IVDR Rollout 2023: Innovation vs Legacy: How to define a Clinical Evidence Strategy for an established analyte/marker or technology versus a novel product.
09:00 – 16:00 CEST
IVDR Rollout 2023: Innovation vs Legacy: How to define a Clinical Evidence Strategy for an established analyte/marker or technology versus a novel product.
Workshop Leader: Warren Jameson, PhD – NAMSA
Presenter: Ciara Airey – Inivata (a subsidiary of NeoGenomics)
Vincent van der Meer (he/him/his) – Medical Device Project B.V. ### 1840753###Workshop Leader###Senior Consultant QA/RA###Medical Device Project B.V.###
Workshop Leader: Vincent van der Meer (he/him/his) – Medical Device Project B.V.
### he/him/his @@@ Robin Meisen ### 1883955###Presenter#########
Carla Gomes – Thermo Fisher Clinical Research Group ### 1827175###Workshop Leader###Sr. Director of Regulatory Affairs###Thermo Fisher Clinical Research Group###
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
###
09:00 – 16:00 CEST
Workshop: Global Regulatory CMC Strategies and Challenges for Biologicals
09:00 – 16:00 CEST
Workshop: Global Regulatory CMC Strategies and Challenges for Biologicals
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
### @@@ Gert W. Bos, FRAPS, MSc, PhD, FRAPS – QServe ### 535440###Moderator###CSO###QServe###
Moderator: Gert W. Bos, FRAPS, MSc, PhD, FRAPS – QServe
### @@@ Rob Nelissen – Orthopaedics Leiden University Medical Center & Secretary General ### 1939248###Panelist###Chairman###Orthopaedics Leiden University Medical Center & Secretary General###
Panelist: Rob Nelissen – Orthopaedics Leiden University Medical Center & Secretary General
### @@@ Bianca Lutters, bianca.lutters@qservegroup.com – Na ### 1523608###Panelist###Head of Clinical Operations###Na###
Panelist: Bianca Lutters, bianca.lutters@qservegroup.com – Na
### @@@ Stan van Belkum ### 1940676###Panelist#########