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
###