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Clinical Trial Events

DIA Europe

Mar 18–20

Mar 18–20, 2025 Ended

Congress Center Basel · Basel, Switzerland · In person and online

DIA Europe 2025, taking place in Basel, Switzerland from March 18-20, 2025, focuses on sustainability, innovation, and collaboration in healthcare. The conference aims to discuss how collaboration and innovation can support sustainability in healthcare. Attendees will gain insights from across the drug development lifecycle and play an active role in shaping the future of the pharmaceutical arena. This event will feature discussions on the environmental impact of pharmaceuticals and the drug development lifecycle, sustainable partnerships, and sustainable healthcare systems. The power of collaboration will be highlighted to inspire actionable outcomes and mobilize solutions within the life sciences community.

Venue
Congress Center Basel
Program
14 tracks · 93 sessions
330 speakers
Organizer
DIA

Agenda

Times in Basel (CET)
Tue, Mar 18 Wed, Mar 19 Thu, Mar 20

  1. 9:30 AM

    30 min

    Talk · Additional Sessions · San Francisco Room

    S0001 - Opening Session

    Ania Mitan, DIA Marwan Fathallah, Drug Information Association (DIA) Patrice Verpillat, European Medicines Agency Rajarshi Banerjee, Perspectum Ltd Nikos Dedes, Greek Patients Association Cynthia Verst, IQVIA Alison Cave, Medicines and Healthcare Products Regulatory Agency (MHRA) Sahirzeeshan Ali, Modi Ventures Peiling Yap, HealthAI

  2. 10:00 AM

    30 min

    Break · Exhibition Hall

    Coffee Break

  3. 10:30 AM

    90 min

    Talk · DIAmond Session · San Francisco Room

    DMD01 - EU Regulatory Townhall - Ensuring Regulatory Excellency

    Julian Isla, Foundation 29 María Lamas, Spanish Agency for Medicines and Medical Devices (AEMPS) Rainer Becker, European Commission Virginia Acha, MSD Emer Cooke, European Medicines Agency Steffen Thirstrup, European Medicines Agency

  4. 10:35 AM

    25 min

    Talk · Sponsored Sessions · Innovation Hub (in Exhibition Hall)

    IH01 - 4 Learnings for Successfully Deploying a Regulatory Writing AI Tool at Scale (Exhibition Hall)

    Emmanuel Walckenaer, Yseop

  5. 11:50 AM

    60 min

    Talk · Additional Sessions · Delhi Room

    S0003 - NextGen Project: Genomic Penetrance aspects of NextGen

    Evangelia Anna Markatou, HL7 Europe Anwar Chahal, WellSpan Health Catherine Chronaki, HL7 Europe Foundation Jasmine Gratton, European Medicines Agency Philippe Page, Human Colossus Foundation

  6. 12:00 PM

    90 min

    Break · Exhibition Hall

    Lunch Break

  7. 12:10 PM

    25 min

    Talk · Sponsored Sessions · Innovation Hub (in Exhibition Hall)

    IH02 - What questions are HCPs asking about your medicines, and do your SRDs answer them? (Exhibition Hall)

    Ian Hamilton, Datapharm Michelle Bridenbaker, Recordati

  8. 12:15 PM

    45 min

    Talk · Sponsored Sessions · Sydney Room

    SPS02 - How does a harmonized, unified, and integrated platform enhance pharmacovigilance processes, and what are the key benefits of consolidating multiple systems into a single solution?

    Raj More, RxLogix

  9. 12:15 PM

    45 min

    Talk · Data Science, RWE & Artificial Intelligence · Boston 1-2 Room

    SPS01 - Lunchtime Conversation: How dynamic, AI-curated real-world data assets ensure long-term data validity, completeness, and comprehensive RWE generation.

    Or Shaked, Briya

  10. 12:15 PM

    60 min

    Poster · Additional Sessions · Shanghai 1-2 Room

    Poster Session 1 - Meeting Unmet Medical Needs in Rare Diseases: Are Patient Preferences and Incentives Aligned with Policy?

    Neil Bertelsen, Health Technology Assessment international (HTAi) Thomas Desmet, KU Leuven Zilke Claessens, KU Leuven Io Wens, KU leuven Alice Vanneste, KU Leuven Linda Smeding, GlaxoSmithKline Edyta Maciolek, CTR Consulting

  11. 1:15 PM

    20 min

    Talk · Sponsored Sessions · Innovation Hub (in Exhibition Hall)

    IH04 - Digital Transformation in Life Sciences: Why Adoption is the Missing Piece (Exhibition Hall)

    Rishabh Mishra, Whatfix

  12. 1:30 PM

    70 min

    Talk · Data Science, RWE & Artificial Intelligence · San Francisco Room

    S0301 - AI in Medicines Development: Making it Happen - Part 1: A European Viewpoint

    Susan Sandler, Johnson & Johnson Nadia Terranova, Merck KGaA, Darmstadt, Germany (EMD Serono, US) Nicolas Loeffler-Perez, Swissmedic Milana Trucl, European Patients' Forum Luis Pinheiro, European Medicines Agency Thomas Brookland, F. Hoffmann-La Roche Ltd

  13. 1:30 PM

    70 min

    Talk · Regulatory Strategy & EU Pharmaceutical Policy · Montreal Room

    S0902 - Need is in the eye of the beholder: Unmet Medical Need from different perspectives and how to find common solutions

    Rick Vreman, Roche Niklas Hedberg, Dental and Pharmaceutical Benefits Agency, TLV Lucia D'Apote, Amgen Julian Isla, Foundation 29 Isabelle Huys, KU Leuven Francesca Cerreta Tamara Di Carlantonio, Roche

  14. 1:30 PM

    70 min

    Talk · Clinical Trials Innovation · Singapore Room

    S0101 - The Right Future Model for Europe: CTR and How to Move Forward (Including X-Border Trials)

    Nikos Dedes, Greek Patients Association Isabelle Clamou, European Commission Ann Marie Janson Lang, Swedish Medical Products Agency Monique Al, CCMO, Then Netherlands Susan Bhatti, Merck BV Martin O'Kane, Novartis Lada Leyens, Takeda Marianne Lunzer, AGES MEA

  15. 1:30 PM

    70 min

    Talk · Pharmacovigilance & Safety · Sydney Room

    S0701 - Evolving Regulatory Landscape in PV

    Phil Tregunno, Medicines and Healthcare Products Regulatory Agency (MHRA) Lucinda Smith, Roche Greg Ball, ASAPprocess Begum Benli Peker, Bristol Myers Squibb Wim van der Spuij, Bristol Myers Squibb

  16. 1:30 PM

    70 min

    Talk · Innovative Therapies, Precision Medicine & Diagnostics · Boston 1-2 Room

    S0501 - Overcoming global challenges for Advanced Therapy Medicinal Products through Collaboration, Regulatory Convergence & Reliance

    Kowid Ho, F. Hoffmann-La Roche Ltd Günter Waxenecker, Austrian Medicines and Medical Devices Agency (AGES) Stuart Beattie, Biogen Julia Djonova, Swissmedic Asmaa Fouad, Egyptian Drug Authority Caroline Pothet, European Medicines Agency Ilona Reischl-Kok, AGES

  17. 1:30 PM

    70 min

    Talk · Global Insights · Shanghai 1-2 Room

    S0403 - China Townhall: Continuous Regulatory Reformation Frosting Chinese Innovation Ecosystem for Global Health

    Fan Zhang, Center for Drug Evaluation (CDE), NMPA Dingheng Zhang, CCFDIE, NMPA Lin Shi, Beijing LNKMED (Lingxun) Medicine Wenhong Li, Hoffman La-Roche Katrin Rupalla, Johnson & Johnson (J&J) Innovative Medicine Jessica Liu, Tigermed Consulting Co., Ltd

  18. 2:30 PM

    120 min

    Talk · DIAlogue Sessions · Delhi Room

    S1105 - Startup Accelerator

    Marianne Lunzer, AGES MEA Anke Arnold-Tugulu, Azafaros B.V. Falk Ehmann, European Medicines Agency Markus Kalousek, BioGeneration Ventures Gurmit Sandhu, Gurmit Sandhu Consulting GmbH Anja Schiel, Norwegian Medicines Agency (NoMA) Elmar Nimmesgern, European Commission Ursula Busse, Self Employed Monique Al, CCMO, Then Netherlands

  19. 2:40 PM

    30 min

    Break · Exhibition Hall

    Coffee Break

  20. 3:10 PM

    70 min

    Talk · Data Science, RWE & Artificial Intelligence · San Francisco Room

    S0302 - AI in the Medicines Lifecycle: Accelerating Innovation. Part 2: A Global Perspective

    Nicolas Loeffler-Perez, Swissmedic Alison Bond, Amgen Sam Laermans, NNIT Michail Doulis, AstraZeneca Luis Pinheiro, European Medicines Agency Alison Cave, Medicines and Healthcare Products Regulatory Agency (MHRA) Ana Padua, Merck

  21. 3:10 PM

    70 min

    Talk · Regulatory Strategy & EU Pharmaceutical Policy · Montreal Room

    S0901 - Multistakeholder Collaboration to Drive Regulatory Science in Europe

    Nick Sykes, EFPIA Sophie Huiskes-Berends, Lygature Nathalie Seigneuret, Innovative Health Initiative (IHI) Sophia Samodelov, University Hospital Zurich Ralf Herold, European Medicines Agency Marjon Pasmooij, Medicines Evaluation Board / Utrecht University

  22. 3:10 PM

    70 min

    Talk · Global Insights · Singapore Room

    S0411 - ICH Townhall

    Lenita Lindström, European Commission Gabriela Zenhaeusern, Swissmedic Julia Djonova, Swissmedic Peter Twomey, European Medicines Agency Pär Tellner, EFPIA

  23. 3:10 PM

    70 min

    Talk · Pharmacovigilance & Safety · Sydney Room

    S0702 - Real World Data Access and Availability: Actions to Accelerate Answers in Pharmacovigilance

    Patrice Verpillat, European Medicines Agency Marieke Schoonen, Amgen Kendal Harrison, MHRA William Blumentals, Sanofi James Whitehead, Egetis Therapeutics

  24. 3:10 PM

    70 min

    Talk · Innovative Therapies, Precision Medicine & Diagnostics · Boston 1-2 Room

    S0502 - Personalised Medicine: Challenges and Opportunities for the Integration in Product Development - Multi-stakeholder Views

    Elizabeth Macintyre, Biomedical Alliance in Europe Caroline Pothet, European Medicines Agency Celine Bourguignon, GSK Tomasz Dyląg, European Commission

  25. 3:10 PM

    70 min

    Talk · Global Insights · Kairo 1-2 Room

    S0402 - Middle East Townhall: Collaboration and Future-Proofing the Regulatory Framework

    Samvel Azatyan, Council for International Organizations of Medical Sciences Donia Al Bastaki, Ministry of Health, Drug and Food Control and Control Administration Kuwait Amira Deia Younes, MSD Asmaa Fouad, Egyptian Drug Authority Fatima Al Kaabi, Emirates Drug Establishment (EDE) Jameel M Althiyabi, Saudi Food & Drug Authority (SFDA) Fadila Lakkis, GSK

  26. 3:10 PM

    70 min

    Talk · Global Insights · Shanghai 1-2 Room

    S0404 - Japan Townhall

    Daisuke Tanaka, Pharmaceuticals and Medical Devices Agency (PMDA) Meni Melek, Novartis Shinichi Noda, Pharmaceuticals and Medical Devices Agency Eri Sekine, CMIC CO., LTD

  27. 4:20 PM

    40 min

    Break · Exhibition Hall

    Coffee Break

  28. 4:25 PM

    25 min

    Talk · Sponsored Sessions · Innovation Hub (in Exhibition Hall)

    IH05 - Safeguarding the Future of Biopharmaceutical Innovation: Biorepository and Stability Storage Solutions for Sustainable Drug Development (Exhibition Hall)

    Wendy Cullen, Astoriom

  29. 5:00 PM

    90 min

    Talk · DIAmond Session · San Francisco Room

    DMD02 - Europe Leading the Charge: Pioneering a Global Digitalisation Strategy for Medicine Regulation

    Valentina Strammiello, European Patients' Forum Chris Walker, Amgen Karl Broich, Federal Institute for Drugs and Medical Devices (BfArM) Aimad Torqui, Medicines Evaluation Board Elena Bonfiglioli, Microsoft Rodrigo Palacios, F. Hoffmann-La Roche Zaide Frias, European Medicines Agency Tomasz Dyląg, European Commission

  30. 5:00 PM

    90 min

    Talk · DIAmond Session · Montreal Room

    DMD03 - Optimising the Value of Patient Experience Data (PED)

    Christian Pfeuffer, EUPATI Antonella Cardone, Cancer Patients Europe Monique Al, CCMO, Then Netherlands Almath Spooner, AbbVie Niklas Hedberg, Dental and Pharmaceutical Benefits Agency, TLV Nikos Dedes, Greek Patients Association Juan Garcia Burgos, European Medicines Agency

  31. 6:30 PM

    60 min

    Networking · Exhibition Hall

    Welcome Reception

  1. 8:30 AM

    70 min

    Talk · CMC & Product Quality · San Francisco Room

    S0201 - Global Partnerships to Accelerate Availability of Quality Medicines

    Mark Pellett, AstraZeneca Susanne Ausborn, Roche Christian Schärer, Swissmedic Ian Jackson, MHRA Evangelos Kotzagiorgis, European Medicines Agency Lorraine Nolan, Health Products Regulatory Authority Hugo Ta, Gilead Sciences Marie Valentin, World Health Organization (WHO) Yasuhiro Kishioka, Pharmaceuticals and Medical Devices Agency (PMDA) Evdokia  Korakianiti, European Medicines Agency Brendan Cuddy, European Medicines Agency

  2. 8:30 AM

    70 min

    Talk · Data Science, RWE & Artificial Intelligence · Montreal Room

    S0303 - Use of RWE for Regulatory Decision Making

    Leonie Rudofsky, Swissmedic Karl Broich, Federal Institute for Drugs and Medical Devices (BfArM) Almath Spooner, AbbVie Amaia Clemente, sanofi Aneta Tyszkiewicz, EFPIA - European Federation of Pharmaceutical Industries and Associations Patrice Verpillat, European Medicines Agency

  3. 8:30 AM

    70 min

    Talk · Global Insights · Singapore Room

    S0405 - European Medicines Agencies Network strategy to 2028: Spotlight on Innovation & Competitiveness

    Beata Stepniewska, Medicines for Europe Nikos Dedes, Greek Patients Association Falk Ehmann, European Medicines Agency María Lamas, Spanish Agency for Medicines and Medical Devices (AEMPS) Katrin Rupalla, Johnson & Johnson (J&J) Innovative Medicine Rui Santos Ivo, INFARMED - National Authority of Medicines and Health Products, I.P. Melanie Carr, European Medicines Agency

  4. 8:30 AM

    70 min

    Roundtable · Regulatory Operations · Sydney Room

    S0801 - Digital Transformation and Structured Data: the Future of Regulatory Operations

    Tim Powell, Biogen Kate Porch, Johnson & Johnson Rodrigo Palacios, F. Hoffmann-La Roche Luis Miranda, CSL Zaide Frias, European Medicines Agency Jamie Morisco, Glemser Technologies Michael Abernathy, Amgen Inc.

  5. 8:30 AM

    70 min

    Talk · Medical Devices & Combination Products · Boston 1-2 Room

    S0601 - Innovative EU Regulations - The Future of Combination Products

    Michael Kuehler, Bayer AG Thomas Wejs Møller, Novo Nordisk Alberto Ganan Jimenez, European Medicines Agency Sabina Hoekstra-van den Bosch, TÜV SÜD Celine Bourguignon, GSK

  6. 8:30 AM

    70 min

    Talk · Clinical Trials Innovation · Delhi Room

    S0102 - Patient Involvement During the Lifecycle of Clinical Trials

    Cathelijne de Gram, Johnson & Johnson Monique Al, CCMO, Then Netherlands Evelijn Zeijdner, IKNL Marina Malikova, Boston University School of Medicine Susan Bhatti, Merck BV Begonya Nafria, Hospital Sant Joan de Déu Barcelona

  7. 8:30 AM

    70 min

    Talk · Innovative Therapies, Precision Medicine & Diagnostics · Kairo 1-2 Room

    S0503 - Understanding Changing European Regulatory Landscape: Combined Clinical Trials and COMBINE Solutions

    Dario Trapani, European Oncology Institute Adriana Racolta, Bayer Mike Wierzba, GSK Thomas Sudhop, BfArM Ana Trullás Jimeno, European Medicines Agency Ditte Zerlang Andersen, Danish Medicines Agency (DKMA) Lucia D'Apote, Amgen Claudia Popp, Roche

  8. 8:30 AM

    70 min

    Talk · DIAlogue Sessions · Shanghai 1-2 Room

    S1104 - Global Solutions to Antimicrobial Resistance (AMR)

    Michael Lobritz, Roche Julia Anna Bielicki, University Children's Hospital Basel Rohit Malpani, Global Antibiotic Research & Development Partnership (GARDP)

  9. 9:40 AM

    50 min

    Break · Exhibition Hall

    Coffee Break

  10. 9:50 AM

    25 min

    Talk · Sponsored Sessions · Innovation Hub (in Exhibition Hall)

    IH06 - Innovating Data Analytics for Drug Safety: Harnessing AI, Automation, and Advanced Insights (Exhibition Hall)

    Raj More, RxLogix

  11. 10:30 AM

    70 min

    Talk · Value & Access · San Francisco Room

    S1002 - HTA Townhall: Outlook and Opportunities for Translating Regulatory Approval into Access Decisions

    Mitchell Silva, EUPATI Belgium vzw Matteo Scarabelli, EFPIA - European Federation of Pharmaceutical Industries and Associations Sonia Pulido Sanchez, AEMPS Michael Berntgen, European Medicines Agency Niklas Hedberg, Dental and Pharmaceutical Benefits Agency, TLV

  12. 10:30 AM

    70 min

    Talk · Data Science, RWE & Artificial Intelligence · Montreal Room

    S0304 - Clinical Evidence Generation In Action

    Patrice Verpillat, European Medicines Agency Gracy Crane, Roche Muriel Pasté, UCB Francesca Frau, Sanofi Karl Broich, Federal Institute for Drugs and Medical Devices (BfArM) François Houÿez, European Organisation for Rare Diseases (EURORDIS) Nafsika Kronidou, Roche Sara Escola, PTC Therapeutics

  13. 10:30 AM

    70 min

    Talk · Global Insights · Singapore Room

    S0406 - International Collaboration (Orbis/Access) Townhall

    Simon Dalla Torre di Sanguinetto, Swissmedic Jon Beaman, MHRA Cornelia Bigler, Swissmedic Donna Janzen, Hoffmann-La Roche, Ltd. Christina Hyldgaard Olesen, H. Lundbeck A/S

  14. 10:30 AM

    70 min

    Roundtable · DIAlogue Sessions · Sydney Room

    S1102 - Stakeholder Engagement with a Purpose: My Role and Behaviors in Building Trust and Driving Success

    Lola Gostelow, PARTNERSHIP BROKERS ASSOCIATION Julie O'Brien, Pfizer Marie-Laure Hecquet, EDQM Council of Europe Evangelos Tasopoulos, EDQM Helga Van Kampen, PARTNERSHIP BROKERS ASSOCIATION

  15. 10:30 AM

    70 min

    Talk · Medical Devices & Combination Products · Boston 1-2 Room

    S0602 - Demystifying the EU AI Act – What will change for medical devices?

    Thorsten Stumpf, Metecon GmbH Sebastian Fischer, TÜV SÜD Product Service GmbH Rajarshi Banerjee, Perspectum Ltd

  16. 10:30 AM

    70 min

    Talk · Regulatory Operations · Delhi Room

    S0802 - How do we enable Patient Centricity through ePI?

    Kate Porch, Johnson & Johnson Juan Garcia Burgos, European Medicines Agency Niklas Jänich, Boehringer Ingelheim Anne Moen, University of Oslo Koen Nauwelaerts, Bayer

  17. 10:30 AM

    70 min

    Talk · Clinical Trials Innovation · Kairo 1-2 Room

    S0103 - Pioneering the Future Today: Clinical Trial Innovation on the Horizon and Examples of Their Application

    Craig Garmendia, FDA Rauha Tulkki-Wilke, DEEP Measures Britta Wagenhuber, Sanofi Lee Aiyegbusi, University of Birmingham Björn Koneswarakantha, Roche Laurence O'Dwyer, Health Products Regulatory Authority Abba Elizabeth Theogaraj, Roche

  18. 10:30 AM

    70 min

    Talk · Regulatory Strategy & EU Pharmaceutical Policy · Shanghai 1-2 Room

    S0903 - Navigating tomorrow with Lessons from the past: Regulatory Innovation in 2050

    Rebecca Lumsden, Sanofi Steffen Thirstrup, European Medicines Agency Daisuke Tanaka, Pharmaceuticals and Medical Devices Agency (PMDA) Pedro Franco, Merck Serono Limited Marco Rafael, Roche Marjon Pasmooij, Medicines Evaluation Board / Utrecht University

  19. 11:50 AM

    60 min

    Poster · Additional Sessions · Shanghai 1-2 Room

    Poster Session 2 - AI Solutions through the Drug Life Cycle with a focus on Safety

    Eva-Maria Reuter, AMS Advanced Medical Services GmbH Nicholas Currlin, AbbVie Pallabi De, Synterex. Inc. Dobrochna Dolicka, United BioSource LLC Marko Korenjak, European Liver Patients' Association Rishi Verma, Stethy and Roche

  20. 11:50 AM

    25 min

    Talk · Sponsored Sessions · Innovation Hub (in Exhibition Hall)

    IH07 - GenAI in Action: Demo and Real-World Case Studies Transforming Medical Writing in Global Pharma (Exhibition Hall)

    Sharon Chen, AlphaLife Sciences

  21. 12:00 PM

    90 min

    Break · Exhibition Hall

    Lunch Break

  22. 12:30 PM

    25 min

    Talk · Sponsored Sessions · Innovation Hub (in Exhibition Hall)

    IH08 - Turbulence Across the Atlantic: Navigating Post-Election Uncertainty at FDA (Exhibition Hall)

    James Rawls, Boston Biodevelopment Helena Correia, Boston Biodevelopment Angela LaVonne Nelson, Boston Biodevelopment

  23. 1:00 PM

    90 min

    Talk · DIAmond Session · San Francisco Room

    DMD04 - Regulatory Agility, Convergence and Reliance

    Bianca Zimon, ANVISA Victoria Palmi, European Medicines Agency Susanne Ausborn, Roche Samvel Azatyan, Council for International Organizations of Medical Sciences Gabriela Zenhaeusern, Swissmedic Petra Doerr, EDQM Evdokia  Korakianiti, European Medicines Agency Sergio Cavalheiro Filho, IFPMA Jon Beaman, MHRA Jameel M Althiyabi, Saudi Food & Drug Authority (SFDA) Marko Eric, Medicines and Medical Devices Agency of Serbia Asmaa Fouad, Egyptian Drug Authority

  24. 1:00 PM

    90 min

    Talk · DIAmond Session · Montreal Room

    DMD05 - Environmental Sustainability in Healthcare

    Cathie Vielle, EDQM/Council of Europe Tatiana Paul A. De Wée, Health Care Without Harm (HCWH) Europe Sarah Ebadi, Roche matt popkin, GSK Tomasz Dyląg, European Commission Fiona Adshead, Sustainable Healthcare Coalition Momir Radulović, Slovenian Medicines and Medical Devices Agency (JAZMP) Kirsty Reid, EFPIA Dan Reed, AstraZeneca Veronika Jekerle, European Medicines Agency

  25. 2:30 PM

    30 min

    Break · Exhibition Hall

    Coffee Break

  26. 2:35 PM

    25 min

    Talk · Sponsored Sessions · Innovation Hub (in Exhibition Hall)

    IH09 - The Synergy of AI and Structured Content Management in Pharmaceutical Documentation (Exhibition Hall)

    Murali Menon, Docuvera

  27. 3:00 PM

    70 min

    Talk · Global Insights · San Francisco Room

    S0407 - WHO Town Hall: Global Collaboration in Regulation - Building Trust in Medical Products

    Naseem Hudroge, WHO Sarah Adam, IFPMA Lembit Rago, Council for International Organizations of Medical Sciences (CIOMS) Vaseeharan SATHIYAMOORTHY, WHO Shanthi Pal, WHO Samvel Azatyan, Council for International Organizations of Medical Sciences

  28. 3:00 PM

    70 min

    Panel · Value & Access · Montreal Room

    S1001 - EU HTA for Orphan Medicinal Products: Where do the trade-offs start? How will JCA be applied in the context of rare diseases and what impact will it have on national-level policies?

    François Houÿez, European Organisation for Rare Diseases (EURORDIS) Mihaela Veringa, Sobi Anja Schiel, Norwegian Medicines Agency (NoMA) Matias Olsen, EUCOPE

  29. 3:00 PM

    70 min

    Talk · Regulatory Strategy & EU Pharmaceutical Policy · Singapore Room

    S0905 - Regulatory Sandbox: Enabling factors on the road toward a successful implementation

    Francois Hebraud, F. Hoffmann-La Roche Ltd Falk Ehmann, European Medicines Agency Magdalini Papadaki, MSD

  30. 3:00 PM

    70 min

    Talk · Regulatory Operations · Boston 1-2 Room

    S0803 - Transforming Regulatory Landscapes: Driving Regulatory Innovation via AI/Automation, Data Exchange and Harmonisation

    Magdalena Bujar, Centre for Innovation in Regulatory Science (CIRS) Claire Harrison, Medicines and Healthcare products Regulatory Agency (MHRA) Vada Perkins, Boehringer Ingelheim Faizan Rahim, Roche Steve Gens, Gens & Associates Inc. Dominique Lagrave, Accumulus Technologies

  31. 3:00 PM

    70 min

    Talk · Pharmacovigilance & Safety · Delhi Room

    S0704 - Innovation in Pharmacovigilance: CAR-T, Gene Therapies and New Modalities

    Irene Navarro de la Fuente, UBC Sara Rito, AstraZeneca Purav Thakkar, APCER LIFE SCIENCES Caroline Pothet, European Medicines Agency Anna Vossenkaemper, AstraZeneca

  32. 3:00 PM

    70 min

    Talk · CMC & Product Quality · Kairo 1-2 Room

    S0202 - Opportunities from Regulatory Reliance on Post-Approval CMC Changes and GMP Inspections

    Evdokia  Korakianiti, European Medicines Agency Günter Waxenecker, Austrian Medicines and Medical Devices Agency (AGES) Marie Valentin, World Health Organization (WHO) Brendan Cuddy, European Medicines Agency Angelika Joos, CRP International Strategy Consulting Isabelle Colmagne-Poulard, Merck KGaA Monica Perea-Velez, GSK Stephan Roenninger, Amgen (Europe) GmbH Amanda Tombs, AstraZeneca

  33. 3:00 PM

    70 min

    Talk · DIAlogue Sessions · Shanghai 1-2 Room

    S1103 - DIA Projects Around the World

    Paul Cordero, Sanofi Sridevi Nagarajan, Argenx Philippe Page, Human Colossus Foundation Maria Vassileva, Drug Information Association (DIA) Maria Paula Bautista, DIA Stephanie Rosner, DIA

  34. 4:10 PM

    40 min

    Break · Exhibition Hall

    Coffee Break

  35. 4:20 PM

    25 min

    Talk · Sponsored Sessions · Innovation Hub (in Exhibition Hall)

    IH10 - Chat With Your Data: Improve and Simplify Processes with GenAI (Exhibition Hall)

    Luisa Burggraf, Generis

  36. 4:50 PM

    70 min

    Talk · Clinical Trials Innovation · San Francisco Room

    S0104 - ACT EU: Accelerating Clinical Trials in Europe through partnership

    François Houÿez, European Organisation for Rare Diseases (EURORDIS) Marianne Lunzer, AGES MEA Ana Zanoletty Perez, European Medicines Agency Elmar Nimmesgern, European Commission Max Dr. Wegner, Bayer AG

  37. 4:50 PM

    70 min

    Talk · Value & Access · Montreal Room

    S1003 - EU HTAR and Surrogate Endpoints in Oncology: How Can We Ensure JCA Supports Faster Patient Access?

    Valentina Strammiello, European Patients' Forum Adam Heathfield, Pfizer Rosa Giuliani, Guy's and St Thomas NHS Foundation Trust Caroline Pothet, European Medicines Agency Anja Schiel, Norwegian Medicines Agency (NoMA)

  38. 4:50 PM

    70 min

    Talk · Data Science, RWE & Artificial Intelligence · Singapore Room

    S0305 - AI in Action: Showcasing Real-World Solutions

    Billy Amzal, Quinten Health Robin Sarfati, Tekkare Cécile Ollivier, Critical Path Institute Remco Munnik, Arcana Life Science Consultancy Anna Litsiou, AstraZeneca Catarina Carrao, BioSciPons Gracy Crane, Roche Estelle Michael, UCB

  39. 4:50 PM

    70 min

    Talk · Medical Devices & Combination Products · Boston 1-2 Room

    S0603 - Global Harmonization of Combination Products Regulation

    Sabina Hoekstra-van den Bosch, TÜV SÜD Kevin Klein, Exon Consultancy Virginia Acha, MSD Donal O'Connor, HPRA

  40. 4:50 PM

    70 min

    Roundtable · Pharmacovigilance & Safety · Delhi Room

    S0703 - Behavioural Science and Risk Management Workshop

    Marie-Claire Wilson, Axian Consulting Beth Webb, MHRA

  41. 4:50 PM

    70 min

    Talk · Global Insights · Kairo 1-2 Room

    S0409 - Latin America Townhall - The role of collaborative networks in strengthening regulatory systems in LATAM

    Cammilla Gomes, Roche Leonardo Semprun, MSD Antonio Lopez Navas, AEMPS Maria Luz Pombo-Castro, Pan American Health Organization (PAHO)

  42. 4:50 PM

    70 min

    Talk · Global Insights · Shanghai 1-2 Room

    S0410 - South East Europe (SEE) Townhall: Modernization of Regulatory Framework through Digitalization, Harmonization, and Reliance

    Marija Trajchuleski, Agency for medicines and medical devices (MALMED) Victoria Palmi, European Medicines Agency Ivana Ferber, Merck Sharp & Dohme Marko Eric, Medicines and Medical Devices Agency of Serbia Melly Lin, F. Hoffmann-La Roche Ltd

  1. 8:30 AM

    70 min

    Panel · Global Insights · San Francisco Room

    S0414 - MHRA Townhall

    James Pound, Medicines and Healthcare Products Regulatory Agency (MHRA) Jon Beaman, MHRA Claire Harrison, Medicines and Healthcare products Regulatory Agency (MHRA) Alison Cave, Medicines and Healthcare Products Regulatory Agency (MHRA)

  2. 8:30 AM

    70 min

    Talk · CMC & Product Quality · Montreal Room

    S0204 - Innovation: Regulatory Tools, approaches and ways of working to facilitate the implementation of Innovation

    Tran Ba Quang Truong, Sanofi Stuart Finnie, Gilead Marcel Hoefnagel, Medicines Evaluation Board Meena Ram, Amicus Therapeutics Gert Thurau, F . Hoffman-La Roche Evdokia  Korakianiti, European Medicines Agency

  3. 8:30 AM

    70 min

    Talk · Medical Devices & Combination Products · Singapore Room

    S0604 - EU COMBINE Programme

    Jana Russo, MedTech Europe Olga Tkachenko, European Commission Claire Temple, Health Products Regulatory Authority Isabelle Clamou, European Commission Monique Al, CCMO, Then Netherlands Ditte Zerlang Andersen, Danish Medicines Agency (DKMA) Lucia D'Apote, Amgen

  4. 8:30 AM

    70 min

    Roundtable · Value & Access · Sydney Room

    S1004 - Workshop on HTA Advice: JSC or National Advice?

    Thomas Ecker Anja Schiel, Norwegian Medicines Agency (NoMA) Inka Heikkinen, Lundbeck Sonia Pulido Sanchez, AEMPS Claudine Sapede, NOVARTIS INTERNATIONAL Matias Olsen, EUCOPE

  5. 8:30 AM

    70 min

    Talk · Regulatory Strategy & EU Pharmaceutical Policy · Boston 1-2 Room

    S0906 - Paediatric Medicines in the EU and Global Contexts: Latest Developments

    Angelika Joos, CRP International Strategy Consulting Jyothsna Krishnan, EFPIA Ralph Bax, European Medicines Agency Sara Escola, PTC Therapeutics

  6. 8:30 AM

    70 min

    Roundtable · Global Insights · Delhi Room

    S0412 - What's next in Collaboration, Reliance and Convergence?

    Jon Beaman, MHRA Fatima Al Kaabi, Emirates Drug Establishment (EDE) Nola Tewabe, Amgen Victoria Palmi, European Medicines Agency Asmaa Fouad, Egyptian Drug Authority Nevena Miletic, F. Hoffmann-La Roche Marko Eric, Medicines and Medical Devices Agency of Serbia Marija Trajchuleski, Agency for medicines and medical devices (MALMED) Bianca Zimon, ANVISA Susanne Ausborn, Roche Sara Torgal, DIA

  7. 8:30 AM

    70 min

    Talk · Data Science, RWE & Artificial Intelligence · Kairo 1-2 Room

    S0306 - International Harmonization and Convergence in RWD

    Patrice Verpillat, European Medicines Agency Rachael Williams, Medicines and Healthcare products Regulatory Agency Melissa Kampman, Health Canada Bart Barefoot, GSK Elena Popa, Bayer Gianmario Candore, Bayer AG

  8. 9:40 AM

    50 min

    Break · Exhibition Hall

    Coffee Break

  9. 9:50 AM

    25 min

    Talk · Sponsored Sessions · Innovation Hub (in Exhibition Hall)

    IH11 - From Regulations to Actions - Boost your Regulatory Intelligence with AI (Exhibition Hall)

    Andreas Zapf, Inconsult GmbH

  10. 10:30 AM

    70 min

    Talk · Global Insights · San Francisco Room

    S0413 - Global Approaches to Drug Shortages

    Karl Broich, Federal Institute for Drugs and Medical Devices (BfArM) Monica Dias, European Medicines Agency Deborah Hay, Australian Government Department of Health and Aged Care Anthony Lostracco, Health Canada / Government of Canada

  11. 10:30 AM

    70 min

    Talk · CMC & Product Quality · Montreal Room

    S0203 - Sustainable Approaches to Product Design, Manufacturing, Testing and Supply Chain Resilience

    Veronika Jekerle, European Medicines Agency Sandra Ducoat, Sanofi Joerg Garbe, F. Hoffmann-La Roche Ltd matt popkin, GSK Cathie Vielle, EDQM/Council of Europe

  12. 10:30 AM

    70 min

    Roundtable · Innovative Therapies, Precision Medicine & Diagnostics · Singapore Room

    S0504 -IVDR Revision - Needs from a Medicines Development Perspective

    Mike Wierzba, GSK Elizabeth Macintyre, Biomedical Alliance in Europe Alberto Ganan Jimenez, European Medicines Agency Claudia Popp, Roche Ditte Zerlang Andersen, Danish Medicines Agency (DKMA) Adriana Racolta, Bayer Celine Bourguignon, GSK Ana Trullás Jimeno, European Medicines Agency

  13. 10:30 AM

    70 min

    Talk · DIAlogue Sessions · Sydney Room

    S1101 - Inclusion of Underserved Populations in Clinical Trials

    Vaseeharan SATHIYAMOORTHY, WHO Martin Hodosi, Kearney Anna Bode, Kearney Alison Cave, Medicines and Healthcare Products Regulatory Agency (MHRA) Christine Mayer-Nicolai, Merck KGaA Marina Malikova, Boston University School of Medicine Emily Fitzgerald, World Economic Forum Sharon Denise Rivera Sanchez, Trials of Color Shefali Goyal, Organon Francesca Cerreta

  14. 10:30 AM

    70 min

    Talk · Clinical Trials Innovation · Boston 1-2 Room

    S0105 - Paediatric Clinical Trials: Challenges and Opportunities

    Charles Benson, Eli Lilly and Company Jan Willem Van der Laan, MEB Laurence Van Bree, Novartis Solange Corriol-Rohou, EFPIA - SCR Consulting Marianne Lunzer, AGES MEA Saskia de Wildt, Radboud University Medical Center Monique Al, CCMO, Then Netherlands

  15. 10:30 AM

    70 min

    Roundtable · Regulatory Strategy & EU Pharmaceutical Policy · Delhi Room

    S0904 - The Impact of Changes to the EU Regulatory Framework on its Ability to Oversee Future Innovation

    Tamara Di Carlantonio, Roche Rebecca Lumsden, Sanofi Alexa Hunter, Merck KGaA Sini Eskola, Takeda Nad�ge Le Roux, BMS Nina Heiss, Merck KGaA Laura Oliveira, MSD Cathelijne de Gram, Johnson & Johnson Nick Sykes, EFPIA

  16. 10:30 AM

    70 min

    Talk · Regulatory Operations · Kairo 1-2 Room

    S0804 - IDMP Data Harmonisation & Multi-Stakeholder Perspectives

    Ana Lopez De La Rica Manjavacas, AEMPS Sridevi Nagarajan, Argenx Sheila Elz, Bayer AG Pharmaceuticals Georg Neuwirther, Austrian Medicines & Medical Devices Agency (AGES) Isabel Chicharo, European Medicines Agency Remco Munnik, Arcana Life Science Consultancy

  17. 11:50 AM

    60 min

    Poster · Additional Sessions · Innovation Hub (in Exhibition Hall)

    Poster Session 3 - Expanding Patient-Centric Innovation: Inclusive Approaches in Clinical Research and Beyond

    Luvanka Hanxhari, Novartis Noemi Pasquarelli, F. Hoffmann-La Roche AG Hayet Bensikaddour, Sanofi Xabier García De Albéniz, Research Triangle Institute HS Martin O'Kane, Novartis

  18. 12:00 PM

    90 min

    Break · Exhibition Hall

    Lunch Break

  19. 1:00 PM

    90 min

    Talk · DIAmond Session · San Francisco Room

    DMD06 - The Future of Innovation in the EU – A Europe of Possibilities

    Matias Olsen, EUCOPE Max Dr. Wegner, Bayer AG Yves Jacob, Sanofi-Aventis Recherche & Développement Gözde S. Briggs, European Patients' Forum María Lamas, Spanish Agency for Medicines and Medical Devices (AEMPS) Melanie Carr, European Medicines Agency Sabine Atzor, F. Hoffmann La Roche Ltd

  20. 2:30 PM

    75 min

    Talk · Additional Sessions · San Francisco Room

    Closing Session

    Lada Leyens, Takeda Monique Al, CCMO, Then Netherlands Sarah Pope Miksinski, Gilead Sciences Mark Pellett, AstraZeneca Gracy Crane, Roche Estelle Michael, UCB Claudia Dollins, GlaxoSmithKline Thomas Wejs Møller, Novo Nordisk Sebastian Fischer, TÜV SÜD Product Service GmbH Sabina Hoekstra-van den Bosch, TÜV SÜD Wim van der Spuij, Bristol Myers Squibb James Whitehead, Egetis Therapeutics Tim Powell, Biogen Kate Porch, Johnson & Johnson Rebecca Lumsden, Sanofi Tamara Di Carlantonio, Roche Inka Heikkinen, Lundbeck Kostas Papadakis, Bayer Sara Torgal, DIA

Speakers