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Preconference Workshops

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Preconference Workshops

All Preconference workshops require a separate registration fee and are not included in main conference pricing. Learn more:  https://www.raps.org/europe-2023/register

Preconference Workshops

  • Wednesday, May 10th
    08:00 – 16:00 CEST
    Be ready for EU CTR: Strategy, Systems and Lessons Learned
    Location: Saffron (1st fl)
    Workshop Leader: Carla Gomes – Thermo Fisher Clinical Research Group
    Presenter: Maria Alexandra Ribeiro – Portuguese National Ethics Committee for Clinical Research (CEIC)
    Presenter: Paolo Croce, PhD – PPD, part of Thermo Fisher Scientific
    Presenter: Eileen Smith, RA – PPD, part of Thermo Fisher Scientific
    Presenter: Rina Kacha – PPD, part of Thermo Fisher Scientific
    Preconference WorkshopPharmaceuticals
  • Wednesday, May 10th
    08:30 – 16:00 CEST
    Workshop: Global Regulatory CMC Strategies and Challenges for Biologicals
    Location: Lavender (1st floor)
    Workshop Leader: Neha Parashar, PMP – argenx
    Presenter: Ankit Geete – BioNTech, Germany
    Preconference WorkshopPharmaceuticals
  • Thursday, May 11th
    09:00 – 10:00 CEST
    Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe? (Part 1)
    Location: Pearl 1
    Moderator & Presenter: Rebecca Lumsden, PhD – Sanofi
    Presenter: Francesca A. Day, PhD – European Medicines Agency
    Presenter: Julie Spony, MA – European Patients' Forum
    Presenter: Laetitia Szaller, MA – AM-Pharma
    Presenter: Fabio Datri, PhD – European Commission
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
    Supported by 
  • Thursday, May 11th
    10:30 – 11:30 CEST
    Will the Revision of the EU general pharmaceuticals legislation deliver a world-class, future-proof medicines regulatory system for Europe?(Part 2 )
    Location: Pearl 1
    Moderator & Presenter: Rebecca Lumsden, PhD – Sanofi
    Presenter: Francesca A. Day, PhD – European Medicines Agency
    Presenter: Julie Spony, MA – European Patients' Forum
    Presenter: Fabio Datri, PhD – European Commission
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Regulatory Strategy Development
    Supported By
  • Thursday, May 11th
    11:45 – 12:45 CEST
    Making full use of early access and regultatory tools available to ATMPs
    Location: Carmine & Charcoal
    Moderator: Jennifer Neff, PhD – Sartorius Stedim Biotech GmbH
    Presenter: Paulette Robinson, Ph.D, RAC – Neurogene
    Presenter: Caroline Pothet – European Medicines Agency
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
    Supported By
  • Thursday, May 11th
    13:45 – 14:45 CEST
    MDR Art. 117 for Combination Products After 2 years. Still the same? State of Play from EMA, NB and Industry
    Location: Pearl 2
    Moderator: Beate R. Schmidt, MSc, MDRA, RAC – Benefits Regulatory Consulting
    Presenter: Stephan Affolter – Ypsomed AG
    Presenter: Christiana Hofmann, PHD – anteris medical GmbH
    Presenter: Christelle Bouygues, PharmD – EMA
    Presenter: Theresa Jeary, BSc (Hons), MSc – BSI Group
    PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
    Supported By
  • Thursday, May 11th
    15:00 – 16:00 CEST
    Regulatory policies and guidelines – are these enabling timely development of Orphan medicines globally?
    Location: Pearl 1
    Moderator & Presenter: Magdalena Bujar, BSc, MSc, PhD – CIRS
    Presenter: Martine Zimmermann, PharmD – Ipsen Innovation
    Presenter: Kristina Larsson, MSc – European Medicines Agency
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Process & Procedures
    Supported By
  • Thursday, May 11th
    16:45 – 17:45 CEST
    EU Regulatory CMC Strategies and Challenges
    Location: Carmine & Charcoal
    Moderator & Presenter: Michael Craig, BSc Pharm MPSI – Parexel
    Presenter: Neha Parashar, PMP – argenx
    Presenter: Veronika Jekerle, PhD – European Medicines Agency
    PharmaceuticalsDomain: Business AcumenKnowledge Area: Industry-specific Knowledge
    Supported By
  • Friday, May 12th
    10:45 – 11:45 CEST
    EMA's PRIME Scheme in Review: Findings, Lessons Learnt and Future Directions
    Location: Pearl 2
    Moderator & Presenter: Kevin Cunningham, PhD – European Medicines Agency
    Presenter: Els Caenen, PharmD – Janssen Pharmaceutical Companies of Johnson & Johnson
    Presenter: Nadege Le Roux – Bristol-Myers Squibb
    Presenter: Francesca Cerreta
    Presenter: Ilona Reischl, PhD – Austrian Medicines Agency, AGES MEA
    PharmaceuticalsDomain: Regulatory Frameworks & StrategyKnowledge Area: Market Strategy
    Supported By
  • Friday, May 12th
    12:00 – 13:00 CEST
    Will Data-Driven Regulatory Science Stimulate Innovation and Initiate a New Regulatory Paradigm?
    Location: Carmine & Charcoal
    Moderator & Presenter: Rebecca Lumsden, PhD – Sanofi
    Presenter: Marjon Pasmooij – Medicines Evaluation Board
    Presenter: Frank Pétavy, MSc – European Medicines Agency
    PharmaceuticalsDomain: Business AcumenKnowledge Area: Project Management
    Supported By
  • Friday, May 12th
    14:00 – 15:00 CEST
    Strategic approaches in pregnancy and paediatrics: Is it time for a paradigm shift?
    Location: Pearl 1
    Moderator: Kate Stockman
    Moderator: Rüdiger Faust, PhD – UCB
    Presenter: Solange Corriol-Rohou, MD – AstraZeneca
    Presenter: Marie Teil, MD – UCB Pharma
    Presenter: Corinne de Vries, MA MSc PhD FISPE – European Medicines Agency
    PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
    Supported By
  • Friday, May 12th
    15:30 – 16:30 CEST
    European Expedited Approval Pathways in a Global Context
    Location: Carmine & Charcoal
    Moderator: Siegfried Schmitt, CSci CChem FRSC – Parexel
    Presenter: Yingying Liu – CSL Behring AG
    Presenter: Thomas Larsson, MSc, BSc – European Medicines Agency
    PharmaceuticalsDomain: Product Development & RegistrationKnowledge Area: Regulatory Guidance
    Supported By