- Friday, May 7, 2021
09:00 – 17:00 CET
Pre-Conference Workshop: Clinical Studies in PMCF
09:00 – 17:00 CET
Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 1187581###Session Leader###Regulatory Strategy Principal###TÜV SÜD Medical Health Service###Session Leader: – TÜV SÜD Medical Health Service
09:00 – 17:00 CET
Pre-Conference Workshop: Risk Management Under the EU Regulations for Medical Devices and In-vitro Diagnostics
09:00 – 17:00 CET
Leon Assink ### 1215845###Session Leader#########Session Leader:
@@@ Inge Willems ### 1225405###Speaker#########Speaker:
@@@ Hester Hasper ### 1225406###Speaker#########Speaker:
09:00 – 17:00 CET
Pre-Conference Workshop: Software as a Medical Device
09:00 – 17:00 CET
Gert W. Bos, PhD FRAPS – QServe ### 535440###Session Leader###CTO, Executive Director & Partner at Qserve Group###QServe###Session Leader: – QServe
@@@ Koen Cobbaert, MA – Philips ### 943170###Session Leader###Senior Manager - Quality, Standards & Regulations###Philips###Session Leader: – Philips
@@@ Abtin Rad – TÜV SÜD Product Service GmbH ### 1187570###Speaker###Global Director Functional Safety, Software and Digitization###TÜV SÜD Product Service GmbH###Speaker: – TÜV SÜD Product Service GmbH
@@@ Zuzanna Kwade ### 1225916###Speaker#########Speaker:
@@@ Tifanny Istamto ### 1225917###Speaker#########Speaker:
09:00 – 17:00 CET
Pre-Conference Workshop
- Monday, May 10, 2021
09:00 – 11:30 CET
Plenary Opening Debate
09:00 – 11:30 CET
Plenary Opening DebateChair: – TÜV SÜD Medical Health Service
Chair: – QServe
Chair: – Founder of Waypoint Consulting
Plenary
Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 1187581###Chair###Regulatory Strategy Principal###TÜV SÜD Medical Health Service###Chair: – TÜV SÜD Medical Health Service
@@@ Gert W. Bos, PhD FRAPS – QServe ### 535440###Chair###CTO, Executive Director & Partner at Qserve Group###QServe###Chair: – QServe
@@@ Eric Klasen, MSc – Founder of Waypoint Consulting ### 972075###Chair###RA & Quality consultant in Life Sciences###Founder of Waypoint Consulting###Chair: – Founder of Waypoint Consulting
09:00 – 18:15 CET
Poster Gallery Viewing
11:30 – 12:00 CET
Visit Sponsors - Brain Break
12:00 – 13:00 CET
Clinical Evaluation
12:00 – 13:00 CET
Clinical EvaluationSession Leader: – Abbott
Speaker: – ELEKTA | Nucletron
Speaker: – TÜV SÜD Product Service GmbH
Speaker: – Smith-Nephew AG
Medical Devices
Philippe Auclair, Pharma Dr, PhD , FRAPS – Abbott ### 535445###Session Leader###Senior Director Regulatory Strategy EMEA###Abbott###Session Leader: – Abbott
@@@ Leo Hovestadt, n/a – ELEKTA | Nucletron ### 716677###Speaker###Director Governmental Affairs EU###ELEKTA | Nucletron###Speaker: – ELEKTA | Nucletron
@@@ Rene Bombien, Cardiac Surgeon – TÜV SÜD Product Service GmbH ### 1187577###Speaker###Teamleader Cardiovascular / Global Trainer Clinical Data in the Clinical Centre of Excellence (cCE)###TÜV SÜD Product Service GmbH###Speaker: – TÜV SÜD Product Service GmbH
@@@ Luca Orlandini, MD – Smith-Nephew AG ### 1213170###Speaker###Vice President Global Medical Affairs###Smith-Nephew AG###Speaker: – Smith-Nephew AG
12:00 – 13:00 CET
Drug-Device Combination Products Under MDR
12:00 – 13:00 CET
Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 1187581###Session Leader###Regulatory Strategy Principal###TÜV SÜD Medical Health Service###Session Leader: – TÜV SÜD Medical Health Service
12:00 – 13:00 CET
Innovative Clinical Trial Design
12:00 – 13:00 CET
Innovative Clinical Trial DesignSession Leader/Speaker: – The Jansen's Foundation
Speaker: – Assistant Professor of Surgery at Boston University, Boston Medical Center
Pharmaceuticals
Neena Nizar, Dr. – The Jansen's Foundation ### 1083169###Session Leader/Speaker###President & Founder###The Jansen's Foundation###Session Leader/Speaker: – The Jansen's Foundation
@@@ Marina A. Malikova, PhD, MSci, MA, CCRA, RAC – Assistant Professor of Surgery at Boston University, Boston Medical Center ### 1187591###Speaker###Executive Director of Research, Operations and Compliance###Assistant Professor of Surgery at Boston University, Boston Medical Center###Speaker: – Assistant Professor of Surgery at Boston University, Boston Medical Center
12:00 – 13:00 CET
Prepare to Pivot: Expectations for Future Hybrid EMA Meetings
12:00 – 13:00 CET
Michelle Zucatti, MPH – 3D Communications ### 1187586###Session Leader/Speaker###Communications Lead###3D Communications###Session Leader/Speaker: – 3D Communications
13:00 – 13:15 CET
Meet The Speaker - Clinical Evaluation
13:00 – 13:15 CET
Meet The Speaker - Drug-Device Combination Products Under MDR
13:00 – 13:15 CET
Meet The Speaker - Innovative Clinical Trial Design
13:00 – 13:15 CET
Meet The Speaker - Prepare to Pivot: Expectations for Future Hybrid EMA Meetings
13:15 – 14:00 CET
Lunch Break - Visit Sponsors - Brain Break
14:00 – 14:45 CET
Sponsored Session
14:45 – 15:00 CET
Visit Sponsors - Brain Break
15:00 – 15:30 CET
Accelerated Pathways: Bringing down Barriers to Supply Orphan Medicines in EU Markets with Very Low Patient Numbers
15:00 – 15:30 CET
Thomas Liebers, MTOPRA – TOPRA, RAPS ### 1187593###Submitter###Director, Regulatory Labeling###TOPRA, RAPS###Submitter: – TOPRA, RAPS
15:00 – 16:00 CET
Functional Safety of Medical Devices
15:00 – 16:00 CET
Functional Safety of Medical DevicesSession Leader/Speaker: – TUV SUD Product Service GmbH
Speaker: – Dr. Ebeling & Assoc. GmbH
Speaker: – MSquared Associates and The Johns Hopkins School of Medicine
Speaker: – M Squared
Medical Devices
Thomas Betzl – TUV SUD Product Service GmbH ### 1187585###Session Leader/Speaker###Team Manager Functional Safety###TUV SUD Product Service GmbH###Session Leader/Speaker: – TUV SUD Product Service GmbH
@@@ Jasmin Lindner, PhD – Dr. Ebeling & Assoc. GmbH ### 1000106###Speaker###Lead Medical Device###Dr. Ebeling & Assoc. GmbH###Speaker: – Dr. Ebeling & Assoc. GmbH
@@@ Stephen C. Weber, MD – MSquared Associates and The Johns Hopkins School of Medicine ### 1187557###Speaker###Senior Medical Advisor###MSquared Associates and The Johns Hopkins School of Medicine###Speaker: – MSquared Associates and The Johns Hopkins School of Medicine
@@@ marie C. Marlow, RN – M Squared ### 580310###Speaker###CEO###M Squared###Speaker: – M Squared
15:00 – 16:00 CET
How to Manage Grace Period?
15:00 – 16:00 CET
Martin Witte – TÜV SÜD Product Service GmbH ### 1187576###Session Leader/Speaker###Senior Director Strategic Business Development###TÜV SÜD Product Service GmbH###Session Leader/Speaker: – TÜV SÜD Product Service GmbH
@@@ Erik R. Vollebregt, n/a – medicaldeviceslegal.com ### 535481###Speaker###Partner###medicaldeviceslegal.com###Speaker: – medicaldeviceslegal.com
15:30 – 16:00 CET
Accelerated Pathways: Take International Collaboration in Paediatrics to the Next Level to Accelerate Access to Paediatric Medicines
15:30 – 16:00 CET
Angelika Joos, n/a – MSD ### 1187564###Submitter###Executive Director Global Regulatory Policy###MSD###Submitter: – MSD
16:00 – 16:15 CET
Meet The Speaker - Accelerated Pathways
16:00 – 16:15 CET
Meet The Speaker - Functional Safety
16:00 – 16:15 CET
Meet The Speaker - Global IVDs
16:00 – 16:15 CET
Meet The Speaker - How to Manage Grace Period?
16:15 – 17:00 CET
Visit Sponsors - Brain Break
17:00 – 17:30 CET
Global Regulatory Changes and Updates: Use of Real World Evidence in FDA Device Applications
17:00 – 17:30 CET
marie C. Marlow, RN – M Squared ### 580310###Speaker###CEO###M Squared###Speaker: – M Squared
@@@ Stephen C. Weber, MD – MSquared Associates and The Johns Hopkins School of Medicine ### 1187557###Speaker###Senior Medical Advisor###MSquared Associates and The Johns Hopkins School of Medicine###Speaker: – MSquared Associates and The Johns Hopkins School of Medicine
17:00 – 18:00 CET
Artificial Intelligence
17:00 – 18:00 CET
Artificial IntelligenceSubmitter: – ELEKTA | Nucletron
Speaker: – Sparta Systems
Speaker: – Marketing Manager
Medical Devices
Leo Hovestadt, n/a – ELEKTA | Nucletron ### 716677###Submitter###Director Governmental Affairs EU###ELEKTA | Nucletron###Submitter: – ELEKTA | Nucletron
@@@ Stephen McCarthy – Sparta Systems ### 1187631###Speaker###VP Digital Innovation###Sparta Systems###Speaker: – Sparta Systems
@@@ Nikhil Shah, n/a – Marketing Manager ### 1187599###Speaker###Marketing Manager###Marketing Manager###Speaker: – Marketing Manager
17:00 – 18:00 CET
Rest of the World
17:00 – 18:00 CET
Rest of the WorldSession Leader: – Parexel
Speaker: – CSL Behring
Speaker: – 3D Communications
Pharmaceuticals
Siegfried Schmitt, CSci CChem FRSC – Parexel ### 907098###Session Leader###Vice President Technical###Parexel###Session Leader: – Parexel
@@@ yingying liu, MSc – CSL Behring ### 1187559###Speaker###Associate director###CSL Behring###Speaker: – CSL Behring
@@@ Kate Dion, MS – 3D Communications ### 757446###Speaker###Communications Lead###3D Communications###Speaker: – 3D Communications
17:00 – 18:30 CET
IVDR Debate - Regulation Changes
17:00 – 18:30 CET
Anja Wiersma, PhD – mi-ce ### 574723###Session Leader/Speaker###CEO and Senior Consultant###mi-ce###Session Leader/Speaker: – mi-ce
@@@ Alex Laan – NAMSA ### 1187572###Session Leader/Speaker###Principal Consultant###NAMSA###Session Leader/Speaker: – NAMSA
@@@ Richard Vincins ### 1254352###Session Leader/Speaker#########Session Leader/Speaker:
18:00 – 18:15 CET
Meet The Speaker - Artificial Intelligence
18:00 – 18:15 CET
Meet The Speaker - Rest of the World
18:30 – 18:45 CET
Meet The Speaker - FIVDR Debate
- Tuesday, May 11, 2021
10:00 – 10:30 CET
Risk Management: Compliance with risk management requirements in ISO 14155:2020 during different clinical development stages of clinical investigations for medical devices, including SaMD
10:00 – 10:30 CET
Maria E. Donawa, MD – Donawa Lifescience ### 746285###Speaker###President###Donawa Lifescience###Speaker: – Donawa Lifescience
@@@ Danielle Giroud – MD-Clinicals SA ### 1187621###Speaker######MD-Clinicals SA###Speaker: – MD-Clinicals SA
10:00 – 11:00 CET
MDR Technical Overview: How to Navigate in the Waters of MDR implementation and Which icebergs to Avoid
10:00 – 11:00 CET
Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 1187581###Session Leader/Speaker###Regulatory Strategy Principal###TÜV SÜD Medical Health Service###Session Leader/Speaker: – TÜV SÜD Medical Health Service
@@@ Gert W. Bos, PhD FRAPS – QServe ### 535440###Speaker###CTO, Executive Director & Partner at Qserve Group###QServe###Speaker: – QServe
10:00 – 11:00 CET
Pandemic Readiness - Business Contingency
10:00 – 11:00 CET
Siegfried Schmitt, CSci CChem FRSC – Parexel ### 907098###Session Leader/Speaker###Vice President Technical###Parexel###Session Leader/Speaker: – Parexel
@@@ Kell Cannon, MBA – 3D Communications ### 1187587###Speaker###Senior Management###3D Communications###Speaker: – 3D Communications
@@@ Bert Regeer, MD – 3D Communications ### 716674###Speaker###Scientific Lead###3D Communications###Speaker: – 3D Communications
10:00 – 11:00 CET
Pressure cooker: Fast Track to IVD-R Compliance
10:00 – 11:00 CET
maurizio suppo, n/a – Qarad ### 1000097###Session Leader/Speaker###Owner & VP###Qarad###Session Leader/Speaker: – Qarad
@@@ Sue Spencer, n/a – Ms ### 1187575###Speaker###IVD Lead/ Principal Consultant###Ms###Speaker: – Ms
10:00 – 17:00 CET
Poster Gallery Viewing
10:30 – 11:00 CET
Risk Management: Making the Risk Management File work for to you to support safety and efficacy of devices.
10:30 – 11:00 CET
tiea theurer – NSAI, Inc ### 720639###Speaker###Medical / MDSAP Lead Auditor###NSAI, Inc###Speaker: – NSAI, Inc
11:00 – 11:15 CET
Meet The Speaker - MDR Technical Overview
11:00 – 11:15 CET
Meet The Speaker - Pandemic Readiness
11:00 – 11:15 CET
Meet The Speaker - Pressure Cooker
11:00 – 11:15 CET
Meet The Speaker - Risk Management
11:15 – 12:00 CET
Visit Sponsors - Brain Break
12:00 – 13:00 CET
Data Security and Digital Health
12:00 – 13:00 CET
Abtin Rad – TÜV SÜD Product Service GmbH ### 1187570###Session Leader/Speaker###Global Director Functional Safety, Software and Digitization###TÜV SÜD Product Service GmbH###Session Leader/Speaker: – TÜV SÜD Product Service GmbH
@@@ Xander Heemskerk, CISSP 27001LI CCSK – Philips ### 1187568###Speaker###Director Product Security###Philips###Speaker: – Philips
12:00 – 13:00 CET
Innovative Regulatory Decision Making - Optimised Development Strategies
12:00 – 13:00 CET
Charlie Mortazavi, SANOFI – SANOFI ### 907082###Session Leader/Speaker###Senior Manager###SANOFI###Session Leader/Speaker: – SANOFI
@@@ Saman Kay, MPharm, MTOPRA, – Clarivate ### 1187589###Speaker###Regulatory intelligence consultant###Clarivate###Speaker: – Clarivate
@@@ Winona Bolislis ### 1254353###Speaker#########Speaker:
@@@ Thomas Kuhler ### 1254354###Speaker#########Speaker:
12:00 – 13:00 CET
IVDR Implementation Best Practices and Challenges
12:00 – 13:00 CET
Lisa Casavant ### 1221971###Moderator#########Moderator:
@@@ ANDREAS STANGE, ANDREAS.STANGE@TUVSUD.com – TUV SUD JAPAN LTD ### 1187582###Panelist###VP###TUV SUD JAPAN LTD###Panelist: – TUV SUD JAPAN LTD
@@@ Nancy J. Morrison, RAC – RQM+ ### 757434###Panelist###Executive Director, Regulatory & Quality Consulting Services###RQM+###Panelist: – RQM+
@@@ Amie Smirthwaite, Ph.D. ### 1187605###Panelist#########Panelist:
@@@ Simon Richards – Abbott Rapid Diagnostics ### 1187627###Panelist######Abbott Rapid Diagnostics###Panelist: – Abbott Rapid Diagnostics
@@@ Laura Tracy ### 1254349###Panelist#########Panelist:
12:00 – 13:00 CET
MDR Technical Documentation – How to approach important requirements today and in future
12:00 – 13:00 CET
Jan-Paul van Loon, MSc, PhD – Demcon BV ### 907088###Session Leader/Speaker###Senior Consultant/ QA/RA Engineer###Demcon BV###Session Leader/Speaker: – Demcon BV
@@@ Martin Witte – TÜV SÜD Product Service GmbH ### 1187576###Speaker###Senior Director Strategic Business Development###TÜV SÜD Product Service GmbH###Speaker: – TÜV SÜD Product Service GmbH
@@@ Johannes Walde, Dipl. Ing. – Berlin Heals GmbH ### 1221560###Speaker###Director Regulatory Affairs & QM###Berlin Heals GmbH###Speaker: – Berlin Heals GmbH
13:00 – 13:15 CET
Meet The Speaker - Data Security and Digital Health
13:00 – 13:15 CET
Meet The Speaker - Implementation Best Practices & Challenges
13:00 – 13:15 CET
Meet The Speaker - Innovative Regulatory Decision Making
13:00 – 13:15 CET
Meet The Speaker - Technical Documentation
13:15 – 14:00 CET
Lunch Break - Visit Sponsors - Brain Break
14:00 – 14:45 CET
Sponsored Sessions
15:00 – 16:00 CET
Digitalisation in Health Care / (Real World) Evidence & Innovative Technologies
15:00 – 16:00 CET
Inka Heikkinen, MSc – MSD ### 1187558###Speaker###Associate Director, Global Regulatory Policy###MSD###Speaker: – MSD
@@@ Mark Levi, PhD – Independent ### 1187566###Speaker###Independent Consultant###Independent###Speaker: – Independent
@@@ Antonina Nikolova, PhD – Parexel ### 1187624###Speaker######Parexel###Speaker: – Parexel
@@@ Irena Milobratovic, M Pharm, RAC – Arriello ### 907132###Speaker###Senior Regulatory Affairs Manager###Arriello###Speaker: – Arriello
15:00 – 16:00 CET
Recognition of CE Marking Outside EU During Transition Period
15:00 – 16:00 CET
Stephan Affolter, dipl. Chemist FH, BS – Ypsomed AG ### 907117###Session Leader/Speaker###Regulatory + Quality Intelligence Manager###Ypsomed AG###Session Leader/Speaker: – Ypsomed AG
@@@ Jayanth K. Katta, PhD – BSI ### 907116###Speaker###Senior Regulatory Lead, Head of UK Approved Body, Medical Devices###BSI###Speaker: – BSI
15:00 – 16:00 CET
Risk Management
15:00 – 16:00 CET
Alex Laan – NAMSA ### 1187572###Session Leader/Speaker###Principal Consultant###NAMSA###Session Leader/Speaker: – NAMSA
@@@ Janet L. Michener Whipple – Validant ### 760776###Speaker###Partner###Validant###Speaker: – Validant
15:00 – 16:00 CET
Software as a Medical Device, Mobile apps, Wearables (Part 1)
15:00 – 16:00 CET
Vidita Desai, MS – Englewood Lab Inc. ### 1187583###Session Leader/Speaker###Regulatory Affairs Supervisor###Englewood Lab Inc.###Session Leader/Speaker: – Englewood Lab Inc.
@@@ Abtin Rad – TÜV SÜD Product Service GmbH ### 1187570###Speaker###Global Director Functional Safety, Software and Digitization###TÜV SÜD Product Service GmbH###Speaker: – TÜV SÜD Product Service GmbH
16:00 – 16:15 CET
Meet The Speaker - Digitalisation in Health Care
16:00 – 16:15 CET
Meet The Speaker - Recognition of CE Marking Outside EU During Transition Period
16:00 – 16:15 CET
Meet The Speaker - Risk Management
16:00 – 16:15 CET
Meet The Speaker - Software as a Medical Device (part 1)
16:15 – 16:30 CET
Visit Expo - Brain Break
16:30 – 17:30 CET
Patient Engagement Focused Drug Development
16:30 – 17:30 CET
Irena Milobratovic, M Pharm, RAC – Arriello ### 907132###Speaker###Senior Regulatory Affairs Manager###Arriello###Speaker: – Arriello
@@@ Theresa M. Shalaby, MSN, RN – Synchrogenix, a Certara Company ### 1187601###Speaker###Senior Regulatory Services Manager###Synchrogenix, a Certara Company###Speaker: – Synchrogenix, a Certara Company
16:30 – 17:30 CET
Postmarketing Clinical Follow-up (PMCF)
16:30 – 17:30 CET
Carine Cochereau ### 1207604###Session Leader#########Session Leader:
@@@ Jon I. Bergsteinsson, M.Sc. Biomed – SMART-TRIAL ### 1187563###Speaker###VP of Global Business Development###SMART-TRIAL###Speaker: – SMART-TRIAL
@@@ Tonia Jeiter, Dr. med. – TÜV SÜD Americas Inc. ### 1187580###Speaker###Clinical Reviewer###TÜV SÜD Americas Inc.###Speaker: – TÜV SÜD Americas Inc.
16:30 – 17:30 CET
Reflection on Pandemic
16:30 – 17:30 CET
Reflection on PandemicModerator: – MS REGULATORY AFFAIRS
Speaker: – Ortho Clinical Diagnostics
Speaker: – Agios Pharmaceuticals
In Vitro Diagnostics
RIDDHI MASURKAR – MS REGULATORY AFFAIRS ### 1187571###Moderator###REGULATORY AFFAIRS EXECUTIVE###MS REGULATORY AFFAIRS###Moderator: – MS REGULATORY AFFAIRS
@@@ Waïss Faissal, PharmD – Ortho Clinical Diagnostics ### 1187596###Speaker###Quality Regulatory and Compliance, Northern Europe Manager###Ortho Clinical Diagnostics###Speaker: – Ortho Clinical Diagnostics
@@@ Sanika Inamdar, MS in Regulatory Affairs – Agios Pharmaceuticals ### 1187607###Speaker###Senior GMP Specialist###Agios Pharmaceuticals ###Speaker: – Agios Pharmaceuticals
16:30 – 17:30 CET
Why the US has overtaken Europe as the innovations leader in software-related Medical Technology - an overview of regulatory challenges in the two top global markets
(Part 2)
16:30 – 17:30 CET
Jaap L. LAUFER, n/a – EMERGO ### 1187602###Session Leader/Speaker###MEDICAL DIRECTOR###EMERGO###Session Leader/Speaker: – EMERGO
@@@ Christophe Amiel, MSc – NA ### 1187598###Speaker###Digital Life Sciences - Senior Director###NA###Speaker: – NA
@@@ Kristian Worziger W. Nielsen, MS Science – 4RA ### 1005451###Speaker###Owner###4RA###Speaker: – 4RA
17:30 – 17:45 CET
Meet The Speaker - Patient Engagement Focused Drug Development
17:30 – 17:45 CET
Meet The Speaker - Postmarketing Clinical Follow-up (PMCF)
17:30 – 17:45 CET
Meet The Speaker - Reflection on Pandemic
17:30 – 17:45 CET
Meet The Speaker - Why the US has overtaken Europe as the innovations leader in software-related Medical Technology
18:00 – 19:00 CET
Poster Session
- Wednesday, May 12, 2021
10:00 – 11:00 CET
ATMPs/Cell and Gene Therapies: Regulatory Affairs in Academia and the Future of CAR T Cell Therapies
10:00 – 11:00 CET
Adam Runkle, ML, MRA – University of Pennsylvania ### 1187588###Speaker###Scientific Program Manager###University of Pennsylvania###Speaker: – University of Pennsylvania
@@@ Orin Chisholm, GCULT, PhD, SFHEA – PharmMed ### 1220926###Speaker###Consultant###PharmMed###Speaker: – PharmMed
10:00 – 11:00 CET
EU MDR Clinical Investigations
10:00 – 11:00 CET
Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 1187581###Session Leader###Regulatory Strategy Principal###TÜV SÜD Medical Health Service###Session Leader: – TÜV SÜD Medical Health Service
10:00 – 11:00 CET
Reference Labs
10:00 – 11:00 CET
Reference LabsSession Leader: – mi-ce
Speaker: – Sciensano
Speaker: – Paul-Ehrlich-Institut
In Vitro Diagnostics
Anja Wiersma, PhD – mi-ce ### 574723###Session Leader###CEO and Senior Consultant###mi-ce###Session Leader: – mi-ce
@@@ Anne Van Nerom, DVM, PhD – Sciensano ### 907109###Speaker###Project leader###Sciensano###Speaker: – Sciensano
@@@ Micha Nuebling, PhD – Paul-Ehrlich-Institut ### 972072###Speaker###Head Department###Paul-Ehrlich-Institut###Speaker: – Paul-Ehrlich-Institut
10:00 – 11:00 CET
The regulatory & standards landscape for AI
10:00 – 11:00 CET
Pat Baird, BS, MBA, MS – Philips ### 805710###Session Leader###Sr. Regulatory Specialist###Philips###Session Leader: – Philips
@@@ Alexander L. Friedman, PhD, RAC – Philips ### 1187630###Speaker###Senior Regulatory Affairs Engineer###Philips###Speaker: – Philips
@@@ Loganathan Kumarasamy, MS, RAC – Zifo Technologies Inc., ### 1187574###Speaker###Head - US Compliance Services###Zifo Technologies Inc.,###Speaker: – Zifo Technologies Inc.,
10:00 – 17:00 CET
Poster Gallery Viewing
11:00 – 11:15 CET
Meet The Speaker - ATMPs/Cell and Gene Therapies
11:00 – 11:15 CET
Meet The Speaker - EU MDR Clinical Investigations
11:00 – 11:15 CET
Meet The Speaker - Reference labs
11:00 – 11:15 CET
Meet The Speaker - The regulatory & standards landscape for AI
11:15 – 12:00 CET
Visit Sponsors - Brain Break
12:00 – 13:00 CET
Biologics and Biosimilars
12:00 – 13:00 CET
Dieter Brazel, PhD, MDRA – CSL Behríng ### 1187584###Session Leader/Speaker###Senior Director GRA CMC###CSL Behríng###Session Leader/Speaker: – CSL Behríng
@@@ Clara Desvignes, MSc – VCLS ### 1187597###Speaker###Senior Regulatory Scientist###VCLS###Speaker: – VCLS
@@@ Gabriela Marton – Arriello s.r.o ### 907134###Speaker###Quality and Regulatory Director ###Arriello s.r.o###Speaker: – Arriello s.r.o
12:00 – 13:00 CET
Economic Operators
12:00 – 13:00 CET
Economic OperatorsSession Leader: – medicaldeviceslegal.com
Speaker: – MDSS GmbH
Speaker: – NAMSA
Speaker: – BSI
Medical Devices
Erik R. Vollebregt, n/a – medicaldeviceslegal.com ### 535481###Session Leader###Partner###medicaldeviceslegal.com###Session Leader: – medicaldeviceslegal.com
@@@ Ludger J. Möller, n/a – MDSS GmbH ### 907125###Speaker###President###MDSS GmbH###Speaker: – MDSS GmbH
@@@ Richard Bassett, Msc, LLM – NAMSA ### 1187567###Speaker###Medical Writer###NAMSA###Speaker: – NAMSA
@@@ Maddalena Pinsi, MSc – BSI ### 1187565###Speaker###Regulatory Lead###BSI###Speaker: – BSI
12:00 – 13:00 CET
Rollout IVDR 2022: (Post) Market Surveillance for IVD Medical Devices; are you ready?
12:00 – 13:00 CET
Julien S. Senac, Ph.D. – TUV SUD ### 1022552###Session Leader/Speaker###Global Director###TUV SUD###Session Leader/Speaker: – TUV SUD
@@@ Alex Laan – NAMSA ### 1187572###Speaker###Principal Consultant###NAMSA###Speaker: – NAMSA
12:30 – 13:00 CET
Aesthetic devices under MDR: Emerging Challenges for Aesthetic Manufacturers: What is the State of the Art?
12:30 – 13:00 CET
Melania Battistella, n/a – TUV SUD ### 1187595###Speaker###global manager aesthetic product###TUV SUD###Speaker: – TUV SUD
12:30 – 13:00 CET
Global Regulatory Changes and Updates
12:30 – 13:00 CET
Industry advocacy; the power of Collective Voice
12:30 – 13:00 CET
Lindsay Stafford, n/a – Orthopaedic Surgical Manufacturers Association (OSMA) ### 1187556###Speaker###N/A###Orthopaedic Surgical Manufacturers Association (OSMA)###Speaker: – Orthopaedic Surgical Manufacturers Association (OSMA)
13:00 – 13:15 CET
Meet The Speaker - Biologics and Biosimilars
13:00 – 13:15 CET
Meet The Speaker - Economic Operators
13:00 – 13:15 CET
Meet The Speaker - Global Regulatory Changes and Updates
13:00 – 13:15 CET
Meet The Speaker - Market Surveillance v. Post Market surveillance
13:15 – 14:00 CET
Lunch Break - Visit Sponsors - Brain Break
14:00 – 14:45 CET
Sponsored Sessions
15:00 – 16:00 CET
Labelling
15:00 – 16:00 CET
LabellingSession Leader/Speaker: – TOPRA, RAPS
Speaker: – Mckesson Canada
Pharmaceuticals
Thomas Liebers, MTOPRA – TOPRA, RAPS ### 1187593###Session Leader/Speaker###Director, Regulatory Labeling###TOPRA, RAPS###Session Leader/Speaker: – TOPRA, RAPS
@@@ Safia Terki, M.Sc., RAC. – Mckesson Canada ### 1187561###Speaker###Senior Specialist, Regulatory Affairs###Mckesson Canada###Speaker: – Mckesson Canada
15:00 – 16:00 CET
LDT's: IVDR Regulatory Strategy: How to comply to IVDR; for Manufacturers and Health institutions with LDTs
15:00 – 16:00 CET
Anja Wiersma, PhD – mi-ce ### 574723###Session Leader/Speaker###CEO and Senior Consultant###mi-ce###Session Leader/Speaker: – mi-ce
15:00 – 16:00 CET
LTD's
15:00 – 16:00 CET
LTD'sSession Leader: – mi-ce
Speaker:
Speaker:
Speaker: – Leiden University Medical Center (LUMC)
Anja Wiersma, PhD – mi-ce ### 574723###Session Leader###CEO and Senior Consultant###mi-ce###Session Leader: – mi-ce
@@@ Els de Queker ### 1254350###Speaker#########Speaker:
@@@ Bart Lubbers ### 1254351###Speaker#########Speaker:
@@@ 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: – Leiden University Medical Center (LUMC)
15:00 – 16:00 CET
Other Regions
15:00 – 16:00 CET
Other RegionsSession Leader/Speaker: – Certification Body Australia
Speaker: – MMGC SRL
Speaker: – MMGC SRL
Speaker: – China Med Device
Medical Devices
Val Theisz, MSc, RAC (EU, U.S.), FRAPS – Certification Body Australia ### 1187562###Session Leader/Speaker###Co-founder, Non-executive Director###Certification Body Australia###Session Leader/Speaker: – Certification Body Australia
@@@ Magdalena Ferrari del Sel, Msc (Eng) – MMGC SRL ### 907096###Speaker###Biomedical Engineer- Regulatory Affairs Senior Consultant-Medical Devices Specialist###MMGC SRL###Speaker: – MMGC SRL
@@@ Monica M. Guaita, MSc(Eng) – MMGC SRL ### 907095###Speaker###CEO&Founder###MMGC SRL###Speaker: – MMGC SRL
@@@ Grace Palma, MBA – China Med Device ### 1187560###Speaker###CEO###China Med Device###Speaker: – China Med Device
15:00 – 16:00 CET
Post Market Surveillance under the MDR
15:00 – 16:00 CET
Post Market Surveillance Session Leader/Speaker: – Medical Device Project B.V.
Speaker: – Dutch National Institute for Public Health and the Environment (RIVM)
Speaker: – Dr. Ebeling & Assoc. GmbH
Medical Devices
Robert A. van Boxtel – Medical Device Project B.V. ### 907078###Session Leader/Speaker###Principal Consultant###Medical Device Project B.V.###Session Leader/Speaker: – Medical Device Project B.V.
@@@ Arjan W. van Drongelen, mSc. – Dutch National Institute for Public Health and the Environment (RIVM) ### 1187622###Speaker###Scientific Officer###Dutch National Institute for Public Health and the Environment (RIVM)###Speaker: – Dutch National Institute for Public Health and the Environment (RIVM)
@@@ Jasmin Lindner, PhD – Dr. Ebeling & Assoc. GmbH ### 1000106###Speaker###Lead Medical Device###Dr. Ebeling & Assoc. GmbH###Speaker: – Dr. Ebeling & Assoc. GmbH
16:00 – 16:15 CET
Meet The Speaker - Labelling
16:00 – 16:15 CET
Meet The Speaker - LDT's
16:00 – 16:15 CET
Meet The Speaker - Other Regions
16:00 – 16:15 CET
Meet The Speaker - Postmarketing Surveillance
16:15 – 17:00 CET
Visit Expo - Brain Break
17:00 – 18:00 CET
Combination Products
17:00 – 18:00 CET
Combination Products Session Leader: – Parexel
Speaker: – European Medicines Agency
Speaker: – Lygature
Pharmaceuticals
Siegfried Schmitt, CSci CChem FRSC – Parexel ### 907098###Session Leader###Vice President Technical###Parexel###Session Leader: – Parexel
@@@ Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 746325###Speaker###Scientific Administrator###European Medicines Agency###Speaker: – European Medicines Agency
@@@ Kevin Klein, n/a – Lygature ### 1187554###Speaker###Program Manager###Lygature###Speaker: – Lygature
17:00 – 18:00 CET
Companion Diagnostics: The Path for Companion Diagnostics Under IVDR
17:00 – 18:00 CET
VIHANGA PAHALAWATTA, RAC-US – Abbott Molecular Inc ### 1187603###Session Leader/Speaker###Regulatory Affairs Manager###Abbott Molecular Inc###Session Leader/Speaker: – Abbott Molecular Inc
@@@ Anne-Charlotte Jarrige, PhD – Voisin Consulting Life Sciences ### 1187600###Speaker###Senior Regulatory Scientist###Voisin Consulting Life Sciences###Speaker: – Voisin Consulting Life Sciences
@@@ Marie Zbinden – Voisin Consulting Life Sciences ### 1187632###Speaker######Voisin Consulting Life Sciences###Speaker: – Voisin Consulting Life Sciences
17:00 – 18:30 CET
Clinical Evaluation Debate
17:00 – 18:30 CET
Clinical Evaluation DebateModerator: – QServe
Panelist: – DARE!! Medical Certifications
Panelist: – TUV SUD America
Panelist: – Treximo
Panelist: – TUV SUD
Panelist: – medicaldeviceslegal.com
Panelist: – TUV SUD
Medical Devices
Gert W. Bos, PhD FRAPS – QServe ### 535440###Moderator###CTO, Executive Director & Partner at Qserve Group###QServe###Moderator: – QServe
@@@ Natascha J. Cuper, n/a – DARE!! Medical Certifications ### 535505###Panelist###Clinical expert###DARE!! Medical Certifications###Panelist: – DARE!! Medical Certifications
@@@ Matthias Fink, n/a – TUV SUD America ### 1187569###Panelist###Manager Clinical Focus Team North America###TUV SUD America###Panelist: – TUV SUD America
@@@ Belinda Larson, MSN, RN, CCRP – Treximo ### 1187590###Panelist###Sr. Director Device and Diagnostic Writing###Treximo###Panelist: – Treximo
@@@ Katalin Meszaros, n/a – TUV SUD ### 1187579###Panelist###Clinical Reviewer###TUV SUD###Panelist: – TUV SUD
@@@ Erik R. Vollebregt, n/a – medicaldeviceslegal.com ### 535481###Panelist###Partner###medicaldeviceslegal.com###Panelist: – medicaldeviceslegal.com
@@@ Tomoko Urakawa Disaro, Dr., Medical Doctor – TUV SUD ### 1187578###Panelist###Clinical Reviewer###TUV SUD###Panelist: – TUV SUD
17:00 – 18:30 CET
Medical Device Quality Management Systems (e.g., ISO 13485)
17:00 – 18:30 CET
Teresa Perry – BSI ### 1187555###Session Leader/Speaker###Global Quality and Accreditation Manager###BSI###Session Leader/Speaker: – BSI
@@@ Michel Marboeuf, MBA – Stryker Corporation ### 1207608###Speaker###Senior Director###Stryker Corporation###Speaker: – Stryker Corporation
@@@ Jan Sterba – Linet spol. s r.o. ### 1187592###Speaker###Regulatory and Certification Manager###Linet spol. s r.o.###Speaker: – Linet spol. s r.o.
18:00 – 18:15 CET
Meet The Speaker - Companion Diagnostics
18:00 – 19:00 CET
Article 117
18:00 – 19:00 CET
Article 117Session Leader: – European Medicines Agency
Speaker: – Ypsomed AG
Speaker: – MSD B.V.
Pharmaceuticals
Armin Ritzhaupt, PhD, MPH – European Medicines Agency ### 746325###Session Leader###Scientific Administrator###European Medicines Agency###Session Leader: – European Medicines Agency
@@@ Stephan Affolter, dipl. Chemist FH, BS – Ypsomed AG ### 907117###Speaker###Regulatory + Quality Intelligence Manager###Ypsomed AG###Speaker: – Ypsomed AG
@@@ Veronica Gonzales, MSc – MSD B.V. ### 1221968###Speaker###Medical Device Regulatory Affairs Liaison###MSD B.V.###Speaker: – MSD B.V.
18:30 – 18:45 CET
Meet The Speaker - Clinical Evaluation Debate
18:30 – 18:45 CET
Meet The Speaker - Medical Device Quality Management Systems
19:00 – 19:15 CET
Meet The Speaker - Combination products and Article 117
