Moderator: Leo Louis, RAC, PMP – Philips
### @@@ abhineet johri, MCA – Siemens Healthineers ### 1828304###Presenter###Regulatory Affairs Professional ###Siemens Healthineers###Presenter: abhineet johri, MCA – Siemens Healthineers
### @@@ Martina Coscia, PhD – confinis AG ### 1828322###Presenter###Head of Innovative Technologies and Clinical Affairs###confinis AG###Presenter: Martina Coscia, PhD – confinis AG
### @@@ Beat Steffen, MSc, FRAPS – confinis ag ### 716683###Presenter###Founder, Chairman of the Board of Directors & CEO###confinis ag###Presenter: Beat Steffen, MSc, FRAPS – confinis ag
###Workshop Leader: Carla Gomes – Thermo Fisher Clinical Research Group
### @@@ Maria Alexandra Ribeiro – Portuguese National Ethics Committee for Clinical Research (CEIC) ### 1930375###Presenter###President###Portuguese National Ethics Committee for Clinical Research (CEIC)###Presenter: Maria Alexandra Ribeiro – Portuguese National Ethics Committee for Clinical Research (CEIC)
### @@@ Paolo Croce, PhD – PPD, part of Thermo Fisher Scientific ### 1930376###Presenter###Associate Director, Regulatory Affairs###PPD, part of Thermo Fisher Scientific###Presenter: Paolo Croce, PhD – PPD, part of Thermo Fisher Scientific
### @@@ Eileen Smith, RA – PPD, part of Thermo Fisher Scientific ### 1930377###Presenter###Regulatory Affairs Manager###PPD, part of Thermo Fisher Scientific###Presenter: Eileen Smith, RA – PPD, part of Thermo Fisher Scientific
### @@@ Rina Kacha – PPD, part of Thermo Fisher Scientific ### 1930378###Presenter###Senior Regulatory Affairs Manager###PPD, part of Thermo Fisher Scientific###Presenter: Rina Kacha – PPD, part of Thermo Fisher Scientific
###Moderator: Kimberly A. Trautman, MS – MEDIcept
### @@@ Kim Young ### 1974523###Moderator#########Moderator: Kim Young
###Moderator & Presenter: Sue Spencer – Qserve group
### @@@ Ed Godber, n/a – Guardant Health ### 1828298###Presenter###Vice President Strategic Partnerships###Guardant Health###Presenter: Ed Godber, n/a – Guardant Health
### @@@ Patrick Fivey (he/him/his) – AstraZeneca ### 1828300###Presenter###Director of Precision Medicine Policy###AstraZeneca###Presenter: Patrick Fivey (he/him/his) – AstraZeneca
### he/him/hisModerator: Giovanni Di Rienzo – Qserve Group
### @@@ Sheila Walsh – BSI ### 1828321###Presenter###Clinical Regulatory Lead###BSI###Presenter: Sheila Walsh – BSI
### @@@ Alexey Shiryaev, MD PhD – DNV Product Assurance AS ### 1645653###Presenter###Global Head of Clinical and Regulatory Affairs###DNV Product Assurance AS###Presenter: Alexey Shiryaev, MD PhD – DNV Product Assurance AS
###Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
### @@@ María Cámara Torres, PhD – Qserve Group ### 1827168###Presenter###Consultant - Medical Writer###Qserve Group###Presenter: María Cámara Torres, PhD – Qserve Group
### @@@ Lise Op de Beeck (she/her/hers) – GymnaUniphy ### 1942154###Presenter###Clinical manager###GymnaUniphy###Presenter: Lise Op de Beeck (she/her/hers) – GymnaUniphy
### she/her/hers @@@ Jorn van Binsbergen, MSc (he/him/his) – Qserve Group ### 1944258###Presenter###Consultant / Clinical writer###Qserve Group###Presenter: Jorn van Binsbergen, MSc (he/him/his) – Qserve Group
### he/him/hisModerator: Robert A. van Boxtel – Medical Device Project B.V.
### @@@ Kevin Madden – BSI Group ### 1828338###Presenter###Head of Professional Development###BSI Group###Presenter: Kevin Madden – BSI Group
### @@@ Martin Witte – TÜV SÜD Product Service GmbH ### 1187576###Presenter###Senior Director###TÜV SÜD Product Service GmbH###Presenter: Martin Witte – TÜV SÜD Product Service GmbH
### @@@ Paul Kosters, PhD (he/him/his) – DEKRA Certification BV ### 1855542###Presenter###Knowledge management manager / project manager###DEKRA Certification BV###Presenter: Paul Kosters, PhD (he/him/his) – DEKRA Certification BV
### he/him/hisModerator: Maurizio Suppo, Dr. – Qarad
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
### @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Presenter###IVDMD Department Manager###GMED Certification Division###Presenter: Catherine Holzmann – GMED Certification Division
### @@@ Olga TKACHENKO, PhD (she/her/hers) – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6 ### 1828315###Presenter###Policy Officer###European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6###Presenter: Olga TKACHENKO, PhD (she/her/hers) – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
### she/her/hers @@@ Elisabeth PhD Dequeker, PhD – University of Leuven ### 1254350###Presenter###Head of Quality Assurance and Regulatory Affairs Officer for Medical Diagnostics###University of Leuven###Presenter: Elisabeth PhD Dequeker, PhD – University of Leuven
### @@@ Richard J. Saunders, FIBMS – QuidelOrtho ### 1828316###Presenter###Technical Director, Regulatory Affairs###QuidelOrtho###Presenter: Richard J. Saunders, FIBMS – QuidelOrtho
### @@@ Stefan Scheib, PhD (he/him/his) – Roche Diagnostics GmbH ### 1836161###Presenter###Global Head of Regulatory Affairs, CoreLab###Roche Diagnostics GmbH###Presenter: Stefan Scheib, PhD (he/him/his) – Roche Diagnostics GmbH
### he/him/his @@@ Heinrich Scheiblauer, Dr – Paul-Ehrlich-Institut ### 1891462###Presenter###Head of the Testing Laboratory for in vitro diagnotic medical devices###Paul-Ehrlich-Institut###Presenter: Heinrich Scheiblauer, Dr – Paul-Ehrlich-Institut
###Moderator: Sabine Haubenreisser, MSc, PhD – European Medicines Agency
### @@@ Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 1187581###Moderator###Regulatory Strategy Principal###TÜV SÜD Medical Health Service###Moderator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
### @@@ Ilona Reischl, PhD (she/her/hers) – Austrian Medicines Agency, AGES MEA ### 1897482###Panelist###Assessor###Austrian Medicines Agency, AGES MEA###Panelist: Ilona Reischl, PhD (she/her/hers) – Austrian Medicines Agency, AGES MEA
### she/her/hers @@@ Falk Ehmann, MD, PhD, MSc, – European Medicines Agency ### 716669###Panelist###Chair Innovation Task Force###European Medicines Agency###Panelist: Falk Ehmann, MD, PhD, MSc, – European Medicines Agency
### @@@ Christelle Bouygues, PharmD (she/her/hers) – EMA ### 1318405###Panelist###Regulatory Affairs Senior Officer###EMA###Panelist: Christelle Bouygues, PharmD (she/her/hers) – EMA
### she/her/hers @@@ Silvy Da Rocha Dias – European Medicines Agency ### 1922318###Panelist######European Medicines Agency###Panelist: Silvy Da Rocha Dias – European Medicines Agency
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Panelist###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Panelist: Marta Carnielli, PharmD – TUV Sud GmbH
### @@@ Suzanne Halliday, MSc. D.Phil. – BSI ### 535446###Panelist###Regulatory Director###BSI###Panelist: Suzanne Halliday, MSc. D.Phil. – BSI
### @@@ Lammert Meinders – Dutch Health and Youth Care Inspectorate ### 1981132###Panelist###Senior Inspector Medical Technology###Dutch Health and Youth Care Inspectorate###Panelist: Lammert Meinders – Dutch Health and Youth Care Inspectorate
### @@@ Flora Giorgio (she/her/hers) – European Commission ### 1930380###Panelist###Acting Head of Unit###European Commission###Panelist: Flora Giorgio (she/her/hers) – European Commission
### she/her/hersModerator & Presenter: Michelle Jump, RAC – MedSec LLC
###Moderator & Presenter: Erik R. Vollebregt – Axon Lawyers
### @@@ Cécile E. Van der Heijden, LLM (she/her/hers) – Axon Lawyers ### 1827162###Presenter###Attorney-at-law###Axon Lawyers###Presenter: Cécile E. Van der Heijden, LLM (she/her/hers) – Axon Lawyers
### she/her/hers @@@ Agnes Szoboszlai – Philips Medical Systems Nederland B.V. ### 1827163###Presenter###Senior Legal Counsel###Philips Medical Systems Nederland B.V.###Presenter: Agnes Szoboszlai – Philips Medical Systems Nederland B.V.
### @@@ Leo Hovestadt – Elekta ### 535504###Presenter###Director Governmental Affairs EU###Elekta###Presenter: Leo Hovestadt – Elekta
###Presenter: Sandra Wheeler, MA Technical Communication – Medtronic
### @@@ Pamela Campo, MS Regulatory Science – Medtronic ### 1827172###Presenter###Principal Regulatory Affairs Specialist###Medtronic###Presenter: Pamela Campo, MS Regulatory Science – Medtronic
###Moderator: Giovanni Di Rienzo – Qserve Group
### @@@ Richard A. Vincins, RAC-MD, CMDA, CQA – Oriel STAT A MATRIX ### 1254352###Presenter###VP Global Regulatory Affairs###Oriel STAT A MATRIX###Presenter: Richard A. Vincins, RAC-MD, CMDA, CQA – Oriel STAT A MATRIX
### @@@ Matthias Bellmann, MA (he/him/his) – TÜV SÜD Product Service GmbH ### 1828310###Presenter###Director Global Focus Team Cardiovascular###TÜV SÜD Product Service GmbH###Presenter: Matthias Bellmann, MA (he/him/his) – TÜV SÜD Product Service GmbH
### he/him/his
Moderator & Presenter: Susana de Azevedo Wäsch – Ypsomed
### @@@ Patrik J. Spirig, MA (he/him/his) – Konapharma ### 1827176###Presenter###CFO###Konapharma###Presenter: Patrik J. Spirig, MA (he/him/his) – Konapharma
### he/him/hisModerator & Presenter: Kevin Cunningham, PhD – European Medicines Agency
### @@@ Els Caenen, PharmD (she/her/hers) – Janssen Pharmaceutical Companies of Johnson & Johnson ### 1967239###Presenter###Director, EMEA Regulatory Lead Multiple Myeloma###Janssen Pharmaceutical Companies of Johnson & Johnson###Presenter: Els Caenen, PharmD (she/her/hers) – Janssen Pharmaceutical Companies of Johnson & Johnson
### she/her/hers @@@ Nadege Le Roux – Bristol-Myers Squibb ### 1967241###Presenter###Senior Director of Regulatory Policy and Intelligence###Bristol-Myers Squibb###Presenter: Nadege Le Roux – Bristol-Myers Squibb
### @@@ Francesca Cerreta ### 1967242###Presenter#########Presenter: Francesca Cerreta
### @@@ Ilona Reischl, PhD (she/her/hers) – Austrian Medicines Agency, AGES MEA ### 1897482###Presenter###Assessor###Austrian Medicines Agency, AGES MEA###Presenter: Ilona Reischl, PhD (she/her/hers) – Austrian Medicines Agency, AGES MEA
### she/her/hersModerator & Presenter: Michael Craig, BSc Pharm MPSI – Parexel
### @@@ Neha Parashar, PMP – argenx ### 1827161###Presenter###Principal Scientist / Associate Director###argenx###Presenter: Neha Parashar, PMP – argenx
### @@@ Veronika Jekerle, PhD – European Medicines Agency ### 1940209###Presenter###Head of Pharmaceutical Quality###European Medicines Agency###Presenter: Veronika Jekerle, PhD – European Medicines Agency
###Moderator: Siegfried Schmitt, CSci CChem FRSC – Parexel
### @@@ Yingying Liu – CSL Behring AG ### 1187559###Presenter###Associate Director, GRA CMC Lead Plasma Fractionation Global Regulatory Affairs CMC###CSL Behring AG###Presenter: Yingying Liu – CSL Behring AG
### @@@ Thomas Larsson, MSc, BSc – European Medicines Agency ### 1650183###Presenter###Senior Scientific Specialist###European Medicines Agency###Presenter: Thomas Larsson, MSc, BSc – European Medicines Agency
###Presenter: Richard Holborow (he/him/his) – BSI
### he/him/his @@@ Silvy Da Rocha Dias – European Medicines Agency ### 1922318###Presenter######European Medicines Agency###Presenter: Silvy Da Rocha Dias – European Medicines Agency
### @@@ Rohan Shah, BS (he/him/his) – BD ### 1941778###Presenter###Senior Manager, Regulatory Affairs###BD###Presenter: Rohan Shah, BS (he/him/his) – BD
### he/him/hisModerator & Presenter: Philippe M. Auclair, Mr – Abbott
###Presenter: Kirsten Sander – Labquality Oy
###Moderator & Presenter: Elisabeth Dequeker, n/a – Prof
### @@@ Tiina Riihimäki, PhD (she/her/hers) – Pharmalex Nordics ### 1930216###Presenter###Director / Head of Medical Devices and IVDs, Nordics###Pharmalex Nordics###Presenter: Tiina Riihimäki, PhD (she/her/hers) – Pharmalex Nordics
### she/her/hersWorkshop Leader: Warren Jameson, PhD – NAMSA
### @@@ Ciara Airey – Inivata (a subsidiary of NeoGenomics) ### 1883953###Presenter###Head of Regulatory###Inivata (a subsidiary of NeoGenomics)###Presenter: Ciara Airey – Inivata (a subsidiary of NeoGenomics)
### @@@ Heike Moehlig-Zuttermeister – Tüv Süd ### 1883954###Presenter###Head of Business Unit IVD###Tüv Süd###Presenter: Heike Moehlig-Zuttermeister – Tüv Süd
###Moderator & Presenter: Andreas Stange – TUV SUD JAPAN LTD
### @@@ Erica Conway, PhD (she/her/hers) – MCRA ### 1828301###Moderator & Presenter###Vice President, IVD Regulatory Affairs - Europe###MCRA###Moderator & Presenter: Erica Conway, PhD (she/her/hers) – MCRA
### she/her/hers @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###Presenter: Tom Patten – NSAI
### @@@ Niels Bojunga, Dr – Molecular Health GmbH ### 1919734###Presenter###SVP of Quality Management###Molecular Health GmbH###Presenter: Niels Bojunga, Dr – Molecular Health GmbH
### @@@ Kees Maquelin – Abbott Diabetes Care ### 1919788###Presenter###Regulatory Affairs Manager Europe###Abbott Diabetes Care###Presenter: Kees Maquelin – Abbott Diabetes Care
### @@@ Leo WJ Klomp – Health and Youth Care Inspectorate (IGJ), Ministry of Health ### 1919791###Presenter###Coordinating Specialist###Health and Youth Care Inspectorate (IGJ), Ministry of Health###Presenter: Leo WJ Klomp – Health and Youth Care Inspectorate (IGJ), Ministry of Health
###Moderator: Elena Kyria – Elemed
###Moderator: Jennifer Neff, PhD – Sartorius Stedim Biotech GmbH
### @@@ Paulette Robinson, Ph.D, RAC – Neurogene ### 1827164###Presenter###Director of Regulatory Affairs###Neurogene###Presenter: Paulette Robinson, Ph.D, RAC – Neurogene
### @@@ Caroline Pothet (she/her/hers) – European Medicines Agency ### 1942126###Presenter###Head of Advanced Therapies - Human Medicines Division###European Medicines Agency###Presenter: Caroline Pothet (she/her/hers) – European Medicines Agency
### she/her/hersModerator: Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services
### @@@ Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group ### 535440###Moderator###CSO###Qserve Group###Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
### @@@ Flora Giorgio (she/her/hers) – European Commission ### 1930380###Presenter###Acting Head of Unit###European Commission###Presenter: Flora Giorgio (she/her/hers) – European Commission
### she/her/hers @@@ Royth Philippp von Hahn, PhD – TUV SUD Product Services ### 1027488###Presenter###Senior Vice President of Medical Health Services (global)###TUV SUD Product Services###Presenter: Royth Philippp von Hahn, PhD – TUV SUD Product Services
### @@@ Graeme Turnbridge – BSI ### 1939249###Presenter###Senior Vice President Global Regulatory and Quality, Medical Devices###BSI###Presenter: Graeme Turnbridge – BSI
### @@@ Alexandre Jauniaux (he/him/his) – Federal Agency of Medicines and Health products ### 1974590###Presenter###Head of division###Federal Agency of Medicines and Health products###Presenter: Alexandre Jauniaux (he/him/his) – Federal Agency of Medicines and Health products
### he/him/hisModerator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
### @@@ Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy ### 574723###Moderator###CEO / senior consultant###mi-CE consultancy###Moderator: Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy
### she/her/hers @@@ Andreas Stange – TUV SUD JAPAN LTD ### 1187582###Presenter###SVP Medical Health Services Regulatory & Quality###TUV SUD JAPAN LTD###Presenter: Andreas Stange – TUV SUD JAPAN LTD
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
### @@@ Elizabeth Harrison, PhD (she/her/hers) – BSI Group ### 1401973###Presenter###Global Head – IVD Medical Devices###BSI Group###Presenter: Elizabeth Harrison, PhD (she/her/hers) – BSI Group
### she/her/hers @@@ Liz Gommans, PhD (she/her/hers) – DEKRA Certification B.V. ### 1967230###Presenter###Technical specialist and RA specialist###DEKRA Certification B.V.###Presenter: Liz Gommans, PhD (she/her/hers) – DEKRA Certification B.V.
### she/her/hers @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###Presenter: Tom Patten – NSAI
###
Moderator: Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting
### @@@ Stephan Affolter – Ypsomed AG ### 907117###Presenter###Director Regulatory + Quality Intelligence###Ypsomed AG###Presenter: Stephan Affolter – Ypsomed AG
### @@@ Christiana Hofmann, PHD (she/her/hers) – anteris medical GmbH ### 1864620###Presenter###Executive Consultant & Business Development###anteris medical GmbH###Presenter: Christiana Hofmann, PHD (she/her/hers) – anteris medical GmbH
### she/her/hers @@@ Christelle Bouygues, PharmD (she/her/hers) – EMA ### 1318405###Presenter###Regulatory Affairs Senior Officer###EMA###Presenter: Christelle Bouygues, PharmD (she/her/hers) – EMA
### she/her/hers @@@ Theresa Jeary, BSc (Hons), MSc – BSI Group ### 535537###Presenter###Principal Technical Specialist ###BSI Group###Presenter: Theresa Jeary, BSc (Hons), MSc – BSI Group
###Moderator: Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services
### @@@ Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group ### 535440###Presenter###CSO###Qserve Group###Presenter: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
### @@@ Flora Giorgio (she/her/hers) – European Commission ### 1930380###Presenter###Acting Head of Unit###European Commission###Presenter: Flora Giorgio (she/her/hers) – European Commission
### she/her/hers @@@ Sietske Eerens – Dutch Health and Youth Care Inspectorate ### 1981929###Presenter###Senior Inspector###Dutch Health and Youth Care Inspectorate###Presenter: Sietske Eerens – Dutch Health and Youth Care Inspectorate
###Moderator: Amie Smirthwaite, BEng, PhD – RQM+
### @@@ Nancy J. Morrison, RAC – RQM+ ### 757434###Presenter###Vice President, Intelligence and Innovation###RQM+###Presenter: Nancy J. Morrison, RAC – RQM+
### @@@ Abtin Rad, Dr. – TÜV SÜD Product Services ### 1187617###Presenter###Global Director Functional Safety, Software, and Digitization###TÜV SÜD Product Services###Presenter: Abtin Rad, Dr. – TÜV SÜD Product Services
###.png)
Moderator: Alex Laan, Dipl.-Ing. – BSI
### @@@ Kristiane Schmidt, PhD (she/her/hers) – Qserve Group ### 1828297###Presenter###Senior Consultant###Qserve Group###Presenter: Kristiane Schmidt, PhD (she/her/hers) – Qserve Group
### she/her/hers @@@ Mohamed-Salah GAROUACHI, PhD, PharmD – Constency Healthcare ### 1828323###Presenter###Managing Director###Constency Healthcare###Presenter: Mohamed-Salah GAROUACHI, PhD, PharmD – Constency Healthcare
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Presenter: Marta Carnielli, PharmD – TUV Sud GmbH
###
Moderator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
### @@@ Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group ### 535440###Moderator###CSO###Qserve Group###Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
### @@@ Jet Schouten – NRC (newspaper) ### 1897490###Panelist###Investigative journalist###NRC (newspaper)###Panelist: Jet Schouten – NRC (newspaper)
### @@@ Rob Nelissen, prof. dr. – Orthopaedics Leiden University Medical Center ### 1939248###Panelist###Chairman###Orthopaedics Leiden University Medical Center###Panelist: Rob Nelissen, prof. dr. – Orthopaedics Leiden University Medical Center
### @@@ Bianca Lutters – QServe Group ### 1523608###Panelist###Head of Clinical Operations###QServe Group###Panelist: Bianca Lutters – QServe Group
### @@@ Stan van Belkum – Central Committee on Research Involving Human Subjects (CCMO) ### 1940676###Panelist###General Director###Central Committee on Research Involving Human Subjects (CCMO)###Panelist: Stan van Belkum – Central Committee on Research Involving Human Subjects (CCMO)
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Panelist###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Panelist: Marta Carnielli, PharmD – TUV Sud GmbH
### @@@ Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy ### 574723###Panelist###CEO / senior consultant###mi-CE consultancy###Panelist: Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy
### she/her/hers @@@ Juan Garcia Burgos, MD – European Medicines Agency ### 1551387###Panelist###Head of Public and Stakeholders Engagement Department###European Medicines Agency###Panelist: Juan Garcia Burgos, MD – European Medicines Agency
###Workshop Leader: Bianca Lutters – QServe Group
### @@@ Marius Woitok, n/a – Med-Clinical ### 1827159###Presenter###Medical Writer Director###Med-Clinical###Presenter: Marius Woitok, n/a – Med-Clinical
### @@@ Chris Webb – Purdie Pascoe ### 1930183###Presenter######Purdie Pascoe###Presenter: Chris Webb – Purdie Pascoe
### @@@ Martha Vakalopoulou – Purdie Pascoe ### 1930184###Presenter######Purdie Pascoe###Presenter: Martha Vakalopoulou – Purdie Pascoe
###Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
### @@@ Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates ### 907081###Presenter###EMEA Regulatory Affairs Leader###W.L. Gore & Associates###Presenter: Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates
### @@@ Gavin Quigley, MBChB FRCS MBA – BSI ### 1827173###Presenter###Internal Clinician###BSI###Presenter: Gavin Quigley, MBChB FRCS MBA – BSI
### @@@ Joshua Bridgens, MBBS FRCS – DePuy Synthes (J&J) ### 1897475###Presenter###Medical Director###DePuy Synthes (J&J)###Presenter: Joshua Bridgens, MBBS FRCS – DePuy Synthes (J&J)
###Moderator: Alex Laan, Dipl.-Ing. – BSI
### @@@ Philippe M. Auclair, Mr – Abbott ### 535445###Presenter###Senior Director RA strategy###Abbott###Presenter: Philippe M. Auclair, Mr – Abbott
### @@@ Christèle East, PhD (she/her/hers) – Namsa ### 1828312###Presenter###Senior Regulatory Consultant, IVD###Namsa###Presenter: Christèle East, PhD (she/her/hers) – Namsa
### she/her/hersPresenter: Stephanie Huebner, MSc, PhD – Olympus Surgical Technologies Europe
###Moderator & Presenter: Magdalena Bujar, BSc, MSc, PhD – CIRS
### @@@ Martine Zimmermann, PharmD – Ipsen Innovation ### 1452236###Presenter######Ipsen Innovation###Presenter: Martine Zimmermann, PharmD – Ipsen Innovation
### @@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Presenter###Head of Orphan Drugs###European Medicines Agency###Presenter: Kristina Larsson, MSc – European Medicines Agency
###Moderator & Presenter: Ashleigh C. Dawley, RAC – Integrated DNA Technologies, Inc., a Danaher Company
### @@@ Melissa Finocchio (she/her/hers) – SOPHiA GENETICS ### 1828313###Presenter###SVP, Chief Regulatory Officer###SOPHiA GENETICS###Presenter: Melissa Finocchio (she/her/hers) – SOPHiA GENETICS
### she/her/hers @@@ Alex Laan, Dipl.-Ing. – BSI ### 1141533###Presenter###Head of IVD Notified Body - Regulatory Services###BSI###Presenter: Alex Laan, Dipl.-Ing. – BSI
###Moderator: Susana de Azevedo Wäsch – Ypsomed
### @@@ Koen Cobbaert (he/him/his) – Philips ### 943170###Presenter###Senior Manager - Quality, Standards & Regulations###Philips###Presenter: Koen Cobbaert (he/him/his) – Philips
### he/him/his @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: Erik R. Vollebregt – Axon Lawyers
### @@@ Celia Cruz, PhD (she/her/hers) – Complear ### 1949771###Presenter###Head of Regulatory Affairs###Complear###Presenter: Celia Cruz, PhD (she/her/hers) – Complear
### she/her/hersWorkshop Leader: Janet L. Michener Whipple – Validant
### @@@ Keith Morel, Ph.D. – Qserve Group ### 535522###Presenter###VP Regulatory Compliance###Qserve Group###Presenter: Keith Morel, Ph.D. – Qserve Group
### @@@ Leo Hovestadt – Elekta ### 716677###Presenter###Director Governmental Affairs Europe###Elekta###Presenter: Leo Hovestadt – Elekta
### @@@ Andreas Purde, Dr – TÜV SÜD Product Service GmbH ### 973395###Presenter###Director###TÜV SÜD Product Service GmbH###Presenter: Andreas Purde, Dr – TÜV SÜD Product Service GmbH
### @@@ Meredith Smith, MPA, PhD, FISPE – EVIDERA ### 1920248###Presenter###Senior Director and Lead###EVIDERA###Presenter: Meredith Smith, MPA, PhD, FISPE – EVIDERA
###Moderator & Presenter: Alexander Stock, PhD – TÜV SÜD Product Service GmbH
###.png)
Presenter: Kimberly A. Trautman, MS – MEDIcept
###Presenter: Edgar Kasteel – MedEnvoy Global BV
###Presenter: Enrico Perfler – 1MED
###
Presenter: Isaac Erickson – Fang Consulting Ltd
###Presenter: Joseph-Richardson Larbi, MSc – Celegence
###Presenter: James Gianoutsos, MBA – Rimsys
###Presenter: Ivan Tommasini – Parexel
###Moderator: Leo Louis, RAC, PMP – Philips
### @@@ Keti S. Agostino, n/a – BSI ### 1614397###Presenter###Regulatory Lead###BSI###Presenter: Keti S. Agostino, n/a – BSI
### @@@ Michelle Sullivan (she/her/hers) – Boston Scientific ### 1970397###Presenter###Head of Public Affairs###Boston Scientific###Presenter: Michelle Sullivan (she/her/hers) – Boston Scientific
### she/her/hersModerator: Kate Stockman
### @@@ Rüdiger Faust, PhD – UCB ### 1828296###Moderator###Global Regulatory Intelligence & Policy Lead###UCB###Moderator: Rüdiger Faust, PhD – UCB
### @@@ Solange Corriol-Rohou, MD (she/her/hers) – AstraZeneca ### 1828324###Presenter###Sr Global Policy Director###AstraZeneca###Presenter: Solange Corriol-Rohou, MD (she/her/hers) – AstraZeneca
### she/her/hers @@@ Marie Teil, MD – UCB Pharma ### 1828299###Presenter###Global Head WoCBA Program###UCB Pharma###Presenter: Marie Teil, MD – UCB Pharma
### @@@ Corinne de Vries, MA MSc PhD FISPE – European Medicines Agency ### 1922323###Presenter###Head of Translational Sciences###European Medicines Agency###Presenter: Corinne de Vries, MA MSc PhD FISPE – European Medicines Agency
###Moderator: Susana de Azevedo Wäsch – Ypsomed
### @@@ Daniëlle Motta, MSc. – Qserve Group ### 1649497###Presenter###Head of Global Registrations and Consultant###Qserve Group###Presenter: Daniëlle Motta, MSc. – Qserve Group
### @@@ Lionel Tussau – atrify ### 1968901###Presenter###Market Unit Healthcare - Global lead###atrify###Presenter: Lionel Tussau – atrify
###Workshop Leader: Vincent van der Meer (he/him/his) – Medical Device Project B.V.
### he/him/his @@@ Manon Gielkens – Medtronic ### 716663###Presenter###Principal Regulatory Affairs Specialist###Medtronic###Presenter: Manon Gielkens – Medtronic
### @@@ Pilar Mestrom – Medtronic ### 1948624###Presenter###Regulatory Affairs Specialist###Medtronic###Presenter: Pilar Mestrom – Medtronic
###Moderator: Giovanni Di Rienzo – Qserve Group
### @@@ Phil Brown ### 1855142###Presenter#########Presenter: Phil Brown
### @@@ Vishal Thakker, MEng (he/him/his) – BSI Group ### 1614543###Presenter###Head of UK Approved Body & Senior Regulatory Lead###BSI Group###Presenter: Vishal Thakker, MEng (he/him/his) – BSI Group
### he/him/his @@@ Jillan Hussein, MEng – MHRA ### 1570677###Presenter###Senior Regulatory Policy Manager###MHRA###Presenter: Jillan Hussein, MEng – MHRA
###Moderator & Presenter: Catarina Carrão – BioSciPons
### @@@ Koen Cobbaert (he/him/his) – Philips ### 943170###Moderator & Presenter###Senior Manager - Quality, Standards & Regulations###Philips###Moderator & Presenter: Koen Cobbaert (he/him/his) – Philips
### he/him/hisModerator & Presenter: Rebecca Lumsden, PhD – Sanofi
### @@@ Marjon Pasmooij – Medicines Evaluation Board ### 1955235###Presenter###Head of Science Department###Medicines Evaluation Board###Presenter: Marjon Pasmooij – Medicines Evaluation Board
### @@@ Frank Pétavy, MSc (he/him/his) – European Medicines Agency ### 1957026###Presenter###Head of Methodology###European Medicines Agency###Presenter: Frank Pétavy, MSc (he/him/his) – European Medicines Agency
### he/him/hisModerator & Presenter: Rebecca Lumsden, PhD – Sanofi
### @@@ Francesca A. Day, PhD (she/her/hers) – European Medicines Agency ### 1922319###Presenter###Head of Therapeutics Area Department###European Medicines Agency###Presenter: Francesca A. Day, PhD (she/her/hers) – European Medicines Agency
### she/her/hers @@@ Julie Spony, MA – European Patients' Forum ### 1948628###Presenter###Policy Officer###European Patients' Forum###Presenter: Julie Spony, MA – European Patients' Forum
### @@@ Laetitia Szaller, MA – AM-Pharma ### 1962129###Presenter###General Counsel & VP Corporate Development###AM-Pharma###Presenter: Laetitia Szaller, MA – AM-Pharma
### @@@ Fabio Datri, PhD – European Commission ### 1980693###Presenter###Policy Officer, Unit B5 Directorate General for Health and Food Safety###European Commission###Presenter: Fabio Datri, PhD – European Commission
###Moderator & Presenter: Rebecca Lumsden, PhD – Sanofi
### @@@ Francesca A. Day, PhD (she/her/hers) – European Medicines Agency ### 1922319###Presenter###Head of Therapeutics Area Department###European Medicines Agency###Presenter: Francesca A. Day, PhD (she/her/hers) – European Medicines Agency
### she/her/hers @@@ Julie Spony, MA – European Patients' Forum ### 1948628###Presenter###Policy Officer###European Patients' Forum###Presenter: Julie Spony, MA – European Patients' Forum
### @@@ Fabio Datri, PhD – European Commission ### 1980693###Presenter###Policy Officer, Unit B5 Directorate General for Health and Food Safety###European Commission###Presenter: Fabio Datri, PhD – European Commission
###Workshop Leader: Neha Parashar, PMP – argenx
### @@@ Ankit Geete – BioNTech, Germany ### 1944257###Presenter###Director###BioNTech, Germany###Presenter: Ankit Geete – BioNTech, Germany
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