Workshop Leader: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
Speaker: Wiebe Postma, PhD – Qserve Group B.V.
Speaker: Yvonne Ndefo, MD, MCh – NSAI
Preconference Workshop
Workshop Leader: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
@@@ Wiebe Postma, PhD – Qserve Group B.V. ### 907094###Speaker###Medical Device CRO Lead###Qserve Group B.V.###Speaker: Wiebe Postma, PhD – Qserve Group B.V.
@@@ Yvonne Ndefo, MD, MCh – NSAI ### 1154007###Speaker###CHIEF CLINICAL EVALUATOR###NSAI###Speaker: Yvonne Ndefo, MD, MCh – NSAI
Session Leader/Speaker: Anja Wiersma, PhD – mi-CE consultancy
Speaker: Erica Conway, PhD – BSI (London)
Speaker: Simon Richards, PhD – Abbott Rapid Diagnostics
Speaker: Micha Nuebling, PhD – Paul-Ehrlich-Institut
Speaker: Philipp Hohenbrink, Dr rer nat – Medical Device Safety Service GmbH
Speaker: Claudia Dollins, PhD – Merck Healthcare KGaA
Preconference Workshop
Session Leader/Speaker: Anja Wiersma, PhD – mi-CE consultancy
@@@ Erica Conway, PhD – BSI (London) ### 535513###Speaker###Global Head - In Vitro Diagnostic Medical Devices###BSI (London)###Speaker: Erica Conway, PhD – BSI (London)
@@@ Simon Richards, PhD – Abbott Rapid Diagnostics ### 585116###Speaker###Vice President Divisional Regulatory Affairs###Abbott Rapid Diagnostics ###Speaker: Simon Richards, PhD – Abbott Rapid Diagnostics
@@@ Micha Nuebling, PhD – Paul-Ehrlich-Institut ### 972072###Speaker###Head Department###Paul-Ehrlich-Institut###Speaker: Micha Nuebling, PhD – Paul-Ehrlich-Institut
@@@ Philipp Hohenbrink, Dr rer nat – Medical Device Safety Service GmbH ### 979232###Speaker###Senior Consultant###Medical Device Safety Service GmbH###Speaker: Philipp Hohenbrink, Dr rer nat – Medical Device Safety Service GmbH
@@@ Claudia Dollins, PhD – Merck Healthcare KGaA ### 979234###Speaker###Head, Global Regulatory Affairs, Translational Medicine & Devices###Merck Healthcare KGaA###Speaker: Claudia Dollins, PhD – Merck Healthcare KGaA
Workshop Leader: Koen Cobbaert, MA – Philips
Speaker: Leo Hovestadt – Elekta
Preconference Workshop
Workshop Leader: Koen Cobbaert, MA – Philips
@@@ Leo Hovestadt – Elekta ### 716677###Speaker###EU Director Governmental Affairs###Elekta###Speaker: Leo Hovestadt – Elekta
Co-Chair: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
Co-Chair: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
Panelist: Simon Richards, PhD – Abbott Rapid Diagnostics
Panelist: Natascha J. Cuper, PhD – DARE Medical Certifications
Panelist: Erica Conway, PhD – BSI (London)
Panelist: Waldo Weijers, PharmD – Medicines Evaluation Board (NL)
Panelist: Eric Klasen, MSc – Founder of Waypoint Consulting
Panelist: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Panelist: Micha Nuebling, PhD – Paul-Ehrlich-Institut
Panelist: Jayanth K. Katta, PhD – BSI
Panelist: Bassil Akra, PhD – QUNIQUE GmbH
Panelist: Elizabeth Gfoeller, MA – Med-El
Panelist: Erik Raadsheer, PhD – Align Technology, BV.
Panelist: Susana Waesch – Ypsomed
Panelist: Klaus-Dieter Ziel – MEDCERT GmbH, Notified Body Germany
Panelist: Erik Hansson – DG for Health and Food Safety (SANTE)
Plenary
Co-Chair: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
@@@ Gert Willem Bos, FRAPS – Qserve Group (Netherlands) ### 535440###Co-Chair###CTO, Executive Director & Partner at Qserve Group###Qserve Group (Netherlands)###Co-Chair: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
@@@ Simon Richards, PhD – Abbott Rapid Diagnostics ### 585116###Panelist###Vice President Divisional Regulatory Affairs###Abbott Rapid Diagnostics ###Panelist: Simon Richards, PhD – Abbott Rapid Diagnostics
@@@ Natascha J. Cuper, PhD – DARE Medical Certifications ### 535505###Panelist###Clinical expert###DARE Medical Certifications###Panelist: Natascha J. Cuper, PhD – DARE Medical Certifications
@@@ Erica Conway, PhD – BSI (London) ### 535513###Panelist###Global Head - In Vitro Diagnostic Medical Devices###BSI (London)###Panelist: Erica Conway, PhD – BSI (London)
@@@ Waldo Weijers, PharmD – Medicines Evaluation Board (NL) ### 716640###Panelist###Senior Advisor###Medicines Evaluation Board (NL)###Panelist: Waldo Weijers, PharmD – Medicines Evaluation Board (NL)
@@@ Eric Klasen, MSc – Founder of Waypoint Consulting ### 972075###Panelist###RA & Quality consultant in Life Sciences###Founder of Waypoint Consulting###Panelist: Eric Klasen, MSc – Founder of Waypoint Consulting
@@@ Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 844383###Panelist###Scientific Administrator###European Medicines Agency###Panelist: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
@@@ Micha Nuebling, PhD – Paul-Ehrlich-Institut ### 972072###Panelist###Head Department###Paul-Ehrlich-Institut###Panelist: Micha Nuebling, PhD – Paul-Ehrlich-Institut
@@@ Jayanth K. Katta, PhD – BSI ### 907116###Panelist###Senior Regulatory Lead###BSI###Panelist: Jayanth K. Katta, PhD – BSI
@@@ Bassil Akra, PhD – QUNIQUE GmbH ### 535482###Panelist###CEO###QUNIQUE GmbH###Panelist: Bassil Akra, PhD – QUNIQUE GmbH
@@@ Elizabeth Gfoeller, MA – Med-El ### 766093###Panelist###Corporate Director, Regulatory Affairs ###Med-El###Panelist: Elizabeth Gfoeller, MA – Med-El
@@@ Erik Raadsheer, PhD – Align Technology, BV. ### 1092331###Panelist###Sr. Director, Regulatory & Government Affairs and Quality Assurance, EMEA###Align Technology, BV.###Panelist: Erik Raadsheer, PhD – Align Technology, BV.
@@@ Susana Waesch – Ypsomed ### 1141752###Panelist###Biotechnologist and vice president###Ypsomed###Panelist: Susana Waesch – Ypsomed
@@@ Klaus-Dieter Ziel – MEDCERT GmbH, Notified Body Germany ### 1141753###Panelist###Managing Director###MEDCERT GmbH, Notified Body Germany###Panelist: Klaus-Dieter Ziel – MEDCERT GmbH, Notified Body Germany
@@@ Erik Hansson – DG for Health and Food Safety (SANTE) ### 535441###Panelist###Deputy Head of Unit Medical Devices and Health Technology Assessment###DG for Health and Food Safety (SANTE)###Panelist: Erik Hansson – DG for Health and Food Safety (SANTE)
Networking & Entertainment