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Learning Level: Advanced
Learning Level: Expert
Learning Level: Foundational
Learning Level: Intermediate
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Speaker List
Speaker List
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Names
Organization
City
State
Country
Australia
Dent, Kea (she/her/hers)
Director
KD&A
Balgowlah Heights, New South Wales, Australia
Favorite
Austria
Carrão, Catarina
CES
BioSciPons
Vienna, Wien, Austria
Favorite
Oberleitner, Andreas (he/him/his)
Chief Regulatory Officer
Platomics
Wien, Austria
Favorite
Reichmann, Patrick (he/him/his)
Quality Assurance and Regulatory Affairs Manager
Dedalus
Wien, Wien, Austria
Favorite
Belgium
Belonogova, Marina (she/her/hers)
Associate Director, Global Regulatory Affairs
Johnson & Johnson
Vlaams-Brabant, Belgium
Favorite
Cobbaert, Koen (he/him/his)
Senior Manager Regulatory Science & Policy
Philips
Brussels, Belgium
Favorite
Kwade, Zuzanna (she/her/hers)
Software Clinical Evaluation Manager
Dedalus
Berchem, Antwerpen, Belgium
Favorite
Madokoro, Marina (she/her/hers)
Regulatory Affair Manager
Johnson & Johnson
Diegem, Vlaams-Brabant, Belgium
Favorite
Van Garsse, Kirsten (she/her/hers)
Business Unit Manager RA IVD & Representative Services
QbD Group NV
Wilrijk, Antwerpen, Belgium
Favorite
Brazil
da Silva Pérez, Patrícia
Team Manager Medical Writing & Sr. Consultant
Qserve Group
Curitiba, Parana, Brazil
Favorite
Korndorfer, Heitor M A.
CEO
MSC MED ENGENHARIA E TECNOLOGIA MEDICA
Curitiba, Parana, Brazil
Favorite
Oliveira, Bruno J S. (he/him/his)
CMO
MSC MED Engenharia e Tecnologia Médica Ltda.
Araraquara, Brazil
Favorite
Verrone, Patricia Luchiari. (she/her/hers)
Regulatory Affairs Manager
Vera Rosas Group
Sao Paulo, Sao Paulo, Brazil
Favorite
Canada
Lehoczki, Arpad (he/him/his)
Vice President, Sales
GlobalVision
Kirkland, Quebec, Canada
Favorite
Czech Republic
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
Favorite
Denmark
TM
Møller, Thomas Wejs
Senior Director, Global Regulatory Affairs, Novo Nordisk
EFPIA ERAO and Device Group
SØBORG, Denmark
Favorite
Sandager, Jacob Moberg (he/him/his)
Senior Circular Plastic Engineer
Novo Nordisk
Søborg, Denmark
Favorite
Finland
Riihimäki, Tiina A. (she/her/hers)
Director, Service Line Lead MedTech Europe
Cencora
Vantaa, Uusimaa, Finland
Favorite
France
Berger, Guillaume
Deputy Manager - IVD Department
GMED
France
Favorite
Bisch, Gaëlle (she/her/hers)
Product Assessor
GMED, France
Ile-de-France, France
Favorite
Delorme, Corinne
Regulatory Intelligence Director
nexialist
La Ciotat, Provence-Alpes-Cote d'Azur, France
Favorite
Desert, Paul (he/him/his)
Global Head of Non clinical Safety & Predictive Sciences
Sanofi R&D Vaccins
Marcy L Etoile, Rhone-Alpes, France
Favorite
ED
Douceron, Estelle (she/her/hers)
Senior Consultant
RQM+
Rhone-Alpes, France
Favorite
Finocchio, Melissa (she/her/hers)
CEO & Founder
Proud Lion Services
Lyon, France
Favorite
Gervais, Anne (she/her/hers)
Global Regulatory Lead • Rare Diseases
Sanofi
La Tour de Salvagny, France
Favorite
Huret, Béatrice
Europe Regulatory Expert, Global Regulatory Affairs
Sanofi
Marcy L Etoile, France
Favorite
Kirkman, Matthew
Clinical Reviewer and Senior Product Specialist for Clinical Data
TÜV SÜD
France
Favorite
Meurant, Robyn
Founder, Principal Consultant
ACT-IVD
Bougival, Ile-de-France, France
Favorite
Miramond, Thomas
Senior Regulatory Consultant
NAMSA
Paris 19 Buttes-Chaumont, Ile-de-France, France
Favorite
Tabutin, Sophie
EMEA/LATAM Regulatory Affairs Leader
W. L. Gore & Associates
Le Cannet, France
Favorite
Thiollière, Sandra (she/her/hers)
Director of Regulatory Affairs
Carthera
Rhone-Alpes, France
Favorite
Voelksen, Rainer
Consultant
France
Favorite
Germany
Abdurrahman, Goran (he/him/his)
Senior IVD Product Specialist
TÜV Rheinland
Nordrhein-Westfalen, Germany
Favorite
Avci, Okan (he/him/his)
Group Leader
Fraunhofer IPA
Stuttgart, Baden-Wurttemberg, Germany
Favorite
Batty, Natalie
Senior Regulatory Affairs Specialist
Immatics
Bonn, Nordrhein-Westfalen, Germany
Favorite
EB
Bess, Elke (she/her/hers)
Auditor / Product Assessor
TÜV Rheinland LGA Products GmbH, Notified Body 0197
Cologne, Nordrhein-Westfalen, Germany
Favorite
Blocher, Mandy (she/her/hers)
Global Regulatory Affairs
Aesculap AG
Tuttlingen, Baden-Wurttemberg, Germany
Favorite
Carnielli, Marta
Head of certification IVD
TUV SUD
munich, Bayern, Germany
Favorite
Ecker, Thomas (he/him/his)
CEO
Ecker + Ecker GmbH
Hamburg, Germany
Favorite
Faber, Sabine
Senior Regulatory Affairs Manager, Labeling
Sanofi
Berlin, Berlin, Germany
Favorite
Fischer, Sebastian
Regulatory Strategy Principal
TÜV SÜD Product Service
Munich, Bayern, Germany
Favorite
Freyer, Oscar (he/him/his)
Research Associate
Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Dresden, Sachsen, Germany
Favorite
Friedrich, Julia (she/her/hers)
Associate Director Post-Market Surveillance
Miltenyi Biotec B.V. & Co. KG
Germany
Favorite
Gerbsch, Norbert (he/him/his)
Head of Dept. Public Affairs
IGES Institut GmbH
Berlin, Berlin, Germany
Favorite
Hammermueller, Leslie (she/her/hers)
Senior Clinical Consultant
AKRA Team GmbH
Landsberg am Lech, Bayern, Germany
Favorite
Hoekstra, Sabina L.
Global Director Regulatory Strategy
TÜV SÜD Medical Health Services
Munich, Bayern, Germany
Favorite
Kasper, Grit (she/her/hers)
Senior Consultant
Metecon GmbH
Mannheim, Baden-Wurttemberg, Germany
Favorite
Kiesselbach, Christoph (he/him/his)
Partner
Schrack & Partner
Reutlingen, Baden-Wurttemberg, Germany
Favorite
Kowalski, Dominik
R&D Project Manager / Regulatory Compliance
Brainlab SE
Ebersberg, Bayern, Germany
Favorite
Matern, Sanja (she/her/hers)
Director Regulatory Information Management
Fresenius Medical Care Deutschland GmbH
Bad Homburg, Hessen, Germany
Favorite
Mathias, Rebecca (she/her/hers)
Research Associate
Else Kröner Fresenius Center for Digital Health, TU Dresden
Dresden, Sachsen, Germany
Favorite
Moeller, Ludger (he/him/his)
CEO
MDSS GmbH
Hannover, Niedersachsen, Germany
Favorite
Möller, Claudia (she/her/hers)
Post-Market Surveillance Expert
Metecon GmbH
Mannheim, Germany
Favorite
Namdjou, Darius-Jean (he/him/his)
Director, Senior Regulatory Lead
Phortas GmbH
Aachen, Nordrhein-Westfalen, Germany
Favorite
Ostermann, Max
Research Associate
Else Kröner Fresenius Center for Digital Health,TUD Dresden University of Technology
Dresden, Germany
Favorite
Schmidt, Beate R.
Consultant
Benefits Regulatory Consulting
Mannheim, Baden-Wurttemberg, Germany
Favorite
Stumpf, Thorsten (he/him/his)
Project Lead Regulatory Affairs, Software & AI
Metecon GmbH
Mannheim, Germany
Favorite
Tolkmitt, Florian
Managing Director
PRO-LIANCE GLOBAL SOLUTIONS GmbH
Frankfurt am Main, Hessen, Germany
Favorite
Toutounji, Mohamad (he/him/his)
CMC Scientist
Molgenium
Düsseldorf, Nordrhein-Westfalen, Germany
Favorite
von Hahn, Royth P. (he/him/his)
Senior Vice President of Medical Health Services (global)
TÜV SÜD Product Services
München, Germany
Favorite
CW
Welzel, Cindy
PostDoc
Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology
Germany
Favorite
Hong Kong
King, Hamish
CEO
Cisema
Wan Chai, Hong Kong
Favorite
Ireland
SC
Clerkin, Seb
Director of Operations and Principle Consultant
GMP Advisory Services
Cork, Cork, Ireland
Favorite
Craig, Michael
Vice President (Technical)
Parexel
Enniscrone, Sligo, Ireland
Favorite
Kearney, Breda
Clinical Regulatory Lead
BSI
Limerick, Limerick, Ireland
Favorite
TM
Melvin, Tom
Associate Professor in Medical Device Regulatory Science
Institute for Clinical Trials, University of Galway
Ireland
Favorite
Patten, Tom
International IVDR Manager
GMED
Ireland
Favorite
Israel
Marchaim, Hagit (she/her/hers)
Owner and principal consultant
HMC-regulation
Aseret, HaDarom, Israel
Favorite
Italy
RC
Camillini, Roberto
Ethical Committee member (IT)
CEROM - https://www.irst.emr.it/it/ricerca-e-innovazione/comitato-etico-della-romagna
Italy
Favorite
Caproni, Marco (he/him/his)
Global Director Software Product Assessment
TÜV SÜD
Emilia-Romagna, Italy
Favorite
Cipolleschi, Luigi
Quality Manager / RA Specialist
Biochemical Systems International S.p.A.
Arezzo, Toscana, Italy
Favorite
Fabi, Sara
Regulatory Lead
BSI group
Rome, Lazio, Italy
Favorite
Mastroroberto, Marianna
Clinical Expert Manager
Kiwa Cermet Italia
Bologna, Emilia-Romagna, Italy
Favorite
Pinsi, Maddalena
Associate Head of Medical Devices Notified Body
BSI Notified Body
Milano, Lombardia, Italy
Favorite
Netherlands
VA
Almeida, Vanda
Responsible AI Clinical Lead
Philips
Eindhoven, Noord-Brabant, Netherlands
Favorite
Al, Monique (she/her/hers)
Special advisor
CCMO
The , Netherlands
Favorite
Bos, Gert W. (he/him/his)
Partner & Chief Scientific Officer (CSO)
QServe Group
Baarn, Gelderland, Netherlands
Favorite
Bouygues, Christelle
Senior Regulatory Affairs Specialist
EMA
Amsterdam, Zuid-Holland, Netherlands
Favorite
Cuper, Natascha J.
Product Reviewer / Internal Clinician
Kiwa Assurance
Woerden, Utrecht, Netherlands
Favorite
de Villa, Elena (she/her/hers)
EMA Product Lead - Oncology and Radiopharmaceuticals Office
European Medicines Agency (EMA)
Netherlands
Favorite
KI
Immonen, Kaisa
Patient and Consumer Liaison
European Medicines Agency
Netherlands
Favorite
Laan, Alex (he/him/his)
Head of IVD Notified Body
BSI
Amsterdam, Noord-Holland, Netherlands
Favorite
Loon, Ellen van. (she/her/hers)
Technical Specialist
DEKRA Certification B.V.
Arnhem, Gelderland, Netherlands
Favorite
Pétavy, Frank (he/him/his)
Head of Methodology
European Medicines Agency
Amsterdam, Noord-Holland, Netherlands
Favorite
Sarwin, Dennis
Team Manager Global Registrations & Consultant
Qserve Group
Netherlands
Favorite
Scanlan, Elizabeth
Scientific Communication Officer
European Medicines Agency
1083 HS Amsterdam, Netherlands
Favorite
Schmidt, Kristiane (she/her/hers)
Prinicipal Consultant & IVD Lead
Qserve Consultancy
Arnhem, Gelderland, Netherlands
Favorite
Segec, Andrej (he/him/his)
Scientific administrator, DARWIN EU® Studies Coordinator
European Medicines Agency
Amsterdam, Noord-Holland, Netherlands
Favorite
Thirstrup, Steffen (he/him/his)
Chief Medical Officer (CMO)
European Medicines Agency (EMA)
Amsterdam, Netherlands
Favorite
van Boxtel, Robert A.
Principal Consultant
Medical Device Project B.V.
Alphen a/d Rijn, Zuid-Holland, Netherlands
Favorite
van der Heijden, Cecile E. (she/her/hers)
Attorney-at-law
Axon Lawyers
Amsterdam, Netherlands
Favorite
Vollebregt, Erik R.
Partner
Axon Lawyers
Amsterdam, Noord-Holland, Netherlands
Favorite
Portugal
Alves, Inês
School of Health and Human Development - University of Évora
ANDO Portugal - National Association for Skeletal Dysplasias
Portugal
Favorite
MC
Carvalho, Mafalda
Clinical Innovation Office Director
North Lisbon University Hospital Centre (ULS Santa Maria)
Portugal
Favorite
de Oliveira, Mariana
PhD Fellow
University of Lisbon, Faculty of Sciences
Lisbon, Portugal
Favorite
Martins, Joao
Director of Regulatory Affairs
Abbott
Amadora, Lisboa, Portugal
Favorite
Spain
Caturla Goñi, Mercè (she/her/hers)
Director, Global Regulatory Affairs
AstraZeneca
Barcelona, Catalonia, Spain
Favorite
Clemente, Amaia
Regulatory Science and Policy Associate Director
Sanofi
Spain
Favorite
Epstein, David (he/him/his)
Professor
Department of Applied Economics, University of Granada, Spain
Granada, Andalucia, Spain
Favorite
Galamba, Carlos
CEO
MDx CRO
Barcelona, Catalonia, Spain
Favorite
Olmos, Ana Pilar
Consultant
Beyond Conception
Madrid, Madrid, Spain
Favorite
Rodriguez Grande, Beatriz
Regulatory Consultant
NAMSA
Madrid, Madrid, Spain
Favorite
Varela, Javier (he/him/his)
Snr Manager Medtech Services
Pharmalex
Madrid, Madrid, Spain
Favorite
Switzerland
Bigler, Cornelia (she/her/hers)
Deputy Head Unit 4, Regulatory Assessment
Swissmedic
Switzerland
Favorite
Deych, Nataliya (she/her/hers)
VP Regulatory Affairs EMEACLA
Edwards Lifesciences Sarl
Founex, Switzerland
Favorite
Emmendoerffer, Andreas (he/him/his)
Principal Regulatory Program Director
Roche
Basel, Basel-Stadt, Switzerland
Favorite
Favre, Philippe (he/him/his)
Associate Director
Zimmer Biomet
Switzerland
Favorite
Marchand, Adrien (he/him/his)
Principal Consultant
Lucendra SA
Mont-sur-Rolle, Vaud, Switzerland
Favorite
Pöttker, Markus (he/him/his)
Director, Global Post-Market Surveillance
Smith+Nephew
Zug, Zug, Switzerland
Favorite
United Kingdom
Alexander, Caroline
Director QA/RA
Genedrive Diagnostics
Manchester, United Kingdom
Favorite
Ball, Ed (he/him/his)
Manager, RA Intelligence
RQM+
United Kingdom
Favorite
Bowden, Hannah (she/her/hers)
AI Airlock Programme Manager
Medicines and Healthcare Products Regulatory Agency
United Kingdom
Favorite
CC
Cacou, Crina (she/her/hers)
Head of Clinical Investigations and Trials Operations
Medicines and Healthcare products Regulatory Agency (MHRA)
London , United Kingdom
Favorite
Conway, Erica (she/her/hers)
Director, Precision Medicine & Digital Health, Global Regulatory Affairs
GSK
England, United Kingdom
Favorite
HC
Coole, Holly
Senior Manager Digital Mental Health
Medicines and Healthcare Products Regulatory Agency (MHRA)
London, England, United Kingdom
Favorite
Doerge, Thomas (he/him/his)
Global Head Active Implantable Medical Devices and SaMD
BSI Group
Milton Keynes, England, United Kingdom
Favorite
Fry, Peter (he/him/his)
Business Unit Manager, Pharma Regulatory Affairs & Country Manager, UK
QbD Group
Chalgrove, England, United Kingdom
Favorite
Halliday, Suzanne
VP Regulatory, Global Regulatory Compliance
BSI
Milton Keynes, England, United Kingdom
Favorite
Hasanova, Maryam (she/her/hers)
Co-Founder & CEO
OncoFlow
Chalfont St Peter, United Kingdom
Favorite
Holborow, Richard G. (he/him/his)
Global Head of Clinical Compliance
BSI
Milton Keynes, England, United Kingdom
Favorite
Jeary, Theresa
Global Head, Medicinal & Biologics Team
BSI
Milton Keynes, England, United Kingdom
Favorite
Kyria, Elena (she/her/hers)
CEO & Founder
Elemed
london, United Kingdom
Favorite
Lumsden, Rebecca (she/her/hers)
Head of Regulatory Science & Policy EU/AMEE
Sanofi
Reading, England, United Kingdom
Favorite
Moon, Linda (she/her/hers)
Director of Global Quality & Accreditation, Regulatory Services
BSI
England, United Kingdom
Favorite
Motsi, Natasha (she/her/hers)
AI Airlock Technical Programme Manager
MHRA
London, United Kingdom
Favorite
Neale, Nadine (she/her/hers)
Diagnostic Regulatory Specialist
Medicines and Healthcare Products Regulatory Agency
London, United Kingdom
Favorite
HN
Newton, Helen (she/her/hers)
Executive Director International CMC EMEA
MSD
London, United Kingdom
Favorite
Nick, Cecil J.
Vice President (Technical)
Parexel
Ashtead, Surrey, England, United Kingdom
Favorite
Obolskiy, Dmitry
Associate Director Regulatory Affairs
QbD Group
England, United Kingdom
Favorite
O'Callaghan, Sean
IVD Technical Specialist and Scheme Manager
BSI
Milton Keynes, United Kingdom
Favorite
Oyinloye, Ola
Regulatory Science Director
Novo Nordisk
United Kingdom
Favorite
Palm, Sofia
Regulatory Lead
BSI
Milton Keynes, England, United Kingdom
Favorite
Partridge, Susan (she/her/hers)
Clinical Regulatory Lead
BSI
Leeds, England, United Kingdom
Favorite
Slater, Katy
Regulatory Director
Komorebi Ltd
Selby, England, United Kingdom
Favorite
Spencer, Sue
Director
Compliance-Connextions Limited
Farnborough, England, United Kingdom
Favorite
Surash, Surash
Medico-Legal Expert Witness
TUV SUD
Hampshire, England, United Kingdom
Favorite
Thain, Darren J.
Director, Global Regulatory Policy and Intelligence
Smith+Nephew
Watford, England, United Kingdom
Favorite
Thakker, Vishal (he/him/his)
Head of UK Approved Body
BSI
Stanmore, England, United Kingdom
Favorite
Torr, Marcus
Head of Post Market Surveys
Purdie Pascoe
London, United Kingdom
Favorite
Toulemonde, Audrey (she/her/hers)
Associate Director, Medtech Services
Cencora
United Kingdom
Favorite
Young, Kim (she/her/hers)
Regional Engagement Director
RAPS
United Kingdom
Favorite
United States
Ansari, Maham
Senior Director, Regulatory Affairs
Precision for Medicine
Frederick, Maryland
Favorite
Borgel, Margot J.
Diagnostic Regulatory Strategy Lead
Astellas
South Carolina
Favorite
Brooke, M. Jason
Attorney & Managing Member
Brooke & Associates
Favorite
Chung, Bethany
Director of Technical Solutions and Innovation
RQM+
Cary, North Carolina
Favorite
Conardy, Brandi
Manager of Regulatory Affairs - Medical Devices
Bausch + Lomb
Saint Charles, Missouri
Favorite
Denniston, Alastair (he/him/his)
Chair of Regulatory Science, and Innovation
University of Birmingham
Favorite
Doorn, Leon J. (he/him/his)
CEO & Co-Founder
MedQAIR
Amsterdam
Favorite
Fulton, Denise
Vice President, Research & Content Strategy
RAPS
Rockville , Maryland
Favorite
Gilbert, Stephen (he/him/his)
Professor of Medical Device Regulatory Science
Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden
Dresden
Favorite
Haake-Schäfer, Sarah (she/her/hers)
Head of Global Regulatory Strategic Innovation
Carl Zeiss Vision International GmbH
Favorite
Jump, Michelle (she/her/hers)
CEO
MedSec LLC
Plainwell, Michigan
Favorite
Kelly, Michelle (she/her/hers)
Toxicologist
NAMSA
Favorite
Kendler, Jonathan (he/him/his)
Human Factors Consultant
Curiolis, Inc.
Favorite
Kerr, James
IVD Technical Team Manager
BSI
Favorite
JK
Kim, Josh
CEO
Artos AI
San Francisco, California
Favorite
Kim, Young
CEO & Principal Consultant
Synex Consulting Ltd.
Seoul, Seoul-t'ukpyolsi
Favorite
Lenic, Ines
Regulatory Affairs Director - EU
AstraZeneca
Favorite
Levi, Mark
Director of Regulatory Affairs
RTI
RTP, North Carolina
Favorite
McKenzie, Jean
Cluster Manager: Cardiovascular
DEKRA Certification B.V.
Favorite
Naughton, Jennifer
Director of Credentialing
RAPS
Virginia
Favorite
Oberlin Hansen, Rolf
Senior Advisor
Danish Medicines Agency (DKMA)
Favorite
Palma, Grace F. (she/her/hers)
Principal
China Med Device
Cambridge, Massachusetts
Favorite
Panten, Sarah
Co-Founder & Managing Partner / Board Member
avasis solutions GmbH / Medical Device Knowledge Unit e.V.
Hamburg, Hamburg
Favorite
Racic, Amra
Vice President - Global Government Strategy
MedTech
Plesanton, California
Favorite
AR
Radwick, Allison E.
Sr Regulatory and Policy Comms Mgr
USP
Rockville, Maryland
Favorite
JR
Rohrberg, Julia
Clinical Evaluation Manager
Heraeus Medical GmbH
Favorite
Santos, Emilie (she/her/hers)
Clinical Evidence Team Lead
Philips Healthcare
Favorite
LS
Schälter, Lisa
Business Area Lead for IVD & Combination, Tissue and Substance-Based Medical Devices
Be-on-Quality GmbH
Favorite
Schuettfort, Erika (she/her/hers)
Self-employed Consultant
Vorsa
Favorite
GS
Spinelli, Gabriella (she/her/hers)
RADIANT CERSI Director, Reader
Brunel University of London
Favorite
DW
Waide, Diarmuid
Senior R.I.M. Consultant
Ennov
Favorite
Whitney, Chang-Hong
President & CEO
Whitney Consulting Ltd.
Boston, Massachusetts
Favorite