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Full Schedule
- Tuesday, May 10, 2022
08:00 – 18:00 CEST
Registration Open
08:00 – 18:00 CEST
Registration Open
09:00 – 16:00 CEST
Building a Sustainable Regulatory Strategy in a Challenging Environment
09:00 – 16:00 CEST
Building a Sustainable Regulatory Strategy in a Challenging Environment Location: Coral & Cyan (1st fl)Session Leader/Speaker: – Nexialist
Speaker: – Nexialist SAS
Speaker: – DQS Medizinprodukte GmbH
Preconference Workshop
Corinne Delorme, RAC – Nexialist ### 1523467###Session Leader/Speaker###Regulatory Intelligence Director###Nexialist###Session Leader/Speaker: – Nexialist
@@@ Vincent Castéras – Nexialist SAS ### 1543942###Speaker###Founder & President###Nexialist SAS###Speaker: – Nexialist SAS
@@@ Szymon Kurdyn – DQS Medizinprodukte GmbH ### 1550651###Speaker###Head of Notified Body (non-active medical devices)###DQS Medizinprodukte GmbH###Speaker: – DQS Medizinprodukte GmbH
09:00 – 16:00 CEST
Implementing PMCF for Medical Devices
09:00 – 16:00 CEST
Implementing PMCF for Medical DevicesLocation: lavenderSession Leader/Speaker: – Qserve Group
Speaker: – Qserve Group B.V.
Preconference Workshop
Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Session Leader/Speaker###CSO - CEO###Qserve Group###Session Leader/Speaker: – Qserve Group
@@@ Wiebe Postma, PhD – Qserve Group B.V. ### 907094###Speaker###Sr Consultant & CRO Service lead###Qserve Group B.V.###Speaker: – Qserve Group B.V.
09:00 – 16:00 CEST
IVDR Implementation Today: Learn From Early Adaptors
09:00 – 16:00 CEST
IVDR Implementation Today: Learn from Early AdaptorsLocation: Magenta (1st fl)Session Leader/Speaker: – TUV SUD JAPAN LTD
Session Leader/Speaker: – mi-CE Consultancy
Speaker: – Synoptyx Inc.
Preconference Workshop
Andreas Stange, PhD – TUV SUD JAPAN LTD ### 1187582###Session Leader/Speaker###VP###TUV SUD JAPAN LTD###Session Leader/Speaker: – TUV SUD JAPAN LTD
@@@ Anja Wiersma, PhD – mi-CE Consultancy ### 574723###Session Leader/Speaker###CEO and Senior Consultant###mi-CE Consultancy###Session Leader/Speaker: – mi-CE Consultancy
@@@ Connie A. Del Buono – Synoptyx Inc. ### 574722###Speaker###Founder, Director Regulatory & Compliance###Synoptyx Inc.###Speaker: – Synoptyx Inc.
09:00 – 16:00 CEST
Regulatory Leadership
09:00 – 16:00 CEST
Regulatory Leadership Location: Carmine & Charcoal (1st fl)Session Leader/Speaker: – Ypsomed AG
Session Leader/Speaker: – Founder of Waypoint Consulting
Speaker: – Elemed
Speaker:
Preconference Workshop
Susana de Azevedo Wäsch, PhD – Ypsomed AG ### 1141752###Session Leader/Speaker###Vice President Quality Management & Regulatory Affairs & Medical Affairs###Ypsomed AG###Session Leader/Speaker: – Ypsomed AG
@@@ Eric Klasen, MSc – Founder of Waypoint Consulting ### 972075###Session Leader/Speaker###RA & Quality consultant in Life Sciences###Founder of Waypoint Consulting###Session Leader/Speaker: – Founder of Waypoint Consulting
@@@ Elena Kyria – Elemed ### 1083155###Speaker###CEO & Founder###Elemed###Speaker: – Elemed
@@@ Ifti Achmed ### 1604877###Speaker#########Speaker:
16:30 – 18:30 CEST
Opening Plenary Session: The Promise and Possibility of Smart Device and Drug Data Repositories to Improve Patient Outcomes
16:30 – 18:30 CEST
Opening Plenary Session: The Promise and Possibility of Smart Device and Drug Data Repositories to Improve Patient OutcomesLocation: Pearl 1 - 3 (ground fl)Moderator: – Qserve Group
Moderator: – TÜV SÜD Medical Health Services
Presenter: – Parexel
Presenter: – NAMSA
Speaker: – European Medicines Agency
Speaker: – BSI
Speaker: – Johnson & Johnson
Speaker: – Alexion Pharmaceuticals
Speaker: – University of Wales, Cardiff, UK
Gert W. Bos, MSc, PhD, FRAPS – Qserve Group ### 535440###Moderator###CSO - CEO###Qserve Group###Moderator: – Qserve Group
@@@ Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services ### 1187581###Moderator###Regulatory Strategy Principal###TÜV SÜD Medical Health Services###Moderator: – TÜV SÜD Medical Health Services
@@@ Siegfried Schmitt, CSci CChem FRSC – Parexel ### 907098###Presenter###Vice President Technical###Parexel###Presenter: – Parexel
@@@ Alex Laan – NAMSA ### 1187572###Presenter###Consultant###NAMSA###Presenter: – NAMSA
@@@ Juan Garcia Burgos – European Medicines Agency ### 1551387###Speaker###Head of Public and Stakeholders Engagement###European Medicines Agency###Speaker: – European Medicines Agency
@@@ Suzanne Halliday, MSc. D.Phil. – BSI ### 535446###Speaker###Regulatory Director###BSI###Speaker: – BSI
@@@ Peter Schroeer – Johnson & Johnson ### 574724###Speaker###Vice President EMEA Leader Clinical, Medical Affairs and RA###Johnson & Johnson###Speaker: – Johnson & Johnson
@@@ Joao Duarte, MSc MPharm – Alexion Pharmaceuticals ### 720625###Speaker###Director, Chief of Staff & Regulatory Science###Alexion Pharmaceuticals###Speaker: – Alexion Pharmaceuticals
@@@ Alan G. Fraser – University of Wales, Cardiff, UK ### 1596842###Speaker###Consultant Cardiologist###University of Wales, Cardiff, UK###Speaker: – University of Wales, Cardiff, UK
18:30 – 20:00 CEST
Opening Reception
