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Patient Access: Regulatory, HTA, and Patient Perspectives on an Orphan Drug – Case Study of Erythropoietic Protoporphyria

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Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting ### 573538###Moderator###Consultant###Benefits Regulatory Consulting###
Moderator: Beate R. Schmidt, MSc, MDRA, RAC – 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: Meriem Bouslouk-Marx, PhD, MSc International Health (she/her/hers) – 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: Jasmin Barman-Aksözen, PhD – International Porphyria Patient Network (IPPN)
### @@@ Karl-Heinz Huemer (he/him/his) – khhconsulting ### 573393###Presenter###Consultant###khhconsulting###
Presenter: Karl-Heinz Huemer (he/him/his) – khhconsulting
### he/him/his @@@ Kristina Larsson, MSc – European Medicines Agency ### 1061459###Panelist###Head of Orphan Drugs###European Medicines Agency###
Panelist: Kristina Larsson, MSc – European Medicines Agency
###
Patient-Centric Endpoints and Use of Digital Health Technologies

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Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting ### 573538###Moderator###Consultant###Benefits Regulatory Consulting###
Moderator: Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting
### @@@ Karl-Heinz Huemer (he/him/his) – khhconsulting ### 573393###Presenter###Consultant###khhconsulting###
Presenter: Karl-Heinz Huemer (he/him/his) – khhconsulting
### he/him/his @@@ Anirban Sadhu (he/him/his) – Teva Pharmaceuticals ### 2177828###Presenter###Vice President Regulatory Affairs###Teva Pharmaceuticals###
Presenter: Anirban Sadhu (he/him/his) – 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: Adrienne Lenz, RAC – Hyman, Phelps & McNamara, P.C.
###
Post Market Clinical Studies

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Bianca Lutters (she/her/hers) – QServe Group ### 1523608###Moderator & Presenter###Head of Clinical Operations###QServe Group###
Moderator & Presenter: Bianca Lutters (she/her/hers) – QServe Group
### she/her/hers @@@ Béatrice Lys ### 2032883###Presenter#########
Presenter: Béatrice Lys
### @@@ Mara Chiaro, DVM (she/her/hers) – Corcym ### 2300350###Presenter###Head of Clinical, Quality and Regulatory###Corcym###
Presenter: Mara Chiaro, DVM (she/her/hers) – Corcym
### she/her/hers
Post-Market requirements: Keeping PSUR and SSCP up to Date

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Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH ### 2016361###Moderator###Managing Director###PRO-LIANCE GLOBAL SOLUTIONS GmbH###
Moderator: Florian Tolkmitt – 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: Delphine Corriette Islanio, M Eng (she/her/hers) – W. L Gore & Associates
### she/her/hers @@@ Elizabeth Gfoeller, MA – MED-EL ### 766093###Presenter###Corporate Director, Regulatory Affairs ###MED-EL###
Presenter: Elizabeth Gfoeller, MA – MED-EL
### @@@ Markus Pöttker (he/him/his) – Smith+Nephew ### 2177811###Presenter###Director, Global Post-Market Surveillance###Smith+Nephew###
Presenter: Markus Pöttker (he/him/his) – Smith+Nephew
### he/him/his
Pre-Clinical Evaluations and Clinical Investigations. Strategizing Towards Efficiency and New Approaches Including in Silico Methods

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Jorn van Binsbergen, MSc (he/him/his) – Qserve ### 1944258###Presenter###Consultant / Clinical writer###Qserve###
Presenter: Jorn van Binsbergen, MSc (he/him/his) – Qserve
### he/him/his @@@ Charlott Danielson, M.Sc. (she/her/hers) – Fraunhofer IMTE ### 2179084###Presenter###Regulatory Affairs Manager###Fraunhofer IMTE###
Presenter: Charlott Danielson, M.Sc. (she/her/hers) – Fraunhofer IMTE
### she/her/hers
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

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Sarah Mathew – BSI ### 2177832###Session Leader/Speaker###Regulatory Lead###BSI###
Session Leader/Speaker: Sarah Mathew – BSI
### @@@ Marco Caproni (he/him/his) – TÜV SÜD ### 2232812###Presenter###Senior Product Specialist, Software###TÜV SÜD###
Presenter: Marco Caproni (he/him/his) – TÜV SÜD
### he/him/his @@@ Daniela Seneca – BSI ### 2232813###Presenter###Regulatory Lead###BSI###
Presenter: Daniela Seneca – BSI
###
Pre-Conference Workshop: EUDAMED

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Jayanth K. Katta, PhD – BSI ### 907116###Workshop Leader###Regulatory Director & Head of Medical Devices Notified Body###BSI###
Workshop Leader: Jayanth K. Katta, PhD – BSI
### @@@ Christoph Kiesselbach (he/him/his) – Schrack & Partner ### 2177850###Presenter###Partner###Schrack & Partner###
Presenter: Christoph Kiesselbach (he/him/his) – Schrack & Partner
### he/him/his @@@ Sally Humphreys, DPhil – BSI ### 2177835###Presenter###Clinical Compliance Manager###BSI###
Presenter: Sally Humphreys, DPhil – BSI
### @@@ Marina Madokoro (she/her/hers) – Johnson & Johnson MedTech ### 2237202###Presenter###UDI regulatory affairs manager ###Johnson & Johnson MedTech###
Presenter: Marina Madokoro (she/her/hers) – Johnson & Johnson MedTech
### she/her/hers
Pre-Conference Workshop: Global Regulatory CMC Approaches for Biologicals: From Strategy to Execution

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Neha Parashar, PMP® and PRINCE2® – Argenx ### 1827161###Workshop Leader###Associate Director/Principal Scientist###Argenx###
Workshop Leader: Neha Parashar, PMP® and PRINCE2® – Argenx
### @@@ Ankit Geete, RAC, PMP, CDMP, CBIP – BioNTech SE ### 1944257###Presenter###Director###BioNTech SE###
Presenter: Ankit Geete, RAC, PMP, CDMP, CBIP – BioNTech SE
###
Pre-Conference Workshop: IVDR Technical Documentation

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Marta Carnielli, PharmD – TUV Sud GmbH ### 1187616###Workshop Leader###Head of Certification IVD###TUV Sud GmbH###
Workshop Leader: Marta Carnielli, PharmD – TUV Sud GmbH
### @@@ Catherine Holzmann, PhD – GMED ### 1828311###Presenter###IVD Department Manager###GMED###
Presenter: Catherine Holzmann, PhD – GMED
### @@@ Alex Laan (he/him/his) – BSI ### 1945990###Presenter###Head of IVD Notified Body###BSI###
Presenter: Alex Laan (he/him/his) – 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: Tom Patten, MSc – NBCG-Med - Notified Body Coordination Group
###
Pre-Conference Workshop: Start-Ups: Effective Use of the Money of Your Investors - Know What to Aim For

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Jennifer Neff, PhD – Entourage GmbH ### 958555###Session Leader###Principal Consultant & Head of Medical Devices###Entourage GmbH###
Session Leader: Jennifer Neff, PhD – Entourage GmbH
### @@@ Robert A. van Boxtel, MSc – Medical Device Project B.V. ### 907078###Presenter###Principal Consultant###Medical Device Project B.V.###
Presenter: Robert A. van Boxtel, MSc – Medical Device Project B.V.
### @@@ Alberto Ganan, PhD – European Medicines Agency ### 2262977###Presenter###Head of Committees and Quality Assurance Department###European Medicines Agency###
Presenter: Alberto Ganan, PhD – European Medicines Agency
### @@@ Constantinos Ziogas, MD (he/him/his) – European Medicines Agency ### 2271494###Presenter###Head of SME Office###European Medicines Agency###
Presenter: Constantinos Ziogas, MD (he/him/his) – European Medicines Agency
### he/him/his @@@ Pascal Werner, MSc – self employed ### 2177863###Presenter###Regulatory Affairs consultant###self employed###
Presenter: Pascal Werner, MSc – self employed
### @@@ Robert Paassen, MSc (he/him/his) – Qserve ### 2177852###Presenter###Consultant###Qserve###
Presenter: Robert Paassen, MSc (he/him/his) – Qserve
### he/him/his @@@ Yamin Wang, Dr. (she/her/hers) – self-employed ### 2278109###Presenter###independent consultant###self-employed###
Presenter: Yamin Wang, Dr. (she/her/hers) – self-employed
### she/her/hers @@@ Patrick Larcier, PharmD – PharmaLex ### 1718947###Presenter###Senior Director, Strategy Product Development Solutions###PharmaLex###
Presenter: Patrick Larcier, PharmD – PharmaLex
### @@@ Golo von Basum, PhD (he/him/his) – von basum consulting ### 2278790###Presenter###CEO###von basum consulting###
Presenter: Golo von Basum, PhD (he/him/his) – von basum consulting
### he/him/his @@@ Andreas Jordan ### 2278791###Presenter#########
Presenter: Andreas Jordan
### @@@ Tim Schnieder ### 2278793###Presenter#########
Presenter: Tim Schnieder
### @@@ Thomas Dobmeyer, Dr (he/him/his) – ekwithree GmbH ### 2281145###Presenter###Advisor###ekwithree GmbH###
Presenter: Thomas Dobmeyer, Dr (he/him/his) – ekwithree GmbH
### he/him/his
Pre-Conference Workshop: What Does it Take From CE to MDSAP?

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Corinne Delorme, RAC – nexialist ### 1523467###Workshop Leader###Regulatory Intelligence Director###nexialist###
Workshop Leader: Corinne Delorme, RAC – nexialist
### @@@ Vincent Castéras, PhD – nexialist ### 1543942###Presenter###CEO and Founder###nexialist###
Presenter: Vincent Castéras, PhD – nexialist
### @@@ Szymon Kurdyn – DQS Medizinprodukte GmbH ### 1550651###Presenter###Head of Notified Body (non-active medical devices)###DQS Medizinprodukte GmbH###
Presenter: Szymon Kurdyn – DQS Medizinprodukte GmbH
### @@@ Maxim Shkolnikov (he/him/his) – TÜV NORD CERT ### 2227006###Presenter###Technical Manager, Medical Device International###TÜV NORD CERT###
Presenter: Maxim Shkolnikov (he/him/his) – TÜV NORD CERT
### he/him/his