- Monday, May 6, 2024
07:30 – 18:00 CEST
Cloakroom
07:30 – 18:00 CEST
Cloakroom (A level)
Location: A 08
07:30 – 18:00 CEST
Registration Hours
07:30 – 18:00 CEST
Registration (A Level)
Location: A level
08:30 – 16:00 CEST
Pre -Conference Workshop: EUDAMED
08:30 – 16:00 CEST
Pre-Conference Workshop: EUDAMEDLocation: B 07 + B 08Workshop Leader: – BSI
Presenter: – Schrack & Partner
Presenter: – BSI
Presenter: – Johnson & Johnson MedTech
Medical Devices
Jayanth K. Katta, PhD – BSI ### 907116###Workshop Leader###Regulatory Director & Head of Medical Devices Notified Body###BSI###Workshop Leader: – BSI
### @@@ Christoph Kiesselbach (he/him/his) – Schrack & Partner ### 2177850###Presenter###Partner###Schrack & Partner###Presenter: – Schrack & Partner
### he/him/his @@@ Sally Humphreys, DPhil – BSI ### 2177835###Presenter###Clinical Compliance Manager###BSI###Presenter: – BSI
### @@@ Marina Madokoro (she/her/hers) – Johnson & Johnson MedTech ### 2237202###Presenter###UDI regulatory affairs manager ###Johnson & Johnson MedTech###Presenter: – Johnson & Johnson MedTech
### she/her/hers08:30 – 16:00 CEST
Pre-Conference Workshop: Artificial Intelligence knocking on your door? The upcoming Artificial Intelligence Regulation’s Technical Documentation Requirements and how to integrate them into an MDR Submission
08:30 – 16:00 CEST
Pre-Conference Workshop: Artificial Intelligence Knocking on Your Door? The Upcoming Artificial Intelligence Regulation’s Technical Documentation Requirements and How to Integrate Them Into an MDR SubmissionLocation: B 05 + B 06Session Leader/Speaker: – BSI
Presenter: – TÜV SÜD
Presenter: – BSI
AI/Software
Sarah Mathew – BSI ### 2177832###Session Leader/Speaker###Regulatory Lead###BSI###Session Leader/Speaker: – BSI
### @@@ Marco Caproni (he/him/his) – TÜV SÜD ### 2232812###Presenter###Senior Product Specialist, Software###TÜV SÜD###Presenter: – TÜV SÜD
### he/him/his @@@ Daniela Seneca – BSI ### 2232813###Presenter###Regulatory Lead###BSI###Presenter: – BSI
### 08:30 – 16:00 CEST
Pre-Conference Workshop: Global Regulatory CMC Approaches for Biologicals: From Strategy to Execution
08:30 – 16:00 CEST
Pre-Conference Workshop: Global Regulatory CMC Approaches for Biologicals: From Strategy to ExecutionLocation: A 04Workshop Leader: – Argenx
Presenter: – BioNTech SE
Pharmaceuticals
Neha Parashar, PMP® and PRINCE2® – Argenx ### 1827161###Workshop Leader###Associate Director/Principal Scientist###Argenx###Workshop Leader: – Argenx
### @@@ Ankit Geete, RAC, PMP, CDMP, CBIP – BioNTech SE ### 1944257###Presenter###Director###BioNTech SE###Presenter: – BioNTech SE
### 08:30 – 16:00 CEST
Pre-Conference Workshop: IVDR Technical Documentation
08:30 – 16:00 CEST
Pre-Conference Workshop: IVDR Technical Documentation Location: B 09Workshop Leader: – TUV Sud GmbH
Presenter: – GMED
Presenter: – BSI
Presenter: – NBCG-Med - Notified Body Coordination Group
IVDs
Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Workshop Leader###Head of Certification IVD###TUV Sud GmbH###Workshop Leader: – TUV Sud GmbH
### @@@ Catherine Holzmann, PhD – GMED ### 1828311###Presenter###IVD Department Manager###GMED###Presenter: – GMED
### @@@ Alex Laan (he/him/his) – BSI ### 1945990###Presenter###Head of IVD Notified Body###BSI###Presenter: – BSI
### he/him/his @@@ Tom Patten, MSc – NBCG-Med - Notified Body Coordination Group ### 1141749###Presenter###Executive Committee -Secretary ###NBCG-Med - Notified Body Coordination Group###Presenter: – NBCG-Med - Notified Body Coordination Group
### 08:30 – 16:00 CEST
Pre-Conference Workshop: Start-Ups: Effective Use of the Money of Your Investors - Know What to Aim For
08:30 – 16:00 CEST
Pre-Conference Workshop: Start-Ups: Effective Use of the Money of Your Investors - Know What to Aim ForLocation: A 05Session Leader: – Entourage GmbH
Presenter: – Medical Device Project B.V.
Presenter: – European Medicines Agency
Presenter: – European Medicines Agency
Presenter: – self employed
Presenter: – Qserve
Presenter:
Presenter: – PharmaLex
Presenter:
Presenter:
Presenter:
Presenter: – ekwithree GmbH
Regulatory Business
Jennifer Neff, PhD – Entourage GmbH ### 958555###Session Leader###Principal Consultant & Head of Medical Devices###Entourage GmbH###Session Leader: – Entourage GmbH
### @@@ Robert A. van Boxtel, MSc – Medical Device Project B.V. ### 907078###Presenter###Principal Consultant###Medical Device Project B.V.###Presenter: – Medical Device Project B.V.
### @@@ Alberto Ganan, PhD – European Medicines Agency ### 2262977###Presenter###Head of Committees and Quality Assurance Department###European Medicines Agency###Presenter: – European Medicines Agency
### @@@ Constantinos Ziogas, MD (he/him/his) – European Medicines Agency ### 2271494###Presenter###Head of SME Office###European Medicines Agency###Presenter: – European Medicines Agency
### he/him/his @@@ Pascal Werner, MSc – self employed ### 2177863###Presenter###Regulatory Affairs consultant###self employed###Presenter: – self employed
### @@@ Robert Paassen, MSc (he/him/his) – Qserve ### 2177852###Presenter###Consultant###Qserve###Presenter: – Qserve
### he/him/his @@@ Yamin Wang ### 2278109###Presenter#########Presenter:
### @@@ Patrick Larcier, PharmD – PharmaLex ### 1718947###Presenter###Senior Director, Strategy Product Development Solutions###PharmaLex###Presenter: – PharmaLex
### @@@ Golo Von Basum ### 2278790###Presenter#########Presenter:
### @@@ Andreas Jordan ### 2278791###Presenter#########Presenter:
### @@@ Tim Schnieder ### 2278793###Presenter#########Presenter:
### @@@ Thomas Dobmeyer, Dr (he/him/his) – ekwithree GmbH ### 2281145###Presenter###Advisor###ekwithree GmbH###Presenter: – ekwithree GmbH
### he/him/his08:30 – 16:00 CEST
Pre-Conference Workshop: What does it take from CE to MDSAP?
08:30 – 16:00 CEST
Pre-Conference Workshop: What Does it Take From CE to MDSAP?Location: A 03Workshop Leader: – nexialist
Presenter: – nexialist
Presenter: – DQS Medizinprodukte GmbH
Presenter: – TÜV NORD CERT
Medical Devices
Corinne Delorme, RAC – nexialist ### 1523467###Workshop Leader###Regulatory Intelligence Director###nexialist###Workshop Leader: – nexialist
### @@@ Vincent Castéras, PhD – nexialist ### 1543942###Presenter###CEO and Founder###nexialist###Presenter: – nexialist
### @@@ Szymon Kurdyn – DQS Medizinprodukte GmbH ### 1550651###Presenter###Head of Notified Body (non-active medical devices)###DQS Medizinprodukte GmbH###Presenter: – DQS Medizinprodukte GmbH
### @@@ Maxim Shkolnikov (he/him/his) – TÜV NORD CERT ### 2227006###Presenter###Technical Manager, Medical Device International###TÜV NORD CERT###Presenter: – TÜV NORD CERT
### he/him/his13:00 – 17:00 CEST
Speaker Ready Room Open (B04)
13:00 – 17:00 CEST
Speaker Ready Room Open (B04)
Location: B 04
14:00 – 16:00 CEST
Career Development for Students
14:00 – 16:00 CEST
Career Development for StudentsLocation: A 06Presenter: – RAPS
Presenter: – Elemed
Presenter: – Regulatory Affairs Professionals Society
Presenter: – International Pharmaceutical Quality (IPQ) Publications (formerly MHRA)
Kim Young – RAPS ### 1974523###Presenter###Regional Engagement Director###RAPS###Presenter: – RAPS
### @@@ Parminder Kalle, BSc (Hons), Dip Prof Skills – Elemed ### 2313223###Presenter###Senior Director, Strategic Solutions###Elemed###Presenter: – Elemed
### @@@ Renee Matthews – Regulatory Affairs Professionals Society ### 1768455###Presenter###Senior Editor, Features###Regulatory Affairs Professionals Society###Presenter: – Regulatory Affairs Professionals Society
### @@@ Janine Jamieson – International Pharmaceutical Quality (IPQ) Publications (formerly MHRA) ### 1327844###Presenter###European Editor###International Pharmaceutical Quality (IPQ) Publications (formerly MHRA)###Presenter: – International Pharmaceutical Quality (IPQ) Publications (formerly MHRA)
### 16:30 – 18:30 CEST
Euro Convergence 2024 Welcome & Opening Plenary : Regulatory Affairs: Science or Art?
16:30 – 18:30 CEST
Euro Convergence 2024 Welcome and Opening Plenary: Regulatory Affairs: Science or Art?Location: C 01Moderator: – TÜV SÜD Medical Health Service
Moderator: – QServe Group B.V.
Panelist: – MED-EL
Panelist: – European Commission
Panelist: – TÜV NORD CERT GmbH
Panelist: – European Medicines Agency
Panelist: – International Porphyria Patient Network (IPPN)
Panelist: – Abbott
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
### @@@ Gert W. Bos, Chairman of the Board and former president RAPS – QServe Group B.V. ### 535440###Moderator###Executive Director & Partner###QServe Group B.V.###Moderator: – QServe Group B.V.
### @@@ Elizabeth Gfoeller, MA – MED-EL ### 766093###Panelist###Corporate Director, Regulatory Affairs ###MED-EL###Panelist: – MED-EL
### @@@ Flora Giorgio (she/her/hers) – European Commission ### 1930380###Panelist###Head of Unit###European Commission###Panelist: – European Commission
### she/her/hers @@@ Bodo Mestmacher – TÜV NORD CERT GmbH ### 2278108###Panelist###TIC Manager MDR###TÜV NORD CERT GmbH###Panelist: – TÜV NORD CERT GmbH
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Panelist###Principal Scientific Administrator###European Medicines Agency###Panelist: – European Medicines Agency
### @@@ Jasmin Barman-Aksözen, PhD – International Porphyria Patient Network (IPPN) ### 2177818###Panelist###Patient Advocate###International Porphyria Patient Network (IPPN)###Panelist: – International Porphyria Patient Network (IPPN)
### @@@ João Martins – Abbott ### 2290124###Panelist###Associate Director of Regulatory Strategy###Abbott###Panelist: – Abbott
### 18:30 – 19:30 CEST
Opening Reception in Exhibit Hall
18:30 – 19:30 CEST
Opening Reception in Exhibit HallLocation: All levels
- Tuesday, May 7, 2024
07:30 – 18:00 CEST
Registration Hours
07:30 – 18:00 CEST
Registration (A Level)
Location: A level
07:30 – 18:00 CEST
Speaker Ready Room Open (B04)
07:30 – 18:00 CEST
Speaker Ready Room Open (B04)
Location: B 04
08:30 – 09:30 CEST
Biocompatibility: ‘Substances of concern’ – Have you checked? GSPR 10.4 a practical guide
08:30 – 09:30 CEST
Biocompatibility: Substances of Concern – Have You Checked? GSPR 10.4 a Practical GuideLocation: A 03 + A 04Moderator: – RAPS Germany
Presenter: – NAMSA
Presenter: – Fresenius Kabi Deutschland GmbH
Presenter: – TÜV SÜD Medical & Health Services
Medical Devices
Barbara Leukers, RAC (she/her/hers) – RAPS Germany ### 1406560###Moderator###Board Member###RAPS Germany###Moderator: – RAPS Germany
### she/her/hers @@@ David John Mandley, PhD (he/him/his) – NAMSA ### 2016359###Presenter###Principal Regulatory Consultant###NAMSA###Presenter: – NAMSA
### he/him/his @@@ Juliane Kuhtz, Dr (she/her/hers) – Fresenius Kabi Deutschland GmbH ### 2199308###Presenter###Manager Regulatory Affairs###Fresenius Kabi Deutschland GmbH###Presenter: – Fresenius Kabi Deutschland GmbH
### she/her/hers @@@ Christina Reufsteck, PhD – TÜV SÜD Medical & Health Services ### 2271414###Presenter###Biocompatibility Expert###TÜV SÜD Medical & Health Services###Presenter: – TÜV SÜD Medical & Health Services
###
08:30 – 09:30 CEST
Development and Registration of Therapeutic Radiopharmaceuticals in the EU - Navigating Opportunities and Challenges
08:30 – 09:30 CEST
Development and Registration of Therapeutic Radiopharmaceuticals in the EU – Navigating Opportunities and ChallengesLocation: A 05 + A 06Pharmaceuticals
Rezaul Karim, PhD, MSc (he/him/his) – Starodub BV ### 2260449###Presenter###Regulatory Affairs Manager###Starodub BV###Presenter: – Starodub BV
### he/him/his
08:30 – 09:30 CEST
Kick-off MDR panel
08:30 – 09:30 CEST
Kick-off MDR PanelLocation: C 01Moderator: – QServe Group B.V.
Moderator: – TÜV SÜD Medical Health Service
Panelist: – CAMD
Panelist: – European Commission
Panelist: – TUV SUD Product Services
Medical Devices
Gert W. Bos, Chairman of the Board and former president RAPS – QServe Group B.V. ### 535440###Moderator###Executive Director & Partner###QServe Group B.V.###Moderator: – QServe Group B.V.
### @@@ 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
### @@@ Thierry Sirdey – CAMD ### 2271046###Panelist###Chair###CAMD ###Panelist: – CAMD
### @@@ Flora Giorgio (she/her/hers) – European Commission ### 1930380###Panelist###Head of Unit###European Commission###Panelist: – European Commission
### she/her/hers @@@ Royth P. von Hahn, PhD – TUV SUD Product Services ### 1027488###Panelist###Senior Vice President of Medical Health Services (global)###TUV SUD Product Services###Panelist: – TUV SUD Product Services
### 08:30 – 09:30 CEST
Patient Access
08:30 – 09:30 CEST
Patient Access: Regulatory, HTA, and Patient Perspectives on an Orphan Drug – Case Study of Erythropoietic ProtoporphyriaLocation: B 07 + B 08Moderator: – Benefits Regulatory Consulting
Presenter: – MBM Future Health, AMNOG Advisory Services
Presenter: – International Porphyria Patient Network (IPPN)
Presenter: – khhconsulting
Panelist: – European Medicines Agency
Pharmaceuticals
Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting ### 573538###Moderator###Consultant###Benefits Regulatory Consulting###Moderator: – Benefits Regulatory Consulting
### @@@ Meriem Bouslouk-Marx, PhD, MSc International Health (she/her/hers) – MBM Future Health, AMNOG Advisory Services ### 2177817###Presenter###German HTA Expert###MBM Future Health, AMNOG Advisory Services###Presenter: – MBM Future Health, AMNOG Advisory Services
### she/her/hers @@@ Jasmin Barman-Aksözen, PhD – International Porphyria Patient Network (IPPN) ### 2177818###Presenter###Patient Advocate###International Porphyria Patient Network (IPPN)###Presenter: – International Porphyria Patient Network (IPPN)
### @@@ Karl-Heinz Huemer (he/him/his) – khhconsulting ### 573393###Presenter###Consultant###khhconsulting###Presenter: – khhconsulting
### he/him/his @@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Panelist###Head of Orphan Drugs###European Medicines Agency###Panelist: – European Medicines Agency
###
08:30 – 09:30 CEST
The EU’s AI Act: Understanding the challenges to AI-enabled Medical Devices conformity assessments .
08:30 – 09:30 CEST
The EU’s AI Act: Understanding the challenges to AI-enabled Medical Devices conformity assessmentsLocation: B 09Presenter: – Siemens Healthineers
Presenter: – Bsi Group The Netherlands
AI/Software
Abhineet Johri – Siemens Healthineers ### 1828304###Presenter###Senior Key expert AI and Regulatory affairs Manager###Siemens Healthineers###Presenter: – Siemens Healthineers
### @@@ Inma Pérez Ruiz (she/her/hers) – Bsi Group The Netherlands ### 2177831###Presenter###Artificial Intelligence Regulatory Lead###Bsi Group The Netherlands###Presenter: – Bsi Group The Netherlands
### she/her/hers
08:30 – 09:30 CEST
The IVDR clock is ticking... but should there be alarm?
08:30 – 09:30 CEST
The IVDR Clock is Ticking... But Should There be Alarm?Location: B 05 + B 06Presenter: – MCRA
Panelist: – BSI
Panelist: – MedTech Europe
Panelist: – TUV Sud GmbH
Panelist: – Federal Ministry of Health Germany
Panelist: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
IVDs
Erica Conway, PhD (she/her/hers) – MCRA ### 1828301###Presenter###Vice President, IVD Regulatory Affairs - Europe###MCRA###Presenter: – MCRA
### she/her/hers @@@ Elizabeth Harrison (she/her/hers) – BSI ### 1401973###Panelist###Global Head, IVD###BSI###Panelist: – BSI
### she/her/hers @@@ Petra Zoellner (she/her/hers) – MedTech Europe ### 1828305###Panelist###Director IVDR-MDR###MedTech Europe###Panelist: – MedTech Europe
### she/her/hers @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Panelist###Head of Certification IVD###TUV Sud GmbH###Panelist: – TUV Sud GmbH
### @@@ Ortwin Schulte – Federal Ministry of Health Germany ### 2261037###Panelist###Head of Unit 124 – Medical Devices Safety###Federal Ministry of Health Germany###Panelist: – Federal Ministry of Health Germany
### @@@ Olga Tkachenko, PhD (she/her/hers) – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6 ### 1828315###Panelist###Policy Officer###European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6###Panelist: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
### she/her/hers
09:45 – 16:45 CEST
Exhibition Open
09:45 – 16:45 CEST
Exhibition Open
Location: Levels A and B
09:50 – 10:50 CEST
Artificial Intelligence in the context of the IVDR – How to keep the revolution under control.
09:50 – 10:50 CEST
Artificial Intelligence in the Context of the IVDR – How to Keep the Revolution Under ControlLocation: C 01Session Leader/Speaker: – TÜV SÜD
Presenter: – Entourage GmbH
AI/Software
Alexander Stock (he/him/his) – TÜV SÜD ### 1827167###Session Leader/Speaker###Project Manager IVD Medical Device Testing###TÜV SÜD###Session Leader/Speaker: – TÜV SÜD
### he/him/his @@@ Sebastian Grömminger (he/him/his) – Entourage GmbH ### 2016365###Presenter###Principal Consultant IVD###Entourage GmbH###Presenter: – Entourage GmbH
### he/him/his
09:50 – 10:50 CEST
Clinical Evaluation
09:50 – 10:50 CEST
Clinical Evaluation: Unifying Clinical Evaluation Requirements: Exploring ISO 18969 and the "New MEDDEV 2.7/1"Location: B 07 + B 08Moderator & Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: – MD-CLINICALS SA
Presenter: – BSI
Presenter: – European Commission - Directorate-General for Health and Food Safety
Medical Devices
Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH ### 2016361###Moderator & Presenter###Managing Director###PRO-LIANCE GLOBAL SOLUTIONS GmbH###Moderator & Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
### @@@ Danielle Giroud, MSci, MBA (she/her/hers) – MD-CLINICALS SA ### 1187621###Presenter###Founder and CEO###MD-CLINICALS SA###Presenter: – MD-CLINICALS SA
### she/her/hers @@@ Rachel Mead, BEng MIET (she/her/hers) – BSI ### 2016362###Presenter###Clinical Regulatory Lead###BSI###Presenter: – BSI
### she/her/hers @@@ Paul Piscoi – European Commission - Directorate-General for Health and Food Safety ### 2063745###Presenter###Policy Officer - Unit D.3: Medical Devices###European Commission - Directorate-General for Health and Food Safety###Presenter: – European Commission - Directorate-General for Health and Food Safety
###
09:50 – 10:50 CEST
Clinical Performance Studies under IVDR
09:50 – 10:50 CEST
Clinical Performance Studies Under IVDRLocation: A 03 + A 04Presenter: – RQM+
Presenter: – Precision for Medicine
IVDs
Margot Borgel, PhD – RQM+ ### 2177857###Presenter###Director, IVD Global Regulatory Affairs###RQM+###Presenter: – RQM+
### @@@ Maham Ansari, MS, RAC – Precision for Medicine ### 1523466###Presenter###Senior Director, IVD Regulatory Affairs###Precision for Medicine###Presenter: – Precision for Medicine
###
09:50 – 10:50 CEST
Emerging Advancements in eCTD: A Panel Discussion on Cloud Integration, Data Standards, and Publishing Perspectives in Regulatory Submissions
09:50 – 10:50 CEST
Emerging Advancements in eCTD: A Panel Discussion on Cloud Integration, Data Standards, and Publishing Perspectives in Regulatory Submissions Location: B 05 + B 06Moderator:
Presenter: – Accumulus Synergy
Presenter: – EXTEDO GmbH
Presenter: – Certara
Pharmaceuticals
Magda Bujar ### 1456630###Moderator#########Moderator:
### @@@ Cesar Vinces – Accumulus Synergy ### 2177849###Presenter###Director, Regulatory Innovation & International Policy Lead###Accumulus Synergy###Presenter: – Accumulus Synergy
### @@@ Frank Dickert (he/him/his) – EXTEDO GmbH ### 1321687###Presenter###Senior Business Consultant###EXTEDO GmbH###Presenter: – EXTEDO GmbH
### he/him/his @@@ Rachel Bombara (she/her/hers) – Certara ### 2177860###Presenter###Regulatory Services Manager###Certara###Presenter: – Certara
### she/her/hers
09:50 – 10:50 CEST
New EU Pharma Legislation
09:50 – 10:50 CEST
New EU Pharma LegislationLocation: A 05 + A 06Presenter: – Sanofi
Presenter: – European Patients' Forum
Presenter: – European Medicines Agency
Presenter: – EFPIA
Presenter: – European Commission
Pharmaceuticals
Rebecca Lumsden, PhD (she/her/hers) – Sanofi ### 1827170###Presenter###Head of Regulatory Science & Policy EU/AMEE###Sanofi###Presenter: – Sanofi
### she/her/hers @@@ Julie Spony, MA – European Patients' Forum ### 1948628###Presenter###Policy Officer###European Patients' Forum###Presenter: – European Patients' Forum
### @@@ Alberto Ganan, PhD – European Medicines Agency ### 2262977###Presenter###Head of Committees and Quality Assurance Department###European Medicines Agency###Presenter: – European Medicines Agency
### @@@ Sini Eskola, M.Sci Pharmacy – EFPIA ### 2293207###Presenter###Director Regulatory Strategy###EFPIA###Presenter: – EFPIA
### @@@ Lilia Luchianov – European Commission ### 2315698###Presenter###Policy officer at DG SANTÉ###European Commission###Presenter: – European Commission
###
09:50 – 10:50 CEST
Regulatory Leadership: Digitization & Digital Health - There is NO turning back!
09:50 – 10:50 CEST
Regulatory Leadership: Digitization and Digital Health – There is NO Turning Back!Location: B 09Session Leader/Speaker: – Boston Scientific
Presenter: – IBEC
Presenter: – Veeva Systems
Presenter: – Boston Scientific
Regulatory Business
Olga Van Grol-Lawlor, MPHIL (she/her/hers) – Boston Scientific ### 1534231###Session Leader/Speaker###Sr. Global Regulatory Intelligence & Advocacy Manager###Boston Scientific###Session Leader/Speaker: – Boston Scientific
### she/her/hers @@@ Sinead Keogh, PhD – IBEC ### 2177904###Presenter###Head of Sectors Ibec, Director Irish MedTech Association,incoming Director BioPharmaChemical Ireland###IBEC###Presenter: – IBEC
### @@@ Amra Racic – Veeva Systems ### 535477###Presenter###Sr. Director Global Government Affairs###Veeva Systems###Presenter: – Veeva Systems
### @@@ Damien Sherlock, MSc – Boston Scientific ### 2232815###Presenter###Senior Quality Manager, Global Digital Health###Boston Scientific###Presenter: – Boston Scientific
###
10:50 – 11:30 CEST
Presenters at Posters (C Level)
10:50 – 11:30 CEST
Presenters at Posters (C Level)Location: C LevelPosters - Click to View
10:50 – 11:30 CEST
Refreshment Break in Exhibit Area on all Levels
10:50 – 11:30 CEST
Refreshment Break in Exhibit Area on All LevelsLocation: All levels
11:30 – 12:00 CEST
Global IVDs
11:30 – 12:00 CEST
UK Market: PMS and Vigilance Requirements for IVDsLocation: B 05 + B 06IVDs
Christèle East (she/her/hers) – Namsa ### 1828312###Presenter###Senior Regulatory Consultant, IVD###Namsa###Presenter: – Namsa
### she/her/hers
11:30 – 12:30 CEST
Career Development: Forging a Career Path in the Age of Technology
11:30 – 12:30 CEST
Career Development: Forging a Career Path in the Age of TechnologyLocation: A 03 + A 04Moderator & Presenter: – Complear
Presenter: – Northeastern University
Presenter: – QARALOGIC
Regulatory Business
Celia Cruz, PhD (she/her/hers) – Complear ### 1949771###Moderator & Presenter###Chief Regulatory Affairs Officer###Complear###Moderator & Presenter: – Complear
### she/her/hers @@@ Karen Zhou, JD, MS, RAC – Northeastern University ### 2129425###Presenter###Professor###Northeastern University###Presenter: – Northeastern University
### @@@ Hasnaa Fatehi, PhD, RAC (Devices) (she/her/hers) – QARALOGIC ### 2235057###Presenter###Chief QA/RA Officer###QARALOGIC###Presenter: – QARALOGIC
### she/her/hers
11:30 – 12:30 CEST
Key trends impacting HTA and Regulatory interface
11:30 – 12:30 CEST
Key Trends Impacting HTA and Regulatory InterfaceLocation: B 07 + B 08Moderator & Presenter: – Sanofi
Presenter: – Sanofi
Presenter: – National Institute for Health and Care Excellence
Panelist: – European Medicines Agency
Pharmaceuticals
Rebecca Lumsden, PhD (she/her/hers) – Sanofi ### 1827170###Moderator & Presenter###Head of Regulatory Science & Policy EU/AMEE###Sanofi###Moderator & Presenter: – Sanofi
### she/her/hers @@@ Nathalie Largeron, MSc, PharmD – Sanofi ### 2177836###Presenter###Global Head of HTA Strategy###Sanofi###Presenter: – Sanofi
### @@@ Katharine Cresswell, MPH (she/her/hers) – National Institute for Health and Care Excellence ### 2177838###Presenter###Scientific Advisor - Science Policy and Research Programme###National Institute for Health and Care Excellence###Presenter: – National Institute for Health and Care Excellence
### she/her/hers @@@ Michael Berntgen, PhD MDRA (he/him/his) – European Medicines Agency ### 2271498###Panelist###Head of Scientific Evidence Generation Department###European Medicines Agency###Panelist: – European Medicines Agency
### he/him/his
11:30 – 12:30 CEST
The MDR and The AI Act: A Match Made in Heaven or The Odd Couple?
11:30 – 12:30 CEST
The MDR and The AI Act: A Match Made in Heaven or The Odd Couple? Location: C 01Moderator: – Mason Hayes & Curran LLP
Presenter: – Philips
Presenter: – Axon Lawyers
Presenter: – Else Kröner Fresenius Center for Digital Health
Presenter: – TÜV Verband
AI/Software
James Gallagher (he/him/his) – Mason Hayes & Curran LLP ### 2177914###Moderator###Partner###Mason Hayes & Curran LLP###Moderator: – Mason Hayes & Curran LLP
### he/him/his @@@ Koen Cobbaert (he/him/his) – Philips ### 943170###Presenter###Senior Manager - Quality, Standards & Regulations###Philips###Presenter: – Philips
### he/him/his @@@ Erik R. Vollebregt, LLM – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: – Axon Lawyers
### @@@ Stephen Gilbert, MRes, PhD (he/him/his) – Else Kröner Fresenius Center for Digital Health ### 2177911###Presenter###Professor of Medical Device Regulatory Science###Else Kröner Fresenius Center for Digital Health###Presenter: – Else Kröner Fresenius Center for Digital Health
### he/him/his @@@ Ariana Sliwa – TÜV Verband ### 2293206###Presenter###Lead "WP7 Certification" TEF-Health###TÜV Verband###Presenter: – TÜV Verband
### 11:30 – 12:30 CEST
The MDR hurdle for startups and innovation - and strategies to overcome it
11:30 – 12:30 CEST
The MDR Hurdle for Startups and Innovation – And Strategies To Overcome ItLocation: B 09Moderator: – Founder of Waypoint Consulting
Presenter: – RoX Health GmbH
Presenter: – self employed
Presenter: – Qserve
Regulatory Business
Eric Klasen, MSc – Founder of Waypoint Consulting ### 972075###Moderator###RA & Quality consultant in Life Sciences###Founder of Waypoint Consulting###Moderator: – Founder of Waypoint Consulting
### @@@ Anja Kassner, Dr (she/her/hers) – RoX Health GmbH ### 2177862###Presenter###Regulatory Affairs and Project Manager###RoX Health GmbH###Presenter: – RoX Health GmbH
### she/her/hers @@@ Pascal Werner, MSc – self employed ### 2177863###Presenter###Regulatory Affairs consultant###self employed###Presenter: – self employed
### @@@ Robert Paassen, MSc (he/him/his) – Qserve ### 2177852###Presenter###Consultant###Qserve###Presenter: – Qserve
### he/him/his
11:30 – 12:30 CEST
UKCA
11:30 – 12:30 CEST
UK MDR: Current State of Play and Future PerspectivesLocation: A 05 + A 06Moderator: – Edwards Lifesciences
Presenter: – TUV SUD
Presenter: – BSI
Presenter:
Medical Devices
Giovanni Di Rienzo – Edwards Lifesciences ### 907127###Moderator###Director, Regulatory Affairs UK###Edwards Lifesciences###Moderator: – Edwards Lifesciences
### @@@ Monisha Phillips, PhD (she/her/hers) – TUV SUD ### 2177812###Presenter###Head of Approved Body###TUV SUD###Presenter: – TUV SUD
### she/her/hers @@@ Vishal Thakker, MEng (he/him/his) – BSI ### 1614543###Presenter###Head of the UK Approved Body###BSI###Presenter: – BSI
### he/him/his @@@ Joseph Burt ### 2314800###Presenter#########Presenter:
### 12:00 – 12:30 CEST
Global IVDs
12:00 – 12:30 CEST
Usability and Human Factors Studies – Considerations During Pre-Market Submission, Similarities and Differences Between the US and EuropeLocation: B 05 + B 06Presenter: – Regulatory Affairs and IP Director
IVDs
Taly Vider Cohen, BSc – Regulatory Affairs and IP Director ### 2177867###Presenter###Regulatory Affairs and IP Director###Regulatory Affairs and IP Director###Presenter: – Regulatory Affairs and IP Director
###
12:30 – 13:00 CEST
SESSION IS FULL: Solutions Circle: RA-GPT – The Future of the Regulatory Profession
12:30 – 13:00 CEST
SESSION IS FULL: Solutions Circle: RA-GPT – The Future of the Regulatory ProfessionLocation: A 08Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Solutions Circle - Ticket Required
Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH ### 2016361###Presenter###Managing Director###PRO-LIANCE GLOBAL SOLUTIONS GmbH###Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
### 12:30 – 13:00 CEST
Solution Circle: The Time is Now: The Journey to Becoming RCC Certified!
12:30 – 13:00 CEST
Solutions Circle: The Time is Now: The Journey to Becoming RCC Certified!Location: B 95Solutions Circle - Ticket Required
Jennifer Naughton, MEd, ICE-CCP, SPHR, CAE – RAPS ### 1763591###Presenter###Director of Credentialing###RAPS###Presenter: – RAPS
### 12:30 – 13:00 CEST
Solution Circle: What can manufacturers learn from effective PMS/PMPF strategies to strengthen their Clinical Evidence with the IVDR transition deadline approaching?
12:30 – 13:00 CEST
Solutions Circle: What Can Manufacturers Learn From Effective PMS/PMPF Strategies to Strengthen Their Clinical Evidence With The IVDR Transition Deadline Approaching?Location: A 08Solutions Circle - Ticket Required
Warren Jameson, Bsi, PhD, MTOPRA – NAMSA ### 1529415###Presenter###Senior Manager, Regulatory and Quality###NAMSA###Presenter: – NAMSA
### 12:30 – 13:45 CEST
Chapter/Local Networking Group Meet and Greets
12:30 – 13:45 CEST
Chapter/Local Networking Group Meet and GreetsLocation: C Level
12:30 – 13:45 CEST
Networking Lunch in Exhibit Hall on all Levels
12:30 – 13:45 CEST
Networking Lunch in Exhibit Hall on All Levels
Location: All Levels
13:00 – 13:30 CEST
Sponsored Presentation: 3 Changes Affecting MedTech Regulatory Teams
13:00 – 13:30 CEST
Sponsored Presentation: 3 Changes Affecting MedTech Regulatory TeamsLocation: B 05 + B 06Presenter: – RegDesk, Inc.
Sponsored Presentation
Priya Paul – RegDesk, Inc. ### 2315849###Presenter###Founder and CEO of RegDesk###RegDesk, Inc.###Presenter: – RegDesk, Inc.
### 13:00 – 13:30 CEST
Sponsored Presentation: How to accelerate global market entry and to reduce time-to-market? A Notified/Certification body perspective
13:00 – 13:30 CEST
Sponsored Presentation: How To Accelerate Global Market Entry and To Reduce Time-To-Market? A Notified/Certification Body PerspectiveLocation: C 01Presenter: – GMED SAS
Presenter: – GMED
Sponsored Presentation
Nabil Riahi – GMED SAS ### 2304183###Presenter###Sales Director###GMED SAS###Presenter: – GMED SAS
### @@@ Thomas Lloret – GMED ### 2304184###Presenter###Group Key Account Manager###GMED###Presenter: – GMED
### 13:00 – 13:30 CEST
Sponsored Presentation: Objective-driven systems: How to build effective and continuous Regulatory Intelligence and Clinical Surveillance
13:00 – 13:30 CEST
Sponsored Presentation: Objective-Driven Systems: How To Build Effective and Continuous Regulatory Intelligence and Clinical SurveillanceLocation: B 09Sponsored Presentation
Ivan Perez Chamorro – MedBoard ### 1949784###Presenter###CEO###MedBoard###Presenter: – MedBoard
### 13:00 – 13:30 CEST
Sponsored Presentations Purdie Pascoe: PMCF Surveys: from plan to action
13:00 – 13:30 CEST
Sponsored Presentation: PMCF Surveys: From Plan to ActionLocation: A 03 + A 04Presenter: – Purdie Pascoe
Presenter: – Purdie Pascoe
Sponsored Presentation
Marcus Torr, MSci – Purdie Pascoe ### 1550370###Presenter###PMCF / MDR Lead###Purdie Pascoe###Presenter: – Purdie Pascoe
### @@@ Tonika R. Chester – Purdie Pascoe ### 2179082###Presenter###PMCF Manager###Purdie Pascoe###Presenter: – Purdie Pascoe
### 13:00 – 13:30 CEST
Sponsored Presentations QbD Group: Transitional provisions of the IVDR - Can I sit back and relax?
13:00 – 13:30 CEST
Sponsored Presentation: Transitional Provisions of the IVDR – Can I Sit Back and Relax?Location: A 05 + A 06Sponsored Presentation
Pieter Bogaert, PhD (he/him/his) – Qarad ### 2237172###Presenter###Senior Consultant IVD - Regulatory Affairs###Qarad###Presenter: – Qarad
### he/him/his
13:00 – 13:30 CEST
Sponsored Presentations RIMSYS: Clearing up EUDAMED confusion for medtech regulatory teams
13:00 – 13:30 CEST
Sponsored Presentation: Clearing Up EUDAMED Confusion for MedTech Regulatory TeamsLocation: B 07 + B 08Sponsored Presentation
Adam Price, MBA – Rimsys ### 1428928###Presenter###Director of Regulatory and Technical Programs###Rimsys###Presenter: – Rimsys
###
13:15 – 13:45 CEST
Repeat: Solutions Circle: RA-GPT – The Future of the Regulatory Profession
13:15 – 13:45 CEST
Repeat: Solutions Circle: RA-GPT – The Future of the Regulatory ProfessionLocation: B 95Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Solutions Circle - Ticket Required
Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH ### 2016361###Presenter###Managing Director###PRO-LIANCE GLOBAL SOLUTIONS GmbH###Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
### 13:15 – 13:45 CEST
Solution Circle: How to distinguish general and specific PMCF activities
13:15 – 13:45 CEST
Solutions Circle: How to Distinguish General and Specific PMCF ActivitiesLocation: A 08Presenter: – SGS Notified Body, 1639
Solutions Circle - Ticket Required
Ivan Stoyanov – SGS Notified Body, 1639 ### 2179081###Presenter###In-house clinician###SGS Notified Body, 1639###Presenter: – SGS Notified Body, 1639
### 13:15 – 13:45 CEST
Solution Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF) according to the IVDR
13:15 – 13:45 CEST
Solutions Circle: Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF) According to The IVDRLocation: A 08Presenter: – TUV Sud GmbH
Solutions Circle - Ticket Required
Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD###TUV Sud GmbH###Presenter: – TUV Sud GmbH
### 13:45 – 14:45 CEST
Finding value in post market clinical data collection
13:45 – 14:45 CEST
Finding Value in Post Market Clinical Data CollectionLocation: C 01Session Leader/Speaker: – QServe Group
Presenter:
Presenter: – Erasmus MC
Medical Devices
Bianca Lutters (she/her/hers) – QServe Group ### 1523608###Session Leader/Speaker###Head of Clinical Operations###QServe Group###Session Leader/Speaker: – QServe Group
### she/her/hers @@@ Caroline Ryan ### 2297662###Presenter#########Presenter:
### @@@ Kelly van der Geest-Aspers, MSc (she/her/hers) – Erasmus MC ### 2300349###Presenter###Teammanager Innovation Support Office Medical Technology###Erasmus MC###Presenter: – Erasmus MC
### she/her/hers
13:45 – 14:45 CEST
IVDR Class D Devices – Latest Updates & Experience
13:45 – 14:45 CEST
IVDR Class D Devices – Latest Updates and ExperienceLocation: A 03 + A 04Presenter: – TÜV SÜD
Presenter: – BSI
Presenter: – Roche Diagnostics GmbH
Presenter: – BSI
IVDs
Stefan Burde, PhD (he/him/his) – TÜV SÜD ### 2129429###Presenter###Director Global Strategic business Development IVD###TÜV SÜD###Presenter: – TÜV SÜD
### he/him/his @@@ Elizabeth Harrison (she/her/hers) – BSI ### 1401973###Presenter###Global Head, IVD###BSI###Presenter: – BSI
### she/her/hers @@@ Stefan Scheib, PhD (he/him/his) – Roche Diagnostics GmbH ### 1836161###Presenter###Global Head of Regulatory Affairs, Core Lab###Roche Diagnostics GmbH###Presenter: – Roche Diagnostics GmbH
### he/him/his @@@ Sara Fabi, MSc – BSI ### 2177847###Presenter###Regulatory Lead###BSI###Presenter: – BSI
###
13:45 – 14:45 CEST
Meeting EMA and FDA: Formal and informal pathways, in search of alignment
13:45 – 14:45 CEST
Meeting EMA and FDA: Formal and Informal Pathways in Search of AlignmentLocation: A 05 + A 06Presenter: – Phortas GmbH
Presenter: – European Medicines Agency
Presenter: – Arriello
Pharmaceuticals
Jasmina Savic – Phortas GmbH ### 2177861###Presenter###Founder and Managing Director###Phortas GmbH###Presenter: – Phortas GmbH
### @@@ Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency ### 2098106###Presenter###Head of Scientific Advice###European Medicines Agency###Presenter: – European Medicines Agency
### he/him/his @@@ Jayne Hunt, PhD (she/her/hers) – Arriello ### 2313227###Presenter###Principal Consultant###Arriello###Presenter: – Arriello
### she/her/hers
13:45 – 14:45 CEST
Randomized Clinical Trials vs. Validation Cohort studies of AI/ML-based SaMDs: what are the differences and guidelines for appraisal of the clinical evidence?
13:45 – 14:45 CEST
Randomized Clinical Trials vs. Validation Cohort Studies of AI/ML-Based SaMDs: What Are the Differences and Guidelines for Appraisal of the Clinical Evidence?Location: B 05 + B 06Presenter: – BioSciPons
Presenter: – Dedalus
AI/Software
Catarina Carrão – BioSciPons ### 1828303###Presenter###Clinical Evaluation Specialist###BioSciPons###Presenter: – BioSciPons
### @@@ Zuzanna Kwade, PhD (she/her/hers) – Dedalus ### 2237168###Presenter###Clinical Evaluation Lead###Dedalus###Presenter: – Dedalus
### she/her/hers
13:45 – 14:45 CEST
The future of standardization in Medtech and its impact on your regulatory compliance
13:45 – 14:45 CEST
The Future of Standardization in Medtech and Its Impact on Your Regulatory ComplianceLocation: B 09Session Leader/Speaker: – Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH
Presenter: – DIN Media (formerly Beuth Verlag)
Presenter: – DIN e.V.
Medical Devices
Sarah Panten – Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH ### 2177865###Session Leader/Speaker###Co-Founder / Speaker of the Board / Co-Founder & Managing Partner###Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH###Session Leader/Speaker: – Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH
### @@@ Sven Bergander, n/a – DIN Media (formerly Beuth Verlag) ### 2185850###Presenter###Head of department platforms & processes###DIN Media (formerly Beuth Verlag)###Presenter: – DIN Media (formerly Beuth Verlag)
### @@@ Sebastian Kriegsmann, n/a – DIN e.V. ### 2185849###Presenter###Head of Digital Infrastructure & IT-Services (CIO)###DIN e.V.###Presenter: – DIN e.V.
### 13:45 – 14:45 CEST
Unveiling Insights: Navigating the public disclosure of clinical trials in an evolving industry
13:45 – 14:45 CEST
Unveiling Insights: Navigating the Public Disclosure of Clinical Trials in an Evolving IndustryLocation: B 07 + B 08Presenter: – IQVIA
Presenter: – Certara
Presenter: – Danish Medicines Agency
Panelist: – European Medicines Agency
Pharmaceuticals
Christopher Bamford, PhD (he/him/his) – IQVIA ### 2177854###Presenter###Director, Clinical Trials Regulatory###IQVIA###Presenter: – IQVIA
### he/him/his @@@ Anaya Rehman, MBBS, MSc – Certara ### 2177823###Presenter###Sr. Transparency Specialist###Certara###Presenter: – Certara
### @@@ Lene Grejs Petersen, M.Pharm – Danish Medicines Agency ### 2262341###Presenter###Senior Adviser###Danish Medicines Agency###Presenter: – Danish Medicines Agency
### @@@ Radu Popescu, MD (he/him/his) – European Medicines Agency ### 2271496###Panelist###Transparency Officer###European Medicines Agency###Panelist: – European Medicines Agency
### he/him/his
15:05 – 16:05 CEST
CDx or not CDx that is the Question
15:05 – 16:05 CEST
CDx or Not CDx, That is The Question – The Impact of The IVD Regulation on IVDs Used in Pharmaceutical Clinical TrialsLocation: B 07 + B 08Presenter: – Aignostics
Presenter: – J&J
Presenter:
Presenter: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
IVDs
Natalie Batty, MPH, CCRA – Aignostics ### 2177913###Presenter###Sr. Regulatory Affairs Specialist###Aignostics###Presenter: – Aignostics
### @@@ Marina Belongova – J&J ### 2271048###Presenter###Associate Director###J&J###Presenter: – J&J
### @@@ Rachel O'Leary ### 2289608###Presenter#########Presenter:
### @@@ 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/hers15:05 – 16:05 CEST
From China to WHO: Strategies & Updates to Accelerate China & WHO Drug Approvals and Master Files
15:05 – 16:05 CEST
From China to WHO: Strategies snd Updates to Accelerate China and WHO Drug Approvals and Master FilesLocation: A 03 + A 04Session Leader/Speaker: – Cisema
Presenter: – Accestra Consulting Company
Presenter: – EXTEDO GmbH
Pharmaceuticals
Hamish King, RAC, LLB – Cisema ### 1321685###Session Leader/Speaker###CEO###Cisema###Session Leader/Speaker: – Cisema
### @@@ April Wang, MA – Accestra Consulting Company ### 1946092###Presenter###Regulatory Affairs Manager###Accestra Consulting Company###Presenter: – Accestra Consulting Company
### @@@ Gerhard Neurauter, PhD (he/him/his) – EXTEDO GmbH ### 2177851###Presenter###Vice President###EXTEDO GmbH###Presenter: – EXTEDO GmbH
### he/him/his
15:05 – 16:05 CEST
MDR Art. 117 for Combination Products. Are the challenges solved now? State of Play from EMA, NB and Industry
15:05 – 16:05 CEST
MDR Art. 117 for Combination Products. Are the Challenges Solved Now? State of Play From EMA, NB and IndustryLocation: B 05 + B 06Session Leader/Speaker: – Ypsomed AG
Presenter: – EMA
Presenter: – Sandoz
Presenter: – BSI Group
Pharmaceuticals
Stephan Affolter – Ypsomed AG ### 907117###Session Leader/Speaker###Director Regulatory + Quality Intelligence###Ypsomed AG###Session Leader/Speaker: – Ypsomed AG
### @@@ Christelle Bouygues, PharmD – EMA ### 1318405###Presenter###Senior Regulatory Affairs Specialist###EMA###Presenter: – EMA
### @@@ Christiana Hofmann, PhD – Sandoz ### 2268391###Presenter###Ass. Director Regulatory Affairs###Sandoz###Presenter: – Sandoz
### @@@ Theresa Jeary, BSc (Hons), MSc – BSI Group ### 535537###Presenter###Global Head, Medicinal & Biologics Team###BSI Group###Presenter: – BSI Group
###
15:05 – 16:05 CEST
Post-market requirements: Keeping PSUR and SSCP up to date
15:05 – 16:05 CEST
Post-Market requirements: Keeping PSUR and SSCP up to DateLocation: B 09Moderator: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: – W. L Gore & Associates
Presenter: – MED-EL
Presenter: – Smith+Nephew
Medical Devices
Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH ### 2016361###Moderator###Managing Director###PRO-LIANCE GLOBAL SOLUTIONS GmbH###Moderator: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
### @@@ Delphine Corriette Islanio, M Eng (she/her/hers) – W. L Gore & Associates ### 2177815###Presenter###EMEA Regulatory Affairs###W. L Gore & Associates###Presenter: – W. L Gore & Associates
### she/her/hers @@@ Elizabeth Gfoeller, MA – MED-EL ### 766093###Presenter###Corporate Director, Regulatory Affairs ###MED-EL###Presenter: – MED-EL
### @@@ Markus Pöttker (he/him/his) – Smith+Nephew ### 2177811###Presenter###Director, Global Post-Market Surveillance###Smith+Nephew###Presenter: – Smith+Nephew
### he/him/his
15:05 – 16:05 CEST
Securing AI solutions in MedTech products
15:05 – 16:05 CEST
Securing AI Solutions in Medtech ProductsLocation: A 05 + A 06Presenter: – Royal Philips
AI/Software
Xander C.W Heemskerk, ing CISSP CCSK – Royal Philips ### 1187568###Presenter###Director Product Security###Royal Philips###Presenter: – Royal Philips
### 15:05 – 16:05 CEST
Use of Real World Evidence
15:05 – 16:05 CEST
Use of Real World Evidence for Regulatory Making for Medical Devices and Diagnostics in EU: A Practical GuideLocation: C 01Session Leader/Speaker: – Notified Body (BSI)
Presenter: – Aetion
Panelist: – Trinity College Dublin
Panelist: – Boston Scientific
Medical Devices
Richard G. Holborow, MSCST RCCP (he/him/his) – Notified Body (BSI) ### 1523592###Session Leader/Speaker###Global Heal of Clinical Compliance###Notified Body (BSI)###Session Leader/Speaker: – Notified Body (BSI)
### he/him/his @@@ Estelle Frappe (she/her/hers) – Aetion ### 2177814###Presenter###Director RWE MD&D###Aetion###Presenter: – Aetion
### she/her/hers @@@ Tom Melvin, MB, BCh, BAO, LRCPI & SI, BCL LLM (NUI) – Trinity College Dublin ### 1344660###Panelist###Associate Professor of Medical Device Regulatory Affairs###Trinity College Dublin###Panelist: – Trinity College Dublin
### @@@ Richard Dujmovic, MSEM (he/him/his) – Boston Scientific ### 2260434###Panelist###Vice President, Regulatory Affairs###Boston Scientific###Panelist: – Boston Scientific
### he/him/his
16:05 – 16:45 CEST
Coffee Break in the Exhibit Hall on all Levels
16:05 – 16:45 CEST
Coffee Break in the Exhibit Hall on All Levels
Location: All Levels
16:05 – 16:45 CEST
Presenters at Posters (C Level)
16:05 – 16:45 CEST
Presenters at Posters (C Level)Location: C LevelPosters - Click to View
16:10 – 16:40 CEST
Sponsored Presentation: How It Works: Your Questions About Notified Bodies & Testing Houses Answered
16:10 – 16:40 CEST
Sponsored Presentation: How It Works: Your Questions About Notified Bodies and Testing Houses AnsweredLocation: B 05 + B 06Presenter: – TÜV SÜD Medical & Health Services
Sponsored Presentation
Martin Witte – TÜV SÜD Medical & Health Services ### 1187576###Presenter###Senior Director Strategic Business Development###TÜV SÜD Medical & Health Services###Presenter: – TÜV SÜD Medical & Health Services
### 16:10 – 16:40 CEST
Sponsored Presentation: Leveraging AI for Successful Clinical Evaluation and PMCF Strategies
16:10 – 16:40 CEST
Sponsored Presentation: Leveraging AI for Successful Clinical Evaluation and PMCF StrategiesLocation: A 05 + A 06Presenter: – Celegence
Presenter: – Celegence
Sponsored Presentation
Shruti Sharma – Celegence ### 2122587###Presenter###Product Specialist – Regulatory Services###Celegence###Presenter: – Celegence
### @@@ Anushree Singh – Celegence ### 2290122###Presenter###Associate Manager, Medical Device Services###Celegence###Presenter: – Celegence
### 16:10 – 16:40 CEST
Sponsored Presentation: MDR has come: A call for a proactive boost in Medtech Innovation Industry
16:10 – 16:40 CEST
Sponsored Presentation: MDR Has Come: A Call for a Proactive Boost in Medtech Innovation IndustryLocation: A 03 + A 04Sponsored Presentation
Alessandro Malaspina, MA (he/him/his) – 1 MED ### 2290120###Presenter###Head of Regulatory Affairs###1 MED###Presenter: – 1 MED
### he/him/his
16:10 – 16:40 CEST
Sponsored Presentation: Regulatory Intelligence: From information overload to strategic decision-making
16:10 – 16:40 CEST
Sponsored Presentation: Regulatory Intelligence: From Information Overload to Strategic Decision-MakingLocation: B 09Moderator: – Veeva Systems
Presenter: – Boston Scientific
Presenter: – Abbott
Sponsored Presentation
Diogo Geraldes, PhD MEng – Veeva Systems ### 2290123###Moderator###Director Regulatory Strategy###Veeva Systems###Moderator: – Veeva Systems
### @@@ Olga Van Grol-Lawlor, MPHIL (she/her/hers) – Boston Scientific ### 1534231###Presenter###Sr. Global Regulatory Intelligence & Advocacy Manager###Boston Scientific###Presenter: – Boston Scientific
### she/her/hers @@@ João Martins – Abbott ### 2290124###Presenter###Associate Director of Regulatory Strategy###Abbott###Presenter: – Abbott
###
16:10 – 16:40 CEST
Sponsored Presentation: Regulatory Transformation: Leveraging AI & Digital Transformation to Enable Regulatory Excellence
16:10 – 16:40 CEST
Sponsored Presentation: Regulatory Transformation: Leveraging AI and Digital Transformation to Enable Regulatory ExcellenceLocation: C 01Presenter: – Essenvia
Presenter: – Essenvia
Sponsored Presentation
Dhriti Roy, PhD (she/her/hers) – Essenvia ### 2122585###Presenter###Vice President of Regulatory Affairs Transformation ###Essenvia###Presenter: – Essenvia
### she/her/hers @@@ Soumya Mahapatra (he/him/his) – Essenvia ### 2122586###Presenter###CEO & Founder###Essenvia###Presenter: – Essenvia
### he/him/his
16:10 – 16:40 CEST
Sponsored Presentation: Using Clock Stops Wisely to Appropriately Address CHMP Issues – Why Time Matters
16:10 – 16:40 CEST
Sponsored Presentation: Using Clock Stops Wisely to Appropriately Address CHMP Issues – Why Time MattersLocation: B 07 + B 08Presenter: – 3D Communications
Presenter: – 3D Communications
Sponsored Presentation
Bert Regeer, MD – 3D Communications ### 720656###Presenter###Senior Science Lead###3D Communications###Presenter: – 3D Communications
### @@@ Lee Mullin, PhD, RAC – 3D Communications ### 2290121###Presenter###Senior Medical Writer###3D Communications###Presenter: – 3D Communications
### 16:45 – 17:45 CEST
Don’t get orphaned: how to be novel in the IVDR environment.
16:45 – 17:45 CEST
Don’t Get Orphaned: How To Be Novel in the IVDR EnvironmentLocation: A 03 + A 04Session Leader/Speaker: – BSI
Presenter: – NAMSA
IVDs
Alex Laan (he/him/his) – BSI ### 1945990###Session Leader/Speaker###Head of IVD Notified Body###BSI###Session Leader/Speaker: – BSI
### he/him/his @@@ Warren Jameson, Bsi, PhD, MTOPRA – NAMSA ### 1529415###Presenter###Senior Manager, Regulatory and Quality###NAMSA###Presenter: – NAMSA
###
16:45 – 17:45 CEST
EMA Scientific Advice for high-risk devices – What we know so far
16:45 – 17:45 CEST
EMA Scientific Advice for High-Risk Devices – What We Know So FarLocation: B 05 + B 06Moderator: – Edwards Lifesciences
Presenter: – Oxford Endovascular Ltd
Presenter: – European Medicines Agency
Medical Devices
Giovanni Di Rienzo – Edwards Lifesciences ### 907127###Moderator###Director, Regulatory Affairs UK###Edwards Lifesciences###Moderator: – Edwards Lifesciences
### @@@ Rebecca Sheridan (she/her/hers) – Oxford Endovascular Ltd ### 2247808###Presenter###VP RAQA###Oxford Endovascular Ltd###Presenter: – Oxford Endovascular Ltd
### she/her/hers @@@ Alberto Ganan, PhD – European Medicines Agency ### 2262977###Presenter###Head of Committees and Quality Assurance Department###European Medicines Agency###Presenter: – European Medicines Agency
###
16:45 – 17:45 CEST
Importance of New Active Substance status for biologics, and CMC strategies for development of C&G therapies
16:45 – 17:45 CEST
Importance of New Active Substance Status for Biologics, and CMC Strategies for Development of C&G TherapiesLocation: A 05 + A 06Session Leader/Speaker: – Fortrea
Presenter: – Sanofi
Panelist:
Pharmaceuticals
Sanjay Jain – Fortrea ### 2177869###Session Leader/Speaker###Senior Director, Global Regulatory Strategy###Fortrea###Session Leader/Speaker: – Fortrea
### @@@ Marie-pierre PETITJEAN, PharmD – Sanofi ### 2177858###Presenter###Europe Regulatory Experts Head###Sanofi###Presenter: – Sanofi
### @@@ Brian Dooley ### 2271495###Panelist#########Panelist:
###
16:45 – 17:45 CEST
Navigating the future: Embracing AI and ChatGPT in Regulatory Affairs and Quality Management for Pharma and MedTech Professionals alike
16:45 – 17:45 CEST
Navigating the future: Embracing AI and ChatGPT in Regulatory Affairs and Quality Management for Pharma and MedTech Professionals AlikeLocation: B 09Session Leader/Speaker: – G&L Healthcare Advisors
Presenter: – China Med Device, LLC
Presenter: – Johner Institut GmbH
AI/Software
Paul Kuiken, BSc (HONS), MBA, FTOPRA, MIOD – G&L Healthcare Advisors ### 2177834###Session Leader/Speaker###Vice President Advisory Services###G&L Healthcare Advisors###Session Leader/Speaker: – G&L Healthcare Advisors
### @@@ Grace Fu, MBA (she/her/hers) – China Med Device, LLC ### 720651###Presenter###Principal###China Med Device, LLC###Presenter: – China Med Device, LLC
### she/her/hers @@@ Andreas Kalchschmid-Lehmann, MSc (he/him/his) – Johner Institut GmbH ### 2260435###Presenter###Co-Lead IVD and Consultant QMS###Johner Institut GmbH###Presenter: – Johner Institut GmbH
### he/him/his
16:45 – 17:45 CEST
Pre-clinical evaluations and clinical investigations. Strategizing towards efficiency and new approaches including in silico methods
16:45 – 17:45 CEST
Pre-Clinical Evaluations and Clinical Investigations. Strategizing Towards Efficiency and New Approaches Including in Silico MethodsLocation: C 01Presenter: – Qserve
Presenter: – Fraunhofer IMTE
Medical Devices
Jorn van Binsbergen, MSc (he/him/his) – Qserve ### 1944258###Presenter###Consultant / Clinical writer###Qserve###Presenter: – Qserve
### he/him/his @@@ Charlott Danielson, M.Sc. (she/her/hers) – Fraunhofer IMTE ### 2179084###Presenter###Regulatory Affairs Manager###Fraunhofer IMTE###Presenter: – Fraunhofer IMTE
### she/her/hers
16:45 – 17:45 CEST
Regulators and Industry perspective on Use of Artificial Intelligence in the Drug Development Lifecycle
16:45 – 17:45 CEST
Regulators and Industry Perspective on Use of Artificial Intelligence in the Drug Development LifecycleLocation: B 07 + B 08Session Leader: – Vita Green Group
Session Leader/Speaker: – Accumulus Synergy
Presenter:
Presenter: – European Medicines Agency
Presenter: – F.Hoffmann-La Roche, Ltd.
AI/Software
Stefanie Faßhauer, MBA – Vita Green Group ### 943172###Session Leader###Global Head Regulatory Affairs###Vita Green Group###Session Leader: – Vita Green Group
### @@@ Khushboo Sharma, MBA – Accumulus Synergy ### 1660692###Session Leader/Speaker###Chief Regulatory Innovation Officer###Accumulus Synergy###Session Leader/Speaker: – Accumulus Synergy
### @@@ Claire Harrison ### 2277736###Presenter#########Presenter:
### @@@ Florian Lasch, PhD (he/him/his) – European Medicines Agency ### 2279656###Presenter###Biostatistics Specialist###European Medicines Agency###Presenter: – European Medicines Agency
### he/him/his @@@ Helena Corte-Real Correia, PhD – F.Hoffmann-La Roche, Ltd. ### 2288762###Presenter###VP, Regulatory Portfolio Data and Content Lead###F.Hoffmann-La Roche, Ltd.###Presenter: – F.Hoffmann-La Roche, Ltd.
###
18:30 – 22:30 CEST
Euro Convergence Networking Dinner (ticket required)
18:30 – 22:30 CEST
Euro Convergence Networking Dinner (ticket required)
- Wednesday, May 8, 2024
07:30 – 15:30 CEST
Speaker Ready Room Open (B04)
07:30 – 15:30 CEST
Speaker Ready Room Open (B04)
Location: B 04
07:30 – 16:00 CEST
Registration Hours
07:30 – 16:00 CEST
Registration (A Level)
Location: A Level
07:30 – 17:00 CEST
Cloakroom
07:30 – 17:00 CEST
Cloakroom (A level)
Location: A 08
08:30 – 09:45 CEST
Conversations That Matter: Interactions with Health Authorities
08:30 – 09:45 CEST
Conversations That Matter: Interactions with Health AuthoritiesLocation: C 01Moderator: – TÜV SÜD Medical Health Service
Moderator: – European Medicines Agency
Panelist: – European Medicines Agency
Panelist: – EMA
Panelist: – BSI
Panelist: – CAMD
Panelist: – European Medicines Agency
Panelist: – European Commission
Panelist: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
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
### @@@ Sabine Haubenreisser, MSc, PhD – European Medicines Agency ### 844384###Moderator###Principal Scientific Administrator###European Medicines Agency###Moderator: – European Medicines Agency
### @@@ Alberto Ganan, PhD – European Medicines Agency ### 2262977###Panelist###Head of Committees and Quality Assurance Department###European Medicines Agency###Panelist: – European Medicines Agency
### @@@ Christelle Bouygues, PharmD – EMA ### 1318405###Panelist###Senior Regulatory Affairs Specialist###EMA###Panelist: – EMA
### @@@ Suzanne Halliday – BSI ### 535446###Panelist###VP Regulatory###BSI###Panelist: – BSI
### @@@ Thierry Sirdey – CAMD ### 2271046###Panelist###Chair###CAMD ###Panelist: – CAMD
### @@@ Constantinos Ziogas, MD (he/him/his) – European Medicines Agency ### 2271494###Panelist###Head of SME Office###European Medicines Agency###Panelist: – European Medicines Agency
### he/him/his @@@ Flora Giorgio (she/her/hers) – European Commission ### 1930380###Panelist###Head of Unit###European Commission###Panelist: – European Commission
### she/her/hers @@@ Olga Tkachenko, PhD (she/her/hers) – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6 ### 1828315###Panelist###Policy Officer###European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6###Panelist: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
### she/her/hers09:45 – 10:25 CEST
Coffee Break in the Exhibit Hall on all Levels
09:45 – 10:25 CEST
Coffee Break in the Exhibit Hall on All LevelsLocation: All Levels
09:45 – 10:25 CEST
Presenters at Posters (C Level)
09:45 – 10:25 CEST
Presenters at Posters (C Level)Location: C LevelPosters - Click to View
09:45 – 15:45 CEST
Exhibition Open
09:45 – 15:45 CEST
Exhibition Open
Location: Levels A and B
10:25 – 11:25 CEST
Application of article 61(10), non-clinical data, for SaMD and AI
10:25 – 11:25 CEST
Application of Article 61(10), Non-Clinical Data, for SaMD and AILocation: B 09Session Leader/Speaker: – Kiwa Dare
Presenter: – Medical Device Project B.V.
AI/Software
Natascha J. Cuper, PhD – Kiwa Dare ### 535505###Session Leader/Speaker###Clinical Product Reviewer###Kiwa Dare ###Session Leader/Speaker: – Kiwa Dare
### @@@ Vincent van der Meer (he/him/his) – Medical Device Project B.V. ### 1840753###Presenter###Senior Consultant QA/RA###Medical Device Project B.V.###Presenter: – Medical Device Project B.V.
### he/him/his
10:25 – 11:25 CEST
Career Development: LIVE LinkedIn review Session
10:25 – 11:25 CEST
Career Development: Live LinkedIn Review SessionLocation: A 03 + A 04Regulatory Business
Elena Kyria (she/her/hers) – Elemed ### 1083155###Presenter###CEO & Founder###Elemed###Presenter: – Elemed
### she/her/hers10:25 – 11:25 CEST
CTA with Devices
10:25 – 11:25 CEST
CTA with Devices: State of Play for Non-CE Marked Diagnostic Tests in European Clinical TrialsLocation: A 05 + A 06Presenter: – Qarad
Presenter: – Entourage GmbH
Pharmaceuticals
Pieter Bogaert, PhD (he/him/his) – Qarad ### 2237172###Presenter###Senior Consultant IVD - Regulatory Affairs###Qarad###Presenter: – Qarad
### he/him/his @@@ Sven Hoffmann, MSc (he/him/his) – Entourage GmbH ### 2016363###Presenter###Head of IVD and Principal Consultant###Entourage GmbH###Presenter: – Entourage GmbH
### he/him/his
10:25 – 11:25 CEST
Global IVDs
10:25 – 11:25 CEST
Tackling Regulatory Challenges in a Global Marketplace: Developing a Robust Performance Evaluation Strategy for IVDsLocation: B 07 + B 08Session Leader/Speaker: – Qserve Group
IVDs
Christie Hughes, MPH, MLS(ASCP), RCC-IVDR – Qserve Group ### 1389439###Session Leader/Speaker###Principal Consultant###Qserve Group###Session Leader/Speaker: – Qserve Group
###
10:25 – 11:25 CEST
Risk Management
10:25 – 11:25 CEST
Collaboration Works: Risk Management – Clinical Evaluation – PMS/PMCF UnitedLocation: B 05 + B 06Moderator: – Medical Device Project B.V.
Presenter: – Escentia GmbH
Presenter: – Smith+Nephew
Presenter: – Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH
Medical Devices
Robert A. van Boxtel, MSc – Medical Device Project B.V. ### 907078###Moderator###Principal Consultant###Medical Device Project B.V.###Moderator: – Medical Device Project B.V.
### @@@ Alexej Agibalow – Escentia GmbH ### 2177809###Presenter###Risk Management Expert###Escentia GmbH###Presenter: – Escentia GmbH
### @@@ Markus Pöttker (he/him/his) – Smith+Nephew ### 2177811###Presenter###Director, Global Post-Market Surveillance###Smith+Nephew###Presenter: – Smith+Nephew
### he/him/his @@@ Sarah Panten – Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH ### 2177865###Presenter###Co-Founder / Speaker of the Board / Co-Founder & Managing Partner###Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH###Presenter: – Medical Device Knowledge Unit (MDKU) e.V. / avasis solutions GmbH
### 10:25 – 11:25 CEST
The paradigm shift in the EU market approval of devices and IVDs - a hot potato?!
10:25 – 11:25 CEST
The Paradigm Shift in the EU Market Approval of Devices and IVDs – a Hot Potato?!Location: C 01Moderator: – QServe Group B.V.
Presenter: – TUV sud
Presenter: – Boston Scientific
Presenter: – QServe Group
Presenter: – Axon Lawyers
Medical Devices
Gert W. Bos, Chairman of the Board and former president RAPS – QServe Group B.V. ### 535440###Moderator###Executive Director & Partner###QServe Group B.V.###Moderator: – QServe Group B.V.
### @@@ Sabina Van den Bosch, FRAPS, pharmD – TUV sud ### 2177908###Presenter###head of reg strategy###TUV sud###Presenter: – TUV sud
### @@@ Olga Van Grol-Lawlor, MPHIL (she/her/hers) – Boston Scientific ### 1534231###Presenter###Sr. Global Regulatory Intelligence & Advocacy Manager###Boston Scientific###Presenter: – Boston Scientific
### she/her/hers @@@ Bianca Lutters (she/her/hers) – QServe Group ### 1523608###Presenter###Head of Clinical Operations###QServe Group###Presenter: – QServe Group
### she/her/hers @@@ Erik R. Vollebregt, LLM – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: – Axon Lawyers
### 11:45 – 12:45 CEST
Clinical Evaluation
11:45 – 12:45 CEST
Clinical Evaluation: Complexity in Simplicity: Regulatory Challenges for Standard of Care Medical DevicesLocation: C 01Session Leader/Speaker: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Presenter: – SLG Prüf- und Zertifizierungs GmbH
Presenter: – QUESTALPHA GmbH & Co. KG
Medical Devices
Milica Bajagic, PhD – PRO-LIANCE GLOBAL SOLUTIONS GmbH ### 2177909###Session Leader/Speaker###Scientific and Software Expert###PRO-LIANCE GLOBAL SOLUTIONS GmbH###Session Leader/Speaker: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
### @@@ Julia Rohrberg, PhD (she/her/hers) – PRO-LIANCE GLOBAL SOLUTIONS GmbH ### 2177910###Presenter###Regulatory and Clinical Expert###PRO-LIANCE GLOBAL SOLUTIONS GmbH###Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
### she/her/hers @@@ Tina Richter, PhD (she/her/hers) – SLG Prüf- und Zertifizierungs GmbH ### 2260436###Presenter###Clinical Evaluation Expert / Auditor###SLG Prüf- und Zertifizierungs GmbH###Presenter: – SLG Prüf- und Zertifizierungs GmbH
### she/her/hers @@@ Martin von Rüden, Dr. – QUESTALPHA GmbH & Co. KG ### 2262464###Presenter###Regulatory Affairs Manager / Director Research###QUESTALPHA GmbH & Co. KG###Presenter: – QUESTALPHA GmbH & Co. KG
###
11:45 – 12:45 CEST
Data Security & Digital Health
11:45 – 12:45 CEST
Data Security and Digital Health: Medical Devices, IVDs and the Increasing EU Regulation of Health DataLocation: B 05 + B 06Presenter: – Axon Lawyers
Presenter: – Elekta
AI/Software
Cecile E. Van der Heijden (she/her/hers) – Axon Lawyers ### 1827162###Presenter###Senior Associate###Axon Lawyers###Presenter: – Axon Lawyers
### she/her/hers @@@ Leo Hovestadt (he/him/his) – Elekta ### 535504###Presenter###Director Governmental Affairs EU###Elekta###Presenter: – Elekta
### he/him/his11:45 – 12:45 CEST
Environmental Regulation
11:45 – 12:45 CEST
Environmental Regulation: How EU Green Deal and Other Environmental Regulations Affect Medical Devices and IVDsLocation: B 07 + B 08Session Leader/Speaker: – Axon Lawyers
Presenter: – MedTech Europe
Medical Devices
Erik R. Vollebregt, LLM – Axon Lawyers ### 535481###Session Leader/Speaker###Partner###Axon Lawyers###Session Leader/Speaker: – Axon Lawyers
### @@@ Jesús Rueda Rodríguez – MedTech Europe ### 574717###Presenter###Director International Affairs###MedTech Europe###Presenter: – MedTech Europe
### 11:45 – 12:45 CEST
Maintaining Compliance: IVDR Post-Certification Activities
11:45 – 12:45 CEST
Maintaining Compliance: IVDR Post-Certification ActivitiesLocation: B 09Presenter: – BSI
Presenter: – Immunotech SAS (Beckman Coulter)
Presenter: – Qarad
IVDs
James Kerr – BSI ### 2177833###Presenter###Technical Specialist & Scheme Manager###BSI###Presenter: – BSI
### @@@ Sophie Roques-Violin, PharmD – Immunotech SAS (Beckman Coulter) ### 2177840###Presenter###Quality and Regulatory Affairs Senior Manager###Immunotech SAS (Beckman Coulter)###Presenter: – Immunotech SAS (Beckman Coulter)
### @@@ Annelies Rotthier, PhD (she/her/hers) – Qarad ### 2177841###Presenter###IVD Manager Device Compliance & Performance Evaluation Studies###Qarad###Presenter: – Qarad
### she/her/hers
11:45 – 12:45 CEST
Patient-Centric Endpoints and Use of Digital Health Technologies
11:45 – 12:45 CEST
Patient-Centric Endpoints and Use of Digital Health TechnologiesLocation: A 03 + A 04Moderator: – Benefits Regulatory Consulting
Presenter: – khhconsulting
Presenter: – Teva Pharmaceuticals
Presenter: – Hyman, Phelps & McNamara, P.C.
Pharmaceuticals
Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting ### 573538###Moderator###Consultant###Benefits Regulatory Consulting###Moderator: – Benefits Regulatory Consulting
### @@@ Karl-Heinz Huemer (he/him/his) – khhconsulting ### 573393###Presenter###Consultant###khhconsulting###Presenter: – khhconsulting
### he/him/his @@@ Anirban Sadhu (he/him/his) – Teva Pharmaceuticals ### 2177828###Presenter###Vice President Regulatory Affairs###Teva Pharmaceuticals###Presenter: – Teva Pharmaceuticals
### he/him/his @@@ Adrienne Lenz, RAC – Hyman, Phelps & McNamara, P.C. ### 535486###Presenter###Principal Medical Device Regulatory Expert###Hyman, Phelps & McNamara, P.C.###Presenter: – Hyman, Phelps & McNamara, P.C.
###
11:45 – 12:45 CEST
Supply Chain/Shortage
11:45 – 12:45 CEST
Supply Chain/ShortageLocation: A 05 + A 06Presenter: – CAI
Presenter: – Parexel International India Safety Services Private Limited
Presenter: – Parexel
Presenter:
Pharmaceuticals
Rachel Harte – CAI ### 1615665###Presenter###Associate Director Regulatory Affairs###CAI###Presenter: – CAI
### @@@ Sarbajit Chakrabarti, MTech, MSc (he/him/his) – Parexel International India Safety Services Private Limited ### 2177829###Presenter###Regulatory Affairs Associate###Parexel International India Safety Services Private Limited###Presenter: – Parexel International India Safety Services Private Limited
### he/him/his @@@ Siegfried Schmitt, PhD – Parexel ### 907098###Presenter###Vice President Technical###Parexel###Presenter: – Parexel
### @@@ Monica Dias ### 2278314###Presenter#########Presenter:
###
12:45 – 13:15 CEST
Solution Circle: Cyber Security – Pitfalls for IVDR Technical File Submission
12:45 – 13:15 CEST
Solutions Circle: Cyber Security – Pitfalls for IVDR Technical File SubmissionLocation: A 08Solutions Circle - Ticket Required
Alexander Stock (he/him/his) – TÜV SÜD ### 1827167###Presenter###Project Manager IVD Medical Device Testing###TÜV SÜD###Presenter: – TÜV SÜD
### he/him/his12:45 – 13:15 CEST
Solution Circle: Essentials of EU Regulatory Intelligence; overview of key aspects of regulatory intelligence
12:45 – 13:15 CEST
Solutions Circle: Essentials of EU Regulatory Intelligence; Overview of Key Aspects of Regulatory IntelligenceLocation: B 95Solutions Circle - Ticket Required
Denis Burkhalter, MSc (he/him/his) – Novartis ### 2177825###Presenter###Regulatory Policy and Intelligence, AD###Novartis###Presenter: – Novartis
### he/him/his12:45 – 13:15 CEST
Solution Circle: How does the SSCP improve patient safety in less than 100 pages?
12:45 – 13:15 CEST
Solutions Circle: How Does the SSCP Improve Patient Safety in Less Than 100 Pages?Location: A 08Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Solutions Circle - Ticket Required
Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH ### 2016361###Presenter###Managing Director###PRO-LIANCE GLOBAL SOLUTIONS GmbH###Presenter: – PRO-LIANCE GLOBAL SOLUTIONS GmbH
### 12:45 – 14:00 CEST
Chapter/Local Networking Group Meet and Greets (C Level)
12:45 – 14:00 CEST
Chapter/Local Networking Group Meet and Greets (C Level)
Location: C Level
12:45 – 14:00 CEST
Networking Lunch in Exhibit Hall on all Levels
12:45 – 14:00 CEST
Networking Lunch in Exhibit Hall on All LevelsLocation: All Levels
13:15 – 13:45 CEST
Sponsored Presentation: Consolidating Economic Operators for Market Access Globally
13:15 – 13:45 CEST
Sponsored Presentation: Consolidating Economic Operators for Market Access GloballyLocation: A 03 + A 04Presenter: – MedEnvoy Global
Sponsored Presentation
Daniëlle Sleegers – MedEnvoy Global ### 2290126###Presenter###Director Regulatory Affairs & PRRC###MedEnvoy Global###Presenter: – MedEnvoy Global
###
13:15 – 13:45 CEST
Sponsored Presentation: Navigating The Future - Insights From The 2024 State Of Medtech Report
13:15 – 13:45 CEST
Sponsored Presentation: Navigating The Future - Insights From The 2024 State Of Medtech ReportLocation: B 05 + B 06Presenter: – Greenlight Guru
Sponsored Presentation
Eric Gaidis – Greenlight Guru ### 2304185###Presenter###Account Executive - Team Lead###Greenlight Guru###Presenter: – Greenlight Guru
###
13:15 – 13:45 CEST
Sponsored Presentation: Raising the Bar on Cybersecurity: Understanding New Regulations and How IEC 81001-5-1 can Help Navigate
13:15 – 13:45 CEST
Sponsored Presentation: Raising the Bar on Cybersecurity: Understanding New Regulations and How IEC 81001-5-1 Can Help NavigateLocation: B 07 + B 08Sponsored Presentation
Michelle Jump, RAC – MedSec LLC ### 1827177###Presenter###CEO###MedSec LLC###Presenter: – MedSec LLC
### 13:15 – 13:45 CEST
Sponsored Presentation: State of the art and the medical device lifecycle
13:15 – 13:45 CEST
Sponsored Presentation: State of the art and the medical device lifecycleLocation: B 09Sponsored Presentation
Ed Ball, Msc, CEng (he/him/his) – RQM+ ### 2094360###Presenter###Manager, Intelligence and Strategic Execution###RQM+###Presenter: – RQM+
### he/him/his13:15 – 13:45 CEST
Sponsored Presentation: The challenge of the transition: a practical guide on how to use data historicity to produce correct rationales and deal effectively with the transition from MDD to MDR
13:15 – 13:45 CEST
Sponsored Presentation: The Challenge of the Transition: A Practical Guide on How To Use Data Historicity To Produce Correct Rationales and Deal Effectively With the Transition From MDD to MDRLocation: A 05 + A 06Sponsored Presentation
Marianna Mastroroberto, MD (she/her/hers) – Kiwa ### 2290125###Presenter###Internal Clinical Expert – Kiwa Cermet Italia NB 0476###Kiwa ###Presenter: – Kiwa
### she/her/hers
13:15 – 13:45 CEST
Sponsored Presentation: The top gotchas when expanding your clinical development into the US
13:15 – 13:45 CEST
Sponsored Presentation: The top gotchas when expanding your clinical development into the USLocation: C 01Presenter: – Pearl Pathways
Sponsored Presentation
Gretchen Miller Bowker – Pearl Pathways ### 2317952###Presenter###Chief Executive Officer###Pearl Pathways###Presenter: – Pearl Pathways
###
13:30 – 14:00 CEST
Solution Circle: Effective Strategies When Approaching Regulatory Due Diligence under the MDR
13:30 – 14:00 CEST
Solutions Circle: Effective Strategies When Approaching Regulatory Due Diligence Under the MDRLocation: A 08Solutions Circle - Ticket Required
Matt Royle, PhD – NAMSA ### 907121###Presenter###Principal Regulatory Consultant###NAMSA###Presenter: – NAMSA
### 13:30 – 14:00 CEST
Solution Circle: Intended purpose, device classification, NB codes and corresponding types of devices /sampling TD under the IVDR
13:30 – 14:00 CEST
Solutions Circle: Intended Purpose, Device Classification, NB Codes, and Corresponding Types of Devices/Sampling TD Under the IVDRLocation: A 08Presenter: – TUV Sud GmbH
Solutions Circle - Ticket Required
Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD###TUV Sud GmbH###Presenter: – TUV Sud GmbH
### 13:30 – 14:00 CEST
Solution Circle:Effective Strategies for High-Quality Clinical Data Collection through Post-market Clinical Follow-Up (PMCF) Surveys and Medical Device Registries
13:30 – 14:00 CEST
Solutions Circle: Effective Strategies for High-Quality Clinical Data Collection Through Post-Market Clinical Follow-Up (PMCF) Surveys and Medical Device RegistriesLocation: B 95Presenter: – BioSciPons
Presenter: – Purdie Pascoe
Solutions Circle - Ticket Required
Catarina Carrão – BioSciPons ### 1828303###Presenter###Clinical Evaluation Specialist###BioSciPons###Presenter: – BioSciPons
### @@@ Marcus Torr, MSci – Purdie Pascoe ### 1550370###Presenter###PMCF / MDR Lead###Purdie Pascoe###Presenter: – Purdie Pascoe
### 14:00 – 15:00 CEST
International Regulatory Frameworks to Accelerate Orphan Drug Registrations
14:00 – 15:00 CEST
International Regulatory Frameworks to Accelerate Orphan Drug RegistrationsLocation: A 05 + A 06Session Leader/Speaker: – Alexion Astra Zeneca Rare Diseases
Presenter: – European Medicines Agency
Presenter: – Foundation of Borys the Hero
Pharmaceuticals
Merce Caturla Goni, PhD (she/her/hers) – Alexion Astra Zeneca Rare Diseases ### 2177816###Session Leader/Speaker###Head of Product Cluster, Regulatory Affairs Marketed Products Strategy###Alexion Astra Zeneca Rare Diseases###Session Leader/Speaker: – Alexion Astra Zeneca Rare Diseases
### she/her/hers @@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Presenter###Head of Orphan Drugs###European Medicines Agency###Presenter: – European Medicines Agency
### @@@ Tomasz Grybek, MA (he/him/his) – Foundation of Borys the Hero ### 2293205###Presenter###CEO###Foundation of Borys the Hero###Presenter: – Foundation of Borys the Hero
### he/him/his
14:00 – 15:00 CEST
Core Data Sheets
14:00 – 15:00 CEST
Data at the Core: Understanding Your Company's Critical Yet Underutilized ToolLocation: A 03 + A 04Moderator: – SANOFI
Presenter: – Asher Biotherapeutics, Inc.
Presenter: – Bayer Plc
Presenter: – F. Hoffmann-La Roche Ltd
Pharmaceuticals
Charlie Mortazavi, SANOFI – SANOFI ### 907082###Moderator###Senior Manger###SANOFI###Moderator: – SANOFI
### @@@ James Cross, PhD (he/him/his) – Asher Biotherapeutics, Inc. ### 1615712###Presenter###Senior Vice President, Regulatory Affairs###Asher Biotherapeutics, Inc.###Presenter: – Asher Biotherapeutics, Inc.
### he/him/his @@@ Deborah Bebbington (she/her/hers) – Bayer Plc ### 2278788###Presenter###Head Global Labeling###Bayer Plc###Presenter: – Bayer Plc
### she/her/hers @@@ Nathalie Gass, PhD (she/her/hers) – F. Hoffmann-La Roche Ltd ### 2299635###Presenter###Regulatory Senior Program Director###F. Hoffmann-La Roche Ltd###Presenter: – F. Hoffmann-La Roche Ltd
### she/her/hers
14:00 – 15:00 CEST
Cybersecurity
14:00 – 15:00 CEST
Cybersecurity: Integrating Medical Device Cybersecurity in the Quality Management SystemLocation: B 07 + B 08Session Leader/Speaker: – MEDIcept, Inc.
Presenter: – RAPS BoD
AI/Software
Gregg W. Van Citters, PhD (he/him/his) – MEDIcept, Inc. ### 2177808###Session Leader/Speaker###Sr. Software Quality Engineer###MEDIcept, Inc.###Session Leader/Speaker: – MEDIcept, Inc.
### he/him/his @@@ Kimberly A. Trautman, MS – RAPS BoD ### 535494###Presenter###Expert###RAPS BoD###Presenter: – RAPS BoD
###
14:00 – 15:00 CEST
Experience gain from implementing Article 5(5) of the IVDR in a network of European Laboratories
14:00 – 15:00 CEST
Experience Gain From Implementing Article 5(5) of the IVDR in a Network of European LaboratoriesLocation: B 09Session Leader/Speaker: – Unilabs
Presenter: – Technische Hochschule Lübeck Fachbereich Angewandte Naturwissenschaften
Presenter: – Axon Lawyers
Presenter: – Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE
IVDs
Marta Montilla – Unilabs ### 2177855###Session Leader/Speaker###Group IVDR Manager###Unilabs###Session Leader/Speaker: – Unilabs
### @@@ Folker Spitzenberger, PhD, MDRA (he/him/his) – Technische Hochschule Lübeck Fachbereich Angewandte Naturwissenschaften ### 2177859###Presenter###Professor for Regulatory Affairs###Technische Hochschule Lübeck Fachbereich Angewandte Naturwissenschaften###Presenter: – Technische Hochschule Lübeck Fachbereich Angewandte Naturwissenschaften
### he/him/his @@@ Erik R. Vollebregt, LLM – Axon Lawyers ### 535481###Presenter###Partner###Axon Lawyers###Presenter: – Axon Lawyers
### @@@ Ozan Aykurt, M.Sc. (he/him/his) – Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE ### 2177864###Presenter###Research Scientist in Regulatory Affairs for (AI/ML-enabled) Digital Health Solutions###Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE###Presenter: – Fraunhofer Research Institution for Individualized and Cell-Based Medical Engineering IMTE
### he/him/his
14:00 – 15:00 CEST
IMDRF Coding
14:00 – 15:00 CEST
IMDRF Coding: Complaints, Vigilance, Trend Analysis, and the Benefits of Codifying Your Post Market Surveillance SystemLocation: B 05 + B 06Moderator: – Medical Device Project B.V.
Presenter: – DLRC
Presenter: – Dutch Health and Youth Care Inspectorate
Medical Devices
Robert A. van Boxtel, MSc – Medical Device Project B.V. ### 907078###Moderator###Principal Consultant###Medical Device Project B.V.###Moderator: – Medical Device Project B.V.
### @@@ Richard Bassett, Msc, LLM – DLRC ### 1187567###Presenter###Principal Regulatory Consultant###DLRC###Presenter: – DLRC
### @@@ Paul Riem Vis – Dutch Health and Youth Care Inspectorate ### 2271044###Presenter######Dutch Health and Youth Care Inspectorate###Presenter: – Dutch Health and Youth Care Inspectorate
###
14:00 – 15:00 CEST
Post Market Clinical Studies
14:00 – 15:00 CEST
Post Market Clinical StudiesLocation: C 01Moderator & Presenter: – QServe Group
Presenter:
Presenter: – Corcym
Medical Devices
Bianca Lutters (she/her/hers) – QServe Group ### 1523608###Moderator & Presenter###Head of Clinical Operations###QServe Group###Moderator & Presenter: – QServe Group
### she/her/hers @@@ Béatrice Lys ### 2032883###Presenter#########Presenter:
### @@@ Mara Chiaro, DVM (she/her/hers) – Corcym ### 2300350###Presenter###Head of Clinical, Quality and Regulatory###Corcym###Presenter: – Corcym
### she/her/hers15:00 – 15:40 CEST
Coffee Break in the Exhibit Hall
15:00 – 15:40 CEST
Coffee Break in the Exhibit HallLocation: All Levels
15:00 – 15:40 CEST
Presenters at Posters (C Level)
15:00 – 15:40 CEST
Presenters at Posters (C Level)Location: C LevelPosters - Click to View
15:40 – 16:40 CEST
An overview of AI, Software and Cybersecurity regulations in Asia
15:40 – 16:40 CEST
An overview of AI, Software and Cybersecurity regulations in AsiaLocation: B 09Presenter: – FSQ Experts
Presenter: – Merative
Presenter: – Compliance and risks
AI/Software
Zhencan Xu, M.Sc. (she/her/hers) – FSQ Experts ### 2177842###Presenter###Medical Device Consultant###FSQ Experts###Presenter: – FSQ Experts
### she/her/hers @@@ Harshita Menon, MS – Merative ### 2177820###Presenter###Regulatory Affairs Specialist###Merative###Presenter: – Merative
### @@@ Pei Yu (Amy) Chen – Compliance and risks ### 1836062###Presenter###Regulatory Compliance Consultant###Compliance and risks###Presenter: – Compliance and risks
###
15:40 – 16:40 CEST
Blood, Sweat and Tears - Biologics and their Challenges
15:40 – 16:40 CEST
Blood, Sweat, and Tears – Biologics and Their ChallengesLocation: A 05 + A 06Moderator: – Parexel
Presenter: – ENTOURAGE GmbH
Presenter: – Pharmaceutcial
Pharmaceuticals
Siegfried Schmitt, PhD – Parexel ### 907098###Moderator###Vice President Technical###Parexel###Moderator: – Parexel
### @@@ Ralf D. Hess, PhD (he/him/his) – ENTOURAGE GmbH ### 2177822###Presenter###Principal Management Consultant###ENTOURAGE GmbH###Presenter: – ENTOURAGE GmbH
### he/him/his @@@ Yingying Liu, MSc (she/her/hers) – Pharmaceutcial ### 1187559###Presenter###Global Regulatory Affairs, Associate Director###Pharmaceutcial###Presenter: – Pharmaceutcial
### she/her/hers
15:40 – 16:40 CEST
IVDR Track Closing Panel: What Are The Remaining Challenges for IVDR?
15:40 – 16:40 CEST
IVDR Track Closing Panel: What Are The Remaining Challenges for IVDR?Location: C 01Moderator: – BSI
Presenter: – mi-CE consultancy
Presenter: – BSI
Presenter: – NBCG-Med - Notified Body Coordination Group
Presenter: – TUV Sud GmbH
Presenter: – European Commission DG for Health and Food Safety Medical Devices Unit SANTE B.6
IVDs
Alex Laan (he/him/his) – BSI ### 1945990###Moderator###Head of IVD Notified Body###BSI###Moderator: – BSI
### he/him/his @@@ Anja Wiersma, PhD (she/her/hers) – mi-CE consultancy ### 574723###Presenter###CEO / senior consultant###mi-CE consultancy###Presenter: – mi-CE consultancy
### she/her/hers @@@ Elizabeth Harrison (she/her/hers) – BSI ### 1401973###Presenter###Global Head, IVD###BSI###Presenter: – BSI
### she/her/hers @@@ Tom Patten, MSc – NBCG-Med - Notified Body Coordination Group ### 1141749###Presenter###Executive Committee -Secretary ###NBCG-Med - Notified Body Coordination Group###Presenter: – NBCG-Med - Notified Body Coordination Group
### @@@ Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Presenter###Head of Certification IVD###TUV Sud GmbH###Presenter: – TUV Sud GmbH
### @@@ 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
15:40 – 16:40 CEST
Orphan Devices
15:40 – 16:40 CEST
Orphan Devices: How to Obtain Orphan or Pediatric Medical Device ApprovalLocation: B 07 + B 08Moderator:
Presenter: – Elekta
Presenter: – Olympus Surgical Technologies Europe
Panelist: – European Medicines Agency
Medical Devices
Nataliya Deych ### 2016357###Moderator#########Moderator:
### @@@ Leo Hovestadt (he/him/his) – Elekta ### 535504###Presenter###Director Governmental Affairs EU###Elekta###Presenter: – Elekta
### he/him/his @@@ 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
### @@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Panelist###Head of Orphan Drugs###European Medicines Agency###Panelist: – European Medicines Agency
###
15:40 – 16:40 CEST
Regulatory Intelligence and Policy Strategy; Dynamic Regulatory Assessment as a case study
15:40 – 16:40 CEST
Regulatory Intelligence and Policy Strategy; Dynamic Regulatory Assessment as a Case StudyLocation: A 03 + A 04Presenter: – UCB
Presenter: – UCB
Presenter: – Gilead
Pharmaceuticals
Kasia A. Nowok, MSc – UCB ### 2177824###Presenter###Regulatory Intelligence Lead EU###UCB###Presenter: – UCB
### @@@ Rüdiger Faust, PhD – UCB ### 1828296###Presenter###Global Regulatory Intelligence & Policy Lead###UCB###Presenter: – UCB
### @@@ Nasir Hussain, BPharm, MBA, PhD (he/him/his) – Gilead ### 2177839###Presenter###EU Regulatory Policy Lead###Gilead###Presenter: – Gilead
### he/him/his
15:40 – 16:40 CEST
Structured Dialogue
15:40 – 16:40 CEST
Structured Dialogue: Innovative Pathways in Europe and UK: A Legal, Manufacturer’s, and Notified Bodies PerspectiveLocation: B 05 + B 06Presenter: – Smith+Nephew
Presenter: – Bristows LLP
Presenter: – Notified Body (BSI)
Panelist: – European Medicines Agency
Medical Devices
Darren J. Thain – Smith+Nephew ### 2177906###Presenter###Director, Regulatory Affairs###Smith+Nephew###Presenter: – Smith+Nephew
### @@@ Alex Denoon (he/him/his) – Bristows LLP ### 2177907###Presenter###Partner###Bristows LLP###Presenter: – Bristows LLP
### he/him/his @@@ Richard G. Holborow, MSCST RCCP (he/him/his) – Notified Body (BSI) ### 1523592###Presenter###Global Heal of Clinical Compliance###Notified Body (BSI)###Presenter: – Notified Body (BSI)
### he/him/his @@@ Alberto Ganan, PhD – European Medicines Agency ### 2262977###Panelist###Head of Committees and Quality Assurance Department###European Medicines Agency###Panelist: – European Medicines Agency
###
16:40 – 17:15 CEST
Closing Remarks & Farewell Toast
16:40 – 17:15 CEST
Closing Remarks and Farewell ToastLocation: BCC Forecourt (outside)
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