Sponsored Presentations - Exhibition Hall

Type here to filter the list

Tuesday, May 5th
08:30 - 16:00 WEST
Pre-Conference Workshop: Driving Change: How to Successfully Implement AI and Digital Transformation in Regulatory Affairs (MD, Pharma, IVDR)
Location: Pavilion 5 - Room 5C
Workshop Leader: Florian Tolkmitt – PRO-LIANCE GLOBAL SOLUTIONS GmbH
Speaker: Sarah Haake-Schäfer (she/her/hers) – Carl Zeiss Vision International GmbH
Speaker: Erika Schuettfort, PhD (she/her/hers) – Vorsa
Speaker: Frank Pétavy, MSc (he/him/his) – European Medicines Agency
Speaker: Emilie Santos, BSc. MSc. PhD (she/her/hers) – Philips Healthcare
Speaker: Julia Friedrich, PhD (she/her/hers) – Miltenyi Biotec B.V. & Co. KG
Speaker: Jean-Pierre Doan, MSc. MBA – Merck KGaA
Speaker: Paul Bolot, PharmD (he/him/his) – Bayer (on behalf of EFPIA)
Speaker: Yun-Hsuan Chang, MD MSc – Scarlet
Pre-Conference WorkshopDigital HealthPharmaceuticalsMedical Devices
Tuesday, May 5th
08:30 - 16:00 WEST
Pre-Conference Workshop: International Regulatory Collaborative Initiatives: Reliance, Work-Sharing - Strategic Regulatory Pathways
Location: Pavilion 5 - Room 5B
Workshop Leader: Mercè Caturla Goñi, PhD (she/her/hers)
Workshop Leader: Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting
Workshop Leader: Alexandra Eckhoff – Sanofi
Speaker: Victoria Palmi Reig – European Medicines Agency (EMA)
Speaker: Tasneem Fatima Keshavji – MHRA
Speaker: Cornelia Bigler, MSc, PhD (she/her/hers) – Swissmedic
Speaker: Sergio Cavalheiro Filho, PharmD (he/him/his) – IFPMA
Pre-Conference WorkshopPharmaceuticals
Wednesday, May 6th
08:30 - 09:30 WEST
Documents Are Data You Never Knew You Had: AI Tools Can Unlock Their Knowledge
Location: Auditorium 4
Moderator: Jean-Pierre Doan, MSc. MBA – Merck KGaA
Speaker: Frank Pétavy, MSc (he/him/his) – European Medicines Agency
Speaker: Paul Bolot, PharmD (he/him/his) – Bayer (on behalf of EFPIA)
Speaker: Matt Rogon, PhD (he/him/his) – Merck Healthcare KGaA, Germany (on behalf of EFPIA)
Pharmaceuticals
Wednesday, May 6th
08:30 - 09:30 WEST
Reimagining Europe's Innovation Landscape: Leveraging New Legislation to Accelerate Development and Maintain Competitiveness
Location: Pavilion 5
Moderator: Alberto Ganan, PhD – European Medicines Agency
Panelist: Steffen Thirstrup, MD, PhD (he/him/his) – European Medicines Agency (EMA)
Panelist: Rui Santos Ivo – INFARMED – National Authority of Medicines and Health Products, I.P.
Panelist: Inês Alves – ANDO Portugal - National Association for Skeletal Dysplasias
Panelist: Nick Sykes – EFPIA
Panelist: Antonios Rodiadis – European Commission
Pharmaceuticals
Wednesday, May 6th
10:45 - 11:45 WEST
New Pharmaceutical Legislation in Europe – From Legislation to Implementation
Location: Pavilion 5
Moderator: Rebecca Lumsden, PhD (she/her/hers) – Sanofi
Speaker: Bruno Sepodes, PharmD MSc PhD MPH – INFARMED – National Authority of Medicines and Health Products, I.P.
Speaker: Marta Marcelino, PharmD – INFARMED – National Authority of Medicines and Health Products, I.P.
Panelist: Alberto Ganan, PhD – European Medicines Agency
Panelist: Kieran Maher, MSc, (he/him/his) – Alexion/AstraZeneca
Panelist: Inês Alves – ANDO Portugal - National Association for Skeletal Dysplasias
Panelist: Antonios Rodiadis – European Commission
Pharmaceuticals
Wednesday, May 6th
12:00 - 13:00 WEST
Evolving Role of Patients in the Pharmaceutical Landscape: a Two—way Street Enabled by Innovation
Location: Pavilion 5
Moderator: Kaisa Immonen, MA – European Medicines Agency
Speaker: Anne Gervais, Pharmacist (she/her/hers) – Sanofi
Speaker: Rosa Gonzalez-Quevedo – European Medicines Agency (EMA)
Panelist: Amaia Clemente, Pharm – Sanofi
Panelist: Bruno Sepodes, PharmD MSc PhD MPH – INFARMED – National Authority of Medicines and Health Products, I.P.
Panelist: Nikos Dedes – European AIDS Treatment Group
Pharmaceuticals
Wednesday, May 6th
12:00 - 13:00 WEST
Opportunities and Challenges with International Collaborative Initiatives
Location: Auditorium 4
Moderator: Mercè Caturla Goñi, PhD (she/her/hers)
Speaker: Victoria Palmi Reig – European Medicines Agency (EMA)
Speaker: Ines Lenic, MSc – AstraZeneca
Speaker: Tasneem Fatima Keshavji – MHRA
Pharmaceuticals
Wednesday, May 6th
14:30 - 15:30 WEST
Combination Products: Navigating Regulatory Landscapes Across EU, US and China
Location: Auditorium 3
Speaker: Hamish King, LLB, RACS – Cisema
Speaker: Alberto Ganan, PhD – European Medicines Agency
Speaker: Matthew Krueger, MS, RAC (US) (he/him/his) – Biologics Consulting Group, Inc.
Speaker: Ellé Lacey, MChem (she/her/hers) – AstraZeneca
Pharmaceuticals
Wednesday, May 6th
14:30 - 15:30 WEST
Electronic Product Information (ePI) in Action: From Pilots to successful Implementation in Europe
Location: Pavilion 5
Moderator: Mercè Caturla Goñi, PhD (she/her/hers)
Speaker: Sabine Faber, PhD – Sanofi
Speaker: Norbert Gerbsch, MSc, PhD (he/him/his) – IGES Institut GmbH
Speaker: Elizabeth Scanlan, MSc, PhD – European Medicines Agency
Pharmaceuticals
Thursday, May 7th
08:30 - 09:30 WEST
From Parallel Pathways to Collaborative workstreams: The Evolving EMA–FDA Regulatory Partnership
Location: Pavilion 5
Moderator: Andreas Emmendoerffer, MD, PhD (he/him/his) – Roche
Speaker: Carlos Aicardo, MSc – European Medicines Agency (EMA)
Speaker: Shannon Thor – U.S. Food and Drug Administration U.S. Mission to the European Union
Pharmaceuticals
Thursday, May 7th
08:30 - 09:30 WEST
Variations 1 Year In
Location: Auditorium 3
Moderator: Jasmina Savic – Phortas GmbH
Speaker: Virginia Rojo Guerra – European Medicines Agency (EMA)
Speaker: Andreia Carvalho, PharmD – Grunenthal Group
Pharmaceuticals
Thursday, May 7th
10:45 - 11:45 WEST
COMBINE: Navigating the Latest Trends in Combined Trials
Location: Pavilion 5
Speaker: Maham Ansari, MS, RAC – Precision for Medicine
Speaker: Marina Belonogova, PhD (she/her/hers) – Johnson & Johnson
Speaker: Monique Al, PhD (she/her/hers) – CCMO
Speaker: Christelle Bouygues, PharmD – EMA
Pharmaceuticals
Thursday, May 7th
10:45 - 11:45 WEST
Real-World Evidence
Location: Auditorium 3
Speaker: Cecil J. Nick, BSc (Hons) – Parexel
Speaker: Andrej Segec, MPharm MSc (he/him/his) – European Medicines Agency
Pharmaceuticals
Thursday, May 7th
12:00 - 13:00 WEST
Conditional Approval and Expedited Pathways: EU and US Regulatory Strategies
Location: Auditorium 3
Speaker: Hagit Marchaim, PhD, MBA (she/her/hers) – HMC-regulation
Speaker: Elena de Villa, MSc (she/her/hers) – European Medicines Agency (EMA)
Pharmaceuticals
Thursday, May 7th
12:00 - 13:00 WEST
Regulatory Affairs as a Cornerstone for NAMs Implementation: Building Collaborative Pathways with EU Health Authorities
Location: Pavilion 5
Moderator: Michael Craig – Parexel
Speaker: Béatrice Huret, PharmD – Sanofi
Speaker: Paul Desert, Pharm D MSc ERT (he/him/his) – Sanofi R&D Vaccins
Speaker: Orla Moriarty, PhD – European Medicines Agency (EMA)
Pharmaceuticals
Thursday, May 7th
14:30 - 15:30 WEST
Advanced therapy medicinal products (ATMPs), challenges of their regulatory pathways and their global potential in rare diseases
Location: Pavilion 5
Speaker: Darius-Jean Namdjou, PhD (he/him/his) – Phortas GmbH
Speaker: Mohamad Toutounji, Ph.D (he/him/his) – Molgenium
Speaker: Catherine Drai – European Medicines Agency
Pharmaceuticals
Thursday, May 7th
14:30 - 15:30 WEST
EU CTR, UK CTA Reform, and ICH E6(R3): Strategies for Clinical Trial Success in the EU and UK
Location: Auditorium 3
Moderator: Kate Stockman – Kenvue
Speaker: Laura Pioppo, Ms – EMA
Speaker: Crina Cacou, PhD CPhys MInstP (she/her/hers) – Medicines and Healthcare products Regulatory Agency (MHRA)
Speaker: Dmitry Obolskiy, PhD – QbD Group
Pharmaceuticals
Thursday, May 7th
16:45 - 17:45 WEST
European Regulatory System for Medicines - Any Question Goes
Location: Pavilion 5
Moderator: Sabine Haubenreisser, MSc, PhD, FRAPS (she/her/hers) – European Medicines Agency
Panelist: Alberto Ganan, PhD – European Medicines Agency
Panelist: Kaisa Immonen, MA – European Medicines Agency
Panelist: Frank Pétavy, MSc (he/him/his) – European Medicines Agency
Panelist: Silvy Da Rocha Dias – European Medicines Agency
Panelist: Marta Marcelino, PharmD – INFARMED – National Authority of Medicines and Health Products, I.P.
Panelist: Ivica Malnar, PhD (he/him/his) – Agency for Medicinal Products and Medical Devices (HALMED)
Pharmaceuticals
Thursday, May 7th
16:45 - 17:45 WEST
Supply Chain/Manufacturing
Location: Auditorium 3
Moderator: Michael Craig – Parexel
Speaker: Athanasios Lapatinas, PhD – European Medicines Agency
Speaker: Hilary Daniel – USP
Pharmaceuticals
Friday, May 8th
11:15 - 12:15 WEST
Life After NBOp: Navigating Post-Market Compliance and Mastering Change Management for Combination Products
Location: Pavilion 5
Speaker: Tiina A. Riihimäki, PhD (she/her/hers) – Cencora
Speaker: Theresa Jeary, MSc – BSI
Speaker: Ana Pilar Olmos – Beyond Conception
Panelist: Christelle Bouygues, PharmD – EMA
Pharmaceuticals
Friday, May 8th
11:15 - 12:15 WEST
One year after – Observations, insights, implications on JCA
Location: Auditorium 3
Speaker: Matteo Scarabelli, PhD (he/him/his) – EFPIA
Speaker: Noemie Manent – European Medicines Agency (EMA)
Speaker: Daria Mari, PharmD (she/her/hers) – regenold GmbH
Speaker: Anne Willemsen
Speaker: Thomas Ecker, MA, PhD (he/him/his) – Ecker + Ecker GmbH
Pharmaceuticals
Friday, May 8th
12:30 - 13:30 WEST
Environment Regulatory
Location: Pavilion 5
Speaker: Thomas Wejs Møller, Master's degree in Political Science – Novo Nordisk A/S
Speaker: Jacob Moberg Sandager, Master’s degree in Materials and Manufacturing (he/him/his) – Novo Nordisk
Speaker: Claudia Vincenzi, MPharm, PhD (she/her/hers) – European Medicines Agency (EMA)
Pharmaceuticals
Friday, May 8th
12:30 - 13:30 WEST
M4Q
Location: Auditorium 3
Moderator: Michael Craig – Parexel
Speaker: David Murray, PhD – Parexel International
Speaker: Ivica Malnar, PhD (he/him/his) – Agency for Medicinal Products and Medical Devices (HALMED)
Speaker: Helen Newton (she/her/hers) – MSD
Pharmaceuticals