- Friday, May 12, 2023
08:00 – 16:30 CEST
Registration Open
08:00 – 16:30 CEST
Registration Open
08:30 – 16:00 CEST
Poster Viewing
08:30 – 16:00 CEST
Poster Viewing
09:00 – 10:15 CEST
Conversations That Matter: Interactions with Health Authorities
09:00 – 10:15 CEST
Conversations That Matter: Interactions with Health AuthoritiesModerator: – European Medicines Agency
Moderator: – TÜV SÜD Medical Health Service
Panelist:
Panelist: – European Medicines Agency
Panelist: – EMA
Panelist:
Panelist: – TÜV SÜD GmbH
Panelist: – BSI
Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Moderator###Principal Scientific Administrator###European Medicines Agency###Moderator: – European Medicines Agency
### @@@ Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 1187581###Moderator###Regulatory Strategy Principal###TÜV SÜD Medical Health Service###Moderator: – TÜV SÜD Medical Health Service
### @@@ Ilona Reischl ### 1897482###Panelist#########Panelist:
### @@@ Falk Ehmann, MD, PhD, MSc, – European Medicines Agency ### 716669###Panelist###Chair Innovation Task Force###European Medicines Agency###Panelist: – European Medicines Agency
### @@@ Christelle Bouygues – EMA ### 1318405###Panelist###Regulatory Affairs Officer###EMA###Panelist: – EMA
### @@@ Silvy Da Rocha Dias ### 1922318###Panelist#########Panelist:
### @@@ Marta Carnielli, PharmD – TÜV SÜD GmbH ### 1187616###Panelist###Head of Certification IVD###TÜV SÜD GmbH###Panelist: – TÜV SÜD GmbH
### @@@ Suzanne Halliday, MSc. D.Phil. – BSI ### 535446###Panelist###Regulatory Director###BSI###Panelist: – BSI
### 10:15 – 10:45 CEST
Chapter/LNG Meet and Greets
10:15 – 10:45 CEST
Chapter/LNG Meet and Greets
Location: Foyer 1
10:15 – 10:45 CEST
Presenters at Posters
10:15 – 10:45 CEST
Presenters at Posters
10:15 – 10:45 CEST
Refreshment Break in Exhibit Area
10:15 – 10:45 CEST
Refreshment Break in Exhibit Area
10:45 – 11:45 CEST
Device Lifetime and Lifecycle Management
10:45 – 11:45 CEST
Device Lifetime and Lifecycle ManagementModerator: – Qserve
Presenter: – Oriel STAT A MATRIX
Presenter: – TÜV SÜD Product Service GmbH
Medical Devices
Domain: Post Approval/Post Market
Knowledge Area: Recordkeeping, Monitoring
Giovanni Di Rienzo – Qserve ### 907127###Moderator###Principal Consultant###Qserve###Moderator: – Qserve
### @@@ Richard A. Vincins, RAC-MD, CMDA, CQA – Oriel STAT A MATRIX ### 1254352###Presenter###VP Global Regulatory Affairs###Oriel STAT A MATRIX###Presenter: – Oriel STAT A MATRIX
### @@@ Matthias Bellmann, MA (he/him/his) – TÜV SÜD Product Service GmbH ### 1828310###Presenter###Director Global Focus Team Cardiovascular###TÜV SÜD Product Service GmbH###Presenter: – TÜV SÜD Product Service GmbH
### he/him/his10:45 – 11:45 CEST
EMA’s PRIME Scheme in review. Findings and Lessons Learnt
10:45 – 11:45 CEST
EMA’s PRIME Scheme in review. Findings and Lessons LearntPharmaceuticals
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Market Strategy
Kevin Cunningham ### 1919733###Moderator & Presenter#########Moderator & Presenter:
### 10:45 – 11:45 CEST
Medical Device Software: Top Recurrent Regulatory Deficiencies from Both FDA and Notified Bodies
10:45 – 11:45 CEST
Medical Device Software: Top Recurrent Regulatory Deficiencies from Both FDA and Notified BodiesPresenter: – RQM+
Presenter: – RQM+
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Regulatory Guidance
Nancy J. Morrison, RAC US and EU – RQM+ ### 757434###Presenter###Vice President, Intelligence & Innovation###RQM+###Presenter: – RQM+
### @@@ Kevin Go, MBA, RAC, CQA – RQM+ ### 1557509###Presenter###Senior Principal###RQM+###Presenter: – RQM+
### 10:45 – 11:45 CEST
Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting system
10:45 – 11:45 CEST
Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting systemModerator: – NAMSA
Presenter: – Qserve Consultancy BV
Presenter: – Genomic Vision
Presenter: – TÜV SÜD GmbH
IVD
Domain: Post Approval/Post Market
Knowledge Area: General
Alex Laan, Dipl.-Ing. – NAMSA ### 1141533###Moderator###Principal Regulatory Consultant, IVD###NAMSA###Moderator: – NAMSA
### @@@ Kristiane Schmidt, PhD (she/her/hers) – Qserve Consultancy BV ### 1828297###Presenter###Senior Consultant###Qserve Consultancy BV###Presenter: – Qserve Consultancy BV
### she/her/hers @@@ Mohamed-Salah GAROUACHI, n/a – Genomic Vision ### 1828323###Presenter###Director, Quality and Regulatory Affairs###Genomic Vision###Presenter: – Genomic Vision
### @@@ Marta Carnielli, PharmD – TÜV SÜD GmbH ### 1187616###Presenter###Head of Certification IVD###TÜV SÜD GmbH###Presenter: – TÜV SÜD GmbH
### 12:00 – 13:00 CEST
Real World Evidence...What Could Possibly go Wrong? A Clinician's Perspective
12:00 – 13:00 CEST
Real World Evidence...What Could Possibly go Wrong? A Clinician's PerspectivePresenter: – BSI
Presenter:
Presenter: – W.L. Gore & Associates
Medical Devices
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Data Management & Analysis
Gavin Quigley, MBChB FRCS MBA – BSI ### 1827173###Presenter###Internal Clinician###BSI###Presenter: – BSI
### @@@ Joshua Bridgens ### 1897475###Presenter#########Presenter:
### @@@ Sophie Tabutin, PharmD, MSc – W.L. Gore & Associates ### 907081###Presenter###EMEA Regulatory Affairs Leader###W.L. Gore & Associates###Presenter: – W.L. Gore & Associates
### 12:00 – 13:00 CEST
Research Use Only (RUO): What does this mean for legacy devices and product development of new in vitro diagnostics under the IVDR?
12:00 – 13:00 CEST
Research Use Only (RUO): What does this mean for legacy devices and product development of new in vitro diagnostics under the IVDR?Presenter: – Integrated DNA Technologies, Inc., a Danaher Company
Presenter: – ASQ, MedTech Europe
IVD
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Regulatory Strategy Development
Ashleigh C. Dawley, RAC – Integrated DNA Technologies, Inc., a Danaher Company ### 1828307###Presenter###Director, Regulatory Affairs and Compliance###Integrated DNA Technologies, Inc., a Danaher Company###Presenter: – Integrated DNA Technologies, Inc., a Danaher Company
### @@@ Melissa Finocchio, ASQ CQE, ASQ CRE, MA Quality Management (she/her/hers) – ASQ, MedTech Europe ### 1828313###Presenter###Chief Regulatory Officer###ASQ, MedTech Europe###Presenter: – ASQ, MedTech Europe
### she/her/hers12:00 – 13:00 CEST
UKCA: challenges and opportunities
12:00 – 13:00 CEST
UKCA: challenges and opportunitiesModerator: – Qserve
Presenter:
Presenter: – BSI Group
Presenter: – MHRA
Medical Devices
Giovanni Di Rienzo – Qserve ### 907127###Moderator###Principal Consultant###Qserve###Moderator: – Qserve
### @@@ Phil Brown ### 1855142###Presenter#########Presenter:
### @@@ Vishal Thakker, MEng (he/him/his) – BSI Group ### 1614543###Presenter###Head of UK Approved Body & Senior Regulatory Lead###BSI Group###Presenter: – BSI Group
### he/him/his @@@ Jillan Hussein, MEng – MHRA ### 1570677###Presenter###Senior Regulatory Policy Manager###MHRA###Presenter: – MHRA
### 12:00 – 13:00 CEST
Will Data-Driven Regulatory Science Stimulate Innovation and Initiate a New Regulatory Paradigm?
12:00 – 13:00 CEST
Will Data-Driven Regulatory Science Stimulate Innovation and Initiate a New Regulatory Paradigm?Pharmaceuticals
Domain: Business Acumen
Knowledge Area: Project Management
Rebecca Lumsden, PhD – Sanofi ### 1827170###Presenter###Head of Regulatory Science & Policy EU/AMEE###Sanofi###Presenter: – Sanofi
### 13:00 – 14:00 CEST
Lunch, Exhibits, Posters
13:00 – 14:00 CEST
Lunch, Exhibits, Posters
13:15 – 13:45 CEST
Sponsored Presentations
13:15 – 13:45 CEST
Sponsored Presentations
14:00 – 15:00 CEST
Due Diligence: Critical Importance of Regulatory & Quality to Support Company or Product Acquisitions
14:00 – 15:00 CEST
Due Diligence: Critical Importance of Regulatory & Quality to Support Company or Product AcquisitionsModerator & Presenter: – Ypsomed
Presenter: – Konapharma
Regulatory Business
Domain: Business Acumen
Knowledge Area: General
Susana de Azevedo Wäsch, n/a – Ypsomed ### 1141752###Moderator & Presenter###VP Quality Management & Regulatory Affairs & Medical Affairs###Ypsomed###Moderator & Presenter: – Ypsomed
### @@@ Patrik J. Spirig, MA (he/him/his) – Konapharma ### 1827176###Presenter###CFO###Konapharma###Presenter: – Konapharma
### he/him/his14:00 – 15:00 CEST
Software and Cybersecurity Specific Requirements - Challenges for Regulatory Compliance and Testing Approaches
14:00 – 15:00 CEST
Software and Cybersecurity Specific Requirements - Challenges for Regulatory Compliance and Testing ApproachesPresenter: – TÜV SÜD Product Service GmbH
IVD
Domain: Product Development & Registration
Knowledge Area: Data Management & Analysis
Alexander Stock, PhD – TÜV SÜD Product Service GmbH ### 1827167###Presenter###Project Manager IVD Medical Device Testing###TÜV SÜD Product Service GmbH###Presenter: – TÜV SÜD Product Service GmbH
### 14:00 – 15:00 CEST
Standards & Compliance: Updates on ‘Sustainable’ Medical Devices
14:00 – 15:00 CEST
Standards & Compliance: Updates on ‘Sustainable’ Medical DevicesMedical Devices
Domain: Scientific & Health Concepts
Knowledge Area: Healthcare Leadership
Keti S. Agostino, n/a – BSI ### 1614397###Presenter###Regulatory Lead###BSI###Presenter: – BSI
### 14:00 – 15:00 CEST
Strategic approaches in pregnancy and paediatrics: Is it time for a paradigm shift?
14:00 – 15:00 CEST
Strategic approaches in pregnancy and paediatrics: Is it time for a paradigm shift?Presenter: – AstraZeneca
Presenter: – UCB
Presenter: – UCB
Presenter: – European Medicines Agency
Pharmaceuticals
Domain: Product Development & Registration
Knowledge Area: Regulatory Guidance
Solange Corriol-Rohou, n/a – AstraZeneca ### 1828324###Presenter###Sr Global Policy Director###AstraZeneca###Presenter: – AstraZeneca
### @@@ Marie Teil, n/a – UCB ### 1828299###Presenter###Head WoCBA###UCB###Presenter: – UCB
### @@@ Rüdiger Faust, PhD – UCB ### 1828296###Presenter###Global Regulatory Intelligence & Policy Lead###UCB###Presenter: – UCB
### @@@ Corinne de Vries, MA MSc PhD FISPE – European Medicines Agency ### 1922323###Presenter###Head of Translational Sciences###European Medicines Agency###Presenter: – European Medicines Agency
### 15:00 – 15:30 CEST
Presenters at Posters
15:00 – 15:30 CEST
Presenters at Posters
15:00 – 15:30 CEST
Refreshment Break in Exhibit Area
15:00 – 15:30 CEST
Refreshment Break in Exhibit Area
15:30 – 16:30 CEST
Closing Panel: Impact of MDCG 2022-14 Position Paper on NB Capacity Since Publication
15:30 – 16:30 CEST
Closing Panel: Impact of MDCG 2022-14 Position Paper on NB Capacity Since PublicationModerator: – Medical Device Project B.V.
Presenter: – BSI Group
Presenter: – TÜV SÜD Product Service GmbH
Presenter: – DEKRA Certification BV
Medical Devices
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Data Management & Analysis
Robert A. van Boxtel – Medical Device Project B.V. ### 907078###Moderator###Principal Consultant###Medical Device Project B.V.###Moderator: – Medical Device Project B.V.
### @@@ Kevin Madden – BSI Group ### 1828338###Presenter###Technical Team Manager - Orthopaedic & Dental Devices, Regulatory Services (Medical Devices)###BSI Group###Presenter: – BSI Group
### @@@ Martin Witte – TÜV SÜD Product Service GmbH ### 1187576###Presenter###Senior Director###TÜV SÜD Product Service GmbH###Presenter: – TÜV SÜD Product Service GmbH
### @@@ Paul Kosters, PhD (he/him/his) – DEKRA Certification BV ### 1855542###Presenter###Knowledge management manager / project manager###DEKRA Certification BV###Presenter: – DEKRA Certification BV
### he/him/his15:30 – 16:30 CEST
Cybersecurity: Compliantly Securing our Healthcare Future
15:30 – 16:30 CEST
Cybersecurity: Compliantly Securing our Healthcare FutureModerator & Presenter: – MedSec LLC
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Market Strategy
Michelle Jump, RAC – MedSec LLC ### 1827177###Moderator & Presenter###CEO###MedSec LLC###Moderator & Presenter: – MedSec LLC
### 15:30 – 16:30 CEST
European Expedited Approval Pathways in a Global Context
15:30 – 16:30 CEST
European Expedited Approval Pathways in a Global ContextPresenter: – CSL Behring AG
Presenter: – European Medicines Agency
Pharmaceuticals
Domain: Product Development & Registration
Knowledge Area: Regulatory Guidance
Yingying Liu – CSL Behring AG ### 1187559###Presenter###Associate Director, GRA CMC Lead Plasma Fractionation Global Regulatory Affairs CMC###CSL Behring AG###Presenter: – CSL Behring AG
### @@@ Thomas Larsson, MSc, BSc – European Medicines Agency ### 1650183###Presenter###Senior Scientific Specialist###European Medicines Agency###Presenter: – European Medicines Agency
### 15:30 – 16:30 CEST
MDCG22-14 Panel: Will IVDR Implementation Benefit From MDCG 2022-14 and if so, How ?
15:30 – 16:30 CEST
MDCG22-14 Panel: Will IVDR Implementation Benefit From MDCG 2022-14 and if so, How ?Moderator: – TÜV SÜD Medical Health Service
Moderator: – mi-CE consultancy
Presenter: – TUV SUD JAPAN LTD
Presenter: – TÜV SÜD GmbH
Presenter: – BSI Group
IVD
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Process & Procedures
Sabina L. Hoekstra-van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Service ### 1187581###Moderator###Regulatory Strategy Principal###TÜV SÜD Medical Health Service###Moderator: – TÜV SÜD Medical Health Service
### @@@ Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy ### 574723###Moderator###CEO###mi-CE consultancy###Moderator: – mi-CE consultancy
### she/her/hers @@@ Andreas Stange – TUV SUD JAPAN LTD ### 1187582###Presenter###SVP Medical Health Services Regulatory & Quality###TUV SUD JAPAN LTD###Presenter: – TUV SUD JAPAN LTD
### @@@ Marta Carnielli, PharmD – TÜV SÜD GmbH ### 1187616###Presenter###Head of Certification IVD###TÜV SÜD GmbH###Presenter: – TÜV SÜD GmbH
### @@@ Elizabeth Harrison, PhD (she/her/hers) – BSI Group ### 1401973###Presenter###Global Head – IVD Medical Devices###BSI Group###Presenter: – BSI Group
### she/her/hers16:30 – 17:00 CEST
Closing Remarks & Farewell Toast
16:30 – 17:00 CEST
Closing Remarks & Farewell Toast
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