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Tuesday, May 13th
08:30 - 16:00 CEST
Preconference Workshop: EU Pharmaceutical Regulatory Reform
Location: Studio 202 (level 2)
Workshop Leader: Rebecca Lumsden, PhD (she/her/hers) – Sanofi
Speaker: Yves Jacob (he/him/his) – Sanofi
Speaker: Alberto Ganan, PhD – European Medicines Agency
Speaker: Lilia Luchianov – European Commission
Speaker: Nikos Dedes
Pharmaceuticals
Wednesday, May 14th
08:30 - 09:30 CEST
EU Pharmaceutical Regulatory Reforms – Time to Consider Implementation Challenges and Opportunities?
Location: Copper Hall (level 0)
Moderator & Presenter: Rebecca Lumsden, PhD (she/her/hers) – Sanofi
Speaker: Yves Jacob (he/him/his) – Sanofi
Speaker: Steffen Thirstrup, MD, PhD (he/him/his) – European Medicines Agency (EMA)
Speaker: Lilia Luchianov – European Commission
Speaker: Nikos Dedes
Speaker: Aimad Torqui – MSD
Pharmaceuticals
Wednesday, May 14th
08:30 - 09:30 CEST
Regulatory Considerations for Gene Therapy in Pediatric Patients
Location: The Arc (level 3)
Moderator: Stefanie Fasshauer, MBA – Cisema
Speaker: Johnathan Akers, Masters of Clinical Research – Independent Regulatory Affairs Professional
Speaker: Giovanni Lesa, PhD – European Medicines Agency
Pharmaceuticals
Wednesday, May 14th
10:45 - 11:45 CEST
Biosimilar Development
Location: Silver Hall (level 0)
Session Leader: Charlie Mortazavi, PharmD, MSc – AstraZeneca Rare Diseases, Alexion
Speaker: Cecil J. Nick, BSc (Hons) – Parexel
Speaker: Steffen Thirstrup, MD, PhD (he/him/his) – European Medicines Agency (EMA)
Speaker: Marija Pesic, Phd (she/her/hers) – Formycon AG, Martinsried/Planegg, Germany
Pharmaceuticals
Wednesday, May 14th
10:45 - 11:45 CEST
EU Variation Regulatory Reform – Creating Innovation in the Life-cycle Management
Location: The Arc (level 3)
Speaker: Agnes Dangy-Caye, Dr (she/her/hers) – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Speaker: Estelle A. Massoubre (she/her/hers) – Kenvue
Speaker: Alberto Ganan, PhD – European Medicines Agency
Pharmaceuticals
Wednesday, May 14th
12:00 - 13:00 CEST
HTA Regulation, Joint Clinical Assessments (JCA) & Joint Scientific Consultations (JSC): Adapting to the New EU Framework
Location: The Arc (level 3)
Session Leader/Speaker: Antje Behring
Speaker: Michael Berntgen, PhD MDRA – European Medicines Agency
Speaker: Anne Willemsen
Pharmaceuticals
Wednesday, May 14th
12:00 - 13:00 CEST
New International: Experiences with the Latest UK Submission Routes
Location: Studio 214 + 216 (level 2)
Session Leader: Kate Stockman
Speaker: Peter Fry – QbD Group
Speaker: Tasneem Fatima Keshavji – MHRA
Speaker: James Crooks – Product Life Group
Pharmaceuticals
Wednesday, May 14th
14:30 - 15:30 CEST
Accelerating Clinical Trials in EU
Location: The Arc (level 3)
Session Leader/Speaker: Rüdiger Faust, PhD – UCB
Speaker: Laura Pioppo, Ms – EMA
Pharmaceuticals
Wednesday, May 14th
14:30 - 15:30 CEST
Medicines Shortages
Location: Studio 214 + 216 (level 2)
Moderator: Michael Craig – Parexel
Speaker: Monica Dias, PhD (she/her/hers) – EMA
Speaker: Caroline De Bodt, PhD (she/her/hers) – UCB
Speaker: Anuja Shukla, MBA (she/her/hers) – UCB Pharma
Speaker: Pieter Jan Desiere – European Medicines Agency (EMA)
Speaker: Solene Jouan
Pharmaceuticals
Thursday, May 15th
08:30 - 09:30 CEST
Clean Industrial Deal
Location: The Arc (level 3)
Session Leader: Kate Stockman
Speaker: Veronika Jekerle, PhD – European Medicines Agency
Speaker: Kirsty Reid, PhD (she/her/hers) – EFPIA
Pharmaceuticals
Thursday, May 15th
08:30 - 09:30 CEST
Reliance Pathways Such as WHO Collaborative Registration Procedure (CRP) to Accelerate the Assessment and Registration of Medicinal Products
Location: Studio 214 + 216 (level 2)
Speaker: Merce Caturla Goni, PhD (she/her/hers) – Alexion Astra Zeneca Rare Diseases
Speaker: Victoria Palmi Reig – European Medicines Agency (EMA)
Pharmaceuticals
Thursday, May 15th
10:45 - 11:45 CEST
Digital Transformation in Regulatory Tools and Dossier Submission
Location: Studio 214 + 216 (level 2)
Moderator & Presenter: Agnes Dangy-Caye, Dr (she/her/hers) – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Speaker: Ashley Jones-Mitchell, BS (she/her/hers) – Accumulus Synergy
Speaker: Hannes Kulovic – European Medicines Agency
Pharmaceuticals
Thursday, May 15th
10:45 - 11:45 CEST
Patient-focused Drug Development in EU: From EPAR to Smpc?
Location: The Arc (level 3)
Session Leader: Charlie Mortazavi, PharmD, MSc – AstraZeneca Rare Diseases, Alexion
Speaker: Amaia Clemente, Pharmacist – Sanofi
Speaker: Kaisa Immonen, MA – European Medicines Agency
Speaker: Nikos Dedes
Pharmaceuticals
Thursday, May 15th
12:00 - 13:00 CEST
CMC Strategy / ICH Q9
Location: The Arc (level 3)
Speaker: Olga Braem, PhD – Kyowa Kirin
Speaker: Veronika Jekerle, PhD – European Medicines Agency
Pharmaceuticals
Thursday, May 15th
12:00 - 13:00 CEST
Current Developments and Regulatory Trends in Clinical Trial Design
Location: Studio 214 + 216 (level 2)
Session Leader/Speaker: Cecil J. Nick, BSc (Hons) – Parexel
Speaker: Darius-Jean Namdjou, PhD – Phortas GmbH
Pharmaceuticals
Thursday, May 15th
14:30 - 15:30 CEST
Combined Studies: Interface Between the Regulations on Clinical Trials of Medicinal Products, Medical Devices and in vitro Diagnostics (Current Situation and Future Regulatory Framework)
Location: Gold Hall (level 0)
Moderator: Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting
Speaker: Piritta M. Maunu (she/her/hers) – PharmaLex Finland
Speaker: Natalie Batty, MPH – Aignostics
Speaker: Ditte Zerlang Andersen, PhD (she/her/hers) – Danish Medicines Agency (DKMA)
Panelist: Christelle Bouygues, PharmD – EMA
Pharmaceuticals
Thursday, May 15th
14:30 - 15:30 CEST
From Confusion to Clarity: Decoding US and European Regulatory Meetings During Development, for Optimal Results
Location: The Arc (level 3)
Session Leader: Charlie Mortazavi, PharmD, MSc – AstraZeneca Rare Diseases, Alexion
Speaker: Hagit Marchaim, PhD, MBA (she/her/hers) – HMC-regulation
Speaker: Iordanis Gravanis, MD, PhD (he/him/his) – European Medicines Agency
Speaker: Christophe Lahorte – FAGG - Federal agency for medicines and health products (Belgium)
Pharmaceuticals
Thursday, May 15th
16:45 - 17:45 CEST
EMA and FDA Programs to Accelerate Innovation in Treating Unmet Medical Needs
Location: Studio 214 + 216 (level 2)
Moderator: Stefanie Fasshauer, MBA – Cisema
Speaker: Hagit Marchaim, PhD, MBA (she/her/hers) – HMC-regulation
Speaker: Kristina Larsson, MSc – European Medicines Agency
Speaker: Shannon Thor – U.S. Food and Drug Administration U.S. Mission to the European Union
Pharmaceuticals
Thursday, May 15th
16:45 - 17:45 CEST
The Value of Integrating Real-world and Trial Data to Increase Patient Benefit
Location: The Arc (level 3)
Session Leader: Charlie Mortazavi, PharmD, MSc – AstraZeneca Rare Diseases, Alexion
Speaker: Cecil J. Nick, BSc (Hons) – Parexel
Speaker: Muriel Pasté, PhD (she/her/hers) – UCB
Panelist: Andrej Segec, MPharm MSc – European Medicines Agency
Pharmaceuticals
Friday, May 16th
10:30 - 11:30 CEST
China Drug Regulatory Pathways: 2025 Key Updates and Deep-dive
Location: Studio 211 + 212 (level 2)
Session Leader/Speaker: Hamish King, RAC, LLB – Cisema
Speaker: Jacky Li, MSc – Cisema (Hong Kong) Limited
Pharmaceuticals
Friday, May 16th
10:30 - 11:30 CEST
Shaping the Future of mRNA Vaccines: A Regulatory Perspective
Location: The Arc (level 3)
Moderator: Stefanie Fasshauer, MBA – Cisema
Presenter: Mohamad Toutounji (he/him/his) – Molgenium
Speaker: Thomas Larsson, MSc, BSc – European Medicines Agency
Pharmaceuticals
Friday, May 16th
11:45 - 12:45 CEST
Device - Drug Borderlines – Challenges in Europe and the USA
Location: The Arc (level 3)
Session Leader/Speaker: Jane L. Arnold-Round, B.Eng Msc. – NAMSA
Speaker: Ortzi OLASOLO – Beyond Conception GmbH
Speaker: Alberto Ganan, PhD – European Medicines Agency
Panelist: Sebastian Fischer – TÜV SÜD Product Service GmbH
Pharmaceuticals
Friday, May 16th
11:45 - 12:45 CEST
Using Artificial Intelligence to Support Regulatory Processes and Decision-Making
Location: Studio 211 + 212 (level 2)
Session Leader/Speaker: Agnes Dangy-Caye, Dr (she/her/hers) – Agnès Dangy-Caye, Regulatory Science and Policy, Sanofi
Speaker: Florian Lasch, PhD (he/him/his) – European Medicines Agency
Speaker: Daria Mari (she/her/hers) – regenold GmbH
Pharmaceuticals