Workshop Leader: Carla Gomes – Thermo Fisher Clinical Research Group
Presenter: Maria Alexandra Ribeiro – Portuguese National Ethics Committee for Clinical Research (CEIC)
Presenter: Paolo Croce, PhD – PPD, part of Thermo Fisher Scientific
Presenter: Eileen Smith, RA – PPD, part of Thermo Fisher Scientific
Presenter: Rina Kacha – PPD, part of Thermo Fisher Scientific
Preconference Workshop
Pharmaceuticals
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
###Workshop Leader: Warren Jameson, PhD – NAMSA
Presenter: Ciara Airey – Inivata (a subsidiary of NeoGenomics)
Presenter: Heike Moehlig-Zuttermeister – Tüv Süd
Preconference Workshop
IVDR
Workshop 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
###Workshop Leader: Bianca Lutters – QServe Group
Presenter: Marius Woitok, n/a – Med-Clinical
Presenter: Chris Webb – Purdie Pascoe
Presenter: Martha Vakalopoulou – Purdie Pascoe
Preconference Workshop
Devices
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
###Workshop Leader: Janet L. Michener Whipple – Validant
Presenter: Keith Morel, Ph.D. – Qserve Group
Presenter: Leo Hovestadt – Elekta
Presenter: Andreas Purde, Dr – TÜV SÜD Product Service GmbH
Presenter: Meredith Smith, MPA, PhD, FISPE – EVIDERA
Preconference Workshop
Devices
Workshop 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
###Workshop Leader: Vincent van der Meer – Medical Device Project B.V.
Presenter: Manon Gielkens – Medtronic
Presenter: Pilar Mestrom – Medtronic
Preconference Workshop
Devices
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
###Workshop Leader: Neha Parashar, PMP – argenx
Presenter: Ankit Geete – BioNTech, Germany
Preconference Workshop
Pharmaceuticals
Workshop Leader: Neha Parashar, PMP – argenx
### @@@ Ankit Geete – BioNTech, Germany ### 1944257###Presenter###Director###BioNTech, Germany###Presenter: Ankit Geete – BioNTech, Germany
###Moderator: Kimberly A. Trautman, MS – MEDIcept
Moderator: Kim Young
Moderator: Kimberly A. Trautman, MS – MEDIcept
### @@@ Kim Young ### 1974523###Moderator#########Moderator: Kim Young
###Moderator: Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service
Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group
Panelist: Jet Schouten – NRC (newspaper)
Panelist: Rob Nelissen, prof. dr. – Orthopaedics Leiden University Medical Center
Panelist: Bianca Lutters – QServe Group
Panelist: Stan van Belkum – Central Committee on Research Involving Human Subjects (CCMO)
Panelist: Marta Carnielli, PharmD – TUV Sud GmbH
Panelist: Anja Wiersma, PhD – mi-CE consultancy
Panelist: Juan Garcia Burgos, MD – European Medicines Agency
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
###