- Thursday, May 11, 2023
08:00 – 09:00 CEST
Live LinkedIn Profile Feedback Session
08:00 – 09:00 CEST
Live LinkedIn Profile Feedback SessionLocation: Coral & Cyan
Elena Kyria – Elemed ### 1083155###Moderator###CEO & Founder###Elemed###Moderator: – Elemed
### 08:00 – 18:00 CEST
Registration Open
08:00 – 18:00 CEST
Registration Open
Location: Lobby - Ground floor
08:30 – 17:45 CEST
Poster Viewing & Voting
08:30 – 17:45 CEST
Poster Viewing & Voting
Location: Level 1
09:00 – 10:00 CEST
Data Security & Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health Data
09:00 – 10:00 CEST
Data Security & Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health DataLocation: Pearl 3Moderator & Presenter: – Axon Lawyers
Presenter: – Axon Lawyers
Presenter: – Philips Medical Systems Nederland B.V.
Presenter: – Elekta
Medical Devices
Domain: Ethics
Knowledge Area: Legal & Regulatory Requirements
Erik R. Vollebregt – Axon Lawyers ### 535481###Moderator & Presenter###Partner###Axon Lawyers###Moderator & Presenter: – Axon Lawyers
### @@@ Cécile E. Van der Heijden, LLM (she/her/hers) – Axon Lawyers ### 1827162###Presenter###Attorney-at-law###Axon Lawyers###Presenter: – Axon Lawyers
### she/her/hers @@@ Agnes Szoboszlai – Philips Medical Systems Nederland B.V. ### 1827163###Presenter###Senior Legal Counsel###Philips Medical Systems Nederland B.V.###Presenter: – Philips Medical Systems Nederland B.V.
### @@@ Leo Hovestadt – Elekta ### 535504###Presenter###Director Governmental Affairs EU###Elekta###Presenter: – Elekta
###
09:00 – 10:00 CEST
IVDR Transition: Quo Vadis? – the current reality
09:00 – 10:00 CEST
IVDR Transition: Quo Vadis? – the current realityLocation: Carmine & CharcoalModerator & Presenter: – TUV SUD JAPAN LTD
Moderator & Presenter: – MCRA
Presenter: – NSAI
Presenter: – Molecular Health GmbH
Presenter: – Abbott Diabetes Care
Presenter: – Health and Youth Care Inspectorate (IGJ), Ministry of Health
IVD
Domain: Product Development & Registration
Knowledge Area: Submission Management
Andreas Stange – TUV SUD JAPAN LTD ### 1187582###Moderator & Presenter###SVP Medical Health Services Regulatory & Quality###TUV SUD JAPAN LTD###Moderator & Presenter: – TUV SUD JAPAN LTD
### @@@ Erica Conway, PhD (she/her/hers) – MCRA ### 1828301###Moderator & Presenter###Vice President, IVD Regulatory Affairs - Europe###MCRA###Moderator & Presenter: – MCRA
### she/her/hers @@@ Tom Patten – NSAI ### 1141749###Presenter###Certification & Inspection Officer - IVD###NSAI###Presenter: – NSAI
### @@@ Niels Bojunga, Dr – Molecular Health GmbH ### 1919734###Presenter###SVP of Quality Management###Molecular Health GmbH###Presenter: – Molecular Health GmbH
### @@@ Kees Maquelin – Abbott Diabetes Care ### 1919788###Presenter###Regulatory Affairs Manager Europe###Abbott Diabetes Care###Presenter: – Abbott Diabetes Care
### @@@ Leo WJ Klomp – Health and Youth Care Inspectorate (IGJ), Ministry of Health ### 1919791###Presenter###Coordinating Specialist###Health and Youth Care Inspectorate (IGJ), Ministry of Health###Presenter: – Health and Youth Care Inspectorate (IGJ), Ministry of Health
###
09:00 – 10:00 CEST
MDCG 2022-14: Game-Changer or 'Shopping List' for MDR Implementation?
09:00 – 10:00 CEST
MDCG 2022-14: Game-Changer or 'Shopping List' for MDR Implementation?Location: Pearl 2Moderator: – TÜV SÜD Medical Health Services
Moderator: – Qserve Group
Presenter: – European Commission
Presenter: – TUV SUD Product Services
Presenter: – BSI
Presenter: – Federal Agency of Medicines and Health products
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Regulatory Guidance
Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services ### 574720###Moderator###Global Director Regulatory Strategy###TÜV SÜD Medical Health Services###Moderator: – TÜV SÜD Medical Health Services
### @@@ Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group ### 535440###Moderator###CSO###Qserve Group###Moderator: – Qserve Group
### @@@ Flora Giorgio (she/her/hers) – European Commission ### 1930380###Presenter###Acting Head of Unit###European Commission###Presenter: – European Commission
### she/her/hers @@@ Royth Philippp von Hahn, PhD – TUV SUD Product Services ### 1027488###Presenter###Senior Vice President of Medical Health Services (global)###TUV SUD Product Services###Presenter: – TUV SUD Product Services
### @@@ Graeme Turnbridge – BSI ### 1939249###Presenter###Senior Vice President Global Regulatory and Quality, Medical Devices###BSI###Presenter: – BSI
### @@@ Alexandre Jauniaux (he/him/his) – Federal Agency of Medicines and Health products ### 1974590###Presenter###Head of division###Federal Agency of Medicines and Health products###Presenter: – Federal Agency of Medicines and Health products
### he/him/his
09:00 – 10:00 CEST
Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)
09:00 – 10:00 CEST
Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)Location: Pearl 1Moderator & Presenter: – Sanofi
Presenter: – European Medicines Agency
Presenter: – European Patients' Forum
Presenter: – AM-Pharma
Presenter: – European Commission
Pharmaceuticals
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Regulatory Strategy Development
Rebecca Lumsden, PhD – Sanofi ### 1827170###Moderator & Presenter###Head of Regulatory Science & Policy EU/AMEE###Sanofi###Moderator & Presenter: – Sanofi
### @@@ Francesca A. Day, PhD (she/her/hers) – European Medicines Agency ### 1922319###Presenter###Head of Therapeutics Area Department###European Medicines Agency###Presenter: – European Medicines Agency
### she/her/hers @@@ Julie Spony, MA – European Patients' Forum ### 1948628###Presenter###Policy Officer###European Patients' Forum###Presenter: – European Patients' Forum
### @@@ Laetitia Szaller, MA – AM-Pharma ### 1962129###Presenter###General Counsel & VP Corporate Development###AM-Pharma###Presenter: – AM-Pharma
### @@@ Fabio Datri, PhD – European Commission ### 1980693###Presenter###Policy Officer, Unit B5 Directorate General for Health and Food Safety###European Commission###Presenter: – European Commission
###
10:00 – 10:30 CEST
Chapter/Local Networking Group Meet and Greets
10:00 – 10:30 CEST
Chapter/Local Networking Group Meet and Greets
Location: Foyer 1
10:00 – 10:30 CEST
Coffee Break - Exhibits, Presenters at Posters
10:00 – 10:30 CEST
Coffee Break - Exhibits, Presenters at Posters
Location: Foyer ground floor & 1st floor
10:00 – 10:30 CEST
Presenters at Posters
10:00 – 10:30 CEST
Presenters at Posters
Location: Foyer - 1st floor
10:00 – 10:30 CEST
Refreshment Break in Exhibit Area
10:00 – 10:30 CEST
Refreshment Break in Exhibit AreaLocation: Foyer ground floor & 1st floor
10:30 – 11:30 CEST
Clinical Evaluation: Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Complaint CER
10:30 – 11:30 CEST
Clinical Evaluation: Measurable Outcome Parameters: Much More Than a Requirement for an MDR-Complaint CERLocation: Pearl 2Moderator: – Qserve Group
Presenter: – Qserve Group
Presenter: – GymnaUniphy
Presenter: – Qserve Group
Medical Devices
Domain: Scientific & Health Concepts
Knowledge Area: Application of Scientific & Clinical Advances
Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group ### 535440###Moderator###CSO###Qserve Group###Moderator: – Qserve Group
### @@@ María Cámara Torres, PhD – Qserve Group ### 1827168###Presenter###Consultant - Medical Writer###Qserve Group###Presenter: – Qserve Group
### @@@ Lise Op de Beeck (she/her/hers) – GymnaUniphy ### 1942154###Presenter###Clinical manager###GymnaUniphy###Presenter: – GymnaUniphy
### she/her/hers @@@ Jorn van Binsbergen, MSc (he/him/his) – Qserve Group ### 1944258###Presenter###Consultant / Clinical writer###Qserve Group###Presenter: – Qserve Group
### he/him/his
10:30 – 11:30 CEST
IMDRF- latest developments and future perspectives
10:30 – 11:30 CEST
IMDRF- latest developments and future perspectives Location: Carmine & CharcoalModerator & Presenter: – Abbott
IVDR
Domain: Regulatory Frameworks & Strategy
Knowledge Area: General
Philippe M. Auclair, Mr – Abbott ### 535445###Moderator & Presenter###Senior Director RA strategy###Abbott###Moderator & Presenter: – Abbott
###
10:30 – 11:30 CEST
Traceability of devices; the administrative burden or a smart set-up for legal manufacturers?
10:30 – 11:30 CEST
Traceability of devices; the administrative burden or a smart set-up for legal manufacturers?Location: Pearl 3Moderator: – Ypsomed
Presenter: – Qserve Group
Presenter: – atrify
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Documentation
Susana de Azevedo Wäsch – Ypsomed ### 1141752###Moderator###VP Quality Management & Regulatory Affairs & Medical Affairs###Ypsomed###Moderator: – Ypsomed
### @@@ Daniëlle Motta, MSc. – Qserve Group ### 1649497###Presenter###Head of Global Registrations and Consultant###Qserve Group###Presenter: – Qserve Group
### @@@ Lionel Tussau – atrify ### 1968901###Presenter###Market Unit Healthcare - Global lead###atrify###Presenter: – atrify
###
10:30 – 11:30 CEST
Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 2)
10:30 – 11:30 CEST
Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe?(Part 2 )Location: Pearl 1Moderator & Presenter: – Sanofi
Presenter: – European Medicines Agency
Presenter: – European Patients' Forum
Presenter: – European Commission
Pharmaceuticals
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Regulatory Strategy Development
Rebecca Lumsden, PhD – Sanofi ### 1827170###Moderator & Presenter###Head of Regulatory Science & Policy EU/AMEE###Sanofi###Moderator & Presenter: – Sanofi
### @@@ Francesca A. Day, PhD (she/her/hers) – European Medicines Agency ### 1922319###Presenter###Head of Therapeutics Area Department###European Medicines Agency###Presenter: – European Medicines Agency
### she/her/hers @@@ Julie Spony, MA – European Patients' Forum ### 1948628###Presenter###Policy Officer###European Patients' Forum###Presenter: – European Patients' Forum
### @@@ Fabio Datri, PhD – European Commission ### 1980693###Presenter###Policy Officer, Unit B5 Directorate General for Health and Food Safety###European Commission###Presenter: – European Commission
### 11:45 – 12:45 CEST
Clinical assessment: how to minimize the questions from your Notified Body
11:45 – 12:45 CEST
Clinical assessment: how to minimize the questions from your Notified BodyLocation: Pearl 2Moderator: – Qserve Group
Presenter: – BSI
Presenter: – DNV Product Assurance AS
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Documentation
Giovanni Di Rienzo – Qserve Group ### 907127###Moderator###Principal Consultant###Qserve Group###Moderator: – Qserve Group
### @@@ Sheila Walsh – BSI ### 1828321###Presenter###Clinical Regulatory Lead###BSI###Presenter: – BSI
### @@@ Alexey Shiryaev, MD PhD – DNV Product Assurance AS ### 1645653###Presenter###Global Head of Clinical and Regulatory Affairs###DNV Product Assurance AS###Presenter: – DNV Product Assurance AS
###
11:45 – 12:45 CEST
Making full use of early access and regultatory tools available to ATMPs
11:45 – 12:45 CEST
Making full use of early access and regultatory tools available to ATMPsLocation: Carmine & CharcoalModerator: – Sartorius Stedim Biotech GmbH
Presenter: – Neurogene
Presenter: – European Medicines Agency
Pharmaceuticals
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Process & Procedures
Jennifer Neff, PhD – Sartorius Stedim Biotech GmbH ### 958555###Moderator###Head of Regulatory Affairs###Sartorius Stedim Biotech GmbH###Moderator: – Sartorius Stedim Biotech GmbH
### @@@ Paulette Robinson, Ph.D, RAC – Neurogene ### 1827164###Presenter###Director of Regulatory Affairs###Neurogene###Presenter: – Neurogene
### @@@ Caroline Pothet (she/her/hers) – European Medicines Agency ### 1942126###Presenter###Head of Advanced Therapies - Human Medicines Division###European Medicines Agency###Presenter: – European Medicines Agency
### she/her/hers
11:45 – 12:45 CEST
Recent developments in UK regulations for IVDs: implications for EU manufacturers.
11:45 – 12:45 CEST
Recent developments in UK regulations for IVDs: implications for EU manufacturers.Location: Pearl 3Moderator: – BSI
Presenter: – Abbott
Presenter: – Namsa
IVD
Domain: Scientific & Health Concepts
Knowledge Area: General
Alex Laan, Dipl.-Ing. – BSI ### 1141533###Moderator###Head of IVD Notified Body - Regulatory Services###BSI###Moderator: – BSI
### @@@ Philippe M. Auclair, Mr – Abbott ### 535445###Presenter###Senior Director RA strategy###Abbott###Presenter: – Abbott
### @@@ Christèle East, PhD (she/her/hers) – Namsa ### 1828312###Presenter###Senior Regulatory Consultant, IVD###Namsa###Presenter: – Namsa
### she/her/hers
11:45 – 12:45 CEST
Using TPLC and GMLP as Your Lighthouse, When Sailing Blind Among AI Icebergs
11:45 – 12:45 CEST
Using TPLC and GMLP as Your Lighthouse, When Sailing Blind Among AI IcebergsLocation: Pearl 1Moderator & Presenter: – BioSciPons
Moderator & Presenter: – Philips
Medical Devices
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Process & Procedures
Catarina Carrão – BioSciPons ### 1828303###Moderator & Presenter###CEO###BioSciPons###Moderator & Presenter: – BioSciPons
### @@@ Koen Cobbaert (he/him/his) – Philips ### 943170###Moderator & Presenter###Senior Manager - Quality, Standards & Regulations###Philips###Moderator & Presenter: – Philips
### he/him/his
12:45 – 13:45 CEST
Chapter/Local Networking Group Meet and Greets
12:45 – 13:45 CEST
Chapter/Local Networking Group Meet and Greets
Location: Foyer 1
12:45 – 13:45 CEST
Lunch, Exhibits, Posters
12:45 – 13:45 CEST
Lunch, Exhibits, PostersLocation: Foyer ground floor & 1st floor
13:00 – 13:30 CEST
Impact of CER on PMCF and Clinical Investigation
13:00 – 13:30 CEST
Sponsored Presentation: Impact of CER on PMCF and Clinical InvestigationLocation: Pearl 2Presenter: – Labquality Oy
Sponsor Presentation
Kirsten Sander – Labquality Oy ### 1949773###Presenter###Clinical Research Manager (Scientific/Medical Writing)###Labquality Oy###Presenter: – Labquality Oy
###
13:00 – 13:30 CEST
Sponsored Presentation: Cybersecurity - New FDA Requirements for Market Applications Effective Now!
13:00 – 13:30 CEST
Sponsored Presentation: Cybersecurity - New FDA Requirements for Market Applications Effective Now!Location: Carmine & CharcoalSponsor Presentation
Kimberly A. Trautman, MS – MEDIcept ### 1945643###Presenter###Managing Director and Vice President###MEDIcept###Presenter: – MEDIcept
### 13:00 – 13:30 CEST
Sponsored Presentation: EU MDR: how attractive is Europe for innovation?
13:00 – 13:30 CEST
Sponsored Presentation: EU MDR: how attractive is Europe for innovation?Location: Pearl 1Sponsor Presentation
Enrico Perfler – 1MED ### 1949772###Presenter###CEO###1MED###Presenter: – 1MED
###
13:00 – 13:30 CEST
Sponsored Presentation: Getting Started With FDA eSTAR Submissions: Common Pitfalls and Suggestions
13:00 – 13:30 CEST
Sponsored Presentation: Getting Started With FDA eSTAR Submissions: Common Pitfalls and SuggestionsLocation: Pearl 3Presenter: – Fang Consulting Ltd
Sponsor Presentation
Isaac Erickson – Fang Consulting Ltd ### 1949774###Presenter###Sr. Regulatory Affairs Consultant###Fang Consulting Ltd###Presenter: – Fang Consulting Ltd
### 13:00 – 13:30 CEST
Sponsored Presentation: Regulatory Strategies for EU Orphan Drug Development
13:00 – 13:30 CEST
Sponsored Presentation: Regulatory Strategies for EU Orphan Drug DevelopmentLocation: Coral & CyanSponsor Presentation
Ivan Tommasini – Parexel ### 1956997###Presenter###Senior Director, Regulatory Strategy Consulting###Parexel###Presenter: – Parexel
###
13:45 – 14:45 CEST
AI/machine learning based-medical software: case studies on model development and regulatory compliance
13:45 – 14:45 CEST
AI/machine learning based-medical software: case studies on model development and regulatory complianceLocation: Pearl 1Moderator: – Philips
Presenter: – Siemens Healthineers
Presenter: – confinis AG
Presenter: – confinis ag
Medical Devices
Domain: Product Development & Registration
Knowledge Area: Market Strategy
Leo Louis, RAC, PMP – Philips ### 1312131###Moderator###Regulatory Affairs Director###Philips###Moderator: – Philips
### @@@ abhineet johri, MCA – Siemens Healthineers ### 1828304###Presenter###Regulatory Affairs Professional ###Siemens Healthineers###Presenter: – Siemens Healthineers
### @@@ Martina Coscia, PhD – confinis AG ### 1828322###Presenter###Head of Innovative Technologies and Clinical Affairs###confinis AG###Presenter: – confinis AG
### @@@ Beat Steffen, MSc, FRAPS – confinis ag ### 716683###Presenter###Founder, Chairman of the Board of Directors & CEO###confinis ag###Presenter: – confinis ag
###
13:45 – 14:45 CEST
CDx or Not CDx, That is The Question - The Impact of the Clinical Trial Regulation on Tests Used in Pharma Studies and Whether and How the IVDR Applies
13:45 – 14:45 CEST
CDx or Not CDx, That is The Question - The Impact of the Clinical Trial Regulation on Tests Used in Pharma Studies and Whether and How the IVDR AppliesLocation: Pearl 3Moderator & Presenter: – Qserve group
Presenter: – Guardant Health
Presenter: – AstraZeneca
IVD
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Regulatory Strategy Development
Sue Spencer – Qserve group ### 1187575###Moderator & Presenter###IVD Lead/ Principal Consultant###Qserve group###Moderator & Presenter: – Qserve group
### @@@ Ed Godber, n/a – Guardant Health ### 1828298###Presenter###Vice President Strategic Partnerships###Guardant Health###Presenter: – Guardant Health
### @@@ Patrick Fivey (he/him/his) – AstraZeneca ### 1828300###Presenter###Director of Precision Medicine Policy###AstraZeneca###Presenter: – AstraZeneca
### he/him/his
13:45 – 14:45 CEST
Designing Training for an Evolving Regulatory Environment
13:45 – 14:45 CEST
Designing Training for an Evolving Regulatory EnvironmentLocation: Carmine & CharcoalPresenter: – Medtronic
Presenter: – Medtronic
Regulatory Business
Domain: Post Approval/Post Market
Knowledge Area: Change Management
Sandra Wheeler, MA Technical Communication – Medtronic ### 1827171###Presenter###Principal Training & Development Specialist###Medtronic###Presenter: – Medtronic
### @@@ Pamela Campo, MS Regulatory Science – Medtronic ### 1827172###Presenter###Principal Regulatory Affairs Specialist###Medtronic###Presenter: – Medtronic
###
13:45 – 14:45 CEST
MDR Art. 117 for Combination Products After 2 years. Still the same? State of Play from EMA, NB and Industry
13:45 – 14:45 CEST
MDR Art. 117 for Combination Products After 2 years. Still the same? State of Play from EMA, NB and IndustryLocation: Pearl 2Moderator: – Benefits Regulatory Consulting
Presenter: – Ypsomed AG
Presenter: – anteris medical GmbH
Presenter: – EMA
Presenter: – BSI Group
Pharmaceuticals
Domain: Product Development & Registration
Knowledge Area: Regulatory Guidance
Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting ### 573538###Moderator###Consultant###Benefits Regulatory Consulting###Moderator: – Benefits Regulatory Consulting
### @@@ Stephan Affolter – Ypsomed AG ### 907117###Presenter###Director Regulatory + Quality Intelligence###Ypsomed AG###Presenter: – Ypsomed AG
### @@@ Christiana Hofmann, PHD (she/her/hers) – anteris medical GmbH ### 1864620###Presenter###Executive Consultant & Business Development###anteris medical GmbH###Presenter: – anteris medical GmbH
### she/her/hers @@@ Christelle Bouygues, PharmD (she/her/hers) – EMA ### 1318405###Presenter###Regulatory Affairs Senior Officer###EMA###Presenter: – EMA
### she/her/hers @@@ Theresa Jeary, BSc (Hons), MSc – BSI Group ### 535537###Presenter###Principal Technical Specialist ###BSI Group###Presenter: – BSI Group
###
15:00 – 16:00 CEST
IVDR – what are the implications for in-house in vitro devices for stakeholders and practical steps for implementation
15:00 – 16:00 CEST
IVDR – what are the implications for in-house in vitro devices for stakeholders and practical steps for implementation Location: Carmine & CharcoalModerator & Presenter: – Prof
Presenter: – Pharmalex Nordics
IVD
Domain: Regulatory Frameworks & Strategy
Knowledge Area: General
Elisabeth Dequeker, n/a – Prof ### 1828308###Moderator & Presenter###Full Professor, Head of Quality Assurance and Regulatory Affairs Officer###Prof###Moderator & Presenter: – Prof
### @@@ Tiina Riihimäki, PhD (she/her/hers) – Pharmalex Nordics ### 1930216###Presenter###Director /
Head of Medical Devices and IVDs, Nordics###Pharmalex Nordics###Presenter: – Pharmalex Nordics
### she/her/hers
15:00 – 16:00 CEST
Medical device regulation in international perspective: EU IMDRF Chair in 2023
15:00 – 16:00 CEST
Medical Device Regulation in International Perspective: EU IMDRF Chair in 2023Location: Pearl 3Moderator: – TÜV SÜD Medical Health Services
Presenter: – Qserve Group
Presenter: – European Commission
Presenter: – Dutch Health and Youth Care Inspectorate
Medical Devices
Domain: Business Acumen
Knowledge Area: Industry-specific Knowledge
Sabina L. Hoekstra -van den Bosch, PharmD FRAPS – TÜV SÜD Medical Health Services ### 574720###Moderator###Global Director Regulatory Strategy###TÜV SÜD Medical Health Services###Moderator: – TÜV SÜD Medical Health Services
### @@@ Gert W. Bos, FRAPS, MSc, PhD, FRAPS – Qserve Group ### 535440###Presenter###CSO###Qserve Group###Presenter: – Qserve Group
### @@@ Flora Giorgio (she/her/hers) – European Commission ### 1930380###Presenter###Acting Head of Unit###European Commission###Presenter: – European Commission
### she/her/hers @@@ Sietske Eerens – Dutch Health and Youth Care Inspectorate ### 1981929###Presenter###Senior Inspector###Dutch Health and Youth Care Inspectorate###Presenter: – Dutch Health and Youth Care Inspectorate
###
15:00 – 16:00 CEST
Regulatory Policies and Guidelines – Are These Enabling Timely Development of Orphan Medicines Globally?
15:00 – 16:00 CEST
Regulatory policies and guidelines – are these enabling timely development of Orphan medicines globally? Location: Pearl 1Moderator & Presenter: – CIRS
Presenter: – Ipsen Innovation
Presenter: – European Medicines Agency
Pharmaceuticals
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Process & Procedures
Magdalena Bujar, BSc, MSc, PhD – CIRS ### 1523611###Moderator & Presenter###Senior Manager###CIRS###Moderator & Presenter: – CIRS
### @@@ Martine Zimmermann, PharmD – Ipsen Innovation ### 1452236###Presenter######Ipsen Innovation###Presenter: – Ipsen Innovation
### @@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Presenter###Head of Orphan Drugs###European Medicines Agency###Presenter: – European Medicines Agency
###
15:00 – 16:00 CEST
Responsibilities and Liabilities in an Interconnected World
15:00 – 16:00 CEST
Responsibilities and Liabilities in an Interconnected WorldLocation: Pearl 2Moderator: – Ypsomed
Presenter: – Philips
Presenter: – Axon Lawyers
Presenter: – Complear
Medical Devices
Susana de Azevedo Wäsch – Ypsomed ### 1141752###Moderator###VP Quality Management & Regulatory Affairs & Medical Affairs###Ypsomed###Moderator: – Ypsomed
### @@@ Koen Cobbaert (he/him/his) – Philips ### 943170###Presenter###Senior Manager - Quality, Standards & Regulations###Philips###Presenter: – Philips
### he/him/his @@@ Erik R. Vollebregt – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: – Axon Lawyers
### @@@ Celia Cruz, PhD (she/her/hers) – Complear ### 1949771###Presenter###Head of Regulatory Affairs###Complear###Presenter: – Complear
### she/her/hers
16:00 – 16:45 CEST
Chapter/Local Networking Group Meet and Greets
16:00 – 16:45 CEST
Chapter/Local Networking Group Meet and Greets
Location: Foyer 1
16:00 – 16:45 CEST
Presenters at Posters
16:00 – 16:45 CEST
Presenters at Posters
Location: Level 1
16:00 – 16:45 CEST
Coffee Break - Exhibits, Presenters at Posters
Location: Foyer ground floor & 1st floor
16:00 – 16:45 CEST
Refreshment Break in Exhibit Area
16:00 – 16:45 CEST
Refreshment Break in Exhibit AreaLocation: Foyer ground floor & 1st floor
16:05 – 16:35 CEST
Sponsored Presentation: Economic Operators: Role of the Importer
16:05 – 16:35 CEST
Sponsored Presentation: Economic Operators: Role of the ImporterLocation: Pearl 1Presenter: – MedEnvoy Global BV
Sponsor Presentation
Edgar Kasteel – MedEnvoy Global BV ### 1949778###Presenter###CEO & Partner###MedEnvoy Global BV###Presenter: – MedEnvoy Global BV
###
16:05 – 16:35 CEST
Sponsored Presentation: Is the EU MDR extension a blessing or a curse?
16:05 – 16:35 CEST
Sponsored Presentation: Is the EU MDR extension a blessing or a curse? Location: Carmine & CharcoalSponsor Presentation
Joseph-Richardson Larbi, MSc – Celegence ### 1444029###Presenter###Medical Device Expert###Celegence###Presenter: – Celegence
###
16:05 – 16:35 CEST
Sponsored Presentation: MDR & IVDR lessons for regulatory strategy
16:05 – 16:35 CEST
Sponsored Presentation: MDR & IVDR lessons for regulatory strategyLocation: Pearl 3Sponsor Presentation
James Gianoutsos, MBA – Rimsys ### 1328412###Presenter###Founder & CEO###Rimsys###Presenter: – Rimsys
###
16:45 – 17:45 CEST
Conformity Assessment of Class D Devices: What is the Current Status?
16:45 – 17:45 CEST
Conformity Assessment of Class D Devices: What is the Current Status?Location: Pearl 2Moderator: – Qarad
Presenter: – TUV Sud GmbH
Presenter: – GMED Certification Division
Presenter: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
Presenter: – University of Leuven
Presenter: – QuidelOrtho
Presenter: – Roche Diagnostics GmbH
Presenter: – Paul-Ehrlich-Institut
IVD
Domain: Product Development & Registration
Knowledge Area: Process & Procedures
Maurizio Suppo, Dr. – Qarad ### 1000097###Moderator###Principal Consultant###Qarad###Moderator: – Qarad
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD at TuV Sud###TUV Sud GmbH###Presenter: – TUV Sud GmbH
### @@@ Catherine Holzmann – GMED Certification Division ### 1828311###Presenter###IVDMD Department Manager###GMED Certification Division###Presenter: – GMED Certification Division
### @@@ Olga TKACHENKO, PhD (she/her/hers) – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6 ### 1828315###Presenter###Policy Officer###European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6###Presenter: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
### she/her/hers @@@ Elisabeth PhD Dequeker, PhD – University of Leuven ### 1254350###Presenter###Head of Quality Assurance and Regulatory Affairs Officer for Medical Diagnostics###University of Leuven###Presenter: – University of Leuven
### @@@ Richard J. Saunders, FIBMS – QuidelOrtho ### 1828316###Presenter###Technical Director, Regulatory Affairs###QuidelOrtho###Presenter: – QuidelOrtho
### @@@ Stefan Scheib, PhD (he/him/his) – Roche Diagnostics GmbH ### 1836161###Presenter###Global Head of Regulatory Affairs, CoreLab###Roche Diagnostics GmbH###Presenter: – Roche Diagnostics GmbH
### he/him/his @@@ Heinrich Scheiblauer, Dr – Paul-Ehrlich-Institut ### 1891462###Presenter###Head of the Testing Laboratory for in vitro diagnotic medical devices###Paul-Ehrlich-Institut###Presenter: – Paul-Ehrlich-Institut
###
16:45 – 17:45 CEST
EU Regulatory CMC Strategies and Challenges
16:45 – 17:45 CEST
EU Regulatory CMC Strategies and ChallengesLocation: Carmine & CharcoalModerator & Presenter: – Parexel
Presenter: – argenx
Presenter: – European Medicines Agency
Pharmaceuticals
Domain: Business Acumen
Knowledge Area: Industry-specific Knowledge
Michael Craig, BSc Pharm MPSI – Parexel ### 535462###Moderator & Presenter###Vice President (Technical)###Parexel###Moderator & Presenter: – Parexel
### @@@ Neha Parashar, PMP – argenx ### 1827161###Presenter###Principal Scientist / Associate Director###argenx###Presenter: – argenx
### @@@ Veronika Jekerle, PhD – European Medicines Agency ### 1940209###Presenter###Head of Pharmaceutical Quality###European Medicines Agency###Presenter: – European Medicines Agency
###
16:45 – 17:45 CEST
Expert Advisory Panel - What Have we Learned?
16:45 – 17:45 CEST
Expert Advisory Panel - What Have we Learned?Location: Pearl 1Presenter: – BSI
Presenter: – European Medicines Agency
Presenter: – BD
Medical Devices
Domain: Product Development & Registration
Knowledge Area: General
Richard Holborow (he/him/his) – BSI ### 1523592###Presenter###Global Head of Clinical Compliance###BSI###Presenter: – BSI
### he/him/his @@@ Silvy Da Rocha Dias – European Medicines Agency ### 1922318###Presenter######European Medicines Agency###Presenter: – European Medicines Agency
### @@@ Rohan Shah, BS (he/him/his) – BD ### 1941778###Presenter###Senior Manager, Regulatory Affairs###BD###Presenter: – BD
### he/him/his
16:45 – 17:45 CEST
Regulation Changes: Incentives for Pediatric Medical Devices in the US and Japan. Implications for the EU.
16:45 – 17:45 CEST
Regulation Changes: Incentives for Pediatric Medical Devices in the US and Japan. Implications for the EU.Location: Pearl 3Presenter: – Olympus Surgical Technologies Europe
Medical Devices
Domain: Regulatory Frameworks & Strategy
Knowledge Area: Market Strategy
Stephanie Huebner, MSc, PhD – Olympus Surgical Technologies Europe ### 1827158###Presenter###Manager Third Party (OEM) Therapeutic Solutions Division, Regulatory Affairs###Olympus Surgical Technologies Europe###Presenter: – Olympus Surgical Technologies Europe
###
18:30 – 21:00 CEST
Networking Dinner – Kanarie Club
18:30 – 21:00 CEST
Networking Dinner – Kanarie Club