- Friday, May 7, 2021
08:30 – 16:30 CEST
Pre-Conference Workshop: Risk Management Under the EU Regulations for Medical Devices and In-vitro Diagnostics
08:30 – 16:30 CEST
Pre-Conference Workshop: Risk Management Under the EU Regulations for Medical Devices and In-vitro DiagnosticsSession Leader: – Medical Device Project
Speaker: – DEKRA Certification B.V.
Speaker: – Medical Device Project
Pre-Conference Workshop
Leon Assink, bSC – Medical Device Project ### 1215845###Session Leader###Senior Consultant###Medical Device Project###Session Leader: – Medical Device Project
@@@ Inge Willems – DEKRA Certification B.V. ### 1225405###Speaker###Project manager Medical Devices###DEKRA Certification B.V.###Speaker: – DEKRA Certification B.V.
@@@ Hester E. Hasper, PhD – Medical Device Project ### 1225406###Speaker###Senior Consultant###Medical Device Project###Speaker: – Medical Device Project
08:45 – 17:00 CEST
Pre-Conference Workshop: Software as a Medical Device
08:45 – 17:00 CEST
Pre-Conference Workshop: Software as a Medical DeviceSession Leader: – Qserve Group
Session Leader: – Philips
Speaker: – Dedalus Healthcare
Speaker: – Alcon
Speaker:
Pre-Conference Workshop
Gert W. Bos, FRAPS, President of RAPS – Qserve Group ### 535440###Session Leader###CSO###Qserve Group###Session Leader: – Qserve Group
@@@ Koen Cobbaert, MA – Philips ### 943170###Session Leader###Senior Manager - Quality, Standards & Regulations###Philips###Session Leader: – Philips
@@@ Zuzanna Kwade, MSc, PhD – Dedalus Healthcare ### 1225916###Speaker###Clinical Evaluation Lead###Dedalus Healthcare###Speaker: – Dedalus Healthcare
@@@ Tifanny Istamto, MBA, MSc – Alcon ### 1225917###Speaker###Strategic account manager, market access and tender###Alcon###Speaker: – Alcon
@@@ Kevin Holochwost ### 1312113###Speaker#########Speaker:
09:00 – 16:15 CEST
Pre-Conference Workshop: Post-Market Reporting: MDR Article 88/Trending and PSUR
09:00 – 16:15 CEST
Pre-Conference Workshop: Post-Market Reporting: MDR Article 88/Trending and PSURSession Leader/Speaker: – Founder of Waypoint Consulting
Speaker: – ELEKTA | Nucletron
Speaker: – NAMSA
Pre-Conference Workshop
Eric Klasen, MSc – Founder of Waypoint Consulting ### 972075###Session Leader/Speaker###RA & Quality consultant in Life Sciences###Founder of Waypoint Consulting###Session Leader/Speaker: – Founder of Waypoint Consulting
@@@ Leo Hovestadt – ELEKTA | Nucletron ### 716677###Speaker###Director Governmental Affairs EU###ELEKTA | Nucletron###Speaker: – ELEKTA | Nucletron
@@@ Alex Laan – NAMSA ### 1187572###Speaker###Principal Consultant###NAMSA###Speaker: – NAMSA
09:00 – 17:00 CEST
Pre-Conference Workshop: Clinical Studies in PMCF
09:00 – 17:00 CEST
Pre-Conference Workshop: Clinical Studies in PMCFSession Leader: – TÜV SÜD Medical Health Service
Speaker: – Qserve Group B.V.
Speaker: – NSAI
Pre-Conference Workshop
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
@@@ Wiebe Postma, PhD – Qserve Group B.V. ### 907094###Speaker###Sr Consultant & CRO Service lead###Qserve Group B.V.###Speaker: – Qserve Group B.V.
@@@ Yvonne Ndefo, MD, MCh – NSAI ### 1154007###Speaker###CHIEF CLINICAL EVALUATOR###NSAI###Speaker: – NSAI
- Monday, May 10, 2021
09:00 – 18:15 CEST
Explore Sponsor Solutions - Visit Sponsor Booths
09:00 – 18:15 CEST
Explore Sponsor Solutions - Visit Sponsor BoothsNetworking
09:00 – 18:15 CEST
Poster Gallery Viewing
09:00 – 18:15 CEST
Poster Gallery Viewing
09:30 – 11:30 CEST
Opening Plenary Session - How to Make Sparks Fly
09:30 – 11:30 CEST
Opening Plenary Session - How to Make Sparks FlyHost: – TÜV SÜD Medical Health Service
Host: – Qserve Group
Host: – Founder of Waypoint Consulting
Panelist: – Danish Medicines Agency, Denmark
Panelist: – European Medicines Agency
Panelist: – BSI
Panelist: – DG for Health and Food Safety (SANTE)
Panelist: – Dutch Health and Youth Care Inspectorate
Panelist: – mi-CE Consultancy
Panelist: – Align Technology, BV.
Panelist: – Medtronic
Panelist: – Ypsomed AG
Panelist: – Pfizer Biopharmaceuticals Group
Plenary
Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 1187581###Host###Regulatory Strategy Principal###TÜV SÜD Medical Health Service###Host: – TÜV SÜD Medical Health Service
@@@ Gert W. Bos, FRAPS, President of RAPS – Qserve Group ### 535440###Host###CSO###Qserve Group###Host: – Qserve Group
@@@ Eric Klasen, MSc – Founder of Waypoint Consulting ### 972075###Host###RA & Quality consultant in Life Sciences###Founder of Waypoint Consulting###Host: – Founder of Waypoint Consulting
@@@ Thomas Wejs Møller – Danish Medicines Agency, Denmark ### 1317708###Panelist###Section Manager – Medical Devices,###Danish Medicines Agency, Denmark###Panelist: – Danish Medicines Agency, Denmark
@@@ Zaïde Frias – European Medicines Agency ### 1317709###Panelist###Head of Digital Business Transformation Task Force###European Medicines Agency###Panelist: – European Medicines Agency
@@@ Suzanne Elizabeth Halliday, MSc. D.Phil. – BSI ### 535446###Panelist###Regulatory Director###BSI###Panelist: – BSI
@@@ 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: – DG for Health and Food Safety (SANTE)
@@@ Laura de Vries, PhD – Dutch Health and Youth Care Inspectorate ### 1089150###Panelist###Coordinating/Specialist Inspector###Dutch Health and Youth Care Inspectorate###Panelist: – Dutch Health and Youth Care Inspectorate
@@@ Anja Wiersma, PhD – mi-CE Consultancy ### 574723###Panelist###CEO and Senior Consultant###mi-CE Consultancy###Panelist: – mi-CE Consultancy
@@@ Erik Raadsheer, PhD – Align Technology, BV. ### 1092331###Panelist###Sr. Director, Regulatory & Government Affairs and Quality Assurance, EMEA###Align Technology, BV.###Panelist: – Align Technology, BV.
@@@ John Brennan – Medtronic ### 1329523###Panelist###Vice President Quality, Regulatory Affairs & Government Affairs, EMEA###Medtronic###Panelist: – Medtronic
@@@ Susana de Azevedo Wäsch – Ypsomed AG ### 1141752###Panelist###Vice President Quality Management & Regulatory Affairs###Ypsomed AG###Panelist: – Ypsomed AG
@@@ Francisco Hernandez, Ph.D – Pfizer Biopharmaceuticals Group ### 1329546###Panelist###Head of Regulatory Affairs, The Netherlands###Pfizer Biopharmaceuticals Group###Panelist: – Pfizer Biopharmaceuticals Group
10:00 – 19:00 CEST
Explore Sponsor Solutions - Visit Sponsor Booths
10:00 – 19:00 CEST
Explore Sponsor Solutions - Visit Sponsor BoothsNetworking
11:30 – 12:00 CEST
Meet The Speakers - Plenary Opening Debate
11:30 – 12:00 CEST
Meet The Speakers - Plenary Opening DebatePlenary
11:30 – 12:00 CEST
Visit Sponsors - Brain Break
11:30 – 12:00 CEST
Visit Sponsors - Brain BreakNetworking
12:00 – 13:00 CEST
Clinical Evaluation
12:00 – 13:00 CEST
88 - 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 – 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 CEST
Drug-Device Combination Products Under MDR
12:00 – 13:00 CEST
50 - Drug-Device Combination Products Under MDRSession Leader: – TÜV SÜD Medical Health Service
Speaker: – TÜV SÜD Japan Ltd.
Speaker: – NL Medicines Evaluation Board
Speaker: – BSI
Speaker:
Medical Devices
Sponsored By: Synchrogenix
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
@@@ Julia Frese – TÜV SÜD Japan Ltd. ### 1187628###Speaker###Director Medical and Health Service###TÜV SÜD Japan Ltd.###Speaker: – TÜV SÜD Japan Ltd.
@@@ Waldo Weijers, PharmD – NL Medicines Evaluation Board ### 716640###Speaker###Senior Advisor###NL Medicines Evaluation Board###Speaker: – NL Medicines Evaluation Board
@@@ Jonathan Sutch, PhD – BSI ### 907128###Speaker###Senior Medicinal Technical Specialist###BSI###Speaker: – BSI
@@@ Janine Jamieson ### 1327844###Speaker#########Speaker:
12:00 – 13:00 CEST
Innovative Clinical Trial Design
12:00 – 13:00 CEST
22 - 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 CEST
Prepare to Pivot: Expectations for Future Hybrid EMA Meetings
12:00 – 13:00 CEST
21 - Prepare to Pivot: Expectations for Future Hybrid EMA MeetingsSession Leader/Speaker: – 3D Communications
Speaker: – 3D Communications
Regulatory business
Michelle Zucatti, MPH – 3D Communications ### 1187586###Session Leader/Speaker###Communications Lead###3D Communications###Session Leader/Speaker: – 3D Communications
@@@ Kell S. Cannon, MBA – 3D Communications ### 1187587###Speaker###Senior Management###3D Communications###Speaker: – 3D Communications
13:00 – 13:15 CEST
Meet The Speaker - Clinical Evaluation
13:00 – 13:15 CEST
Meet The Speaker - Clinical EvaluationMedical Devices
13:00 – 13:15 CEST
Meet The Speaker - Drug-Device Combination Products Under MDR
13:00 – 13:15 CEST
Meet The Speaker - Drug-Device Combination Products Under MDRMedical Devices
13:00 – 13:15 CEST
Meet The Speaker - Innovative Clinical Trial Design
13:00 – 13:15 CEST
Meet The Speaker - Innovative Clinical Trial DesignPharmaceuticals
13:00 – 13:15 CEST
Meet The Speaker - Prepare to Pivot: Expectations for Future Hybrid EMA Meetings
13:00 – 13:15 CEST
Meet The Speaker - Prepare to Pivot: Expectations for Future Hybrid EMA Meetings In Vitro Diagnostics
13:15 – 14:00 CEST
Lunch Break - Visit Sponsors - Brain Break
13:15 – 14:00 CEST
Lunch Break - Visit Sponsors - Brain BreakNetworking
13:15 – 14:00 CEST
Meet and Greet: RAPS Netherlands Chapter
13:15 – 14:00 CEST
Meet and Greet: RAPS Netherlands Chapter Session Leader: – DARE!! Medical Certifications
Session Leader: – Medical Device Project B.V.
Networking
Natascha J. Cuper – DARE!! Medical Certifications ### 535505###Session Leader###Clinical expert###DARE!! Medical Certifications###Session Leader: – DARE!! Medical Certifications
@@@ Robert A. van Boxtel, MSc – Medical Device Project B.V. ### 907078###Session Leader###Principal Consultant###Medical Device Project B.V.###Session Leader: – Medical Device Project B.V.
13:15 – 14:00 CEST
Meet and Greet: RAPS UK Local Networking Group
13:15 – 14:00 CEST
Meet and Greet: RAPS UK Local Networking Group Session Leader: – RadBee Ltd
Session Leader: – Qualitas Professional Services, LLC
Networking
Rina Nir – RadBee Ltd ### 1300388###Session Leader###CEO###RadBee Ltd###Session Leader: – RadBee Ltd
@@@ Lena Cordie-Bancroft – Qualitas Professional Services, LLC ### 743793###Session Leader###President###Qualitas Professional Services, LLC###Session Leader: – Qualitas Professional Services, LLC
13:30 – 14:00 CEST
Meet the Authors - Regulatory Intelligence
13:30 – 14:00 CEST
Meet the Authors - Regulatory IntelligenceCo-Author: – Seagen
Co-Author: – Parexel
Co-Author: – Clarivate
Networking
Linda Bowen, MS, RAC, FRAPS – Seagen ### 551690###Co-Author###Head of Regulatory Policy and Intelligence###Seagen###Co-Author: – Seagen
@@@ Siegfried Schmitt, CSci CChem FRSC – Parexel ### 907098###Co-Author###Vice President Technical###Parexel###Co-Author: – Parexel
@@@ Celine Rodier Seguy, PharmD, DES – Clarivate ### 1294064###Co-Author###Senior Health Policy Manager###Clarivate###Co-Author: – Clarivate
14:00 – 14:45 CEST
How Can Regulatory Intelligence Support Better Decision Making?
14:00 – 14:45 CEST
82 - How Can Regulatory Intelligence Support Better Decision Making?Speaker: – IQVIA
Speaker: – IQVIA
Sponsored Session
Raquel Carnero Gomez – IQVIA ### 1327836###Speaker######IQVIA###Speaker: – IQVIA
@@@ Irene Garcia Bravo – IQVIA ### 1328176###Speaker######IQVIA###Speaker: – IQVIA
14:00 – 14:45 CEST
Medical Writing and Submission Compilation Made Easy: Technology Solutions from Regulatory Experts
14:00 – 14:45 CEST
30 - Medical Writing and Submission Compilation Made Easy: Technology Solutions from Regulatory ExpertsSpeaker: – Synchrogenix, a Certara company
Speaker: – Synchrogenix, a Certara company
Speaker: – Synchrogenix, a Certara company
Sponsored Session
Gabriella Mangino – Synchrogenix, a Certara company ### 1326509###Speaker###Product Manager###Synchrogenix, a Certara company###Speaker: – Synchrogenix, a Certara company
@@@ Steve Sibley – Synchrogenix, a Certara company ### 1326510###Speaker###Vice President, Global Submissions and Submission Leadership###Synchrogenix, a Certara company###Speaker: – Synchrogenix, a Certara company
@@@ Justin Savesky – Synchrogenix, a Certara company ### 1326511###Speaker###Sr. Director, Regulatory Science Technology###Synchrogenix, a Certara company###Speaker: – Synchrogenix, a Certara company
14:00 – 14:45 CEST
Pre-IND Considerations - What to Do and When to Do it
14:00 – 14:45 CEST
20 - Pre-IND Considerations - What to Do and When to Do itSpeaker: – Scilucent
Speaker:
Sponsored Session
Andrew S. Verderame, RAC, MBA – Scilucent ### 1317224###Speaker######Scilucent###Speaker: – Scilucent
@@@ Agnes Cobbum ### 1327835###Speaker#########Speaker:
14:45 – 15:00 CEST
Visit Sponsors - Brain Break
14:45 – 15:00 CEST
Visit Sponsors - Brain BreakNetworking
15:00 – 15:30 CEST
Accelerated Pathways: Bringing down Barriers to Supply Orphan Medicines in EU Markets with Very Low Patient Numbers
15:00 – 15:30 CEST
24 - Accelerated Pathways: Bringing Down Barriers to Supply Orphan Medicines in EU Markets with Very Low Patient NumbersSpeaker: – PRA Health Sciences
Speaker: – PRA Health Sciences
Pharmaceuticals
Thomas Liebers, MTOPRA – PRA Health Sciences ### 1187593###Speaker###Senior Director, Regulatory Labeling###PRA Health Sciences###Speaker: – PRA Health Sciences
@@@ Betti Mozes-Stoddart – PRA Health Sciences ### 1187618###Speaker###Regulatory Labeling Manager###PRA Health Sciences###Speaker: – PRA Health Sciences
15:00 – 16:00 CEST
Functional Safety of Medical Devices
15:00 – 16:00 CEST
55 - 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 E. Marlow, RN – M Squared ### 580310###Speaker###CEO###M Squared###Speaker: – M Squared
15:00 – 16:00 CEST
Global IVDs: Establishing an Effective Regulatory/Quality Program for Global Markets
15:00 – 16:00 CEST
55 - Global IVDs: Establishing an Effective Regulatory/Quality Program for Global MarketsSession Leader/Speaker: – Lumos Diagnostics
Speaker: – World Health Organization
Speaker: – bioMérieux
In Vitro Diagnostics
Susan Hibbeln, MS, RAC – Lumos Diagnostics ### 716672###Session Leader/Speaker###Sr Director, Regulatory Affairs###Lumos Diagnostics###Session Leader/Speaker: – Lumos Diagnostics
@@@ Irena Prat, MSc – World Health Organization ### 1218175###Speaker###Team Lead###World Health Organization###Speaker: – World Health Organization
@@@ Benedicte Astier Roche – bioMérieux ### 1324151###Speaker###Quality Leader###bioMérieux###Speaker: – bioMérieux
15:00 – 16:00 CEST
How to Manage Grace Period?
15:00 – 16:00 CEST
60 - How to Manage Grace Period?Session Leader/Speaker: – TÜV SÜD Product Service GmbH
Speaker: – medicaldeviceslegal.com
Speaker: – Med-El
Medical Devices
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 – medicaldeviceslegal.com ### 535481###Speaker###Partner###medicaldeviceslegal.com###Speaker: – medicaldeviceslegal.com
@@@ Elizabeth Gfoeller, MA – Med-El ### 766093###Speaker###Corporate Director, Regulatory Affairs ###Med-El###Speaker: – Med-El
15:30 – 16:00 CEST
Accelerated Pathways: Take International Collaboration in Paediatrics to the Next Level to Accelerate Access to Paediatric Medicines
15:30 – 16:00 CEST
24 - Accelerated Pathways: Take International Collaboration in Paediatrics to the Next Level to Accelerate Access to Paediatric MedicinesPharmaceuticals
Angelika Joos, Pharmacist – MSD ### 1187564###Submitter###Executive Director Global Regulatory Policy###MSD###Submitter: – MSD
16:00 – 16:15 CEST
Meet The Speaker - Accelerated Pathways
16:00 – 16:15 CEST
Meet The Speaker - Accelerated PathwaysPharmaceuticals
16:00 – 16:15 CEST
Meet The Speaker - Functional Safety
16:00 – 16:15 CEST
Meet The Speaker - Functional SafetyMedical Devices
16:00 – 16:15 CEST
Meet The Speaker - Global IVDs
16:00 – 16:15 CEST
Meet The Speaker - Global IVDsIn Vitro Diagnostics
16:00 – 16:15 CEST
Meet The Speaker - How to Manage Grace Period?
16:00 – 16:15 CEST
Meet The Speaker - How to Manage Grace Period?Medical Devices
16:15 – 17:00 CEST
Visit Sponsors - Brain Break
16:15 – 17:00 CEST
Visit Sponsors - Brain BreakNetworking
17:00 – 17:30 CEST
Global Regulatory Changes and Updates: Use of Real World Evidence in FDA Device Applications
17:00 – 17:30 CEST
45 - Global Regulatory Changes and Updates: Use of Real World Evidence in FDA Device ApplicationsSpeaker: – M Squared
Speaker: – MSquared Associates and The Johns Hopkins School of Medicine
Medical Devices
Sponsored By: Bannick LLC
Marie E. 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 CEST
Artificial Intelligence in MDR
17:00 – 18:00 CEST
70 - Artificial Intelligence in MDR Speaker: – ELEKTA | Nucletron
Speaker: – Sparta Systems
Medical Devices
Leo Hovestadt – ELEKTA | Nucletron ### 716677###Speaker###Director Governmental Affairs EU###ELEKTA | Nucletron###Speaker: – ELEKTA | Nucletron
@@@ Stephen McCarthy – Sparta Systems ### 1187631###Speaker###VP Digital Innovation###Sparta Systems###Speaker: – Sparta Systems
17:00 – 18:00 CEST
Rest of the World
17:00 – 18:00 CEST
22 - 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 CEST
IVDR Debate - Regulation Changes
17:00 – 18:30 CEST
55 - IVDR Debate - Regulation ChangesSession Leader/Speaker: – mi-CE Consultancy
Session Leader/Speaker: – NAMSA
Session Leader/Speaker:
In Vitro Diagnostics
Anja Wiersma, PhD – mi-CE Consultancy ### 574723###Session Leader/Speaker###CEO and Senior Consultant###mi-CE Consultancy###Session Leader/Speaker: – mi-CE Consultancy
@@@ Alex Laan – NAMSA ### 1187572###Session Leader/Speaker###Principal Consultant###NAMSA###Session Leader/Speaker: – NAMSA
@@@ Richard Vincins ### 1254352###Session Leader/Speaker#########Session Leader/Speaker:
17:30 – 18:00 CEST
Global Regulatory Changes and Updates: Global Medical Device Regulatory Strategy
17:30 – 18:00 CEST
42 - Driving Successful Medical Device Product LaunchesSpeaker: – Siemens Healthineers
Speaker: – Regulatory Intelligence Associates, LLC
Medical Devices
Susumu Nozawa, RAC, FRAPS – Siemens Healthineers ### 1293270###Speaker###Head of Regulatory Policy - North America###Siemens Healthineers###Speaker: – Siemens Healthineers
@@@ Peter A. Takes, PhD, RAC, FRAPS – Regulatory Intelligence Associates, LLC ### 1293271###Speaker###Principal###Regulatory Intelligence Associates, LLC###Speaker: – Regulatory Intelligence Associates, LLC
18:00 – 18:15 CEST
Combined Meet The Speaker - Global Regulatory Changes and Updates & Driving Successful Medical Device Product Launches
18:00 – 18:15 CEST
Combined Meet The Speaker - Global Regulatory Changes and Updates & Driving Successful Medical Device Product LaunchesMedical Devices
18:00 – 18:15 CEST
Meet The Speaker - Artificial Intelligence
18:00 – 18:15 CEST
Meet The Speaker - Artificial IntelligenceMedical Devices
18:00 – 18:15 CEST
Meet The Speaker - Rest of the World
18:00 – 18:15 CEST
Meet The Speaker - Rest of the WorldPharmaceuticals
18:30 – 18:45 CEST
Meet The Speaker - FIVDR Debate
18:30 – 18:45 CEST
Meet The Speaker - IVDR Debate In Vitro Diagnostics
- Tuesday, May 11, 2021
10:00 – 10:30 CEST
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 CEST
40 - Risk Management: Compliance with Risk Management Requirements in ISO 14155:2020 During Different Clinical Development Stages of Clinical Investigations for Medical Devices, Including SaMDSpeaker: – Donawa Lifescience
Speaker: – MD-Clinicals SA
Medical Devices
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 CEST
MDR Technical Overview: How to Navigate in the Waters of MDR implementation and Which icebergs to Avoid
10:00 – 11:00 CEST
72 - MDR Technical Overview: How to Navigate in the Waters of MDR implementation and Which icebergs to AvoidSession Leader/Speaker: – TÜV SÜD Medical Health Service
Speaker: – Qserve Group
Speaker: – Intertek Medical Notified Body AB, NB 2862
Speaker: – Med-El
Medical Devices
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, FRAPS, President of RAPS – Qserve Group ### 535440###Speaker###CSO###Qserve Group###Speaker: – Qserve Group
@@@ Ella Helgeman, MsC EE, MBA – Intertek Medical Notified Body AB, NB 2862 ### 1329536###Speaker###Regulatory and Quality Manager###Intertek Medical Notified Body AB, NB 2862###Speaker: – Intertek Medical Notified Body AB, NB 2862
@@@ Elizabeth Gfoeller, MA – Med-El ### 766093###Speaker###Corporate Director, Regulatory Affairs ###Med-El###Speaker: – Med-El
10:00 – 11:00 CEST
Pandemic Readiness - Business Contingency
10:00 – 11:00 CEST
20 - Pandemic Readiness - Business ContingencySession Leader/Speaker: – Parexel
Speaker: – 3D Communications
Speaker: – 3D Communications
Pharmaceuticals
Siegfried Schmitt, CSci CChem FRSC – Parexel ### 907098###Session Leader/Speaker###Vice President Technical###Parexel###Session Leader/Speaker: – Parexel
@@@ Kell S. 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 CEST
Pressure cooker: Fast Track to IVD-R Compliance
10:00 – 11:00 CEST
45 - Pressure cooker: Fast Track to IVD-R ComplianceSession Leader/Speaker: – Qarad
Speaker: – Qserve Group
In Vitro Diagnostics
Maurizio Suppo – Qarad ### 1000097###Session Leader/Speaker###Owner & VP###Qarad###Session Leader/Speaker: – Qarad
@@@ Sue Spencer – Qserve Group ### 1187575###Speaker###IVD Lead/ Principal Consultant###Qserve Group###Speaker: – Qserve Group
10:00 – 17:00 CEST
Poster Gallery Viewing
10:00 – 17:00 CEST
Poster Gallery Viewing
10:00 – 19:00 CEST
Sponsor Solutions - Visit Sponsor Booths
10:00 – 19:00 CEST
Sponsor Solutions - Visit Sponsor BoothsNetworking
10:30 – 11:00 CEST
Making the Risk Management File work for to you to support safety and efficacy of devices.
10:30 – 11:00 CEST
40 - Making the Risk Management File work for to you to support safety and efficacy of devices.Medical Devices
Tiea Theurer – NSAI, Inc ### 720639###Speaker###Medical / MDSAP Lead Auditor###NSAI, Inc###Speaker: – NSAI, Inc
11:00 – 11:15 CEST
Meet The Speaker - MDR Technical Overview
11:00 – 11:15 CEST
Meet The Speaker - MDR Technical OverviewMedical Devices
11:00 – 11:15 CEST
Meet The Speaker - Pandemic Readiness
11:00 – 11:15 CEST
Meet The Speaker - Pandemic Readiness Pharmaceuticals
11:00 – 11:15 CEST
Meet The Speaker - Pressure Cooker
11:00 – 11:15 CEST
Meet The Speaker - Pressure CookerIn Vitro Diagnostics
11:00 – 11:15 CEST
Meet The Speaker - Risk Management
11:00 – 11:15 CEST
Meet The Speaker - Risk ManagementMedical Devices
11:15 – 12:00 CEST
Visit Sponsors - Brain Break
11:15 – 12:00 CEST
Visit Sponsors - Brain BreakNetworking
12:00 – 13:00 CEST
Data Security and Digital Health
12:00 – 13:00 CEST
50 - Data Security and Digital HealthSession Leader/Speaker: – TÜV SÜD Product Service GmbH
Speaker: – Philips
Medical Devices
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 – Philips ### 1187568###Speaker###
CISSP CCSK ISO27001 LI
Director Product Security
###Philips###Speaker: – Philips
12:00 – 13:00 CEST
Innovative Regulatory Decision Making - Optimised Development Strategies
12:00 – 13:00 CEST
30 - Innovative Regulatory Decision Making - Optimised Development StrategiesSession Leader/Speaker: – SANOFI
Speaker: – Clarivate
Speaker: – Sanofi
Speaker: – Sanofi
Pharmaceuticals
Sponsored By: Synchrogenix
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 Rei Bolislis, MA – Sanofi ### 1254353###Speaker###Regulatory Science and Policy Manager###Sanofi###Speaker: – Sanofi
@@@ Thomas Kuhler, PhD – Sanofi ### 1254354###Speaker###Head Global Regulatory Science and Policy EU/AMEE###Sanofi###Speaker: – Sanofi
12:00 – 13:00 CEST
IVDR Implementation Best Practices and Challenges
12:00 – 13:00 CEST
50 - IVDR Implementation Best Practices and ChallengesModerator:
Panelist: – TUV SUD JAPAN LTD
Panelist: – RQM+
Panelist: – Abbott Rapid Diagnostics
Panelist: – Leica Biosystems
In Vitro Diagnostics
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
@@@ Amie Smirthwaite, PhD – RQM+ ### 1187605###Panelist###Global VP, Clinical Services###RQM+###Panelist: – RQM+
@@@ Simon Richards – Abbott Rapid Diagnostics ### 1187627###Panelist######Abbott Rapid Diagnostics###Panelist: – Abbott Rapid Diagnostics
@@@ Laura Tracy – Leica Biosystems ### 1254349###Panelist###Senior Manager Global Regulatory Affairs###Leica Biosystems###Panelist: – Leica Biosystems
12:00 – 13:00 CEST
MDR Technical Documentation – How to approach important requirements today and in future
12:00 – 13:00 CEST
67 - MDR Technical Documentation – How to approach important requirements today and in futureSession Leader/Speaker: – Demcon BV
Speaker: – TÜV SÜD Product Service GmbH
Speaker: – Berlin Heals GmbH
Medical Devices
Jan-Paul van Loon, MSc, PhD – Demcon BV ### 907088###Session Leader/Speaker###Senior 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 CEST
Meet The Speaker - Data Security and Digital Health
13:00 – 13:15 CEST
Meet The Speaker - Data Security and Digital HealthMedical Devices
13:00 – 13:15 CEST
Meet The Speaker - Implementation Best Practices & Challenges
13:00 – 13:15 CEST
Meet The Speaker - Implementation Best Practices & ChallengesIn Vitro Diagnostics
13:00 – 13:15 CEST
Meet The Speaker - Innovative Regulatory Decision Making
13:00 – 13:15 CEST
Meet The Speaker - Innovative Regulatory Decision MakingPharmaceuticals
13:00 – 13:15 CEST
Meet The Speaker - Technical Documentation
13:00 – 13:15 CEST
Meet The Speaker - Technical DocumentationMedical Devices
13:15 – 14:00 CEST
Lunch Break - Visit Sponsors - Brain Break
13:15 – 14:00 CEST
Lunch Break - Visit Sponsors - Brain BreakNetworking
13:15 – 14:00 CEST
Meet and Greet: RAPS Germany Chapter
13:15 – 14:00 CEST
Meet and Greet: RAPS Germany Chapter Session Leader: – MDSS GmbH
Session Leader: – Sartorius Stedim Biotech GmbH
Networking
Ludger J. Möller – MDSS GmbH ### 907125###Session Leader###President###MDSS GmbH###Session Leader: – MDSS GmbH
@@@ Jennifer Neff, PhD – Sartorius Stedim Biotech GmbH ### 958555###Session Leader###Head of Regulatory Affairs###Sartorius Stedim Biotech GmbH###Session Leader: – Sartorius Stedim Biotech GmbH
13:15 – 14:00 CEST
Meet and Greet: RAPS Netherlands Chapter
13:15 – 14:00 CEST
Meet and Greet: RAPS Netherlands Chapter Session Leader: – mi-CE Consultancy
Session Leader:
Networking
Anja Wiersma, PhD – mi-CE Consultancy ### 574723###Session Leader###CEO and Senior Consultant###mi-CE Consultancy###Session Leader: – mi-CE Consultancy
@@@ Rick Paauw ### 1300390###Session Leader###Chapter Treasurer######Session Leader:
13:15 – 14:00 CEST
Meet and Greet: RAPS Switzerland Chapter
13:15 – 14:00 CEST
Meet and Greet: RAPS Switzerland Chapter Session Leader: – Medidee Services SA
Session Leader:
Networking
Michael Maier, MBA, RAC – Medidee Services SA ### 915009###Session Leader###Senior Partner###Medidee Services SA###Session Leader: – Medidee Services SA
@@@ Charlotte Serra ### 1300389###Session Leader###Chapter Volunteer######Session Leader:
13:30 – 14:00 CEST
Meet the Authors - Software as a Medical Device
13:30 – 14:00 CEST
Meet the Authors - Software as a Medical DeviceCo-Author: – Qserve Group
Co-Author: – Philips
Networking
Gert W. Bos, FRAPS, President of RAPS – Qserve Group ### 535440###Co-Author###CSO###Qserve Group###Co-Author: – Qserve Group
@@@ Koen Cobbaert, MA – Philips ### 943170###Co-Author###Senior Manager - Quality, Standards & Regulations###Philips###Co-Author: – Philips
14:00 – 14:45 CEST
All Paths Begin with Clinical Evidence, But Where Can I Go?
14:00 – 14:45 CEST
65 - All Paths Begin with Clinical Evidence, But Where Can I Go?Speaker: – Bannick LLC
Speaker: – Bannick LLC
Speaker: – Bannick LLC
Sponsored Session
Sponsored By: Bannick LLC
Karen Bannick McQuoid, MA, FRAPS, RAC – Bannick LLC ### 907111###Speaker###CEO###Bannick LLC###Speaker: – Bannick LLC
@@@ Jim Webb – Bannick LLC ### 1331034###Speaker###Director of Operations and Quality###Bannick LLC###Speaker: – Bannick LLC
@@@ Stefanie Martinez-Koenig – Bannick LLC ### 1331031###Speaker###Director of Clinical and Regulatory Affairs###Bannick LLC###Speaker: – Bannick LLC
14:00 – 14:45 CEST
Boosting IVDR Transition with Workforce of IVD-industry Experienced Partners
14:00 – 14:45 CEST
30 - Boosting IVDR Transition with Workforce of IVD-industry Experienced PartnersSponsored Session
Anu Jääskeläinen, PhD – Labquality Oy ### 1326512###Speaker###Quality and Regulatory Affairs Manager###Labquality Oy###Speaker: – Labquality Oy
14:00 – 14:45 CEST
Transforming Regulatory Affairs
14:00 – 14:45 CEST
35 - Transforming Regulatory AffairsSpeaker: – Generis
Speaker: – AbbVie
Sponsored Session
Max Kelleher – Generis ### 1328016###Speaker###COO###Generis###Speaker: – Generis
@@@ Eric Cardwell – AbbVie ### 1328017###Speaker###Director, Regulatory Information Management & Lifecycle Management, Regulatory Operations###AbbVie###Speaker: – AbbVie
15:00 – 16:00 CEST
Digitalisation in Health Care / (Real World) Evidence & Innovative Technologies
15:00 – 16:00 CEST
40 - Digitalisation in Health Care / (Real World) Evidence & Innovative TechnologiesSpeaker: – MSD
Speaker: – Independent
Speaker: – Parexel
Speaker: – Arriello
Pharmaceuticals
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 CEST
Recognition of CE Marking Outside EU During Transition Period
15:00 – 16:00 CEST
45 - Recognition of CE Marking Outside EU During Transition PeriodSession Leader/Speaker: – Ypsomed AG
Speaker: – BSI
Medical Devices
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 CEST
Risk Management
15:00 – 16:00 CEST
45 - Risk Management: Risk Assessment of IVD Devices Under the New IVDR, Including Risk Versus Benefit DeterminationSession Leader/Speaker: – NAMSA
Speaker: – Validant
In Vitro Diagnostics
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 CEST
Software as a Medical Device, Mobile apps, Wearables
15:00 – 16:00 CEST
55 - Software as a Medical Device, Mobile apps, Wearables Session Leader/Speaker: – Carl Zeiss
Speaker: – TÜV SÜD Product Service GmbH
Medical Devices
Vidita Desai, MS – Carl Zeiss ### 1187583###Session Leader/Speaker###Sr. Regulatory Affairs Specialist###Carl Zeiss###Session Leader/Speaker: – Carl Zeiss
@@@ 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 CEST
Meet The Speaker - Digitalisation in Health Care
16:00 – 16:15 CEST
Meet The Speaker - Digitalisation in Health CarePharmaceuticals
16:00 – 16:15 CEST
Meet The Speaker - Recognition of CE Marking Outside EU During Transition Period
16:00 – 16:15 CEST
Meet The Speaker - Recognition of CE Marking Outside EU During Transition PeriodMedical Devices
16:00 – 16:15 CEST
Meet The Speaker - Risk Management
16:00 – 16:15 CEST
Meet The Speaker - Risk ManagementIn Vitro Diagnostics
16:00 – 16:15 CEST
Meet The Speaker - Software as a Medical Device, Mobile Apps, Wearables
16:00 – 16:15 CEST
Meet The Speaker - Software as a Medical Device, Mobile Apps, WearablesMedical Devices
16:15 – 16:30 CEST
Brain Break - Visit Sponsor Booths
16:15 – 16:30 CEST
Brain Break - Visit Sponsor BoothsNetworking
16:30 – 17:30 CEST
Patient Engagement Focused Drug Development
16:30 – 17:30 CEST
20 - Patient Engagement Focused Drug DevelopmentSpeaker: – Arriello
Speaker: – Synchrogenix, a Certara Company
Pharmaceuticals
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 CEST
Postmarketing Clinical Follow-up (PMCF)
16:30 – 17:30 CEST
70 - Postmarketing Clinical Follow-up (PMCF)Session Leader: – Integra LifeSciences
Speaker: – SMART-TRIAL
Speaker: – TÜV SÜD Americas Inc.
Medical Devices
Carine Cochereau, PhD – Integra LifeSciences ### 1207604###Session Leader###VP Regulatory International###Integra LifeSciences ###Session Leader: – Integra LifeSciences
@@@ Jon Ingi 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 CEST
Reflection on Pandemic
16:30 – 17:30 CEST
25 - Reflection on PandemicModerator: – MS REGULATORY AFFAIRS
Speaker: – Ortho Clinical Diagnostics
Speaker: – Agios Pharmaceuticals
In Vitro Diagnostics
Sponsored By: Schlafender Hase
Riddhi Masurkar – MS REGULATORY AFFAIRS ### 1187571###Moderator###REGULATORY AFFAIRS EXECUTIVE###MS REGULATORY AFFAIRS###Moderator: – MS REGULATORY AFFAIRS
@@@ Waïss Faissal, PharmD, PhD, MSc – Ortho Clinical Diagnostics ### 1187596###Speaker###Quality Regulatory and Compliance Manager - Northern Europe###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 CEST
Turbulent Times in Europe: Why the US is taking over the lead in Medical Technology Innovation
16:30 – 17:30 CEST
40 - Turbulent Times in Europe: Why the US is taking over the lead in Medical Technology InnovationSession Leader/Speaker: – EMERGO
Speaker: – NA
Speaker: – 4RA
Medical Devices
Jaap L. Laufer, MD, PharmD. – 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 CEST
Meet The Speaker - Patient Engagement Focused Drug Development
17:30 – 17:45 CEST
Meet The Speaker - Patient Engagement Focused Drug DevelopmentPharmaceuticals
17:30 – 17:45 CEST
Meet The Speaker - Postmarketing Clinical Follow-up (PMCF)
17:30 – 17:45 CEST
Meet The Speaker - Postmarketing Clinical Follow-up (PMCF)Medical Devices
17:30 – 17:45 CEST
Meet The Speaker - Reflection on Pandemic
17:30 – 17:45 CEST
Meet The Speaker - Reflection on PandemicIn Vitro Diagnostics
17:30 – 17:45 CEST
Meet The Speaker - Software-related Medical Technology
17:30 – 17:45 CEST
Meet The Speaker - Software-related Medical TechnologyMedical Devices
18:00 – 19:00 CEST
Poster Session: IVDR & Medical Devices
18:00 – 19:00 CEST
25 - Poster Session: IVDR & Medical DevicesPoster Presentation
Leo Louis ### 1312131###Moderator#########Moderator:
18:00 – 19:00 CEST
Poster Session: Pharmaceuticals
18:00 – 19:00 CEST
15 - Poster Session: PharmaceuticalsPoster Presentation
Colette Shortt, MSc,PhD, MBA ### 973109###Moderator###Regulatory Director######Moderator:
- Wednesday, May 12, 2021
10:00 – 11:00 CEST
Article 117
10:00 – 11:00 CEST
Article 117Moderator: – Parexel
Speaker: – Ypsomed AG
Speaker: – MSD B.V.
Speaker: – TÜV SÜD Japan Ltd.
Speaker:
Pharmaceuticals
Siegfried Schmitt, CSci CChem FRSC – Parexel ### 907098###Moderator###Vice President Technical###Parexel###Moderator: – Parexel
@@@ 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.
@@@ Julia Frese – TÜV SÜD Japan Ltd. ### 1187628###Speaker###Director Medical and Health Service###TÜV SÜD Japan Ltd.###Speaker: – TÜV SÜD Japan Ltd.
@@@ Nada Alkhayat ### 1328520###Speaker#########Speaker:
10:00 – 11:00 CEST
EU MDR Clinical Investigations
10:00 – 11:00 CEST
50 - EU MDR Clinical InvestigationsSession Leader: – TÜV SÜD Medical Health Service
Speaker: – Federal Agency of Medecines and Health Products
Speaker: – Qserve CRO
Medical Devices
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
@@@ Steve Eglem, MSc – Federal Agency of Medecines and Health Products ### 716662###Speaker###Head of Unit Clinical Investigation & Unmet Medical needs###Federal Agency of Medecines and Health Products###Speaker: – Federal Agency of Medecines and Health Products
@@@ Loes Pelgrim, Msc., ACRP-CP – Qserve CRO ### 907093###Speaker###Commercial Lead/Senior Clinical Project Manager ###Qserve CRO###Speaker: – Qserve CRO
10:00 – 11:00 CEST
Reference Labs
10:00 – 11:00 CEST
42 - Reference LabsSession Leader: – mi-CE Consultancy
Speaker: – Sciensano
Speaker: – Paul-Ehrlich-Institut
In Vitro Diagnostics
Anja Wiersma, PhD – mi-CE Consultancy ### 574723###Session Leader###CEO and Senior Consultant###mi-CE Consultancy###Session Leader: – mi-CE Consultancy
@@@ 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 CEST
The Regulatory & Standards Landscape for AI
10:00 – 11:00 CEST
The Regulatory & Standards Landscape for AISession Leader: – Philips
Speaker: – Philips
Speaker: – Zifo Technologies Inc.,
Medical Devices
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 CEST
Poster Gallery Viewing
10:00 – 17:00 CEST
Poster Gallery Viewing
10:00 – 19:00 CEST
Sponsor Solutions - Visit Sponsor Booths
10:00 – 19:00 CEST
Sponsor Solutions - Visit Sponsor BoothsNetworking
11:00 – 11:15 CEST
Meet The Speaker - Article 117
11:00 – 11:15 CEST
Meet The Speaker - Article 117Pharmaceuticals
11:00 – 11:15 CEST
Meet The Speaker - EU MDR Clinical Investigations
11:00 – 11:15 CEST
Meet The Speaker - EU MDR Clinical InvestigationsMedical Devices
11:00 – 11:15 CEST
Meet The Speaker - Reference labs
11:00 – 11:15 CEST
Meet The Speaker - Reference labsIn Vitro Diagnostics
11:00 – 11:15 CEST
Meet The Speaker - The Regulatory & Standards Landscape for AI
11:00 – 11:15 CEST
Meet The Speaker - The Regulatory & Standards Landscape for AIMedical Devices
11:15 – 12:00 CEST
Visit Sponsors - Brain Break
11:15 – 12:00 CEST
Visit Sponsors - Brain BreakNetworking
12:00 – 12:30 CEST
Aesthetic devices under MDR: Emerging Challenges for Aesthetic Manufacturers: What is the State of the Art?
12:00 – 12:30 CEST
Aesthetic devices under MDR: Emerging Challenges for Aesthetic Manufacturers: What is the State of the Art?Medical Devices
Melania Battistella – TUV SUD ### 1187595###Speaker###Global Manager Aesthetic Product###TUV SUD###Speaker: – TUV SUD
12:00 – 13:00 CEST
ATMPs/Cell and Gene Therapies: Regulatory Affairs in Academia and the Future of CAR T Cell Therapies
12:00 – 13:00 CEST
ATMPs/Cell and Gene Therapies: Regulatory Affairs in Academia and the Future of CAR T Cell TherapiesSpeaker: – PharmMed
Speaker:
Pharmaceuticals
Orin Chisholm, GCULT, PhD, SFHEA – PharmMed ### 1220926###Speaker###Consultant###PharmMed###Speaker: – PharmMed
@@@ Lutz Uharek ### 1332710###Speaker#########Speaker:
12:00 – 13:00 CEST
Economic Operators
12:00 – 13:00 CEST
70 - Economic OperatorsSession Leader: – medicaldeviceslegal.com
Speaker: – MDSS GmbH
Speaker: – NAMSA
Speaker: – BSI
Medical Devices
Erik R. Vollebregt – medicaldeviceslegal.com ### 535481###Session Leader###Partner###medicaldeviceslegal.com###Session Leader: – medicaldeviceslegal.com
@@@ Ludger J. Möller – 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 CEST
Rollout IVDR 2022: (Post) Market Surveillance for IVD Medical Devices; Are You Ready?
12:00 – 13:00 CEST
25 - Rollout IVDR 2022: (Post) Market Surveillance for IVD Medical Devices; Are You Ready?Session Leader/Speaker: – TUV SUD
Speaker: – NAMSA
In Vitro Diagnostics
Julien S. Senac, PhD – TUV SUD ### 1022552###Session Leader/Speaker###Director - IVD Global Focus Team###TUV SUD###Session Leader/Speaker: – TUV SUD
@@@ Alex Laan – NAMSA ### 1187572###Speaker###Principal Consultant###NAMSA###Speaker: – NAMSA
12:30 – 13:00 CEST
Industry Advocacy; the Power of Collective Voice
12:30 – 13:00 CEST
Industry Advocacy; the Power of Collective VoiceSpeaker: – Orthopaedic Surgical Manufacturers Association (OSMA)
CeramTec GmbH
Medical Devices
Lindsay Stafford, MS – Orthopaedic Surgical Manufacturers Association (OSMA)
CeramTec GmbH ### 1187556###Speaker###Regulatory Affairs Manager (CeramTec GmbH)###Orthopaedic Surgical Manufacturers Association (OSMA)
CeramTec GmbH###Speaker: – Orthopaedic Surgical Manufacturers Association (OSMA)
CeramTec GmbH
13:00 – 13:15 CEST
Meet The Speaker - Aesthetic Devices Under MDR & Industry Advocacy; the Power of Collective Voice
Industry advocacy; the power of Collective Voice
13:00 – 13:15 CEST
Meet The Speaker - Aesthetic Devices Under MDR & Industry Advocacy; the Power of Collective VoiceMedical Devices
13:00 – 13:15 CEST
Meet The Speaker - ATMPs/Cell and Gene Therapies
13:00 – 13:15 CEST
Meet The Speaker - ATMPs/Cell and Gene TherapiesPharmaceuticals
13:00 – 13:15 CEST
Meet The Speaker - Economic Operators
13:00 – 13:15 CEST
Meet The Speaker - Economic OperatorsMedical Devices
13:00 – 13:15 CEST
Meet The Speaker - Rollout IVDR 2022: (Post) Market Surveillance for IVD Medical Devices; Are You Ready?
13:00 – 13:15 CEST
Meet The Speaker - Rollout IVDR 2022: (Post) Market Surveillance for IVD Medical Devices; Are You Ready?In Vitro Diagnostics
13:15 – 14:00 CEST
Lunch Break - Visit Sponsors - Brain Break
13:15 – 14:00 CEST
Lunch Break - Visit Sponsors - Brain BreakNetworking
13:40 – 14:00 CEST
Roundtable Discussion: Find the Elusive PMCF Data: The Needle in the Haystack
13:40 – 14:00 CEST
Roundtable Discussion: Find the Elusive PMCF Data: The Needle in the HaystackHost: – Bannick LLC
Host: – Graematter, Inc.
Sponsored Session
Sponsored By: Bannick LLC
Karen Bannick McQuoid, MA, FRAPS, RAC – Bannick LLC ### 907111###Host###CEO###Bannick LLC###Host: – Bannick LLC
@@@ Melissa Walker, MS, RAC, FRAPS – Graematter, Inc. ### 609472###Host###President & CTO###Graematter, Inc.###Host: – Graematter, Inc.
13:40 – 14:00 CEST
Roundtable Discussion: Meeting FDA : Do's and Don'ts
13:40 – 14:00 CEST
Roundtable Discussion: Meeting FDA : Do's and Don'tsSponsored Session
Andrew S. Verderame, RAC, MBA – Scilucent ### 1317224###Host######Scilucent###Host: – Scilucent
13:40 – 14:00 CEST
Roundtable Discussion: RegOps - Integrate Compliancy to Medical Software Development
13:40 – 14:00 CEST
Roundtable Discussion: RegOps - Integrate Compliancy to Medical Software DevelopmentSponsored Session
Mika Siitonen – Labquality ### 1331035###Host######Labquality###Host: – Labquality
13:40 – 14:00 CEST
Roundtable Discussion: Using a Global Regulatory Intelligence Database for Better Decision-Making
13:40 – 14:00 CEST
Roundtable Discussion: Using a Global Regulatory Intelligence Database for Better Decision-MakingSponsored Session
Eva Petersen ### 1331040###Speaker#########Speaker:
@@@ Sue Plant ### 1331041###Speaker#########Speaker:
14:00 – 14:45 CEST
Global Digital Transformation for MedTech Regulatory Affairs
14:00 – 14:45 CEST
Global Digital Transformation for MedTech Regulatory AffairsSpeaker: – Rimsys Regulatory Management Software
Sponsored Session
James Gianoutsos – Rimsys Regulatory Management Software ### 1328412###Speaker###Founder & President###Rimsys Regulatory Management Software###Speaker: – Rimsys Regulatory Management Software
14:00 – 14:45 CEST
Maintaining Regulatory Compliance in an Age of Continual Change and Digitalization
14:00 – 14:45 CEST
52 - Maintaining Regulatory Compliance in an Age of Continual Change and DigitalizationSpeaker: – Veeva MedTech Europe
Speaker: – EMCD, TERUMO EUROPE NV
Speaker: – Alcon Laboratories Inc
Sponsored Session
Annemien Pullen, PhD – Veeva MedTech Europe ### 863187###Speaker###Senior Director MedTech Strategy###Veeva MedTech Europe###Speaker: – Veeva MedTech Europe
@@@ Marie-Pierre Dewez – EMCD, TERUMO EUROPE NV ### 1328374###Speaker###Clinical Operations Director###EMCD, TERUMO EUROPE NV###Speaker: – EMCD, TERUMO EUROPE NV
@@@ Lori K. Holder, RAC – Alcon Laboratories Inc ### 1000136###Speaker###Senior Director, Global Regulatory Operations###Alcon Laboratories Inc###Speaker: – Alcon Laboratories Inc
14:00 – 14:45 CEST
The Leading Global Solution for All Your Proofreading Tasks
14:00 – 14:45 CEST
The Leading Global Solution for All Your Proofreading TasksSpeaker: – Schlafender Hase GmbH
Sponsored Session
Sponsored By: Schlafender Hase
Dean Halliday – Schlafender Hase GmbH ### 1327837###Speaker###Regional Sales Director###Schlafender Hase GmbH###Speaker: – Schlafender Hase GmbH
15:00 – 15:30 CEST
Labelling: Robust Labeling Systems – key to avoiding inspection findings, recalls and the cost of reworking batches
15:00 – 15:30 CEST
Labelling: Robust Labeling Systems – key to avoiding inspection findings, recalls and the cost of reworking batchesSpeaker: – PRA Health Sciences
Speaker:
Pharmaceuticals
Thomas Liebers, MTOPRA – PRA Health Sciences ### 1187593###Speaker###Senior Director, Regulatory Labeling###PRA Health Sciences###Speaker: – PRA Health Sciences
@@@ Jithin Sasi ### 1187619###Speaker#########Speaker:
15:00 – 16:00 CEST
IVDR Regulatory Strategy: How to Comply to IVDR; for Manufacturers and Health institutions with LDTs
15:00 – 16:00 CEST
IVDR Regulatory Strategy: How to Comply to IVDR; for Manufacturers and Health institutions with LDTsSession Leader/Speaker: – mi-CE Consultancy
Speaker: – University Hospital Leuven, Belgium
Speaker: – Leiden University Medical Center/ESLHO
In Vitro Diagnostics
Anja Wiersma, PhD – mi-CE Consultancy ### 574723###Session Leader/Speaker###CEO and Senior Consultant###mi-CE Consultancy###Session Leader/Speaker: – mi-CE Consultancy
@@@ Elisabeth PhD Dequeker, PhD – University Hospital Leuven, Belgium ### 1254350###Speaker###Full Professor in Quality Management###University Hospital Leuven, Belgium###Speaker: – University Hospital Leuven, Belgium
@@@ Bart Lubbers, PhD – Leiden University Medical Center/ESLHO ### 1254351###Speaker###Project manager###Leiden University Medical Center/ESLHO###Speaker: – Leiden University Medical Center/ESLHO
15:00 – 16:00 CEST
Other Regions
15:00 – 16:00 CEST
Other RegionsSession Leader/Speaker: – Certification Body Australia
Speaker: – MMGC SRL
Speaker: – RAPS Member and education committee
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
@@@ Monica M. Guaita, MSc(Eng) – MMGC SRL ### 907095###Speaker###CEO&Founder###MMGC SRL###Speaker: – MMGC SRL
@@@ Grace Palma, MBA – RAPS Member and education committee ### 1187560###Speaker###CEO###RAPS Member and education committee###Speaker: – RAPS Member and education committee
15:00 – 16:00 CEST
Post Market Surveillance under the MDR
15:00 – 16:00 CEST
57 - 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
Speaker: – MDSS GmbH
Medical Devices
Sponsored By: Bannick LLC
Robert A. van Boxtel, MSc – 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
@@@ Ludger J. Möller – MDSS GmbH ### 907125###Speaker###President###MDSS GmbH###Speaker: – MDSS GmbH
15:30 – 16:00 CEST
Labelling: Private Label Drugs Challenges to Meet the Regulatory Requirements
15:30 – 16:00 CEST
Labelling: Private Label Drugs Challenges to Meet the Regulatory RequirementsSpeaker: – Pharmaceutical Industry
Pharmaceuticals
Sponsored By: Schlafender Hase
Safia Terki, M.Sc., RAC. – Pharmaceutical Industry ### 1187561###Speaker###Senior Specialist, Regulatory Affairs###Pharmaceutical Industry###Speaker: – Pharmaceutical Industry
16:00 – 16:15 CEST
Meet The Speaker - Labelling
16:00 – 16:15 CEST
Meet The Speaker - LabellingPharmaceuticals
16:00 – 16:15 CEST
Meet The Speaker - LDT's
16:00 – 16:15 CEST
Meet The Speaker - LDT's In Vitro Diagnostics
16:00 – 16:15 CEST
Meet The Speaker - Other Regions
16:00 – 16:15 CEST
Meet The Speaker - Other RegionsMedical Devices
16:00 – 16:15 CEST
Meet The Speaker - Postmarketing Surveillance
16:00 – 16:15 CEST
Meet The Speaker - Postmarket SurveillanceMedical Devices
16:15 – 17:00 CEST
Visit Sponsors - Brain Break
16:15 – 17:00 CEST
Visit Sponsors - Brain BreakNetworking
17:00 – 18:00 CEST
Biologics and Biosimilars
17:00 – 18:00 CEST
Biologics and BiosimilarsSession Leader/Speaker: – CSL Behríng
Speaker: – VCLS
Speaker: – Arriello Ireland Ltd.
Pharmaceuticals
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 Ireland Ltd. ### 907134###Speaker###Quality and Regulatory Director ###Arriello Ireland Ltd.###Speaker: – Arriello Ireland Ltd.
17:00 – 18:00 CEST
Companion Diagnostics: The Path for Companion Diagnostics Under IVDR
17:00 – 18:00 CEST
Companion Diagnostics: The Path for Companion Diagnostics Under IVDRSession Leader/Speaker: – Abbott Molecular Inc
Speaker: – Voisin Consulting Life Sciences
Speaker: – Voisin Consulting Life Sciences
Speaker: – European Medicines Agency
In Vitro Diagnostics
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, PhD – Voisin Consulting Life Sciences ### 1187632###Speaker###Senior Regulatory Scientist###Voisin Consulting Life Sciences###Speaker: – Voisin Consulting Life Sciences
@@@ Falk Ehmann, MD, PhD, MSc, – European Medicines Agency ### 716669###Speaker###Head Innovation Task Force###European Medicines Agency###Speaker: – European Medicines Agency
17:00 – 18:30 CEST
Clinical Evaluation Debate
17:00 – 18:30 CEST
60 - Clinical Evaluation DebateModerator: – Qserve Group
Panelist: – DARE!! Medical Certifications
Panelist: – TUV SUD America
Panelist: – Treximo
Panelist: – TUV SUD
Panelist: – medicaldeviceslegal.com
Panelist: – TUV SUD
Medical Devices
Gert W. Bos, FRAPS, President of RAPS – Qserve Group ### 535440###Moderator###CSO###Qserve Group###Moderator: – Qserve Group
@@@ Natascha J. Cuper – DARE!! Medical Certifications ### 535505###Panelist###Clinical expert###DARE!! Medical Certifications###Panelist: – DARE!! Medical Certifications
@@@ Matthias Fink, MD – 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 Medical Writing, Devices and Diagnostics###Treximo###Panelist: – Treximo
@@@ Katalin Meszaros, Dr – TUV SUD ### 1187579###Panelist###Clinical Reviewer###TUV SUD###Panelist: – TUV SUD
@@@ Erik R. Vollebregt – medicaldeviceslegal.com ### 535481###Panelist###Partner###medicaldeviceslegal.com###Panelist: – medicaldeviceslegal.com
@@@ Tomoko Urakawa Disaro, MD – TUV SUD ### 1187578###Panelist###Clinical Reviewer###TUV SUD###Panelist: – TUV SUD
17:00 – 18:30 CEST
Medical Device Quality Management Systems (e.g., ISO 13485)
17:00 – 18:30 CEST
Medical Device Quality Management Systems (e.g., ISO 13485)Session Leader/Speaker: – BSI
Speaker: – Stryker Corporation
Speaker: – Linet spol. s r.o.
Medical Devices
Teresa Perry, BSc MSc – 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 CEST
Meet The Speaker - Biologics and Biosimilars
18:00 – 18:15 CEST
Meet The Speaker - Biologics and BiosimilarsIn Vitro Diagnostics
18:00 – 18:15 CEST
Meet The Speaker - Companion Diagnostics
18:00 – 18:15 CEST
Meet The Speaker - Companion DiagnosticsIn Vitro Diagnostics
18:15 – 19:15 CEST
Combination Products
18:15 – 19:15 CEST
Combination Products Session Leader: – Parexel
Speaker:
Speaker: – European Medicines Agency
Pharmaceuticals
Siegfried Schmitt, CSci CChem FRSC – Parexel ### 907098###Session Leader###Vice President Technical###Parexel###Session Leader: – Parexel
@@@ Paola Minghetti ### 1293268###Speaker#########Speaker:
@@@ Christelle Bouygues – European Medicines Agency ### 1318405###Speaker###Regulatory Affairs Officer###European Medicines Agency###Speaker: – European Medicines Agency
18:30 – 18:45 CEST
Meet The Speaker - Clinical Evaluation Debate
18:30 – 18:45 CEST
Meet The Speaker - Clinical Evaluation DebateMedical Devices
18:30 – 18:45 CEST
Meet The Speaker - Medical Device Quality Management Systems
18:30 – 18:45 CEST
Meet The Speaker - Medical Device Quality Management SystemsMedical Devices
19:15 – 19:30 CEST
Meet The Speaker - Combination Products
19:15 – 19:30 CEST
Meet The Speaker - Combination Products Pharmaceuticals
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