultant
Medical Device Project B.V.
Alphen a/d Rijn, Zuid-Holland, Netherlands
-
Medicines and Healthcare Products Regulatory Agency
-
-
-
Medicines and Healthcare products Regulatory Agency (MHRA)
-
CC
Cacou, Crina (she/her/hers)
Head of Clinical Investigations and Trials Operations
Medicines and Healthcare products Regulatory Agency (MHRA)
London , United Kingdom
-
HC
Coole, Holly
Senior Manager Digital Mental Health
Medicines and Healthcare Products Regulatory Agency (MHRA)
London, England, United Kingdom
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MedQAIR
-
-
MedSec LLC
-
-
MedTech
-
Racic, Amra
Vice President - Global Government Strategy
MedTech
Plesanton, California
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Metecon GmbH
-
-
-
-
MHRA
-
-
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Miltenyi Biotec B.V. & Co. KG
-
-
Molgenium
-
-
MSC MED Engenharia e Tecnologia Médica Ltda.
-
-
MSC MED ENGENHARIA E TECNOLOGIA MEDICA
-
-
MSD
-
-
NAMSA
-
-
Miramond, Thomas
Senior Regulatory Consultant
NAMSA
Paris 19 Buttes-Chaumont, Ile-de-France, France
-
-
nexialist
-
Delorme, Corinne
Regulatory Intelligence Director
nexialist
La Ciotat, Provence-Alpes-Cote d'Azur, France
-
NICE
-
-
North Lisbon University Hospital Centre (ULS Santa Maria)
-
MC
Carvalho, Mafalda
Clinical Innovation Office Director
North Lisbon University Hospital Centre (ULS Santa Maria)
Portugal
-
Novo Nordisk
-
Oyinloye, Ola
Regulatory Science Director
Novo Nordisk
United Kingdom
-
-
OncoFlow
-
-
osapiens / BYRD.Health
-
-
Parexel
-
Craig, Michael
Vice President (Technical)
Parexel
Enniscrone, Sligo, Ireland
-
Nick, Cecil J.
Vice President (Technical)
Parexel
Ashtead, Surrey, England, United Kingdom
-
Parexel International
-
Murray, David
Vice President - Technical, Parexel Consulting (PC).
Parexel International
-
Pharmalex
-
-
Philips
-
VA
Almeida, Vanda
Responsible AI Clinical Lead
Philips
Eindhoven, Noord-Brabant, Netherlands
-
-
Philips Healthcare
-
-
Phortas GmbH
-
-
Platomics
-
-
Precision for Medicine
-
Ansari, Maham
Senior Director, Regulatory Affairs
Precision for Medicine
Frederick, Maryland
-
ProductLife Group
-
-
PRO-LIANCE Global Solutions GmbH
-
-
Tolkmitt, Florian
Managing Director
PRO-LIANCE GLOBAL SOLUTIONS GmbH
Frankfurt am Main, Hessen, Germany
-
Proud Lion Services
-
-
Purdie Pascoe
-
-
Torr, Marcus
Head of Post Market Surveys
Purdie Pascoe
London, United Kingdom
-
QbD Group
-
Fry, Peter (he/him/his)
Business Unit Manager, Pharma Regulatory Affairs & Country Manager, UK
QbD Group
Chalgrove, England, United Kingdom
-
Obolskiy, Dmitry
Associate Director Regulatory Affairs
QbD Group
England, United Kingdom
-
QbD Group NV
-
-
Qserve Consultancy
-
-
QServe Group
-
-
-
-
Sarwin, Dennis
Team Manager Global Registrations & Consultant
Qserve Group
Netherlands
-
RAPS
-
Fulton, Denise
Vice President, Research & Content Strategy
RAPS
Rockville , Maryland
-
-
-
regenold GmbH
-
-
Regulatory Affairs Professionals Society
-
TY
Young, Tricia
Manager
Regulatory Affairs Professionals Society
Rockville, Maryland
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REMATIQ
-
-
Rimsys Inc.
-
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Roche
-
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RQM+
-
-
Chung, Bethany
Director of Technical Solutions and Innovation
RQM+
Cary, North Carolina
-
-
RTI
-
Levi, Mark
Director of Regulatory Affairs
RTI
RTP, North Carolina
-
Sanofi
-
Clemente, Amaia
Regulatory Science and Policy Associate Director
Sanofi
Spain
-
-
Faber, Sabine
Senior Regulatory Affairs Manager, Labeling
Sanofi
Berlin, Berlin, Germany
-
-
Huret, Béatrice
Europe Regulatory Expert, Global Regulatory Affairs
Sanofi
Marcy L Etoile, France
-
-
Sanofi R&D Vaccins
-
Desert, Paul (he/him/his)
Global Head of Non clinical Safety & Predictive Sciences
Sanofi R&D Vaccins
Marcy L Etoile, Rhone-Alpes, France
-
Schrack & Partner
-
-
Scilife
-
-
Smith+Nephew
-
-
-
Thain, Darren J.
Director, Global Regulatory Policy and Intelligence
Smith+Nephew
Watford, England, United Kingdom
-
Swissmedic
-
-
Swissmedic, Swiss Agency for Therapeutic Products
-
-
Synex Consulting Ltd.
-
Kim, Young
CEO & Principal Consultant
Synex Consulting Ltd.
Seoul, Seoul-t'ukpyolsi
-
TÜV Rheinland
-
-
TÜV Rheinland LGA Products GmbH, Notified Body 0197
-
EB
Bess, Elke (she/her/hers)
Auditor / Product Assessor
TÜV Rheinland LGA Products GmbH, Notified Body 0197
Cologne, Nordrhein-Westfalen, Germany
-
TÜV SÜD
-
-
CB
Beulshausen, Christine
Global Expertise Manager Clinical Audit at TÜV SÜD, Project Manager MedTech GCP Service
TÜV SÜD
-
-
Kirkman, Matthew
Clinical Reviewer and Senior Product Specialist for Clinical Data
TÜV SÜD
France
-
-
TÜV SÜD Medical Health Services
-
Hoekstra, Sabina L.
Global Director Regulatory Strategy
TÜV SÜD Medical Health Services
Munich, Bayern, Germany
-
TÜV SÜD Product Service
-
Fischer, Sebastian
Regulatory Strategy Principal
TÜV SÜD Product Service
Munich, Bayern, Germany
-
TÜV SÜD Product Services
-
-
TUV SUD
-
-
Surash, Surash
Medico-Legal Expert Witness
TUV SUD
Hampshire, England, United Kingdom
-
University of Birmingham
-
-
University of Lisbon, Faculty of Sciences
-
-
USP
-
AC
Cadwallader, Amy
Director, Regulatory and Public Policy Development and Quality Institute
USP
-
-
Vera Rosas Group
-
-
Vorsa
-
-
W. L. Gore & Associates
-
Tabutin, Sophie
EMEA/LATAM Regulatory Affairs Leader
W. L. Gore & Associates
Le Cannet, France
-
Whitney Consulting Ltd.
-
-
Zimmer Biomet
-
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.jpg "Van Garsse, Kirsten (she/her/hers) photo")
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.jpg "Desert, Paul (he/him/his) photo")
.jpg "Abdurrahman, Goran (he/him/his) photo")
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.jpg "Verrone, Patricia Luchiari. (she/her/hers) photo")
