Workshop Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Preconference Workshop
Workshop Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Workshop Leader: Bassil Akra, PhD – QUNIQUE GmbH
Speaker: Martin Witte – TÜV SÜD Product Service GmbH
Speaker: Peter W. Bowness, PhD – British Standards Institution
Speaker: Dominik Herzog, Dr – TentaMedix GmbH
Speaker: Christoph D. Lindner, PhD, MSc – TUV Sud Product Service GmbH
Speaker: Christian Johner
Speaker: Andreas Purde, Dr – TÜV SÜD Product Service GmbH
Preconference Workshop
Workshop Leader: Bassil Akra, PhD – QUNIQUE GmbH
@@@ Martin Witte – TÜV SÜD Product Service GmbH ### 973390###Speaker###Global Director###TÜV SÜD Product Service GmbH###Speaker: Martin Witte – TÜV SÜD Product Service GmbH
@@@ Peter W. Bowness, PhD – British Standards Institution ### 973391###Speaker###Technical Team Manager###British Standards Institution###Speaker: Peter W. Bowness, PhD – British Standards Institution
@@@ Dominik Herzog, Dr – TentaMedix GmbH ### 973392###Speaker###Managing Director###TentaMedix GmbH###Speaker: Dominik Herzog, Dr – TentaMedix GmbH
@@@ Christoph D. Lindner, PhD, MSc – TUV Sud Product Service GmbH ### 973393###Speaker###Teamleader Medical Device Testing###TUV Sud Product Service GmbH###Speaker: Christoph D. Lindner, PhD, MSc – TUV Sud Product Service GmbH
@@@ Christian Johner ### 973394###Speaker#########Speaker: Christian Johner
@@@ Andreas Purde, Dr – TÜV SÜD Product Service GmbH ### 973395###Speaker###Director###TÜV SÜD Product Service GmbH###Speaker: Andreas Purde, Dr – TÜV SÜD Product Service GmbH
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
Moderator: Amanda Maxwell, BA – Medtech Insight
Speaker: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
Speaker: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
Speaker: Erik Vollebregt
Medical Devices
Moderator: Amanda Maxwell, BA – Medtech Insight
@@@ Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH ### 574720###Speaker###Regulatory Strategy Principal###TUV SUD Product Service GmbH###Speaker: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
@@@ Gert Willem Bos, FRAPS – Qserve Group (Netherlands) ### 535440###Speaker###CTO, Executive Director & Partner at Qserve Group###Qserve Group (Netherlands)###Speaker: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
@@@ Erik Vollebregt ### 535481###Speaker###Partner######Speaker: Erik Vollebregt
Session Leader: Jayanth K. Katta, PhD – BSI
Speaker: Jane Arnold-Round, B.Eng Msc.
Speaker: Jonathan Sutch, PhD – BSI
Speaker: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Medical Devices
Session Leader: Jayanth K. Katta, PhD – BSI
@@@ Jane Arnold-Round, B.Eng Msc. ### 907114###Speaker#########Speaker: Jane Arnold-Round, B.Eng Msc.
@@@ Jonathan Sutch, PhD – BSI ### 907128###Speaker###Medicinal Technical Specialist###BSI###Speaker: Jonathan Sutch, PhD – BSI
@@@ Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 844383###Speaker###Scientific Administrator###European Medicines Agency###Speaker: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Session Leader: Maria E. Donawa, MD – Donawa Lifescience
Speaker: Daniela Karrer – Donawa Lifescience
Speaker: Matteo Mosso – Donawa Lifescience
In Vitro Diagnostics
Session Leader: Maria E. Donawa, MD – Donawa Lifescience
@@@ Daniela Karrer – Donawa Lifescience ### 716657###Speaker###VP Operations and Clinical Affairs###Donawa Lifescience###Speaker: Daniela Karrer – Donawa Lifescience
@@@ Matteo Mosso – Donawa Lifescience ### 907110###Speaker###Senior Clinical Project Manager###Donawa Lifescience###Speaker: Matteo Mosso – Donawa Lifescience
Networking & Entertainment
Networking & Entertainment
Speaker: Stephan Affolter – Ypsomed AG
Medical Devices
Speaker: Stephan Affolter – Ypsomed AG
Session Leader/Speaker: Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates
Speaker: Jayanth K. Katta, PhD – BSI
Medical Devices
Session Leader/Speaker: Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates
@@@ Jayanth K. Katta, PhD – BSI ### 907116###Speaker###Senior Regulatory Lead###BSI###Speaker: Jayanth K. Katta, PhD – BSI
Session Leader/Speaker: Luc Van Hove, MD, PhD – MARACA International bvba
Speaker: Menno Prins, PhD – Eindhoven University of Technology
Speaker: Angel Delpozo, MSC – BioKeralty Research Institute
Speaker: Quentin Pankhurst
In Vitro Diagnostics
Session Leader/Speaker: Luc Van Hove, MD, PhD – MARACA International bvba
@@@ Menno Prins, PhD – Eindhoven University of Technology ### 907100###Speaker###Professor###Eindhoven University of Technology###Speaker: Menno Prins, PhD – Eindhoven University of Technology
@@@ Angel Delpozo, MSC – BioKeralty Research Institute ### 907101###Speaker###Deputy Manager of programs strategy###BioKeralty Research Institute###Speaker: Angel Delpozo, MSC – BioKeralty Research Institute
@@@ Quentin Pankhurst ### 1092330###Speaker#########Speaker: Quentin Pankhurst
Speaker: Rainer Voelksen, FRAPS – VOELKSEN Regulatory Affairs
Medical Devices
Speaker: Rainer Voelksen, FRAPS – VOELKSEN Regulatory Affairs
Networking & Entertainment
Networking & Entertainment
Session Leader: Michael Maier, MBA, RAC – Medidee Services SA
Speaker: Tim Farley, PhD – Medidee Services SA
Speaker: Sandra Klompmaker, PhD – Medidee Services
In Vitro Diagnostics
Session Leader: Michael Maier, MBA, RAC – Medidee Services SA
@@@ Tim Farley, PhD – Medidee Services SA ### 943357###Speaker###Senior Consultant###Medidee Services SA###Speaker: Tim Farley, PhD – Medidee Services SA
@@@ Sandra Klompmaker, PhD – Medidee Services ### 1077038###Speaker###Senior Associate###Medidee Services###Speaker: Sandra Klompmaker, PhD – Medidee Services
Session Leader/Speaker: Jan-Paul van Loon, MSc, PhD – Qserve Consultancy BV
Speaker: Jane Arnold-Round, B.Eng Msc.
Medical Devices
Session Leader/Speaker: Jan-Paul van Loon, MSc, PhD – Qserve Consultancy BV
@@@ Jane Arnold-Round, B.Eng Msc. ### 907114###Speaker#########Speaker: Jane Arnold-Round, B.Eng Msc.
Session Leader/Speaker: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Speaker: Hans Strobel – dokspot GmbH, Zurich, Switzerland
Speaker: Reinhart Seibl
Medical Devices
Session Leader/Speaker: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
@@@ Hans Strobel – dokspot GmbH, Zurich, Switzerland ### 907079###Speaker###CEO###dokspot GmbH, Zurich, Switzerland###Speaker: Hans Strobel – dokspot GmbH, Zurich, Switzerland
@@@ Reinhart Seibl ### 1055965###Speaker#########Speaker: Reinhart Seibl
Networking & Entertainment
Networking & Entertainment
Networking & Entertainment
Speaker: Martin de Bruin
Author: Rod Beuzeval – Meddev Solutions
Meet the Author
Author: Rod Beuzeval – Meddev Solutions
Speaker: Alex Laan – NAMSA
Medical Devices
Speaker: Alex Laan – NAMSA
Speaker: Hilary A. Baldwin – Caris Life Sciences
Chair: Luc Van Hove, MD, PhD – MARACA International bvba
Speaker: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
In Vitro Diagnostics
Speaker: Hilary A. Baldwin – Caris Life Sciences
@@@ Luc Van Hove, MD, PhD – MARACA International bvba ### 716641###Chair###CEO###MARACA International bvba###Chair: Luc Van Hove, MD, PhD – MARACA International bvba
@@@ Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 844383###Speaker###Scientific Administrator###European Medicines Agency###Speaker: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Session Leader/Speaker: John C. Lockwood, CBA, RAC, CSQE – Pearl Pathways
Speaker: John Van Hoven, MS – Rocky Mountain Regulatory and Quality Partners
Medical Devices
Session Leader/Speaker: John C. Lockwood, CBA, RAC, CSQE – Pearl Pathways
@@@ John Van Hoven, MS – Rocky Mountain Regulatory and Quality Partners ### 907097###Speaker###President & CEO###Rocky Mountain Regulatory and Quality Partners###Speaker: John Van Hoven, MS – Rocky Mountain Regulatory and Quality Partners
Networking & Entertainment
Networking & Entertainment
Networking & Entertainment
Session Leader/Speaker: Rachel Kennedy, RAC – LabCorp.
In Vitro Diagnostics
Session Leader/Speaker: Rachel Kennedy, RAC – LabCorp.
Session Leader/Speaker: Keith Morel, PhD – Qserve Group Inc. - ENTERPRISE
Speaker: Leonard Buchner, MS – Qserve Group
Medical Devices
Session Leader/Speaker: Keith Morel, PhD – Qserve Group Inc. - ENTERPRISE
@@@ Leonard Buchner, MS – Qserve Group ### 992404###Speaker###Principle Consultant###Qserve Group###Speaker: Leonard Buchner, MS – Qserve Group
Session Leader/Speaker: Jason R. Krzeszak, MSE, MBA – NAMSA
Speaker: Deepa Arora, MD – Clinexel Life Sciences Private Limited
Speaker: Melissa Walker, MS, RAC, FRAPS – Graematter, Inc.
Medical Devices
Session Leader/Speaker: Jason R. Krzeszak, MSE, MBA – NAMSA
@@@ Deepa Arora, MD – Clinexel Life Sciences Private Limited ### 907115###Speaker###Founder-Director###Clinexel Life Sciences Private Limited###Speaker: Deepa Arora, MD – Clinexel Life Sciences Private Limited
@@@ Melissa Walker, MS, RAC, FRAPS – Graematter, Inc. ### 609472###Speaker###President & CTO###Graematter, Inc.###Speaker: Melissa Walker, MS, RAC, FRAPS – Graematter, Inc.
Networking & Entertainment
Networking & Entertainment
Session Leader/Speaker: Natascha J. Cuper, PhD – DARE Medical Certifications
Speaker: Robert van Boxtel, MSc. – Medical Device Project B.V.
Medical Devices
Session Leader/Speaker: Natascha J. Cuper, PhD – DARE Medical Certifications
@@@ Robert van Boxtel, MSc. – Medical Device Project B.V. ### 907078###Speaker###Principal Consultant###Medical Device Project B.V.###Speaker: Robert van Boxtel, MSc. – Medical Device Project B.V.
Session Leader: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
Panelist: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
Panelist: Andreas Stange, PhD – TÜV SÜD Japan
Panelist: Tom Patten – NSAI
Panelist: Sue Spencer – Qserve Group (United Kingdom)
Panelist: Simon Richards, PhD – Abbott Rapid Diagnostics
In Vitro Diagnostics
Session Leader: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
@@@ Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 844383###Panelist###Scientific Administrator###European Medicines Agency###Panelist: Armin Ritzhaupt, PhD, MPH – European Medicines Agency
@@@ Andreas Stange, PhD – TÜV SÜD Japan ### 585266###Panelist###Vice President###TÜV SÜD Japan###Panelist: Andreas Stange, PhD – TÜV SÜD Japan
@@@ Tom Patten – NSAI ### 1141749###Panelist###Certification and Inspection Officer###NSAI###Panelist: Tom Patten – NSAI
@@@ Sue Spencer – Qserve Group (United Kingdom) ### 535447###Panelist###IVD Lead/ Principal Consultant###Qserve Group (United Kingdom)###Panelist: Sue Spencer – Qserve Group (United Kingdom)
@@@ Simon Richards, PhD – Abbott Rapid Diagnostics ### 585116###Panelist###Vice President Divisional Regulatory Affairs###Abbott Rapid Diagnostics ###Panelist: Simon Richards, PhD – Abbott Rapid Diagnostics
Session Leader: Ludger Johannes Moeller – Medical Device Safety Service GmbH
Speaker: Erik Vollebregt
Speaker: Thomas Sproho, Dipl.-Kfm. – Chubb
Speaker: Chad Reynolds – Maetrics
Medical Devices
Session Leader: Ludger Johannes Moeller – Medical Device Safety Service GmbH
@@@ Erik Vollebregt ### 535481###Speaker###Partner######Speaker: Erik Vollebregt
@@@ Thomas Sproho, Dipl.-Kfm. – Chubb ### 949938###Speaker###Regional Head Life Science Continental Europe###Chubb###Speaker: Thomas Sproho, Dipl.-Kfm. – Chubb
@@@ Chad Reynolds – Maetrics ### 1077037###Speaker###Director, Solutions Delivery###Maetrics###Speaker: Chad Reynolds – Maetrics
Networking & Entertainment
Networking & Entertainment
Session Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Speaker: Yingying Liu, M.Sc. – CSL Behring
Medical Devices
Session Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
@@@ Yingying Liu, M.Sc. – CSL Behring ### 907090###Speaker###Associate Director###CSL Behring###Speaker: Yingying Liu, M.Sc. – CSL Behring
Session Leader/Speaker: Adrian Keene, BSc (Hons) – NAMSA
Speaker: Daniela Karrer – Donawa Lifescience
Medical Devices
Session Leader/Speaker: Adrian Keene, BSc (Hons) – NAMSA
@@@ Daniela Karrer – Donawa Lifescience ### 716657###Speaker###VP Operations and Clinical Affairs###Donawa Lifescience###Speaker: Daniela Karrer – Donawa Lifescience
Session Leader: Anja Wiersma, PhD – mi-CE consultancy
Speaker: Jacques J.M van Dongen, MD, PhD – Leiden University Medical Center (LUMC)
In Vitro Diagnostics
Session Leader: Anja Wiersma, PhD – mi-CE consultancy
@@@ Jacques J.M van Dongen, MD, PhD – Leiden University Medical Center (LUMC) ### 955340###Speaker###Full professor of Medical Immunology###Leiden University Medical Center (LUMC)###Speaker: Jacques J.M van Dongen, MD, PhD – Leiden University Medical Center (LUMC)
Session Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Speaker: Joalin Lim, BSc, MSc, PhDc, CCRP, ISO13485:2016 Lead Auditor – Agape-Life Support System Pte Ltd (Agape-Life MedTech Group)
Medical Devices
Session Leader: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
### @@@ Joalin Lim, BSc, MSc, PhDc, CCRP, ISO13485:2016 Lead Auditor – Agape-Life Support System Pte Ltd (Agape-Life MedTech Group) ### 1055945###Speaker###CEO/Founder###Agape-Life Support System Pte Ltd (Agape-Life MedTech Group)###Speaker: Joalin Lim, BSc, MSc, PhDc, CCRP, ISO13485:2016 Lead Auditor – Agape-Life Support System Pte Ltd (Agape-Life MedTech Group)
###Networking & Entertainment
Session Leader/Speaker: Anne Van Nerom, DVM, PhD – Sciensano
In Vitro Diagnostics
Session Leader/Speaker: Anne Van Nerom, DVM, PhD – Sciensano
Session Leader/Speaker: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Speaker: Joyce Hansen – Johnson & Johnson
Medical Devices
Session Leader/Speaker: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
@@@ Joyce Hansen – Johnson & Johnson ### 1139272###Speaker###Vice President, Microbiological Quality and Sterility Assurance###Johnson & Johnson###Speaker: Joyce Hansen – Johnson & Johnson
Session Leader/Speaker: Leo Hovestadt – Elekta
Speaker: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
Speaker: Giovanni Di Rienzo – Qserve Consultancy
Speaker: Julien Senac
Medical Devices
Session Leader/Speaker: Leo Hovestadt – Elekta
@@@ Gert Willem Bos, FRAPS – Qserve Group (Netherlands) ### 535440###Speaker###CTO, Executive Director & Partner at Qserve Group###Qserve Group (Netherlands)###Speaker: Gert Willem Bos, FRAPS – Qserve Group (Netherlands)
@@@ Giovanni Di Rienzo – Qserve Consultancy ### 907127###Speaker###Senior Consultant###Qserve Consultancy###Speaker: Giovanni Di Rienzo – Qserve Consultancy
@@@ Julien Senac ### 1022552###Speaker###Director, IVD Global Focus Team######Speaker: Julien Senac
Networking & Entertainment
Networking & Entertainment
Session Leader/Speaker: Matt Royle, PhD – NAMSA
Medical Devices
Session Leader/Speaker: Matt Royle, PhD – NAMSA
Session Leader: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
Speaker: Steve Eglem, MSc – AFMPH (Competent Authority of Belgium)
Speaker: Wiebe Postma, PhD – Qserve Group B.V.
Medical Devices
Session Leader: Sabina Hoekstra-van den Bosch, PharmD, FRAPS – TUV SUD Product Service GmbH
@@@ Steve Eglem, MSc – AFMPH (Competent Authority of Belgium) ### 716662###Speaker###Head of Unit Clinical Investigation & Unmet Medical needs###AFMPH (Competent Authority of Belgium)###Speaker: Steve Eglem, MSc – AFMPH (Competent Authority of Belgium)
@@@ 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.
Session Leader: Michael Maier, MBA, RAC – Medidee Services SA
Speaker: Robyn Meurant – NSF International
Speaker: Rima Padovani, PhD – Medidee Services SA
Speaker: Mark Lanigan – World Health Organization
In Vitro Diagnostics
Session Leader: Michael Maier, MBA, RAC – Medidee Services SA
@@@ Robyn Meurant – NSF International ### 716649###Speaker###Executive Director, Regulatory Team, IVDs and Medical Devices###NSF International###Speaker: Robyn Meurant – NSF International
@@@ Rima Padovani, PhD – Medidee Services SA ### 1022270###Speaker###Senior Associate###Medidee Services SA###Speaker: Rima Padovani, PhD – Medidee Services SA
@@@ Mark Lanigan – World Health Organization ### 943227###Speaker###Technical Officer###World Health Organization###Speaker: Mark Lanigan – World Health Organization
Networking & Entertainment
Networking & Entertainment
Author: Rod Beuzeval – Meddev Solutions
Meet the Author
Author: Rod Beuzeval – Meddev Solutions
Speaker: Katarina Kresankova – Schlafender Hase GmbH
Speaker: Marc Chaillou – Schlafender Hase GmbH
Sponsored Session
Speaker: Katarina Kresankova – Schlafender Hase GmbH
@@@ Marc Chaillou – Schlafender Hase GmbH ### 1154945###Speaker###Regional Sales Director###Schlafender Hase GmbH###Speaker: Marc Chaillou – Schlafender Hase GmbH
Session Leader/Speaker: Diana Nogueira, MSc, PhD – Qserve Group Deutschland GmbH
Speaker: Karen Bannick McQuoid, MA, FRAPS, RAC – Bannick LLC
Speaker: Giovanni Di Rienzo – Qserve Consultancy
Medical Devices
Session Leader/Speaker: Diana Nogueira, MSc, PhD – Qserve Group Deutschland GmbH
@@@ Karen Bannick McQuoid, MA, FRAPS, RAC – Bannick LLC ### 907111###Speaker###CEO###Bannick LLC###Speaker: Karen Bannick McQuoid, MA, FRAPS, RAC – Bannick LLC
@@@ Giovanni Di Rienzo – Qserve Consultancy ### 907127###Speaker###Senior Consultant###Qserve Consultancy###Speaker: Giovanni Di Rienzo – Qserve Consultancy
Speaker: Pat Baird, MBA, MS – Philips
Medical Devices
Speaker: Pat Baird, MBA, MS – Philips
Session Leader/Speaker: Luc Van Hove, MD, PhD – MARACA International bvba
In Vitro Diagnostics
Session Leader/Speaker: Luc Van Hove, MD, PhD – MARACA International bvba
Networking & Entertainment
Networking & Entertainment
Networking & Entertainment
Speaker: Abtin Rad
Medical Devices
Speaker: Abtin Rad
Session Leader/Speaker: Hilary A. Baldwin – Caris Life Sciences
In Vitro Diagnostics
Session Leader/Speaker: Hilary A. Baldwin – Caris Life Sciences
Session Leader/Speaker: Kimberly Ann Trautman, MS
Speaker: Richard Bassett, LLM, Msc, Bsc – NAMSA
Medical Devices
Session Leader/Speaker: Kimberly Ann Trautman, MS
@@@ Richard Bassett, LLM, Msc, Bsc – NAMSA ### 907120###Speaker###Medical Writer###NAMSA###Speaker: Richard Bassett, LLM, Msc, Bsc – NAMSA
Networking & Entertainment
Networking & Entertainment
Networking & Entertainment
Poster Presenter: Shristi Shrestha, MSc – Lübeck University of Applied Sciences
Poster
Poster Presenter: Shristi Shrestha, MSc – Lübeck University of Applied Sciences
Poster Presenter: Dragana Bundalo, MSc – PharmaSwiss
Poster
Poster Presenter: Dragana Bundalo, MSc – PharmaSwiss
Poster Presenter: Dzeparoski Marjan, PhD – Bionika Pharmaceuticals
Poster
Poster Presenter: Dzeparoski Marjan, PhD – Bionika Pharmaceuticals
Moderator: Charlie Mortazavi, PharmD – SANOFI
Poster Presenter: Shristi Shrestha, MSc – Lübeck University of Applied Sciences
Poster Presenter: Dragana Bundalo, MSc – PharmaSwiss
Poster Presenter: Dzeparoski Marjan, PhD – Bionika Pharmaceuticals
Poster Presenter: Reeshav Pradhan, MSc. – Technical University of Applied Science Luebeck
Poster Presenter: Umesh Satyal, MSc – Lübeck University of Applied Science, Lübeck, Germany
Poster
Moderator: Charlie Mortazavi, PharmD – SANOFI
@@@ Shristi Shrestha, MSc – Lübeck University of Applied Sciences ### 907105###Poster Presenter###Student###Lübeck University of Applied Sciences###Poster Presenter: Shristi Shrestha, MSc – Lübeck University of Applied Sciences
@@@ Dragana Bundalo, MSc – PharmaSwiss ### 907091###Poster Presenter###Regulatory Affairs Associate###PharmaSwiss###Poster Presenter: Dragana Bundalo, MSc – PharmaSwiss
@@@ Dzeparoski Marjan, PhD – Bionika Pharmaceuticals ### 907084###Poster Presenter###RA&PV Manager###Bionika Pharmaceuticals###Poster Presenter: Dzeparoski Marjan, PhD – Bionika Pharmaceuticals
@@@ Reeshav Pradhan, MSc. – Technical University of Applied Science Luebeck ### 1145306###Poster Presenter######Technical University of Applied Science Luebeck###Poster Presenter: Reeshav Pradhan, MSc. – Technical University of Applied Science Luebeck
@@@ Umesh Satyal, MSc – Lübeck University of Applied Science, Lübeck, Germany ### 1145308###Poster Presenter###Student###Lübeck University of Applied Science, Lübeck, Germany###Poster Presenter: Umesh Satyal, MSc – Lübeck University of Applied Science, Lübeck, Germany
Poster Presenter: Olivia McDermott, Ph.D – Olivia McDermott Hayes
Poster
Poster Presenter: Olivia McDermott, Ph.D – Olivia McDermott Hayes
Poster Presenter: Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health
Poster
Poster Presenter: Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health
Moderator: Charlie Mortazavi, PharmD – SANOFI
Poster Presenter: Olivia McDermott, Ph.D – Olivia McDermott Hayes
Poster Presenter: Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health
Poster
Moderator: Charlie Mortazavi, PharmD – SANOFI
@@@ Olivia McDermott, Ph.D – Olivia McDermott Hayes ### 907092###Poster Presenter###Lecturer in Healthcare Regulatory Affairs###Olivia McDermott Hayes###Poster Presenter: Olivia McDermott, Ph.D – Olivia McDermott Hayes
@@@ Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health ### 907102###Poster Presenter###Regulatory Affairs Specialist in Central America###Cardinal Health###Poster Presenter: Monica Hernandez, Bachelor in Biopharmaceutical Chemistry – Cardinal Health
Networking & Entertainment
Speaker: Aimad Torqui – MSD
Chair: Colette Shortt, MSc,PhD, MBA
Speaker: Elizabeth Scanlan, MSc, PhD – European Medicines Agency
Pharmaceuticals
Speaker: Aimad Torqui – MSD
@@@ Colette Shortt, MSc,PhD, MBA ### 973109###Chair###Regulatory Director######Chair: Colette Shortt, MSc,PhD, MBA
@@@ Elizabeth Scanlan, MSc, PhD – European Medicines Agency ### 1096900###Speaker###Scientific Communication Officer###European Medicines Agency###Speaker: Elizabeth Scanlan, MSc, PhD – European Medicines Agency
Chair: Colette Shortt, MSc,PhD, MBA
Speaker: Camille Piriou, PharmD – BlueReg
Pharmaceuticals
Chair: Colette Shortt, MSc,PhD, MBA
@@@ Camille Piriou, PharmD – BlueReg ### 1079441###Speaker###Senior Consultant Regulatory Affairs###BlueReg###Speaker: Camille Piriou, PharmD – BlueReg
Networking & Entertainment
Speaker: Maria Mercedes Bertoli, PhD – Self-employee
Chair: Jennifer Neff, PhD – bess AG
Pharmaceuticals
Speaker: Maria Mercedes Bertoli, PhD – Self-employee
@@@ Jennifer Neff, PhD – bess AG ### 958555###Chair###Director QM/RA & Medical Affairs###bess AG###Chair: Jennifer Neff, PhD – bess AG
Speaker: Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc.
Chair: Jennifer Neff, PhD – bess AG
Speaker: Kristina Larsson, MSc – European Medicines Agency
Pharmaceuticals
Speaker: Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc.
@@@ Jennifer Neff, PhD – bess AG ### 958555###Chair###Director QM/RA & Medical Affairs###bess AG###Chair: Jennifer Neff, PhD – bess AG
@@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Speaker###Head of Orphan Drugs###European Medicines Agency###Speaker: Kristina Larsson, MSc – European Medicines Agency
Networking & Entertainment
Session Leader: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
Speaker: Stephanie O. Omokaro, MD – U.S. Food & Drug Administration
Speaker: Anthony Humphreys – European Medicines Agency
Pharmaceuticals
Session Leader: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
@@@ Stephanie O. Omokaro, MD – U.S. Food & Drug Administration ### 858252###Speaker###Division Deputy Director###U.S. Food & Drug Administration###Speaker: Stephanie O. Omokaro, MD – U.S. Food & Drug Administration
@@@ Anthony Humphreys – European Medicines Agency ### 978348###Speaker###Head Regulatory Science and Innovation Taskforce###European Medicines Agency###Speaker: Anthony Humphreys – European Medicines Agency
Networking & Entertainment
Session Leader/Speaker: Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc.
Speaker: Patrick Celis, PhD – European Medicines Agency
Pharmaceuticals
Session Leader/Speaker: Mridula Shukla, Masters in Biotechnology – Arcutis Biotherapeutics Inc.
@@@ Patrick Celis, PhD – European Medicines Agency ### 1096893###Speaker###Scientific Officer###European Medicines Agency###Speaker: Patrick Celis, PhD – European Medicines Agency
Networking & Entertainment
Session Leader/Speaker: Peter Lassoff, PharmD – Syneos Health
Speaker: John S. Klein, MS MBA – NorthCoast Clinical Consulting, LLC
Pharmaceuticals
Session Leader/Speaker: Peter Lassoff, PharmD – Syneos Health
@@@ John S. Klein, MS MBA – NorthCoast Clinical Consulting, LLC ### 907104###Speaker###Principal###NorthCoast Clinical Consulting, LLC###Speaker: John S. Klein, MS MBA – NorthCoast Clinical Consulting, LLC
Speaker: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
Session Leader: Peter Lassoff, PharmD – Syneos Health
Pharmaceuticals
Speaker: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
@@@ Peter Lassoff, PharmD – Syneos Health ### 907103###Session Leader###Senior Vice President, Regulatory Affairs###Syneos Health###Session Leader: Peter Lassoff, PharmD – Syneos Health
Networking & Entertainment
Session Leader/Speaker: Tracy Meffen, MS, CQA, RAC – Genevant Sciences
Speaker: Andreas N. Kuhn, Dr – BioNTech RNA Pharmaceuticals GmbH
Speaker: Ana Hidalgo-Simon, MD, PhD – European Medicines Agency
Pharmaceuticals
Session Leader/Speaker: Tracy Meffen, MS, CQA, RAC – Genevant Sciences
@@@ Andreas N. Kuhn, Dr – BioNTech RNA Pharmaceuticals GmbH ### 907113###Speaker###Senior Vice President RNA Biochemistry & Manufacturing###BioNTech RNA Pharmaceuticals GmbH###Speaker: Andreas N. Kuhn, Dr – BioNTech RNA Pharmaceuticals GmbH
@@@ Ana Hidalgo-Simon, MD, PhD – European Medicines Agency ### 1061460###Speaker######European Medicines Agency###Speaker: Ana Hidalgo-Simon, MD, PhD – European Medicines Agency
Networking & Entertainment
Speaker: Yingying Liu, M.Sc. – CSL Behring
Chair: Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk
Pharmaceuticals
Speaker: Yingying Liu, M.Sc. – CSL Behring
@@@ Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk ### 535465###Chair###Head of Global Regulatory Affairs and Compliance###Trident Pharmaceuticals limited & Spinos Clinical Research Uk###Chair: Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk
Speaker: Stefanie Faßhauer, MBA – PharmaLex
Chair: Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk
Pharmaceuticals
Speaker: Stefanie Faßhauer, MBA – PharmaLex
@@@ Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk ### 535465###Chair###Head of Global Regulatory Affairs and Compliance###Trident Pharmaceuticals limited & Spinos Clinical Research Uk###Chair: Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk
Networking & Entertainment
Speaker: David Thompson, N/A – Clarity compliance solutions ltd
Speaker: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
Pharmaceuticals
Speaker: David Thompson, N/A – Clarity compliance solutions ltd
@@@ Siegfried Schmitt, PhD CSci CChem FRSC – Parexel ### 907098###Speaker###Vice President Technical###Parexel###Speaker: Siegfried Schmitt, PhD CSci CChem FRSC – Parexel
Speaker: Irena Milobratovic, MPharm, RAC – Arriello
Speaker: Claudia Louati, MS – US Food and Drug Administration, Europe Office
Speaker: Gabriela Marton – Arriello s.r.o
Chair: Jennifer Neff, PhD – bess AG
Pharmaceuticals
Speaker: Irena Milobratovic, MPharm, RAC – Arriello
@@@ Claudia Louati, MS – US Food and Drug Administration, Europe Office ### 951800###Speaker###Policy Advisor###US Food and Drug Administration, Europe Office###Speaker: Claudia Louati, MS – US Food and Drug Administration, Europe Office
@@@ Gabriela Marton – Arriello s.r.o ### 907134###Speaker###Quality and Regulatory Director ###Arriello s.r.o###Speaker: Gabriela Marton – Arriello s.r.o
@@@ Jennifer Neff, PhD – bess AG ### 958555###Chair###Director QM/RA & Medical Affairs###bess AG###Chair: Jennifer Neff, PhD – bess AG
Networking & Entertainment
Session Leader/Speaker: Charlie Mortazavi, PharmD – SANOFI
Pharmaceuticals
Session Leader/Speaker: Charlie Mortazavi, PharmD – SANOFI
Speaker: Mark Louis Slisz, US & EU RAC – Pearl Pathways
Chair: Charlie Mortazavi, PharmD – SANOFI
Pharmaceuticals
Speaker: Mark Louis Slisz, US & EU RAC – Pearl Pathways
@@@ Charlie Mortazavi, PharmD – SANOFI ### 907082###Chair###SENIOR MANAGER###SANOFI###Chair: Charlie Mortazavi, PharmD – SANOFI
Networking & Entertainment
Speaker: Robert Seevers, PhD – Pearl Pathways
Chair: Mark Di Cioccio – Team Consulting
Pharmaceuticals
Speaker: Robert Seevers, PhD – Pearl Pathways
@@@ Mark Di Cioccio – Team Consulting ### 958556###Chair###Head of QA###Team Consulting###Chair: Mark Di Cioccio – Team Consulting
Chair: Mark Di Cioccio – Team Consulting
Speaker: Philip M. Budashewitz, RPh MA – U.S. Food and Drug Administration
Pharmaceuticals
Chair: Mark Di Cioccio – Team Consulting
@@@ Philip M. Budashewitz, RPh MA – U.S. Food and Drug Administration ### 1090230###Speaker###Director, Office of Medical Policy Initiatives. CDER, FDA ###U.S. Food and Drug Administration ###Speaker: Philip M. Budashewitz, RPh MA – U.S. Food and Drug Administration
Networking & Entertainment
Session Leader: Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk
Panelist: Fergus Sweeney
Panelist: Stephanie O. Omokaro, MD – U.S. Food & Drug Administration
Panelist: Sharry Arora
Session Leader: Pallavi Trivedi, MPH, RAC – Trident Pharmaceuticals limited & Spinos Clinical Research Uk
@@@ Fergus Sweeney ### 1070852###Panelist#########Panelist: Fergus Sweeney
@@@ Stephanie O. Omokaro, MD – U.S. Food & Drug Administration ### 858252###Panelist###Division Deputy Director###U.S. Food & Drug Administration###Panelist: Stephanie O. Omokaro, MD – U.S. Food & Drug Administration
@@@ Sharry Arora ### 1155205###Panelist#########Panelist: Sharry Arora
Networking & Entertainment