- 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/hers
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 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: – self-employed
Presenter: – PharmaLex
Presenter: – von basum consulting
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, Dr. (she/her/hers) – self-employed ### 2278109###Presenter###independent consultant###self-employed###Presenter: – self-employed
### she/her/hers @@@ Patrick Larcier, PharmD – PharmaLex ### 1718947###Presenter###Senior Director, Strategy Product Development Solutions###PharmaLex###Presenter: – PharmaLex
### @@@ Golo von Basum, PhD (he/him/his) – von basum consulting ### 2278790###Presenter###CEO###von basum consulting###Presenter: – von basum consulting
### he/him/his @@@ 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/his
08:30 – 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/his
13:00 – 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
