Full Schedule

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Tuesday, October 27, 2020
08:30 – 09:30 CET

Beyond the Corrigendum: Strategies for Optimal Use of MDR Grace Period
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

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Amanda Maxwell, BA – Medtech Insight ### 1135103###Moderator###EU regulatory affairs editor###Medtech Insight###
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
08:30 – 09:30 CET

Combination Products
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

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Jayanth K. Katta, PhD – BSI ### 907116###Session Leader###Senior Regulatory Lead###BSI###
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
08:30 – 09:30 CET

Conduct of an Actual IVD Study Compared with Provisions of ISO 20916:2019 - The New Standard for IVD Clinical Performance Studies
Session Leader: Maria E. Donawa, MD – Donawa Lifescience
Speaker: Daniela Karrer – Donawa Lifescience
Speaker: Matteo Mosso – Donawa Lifescience
In Vitro Diagnostics

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Maria E. Donawa, MD – Donawa Lifescience ### 746285###Session Leader###President###Donawa Lifescience###
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
09:30 – 09:45 CET

Brain Break

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09:30 – 09:45 CET

Meet the Speakers: Beyond the Corrigendum: Strategies for Optimal Use of MDR Grace Period
Networking & Entertainment

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09:30 – 09:45 CET

Meet the Speakers: Combination Products
Networking & Entertainment

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09:30 – 09:45 CET

Meet the Speakers: Conduct of an Actual IVD Study Compared with Provisions of ISO 20916:2019 - The New Standard for IVD Clinical Performance Studies
Networking & Entertainment

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09:45 – 10:15 CET

International Regulatory Changes: Member States - Deal or No Deal: The Impact of the MRA Switzerland – EU on Medtech in Europe
Speaker: Stephan Affolter – Ypsomed AG
Medical Devices

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Stephan Affolter – Ypsomed AG ### 907117###Speaker###Regulatory + Quality Intelligence Manager###Ypsomed AG###
Speaker: Stephan Affolter – Ypsomed AG
09:45 – 10:45 CET

MDR: Lessons Learned
Session Leader/Speaker: Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates
Speaker: Jayanth K. Katta, PhD – BSI
Medical Devices

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Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates ### 907081###Session Leader/Speaker###EMEA Regulatory Affairs Leader###W.L. Gore & Associates###
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
09:45 – 10:45 CET

Regulatory Hurdles to Overcome to Introduce Nanotechnology-based IVD and Medical Devices to the EU Market, A Safe-N-Medtech Concern
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

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Luc Van Hove, MD, PhD – MARACA International bvba ### 716641###Session Leader/Speaker###CEO###MARACA International bvba###
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
10:15 – 10:45 CET

International Regulatory Changes: Member States - Legal Structure Changes: Pharma, Biotech and Medical Devices Back in DG Health; New German Law (BfArM Receiving Executive Power)
Speaker: Rainer Voelksen, FRAPS – VOELKSEN Regulatory Affairs
Medical Devices

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Rainer Voelksen, FRAPS – VOELKSEN Regulatory Affairs ### 907129###Speaker###Director###VOELKSEN Regulatory Affairs###
Speaker: Rainer Voelksen, FRAPS – VOELKSEN Regulatory Affairs
10:45 – 11:00 CET

Meet the Speakers: International Regulatory Changes: Member States
Networking & Entertainment

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10:45 – 11:00 CET

Meet the Speakers: MDR: Lessons Learned
Networking & Entertainment

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10:45 – 11:00 CET

Meet the Speakers: Regulatory Hurdles to Overcome to Introduce Nanotechnology-based IVD and Medical Devices to the EU Market, A Safe-N-Medtech Concern
Networking & Entertainment

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10:45 – 11:15 CET

Engage with Solution Providers/Brain Break

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11:15 – 12:15 CET

Give Me Data: Challenges and Opportunities of Real-World Evidence
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

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Michael Maier, MBA, RAC – Medidee Services SA ### 915009###Session Leader###Senior Partner###Medidee Services SA###
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
11:15 – 12:15 CET

MDR Technical Documentation for Legacy Products: Practical Tips and Tricks!
Session Leader/Speaker: Jan-Paul van Loon, MSc, PhD – Qserve Consultancy BV
Speaker: Jane Arnold-Round, B.Eng Msc.
Medical Devices

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Jan-Paul van Loon, MSc, PhD – Qserve Consultancy BV ### 907088###Session Leader/Speaker###Senior Consultant###Qserve Consultancy BV###
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.
11:15 – 12:15 CET

UDI/Labeling
Session Leader/Speaker: Lena Cordie-Bancroft – Qualitas Professional Services, LLC
Speaker: Hans Strobel – dokspot GmbH, Zurich, Switzerland
Speaker: Reinhart Seibl
Medical Devices

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Lena Cordie-Bancroft – Qualitas Professional Services, LLC ### 743793###Session Leader/Speaker###President###Qualitas Professional Services, LLC###
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
12:15 – 12:30 CET

Meet the Speakers: Give Me Data: Challenges and Opportunities of Real-World Evidence
Networking & Entertainment

Favorite
12:15 – 12:30 CET

Meet the Speakers: MDR Technical Documentation for Legacy Products: Practical Tips and Tricks!
Networking & Entertainment

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12:15 – 12:30 CET

Meet the Speakers: UDI/Labeling
Networking & Entertainment

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12:15 – 13:30 CET

Engage with Solution Providers/Lunch Break

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12:30 – 13:15 CET

Hot RA/QA/Clinical Topics (Sponsored by: Qserve)
Speaker: Martin de Bruin
Sponsored Session

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Martin de Bruin ### 1163346###Speaker#########
Speaker: Martin de Bruin
12:30 – 13:15 CET

Meet the Authors: European Medical Device Regulation Guidebook
Author: Rod Beuzeval – Meddev Solutions
Meet the Author

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Rod Beuzeval – Meddev Solutions ### 1142537###Author###Director###Meddev Solutions###
Author: Rod Beuzeval – Meddev Solutions
13:30 – 14:30 CET

Challenges and Understanding of the Periodic Safety Update Report (PSUR)
Speaker: Alex Laan – NAMSA
Medical Devices

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Alex Laan – NAMSA ### 1141533###Speaker###Principal Regulatory Consultant, IVD###NAMSA###
Speaker: Alex Laan – NAMSA
13:30 – 14:30 CET

Implementing Practices to Comply with the In Vitro Diagnostics Regulation
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

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Hilary A. Baldwin – Caris Life Sciences ### 716644###Speaker###Regulatory Director###Caris Life Sciences###
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
13:30 – 14:30 CET

Working with FDA: How to Get the Most Out of Your FDA Meetings and Interactions
Session Leader/Speaker: John C. Lockwood, CBA, RAC, CSQE – Pearl Pathways
Speaker: John Van Hoven, MS – Rocky Mountain Regulatory and Quality Partners
Medical Devices

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John C. Lockwood, CBA, RAC, CSQE – Pearl Pathways ### 720641###Session Leader/Speaker###Director###Pearl Pathways###
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
14:30 – 14:45 CET

Brain Break

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14:30 – 14:45 CET

Meet the Speakers: Challenges and Understanding of the Periodic Safety Update Report (PSUR)
Networking & Entertainment

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14:30 – 14:45 CET

Meet the Speakers: Implementing Practices to Comply with the In Vitro Diagnostics Regulation
Networking & Entertainment

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14:30 – 14:45 CET

Meet the Speakers: Working with FDA: How to Get the Most Out of Your FDA Meetings and Interactions
Networking & Entertainment

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14:45 – 15:45 CET

Performance Evaluation Reports - Planning and Preparation in Anticipation of IVDR Requirements
Session Leader/Speaker: Rachel Kennedy, RAC – LabCorp.
In Vitro Diagnostics

Favorite

Rachel Kennedy, RAC – LabCorp. ### 953643###Session Leader/Speaker###Executive Director, Regulatory, Covance Medical Device & Diagnostics Service###LabCorp.###
Session Leader/Speaker: Rachel Kennedy, RAC – LabCorp.
14:45 – 15:45 CET

Vigilance and Trend Reporting
Session Leader/Speaker: Keith Morel, PhD – Qserve Group Inc. - ENTERPRISE
Speaker: Leonard Buchner, MS – Qserve Group
Medical Devices

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Keith Morel, PhD – Qserve Group Inc. - ENTERPRISE ### 535522###Session Leader/Speaker###VP, Regulatory Compliance###Qserve Group Inc. - ENTERPRISE###
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
14:45 – 15:45 CET

Working with FDA: Factors for Successful Approval
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

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Jason R. Krzeszak, MSE, MBA – NAMSA ### 907106###Session Leader/Speaker###Principal Product Development Strategist (Clinical/Reg.)###NAMSA###
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.
15:45 – 16:00 CET

Meet the Speakers: Performance Evaluation Reports - Planning and Preparation in Anticipation of IVDR Requirements
Networking & Entertainment

Favorite
15:45 – 16:00 CET

Meet the Speakers: Vigilance and Trend Reporting
Networking & Entertainment

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15:45 – 16:00 CET

Meet the Speakers: Working with FDA: Factors for Successful Approval
Networking & Entertainment

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15:45 – 16:15 CET

Engage with Solution Providers/Brain Break

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16:15 – 17:45 CET

Clinical Evaluation: Clinical Data Versus Non-clinical Data; How to Interpret Article 61.10
Session Leader/Speaker: Natascha J. Cuper, PhD – DARE Medical Certifications
Speaker: Robert van Boxtel, MSc. – Medical Device Project B.V.
Medical Devices

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Natascha J. Cuper, PhD – DARE Medical Certifications ### 535505###Session Leader/Speaker###Clinical expert###DARE Medical Certifications###
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.
16:15 – 17:45 CET

Fireside Debate with IVDR Notified Body and Industry Representation
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

Favorite

Gert Willem Bos, FRAPS – Qserve Group (Netherlands) ### 535440###Session Leader###CTO, Executive Director & Partner at Qserve Group###Qserve Group (Netherlands)###
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
16:15 – 17:45 CET

MDR Implementation: Economic Operator Requirements
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

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Ludger Johannes Moeller – Medical Device Safety Service GmbH ### 907125###Session Leader###President, MDSS GmbH###Medical Device Safety Service GmbH###
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
17:45 – 18:00 CET

Meet the Speakers: Clinical evaluation: Clinical data versus non-clinical data; how to interpret Article 61.10
Networking & Entertainment

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17:45 – 18:00 CET

Meet the Speakers: Fireside debate with IVDR notified body and industry representation
Networking & Entertainment

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17:45 – 18:00 CET

Meet the Speakers: MDR Implementation: Economic Operator Requirements
Networking & Entertainment

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