Programmes

See below the programme for the TOPRA Annual Symposium. The programme for Veterinary Medicines; and Regulatory Updates for Start-ups, SMEs and Academia will be available soon.

Human Medicines Symposium 2023

23 October


  All times GMT
  12:00 - 12:40  Registration for the Human Medicines Symposium and welcome
  12:40 – 14:10

HM1: Update on EU new regulatory legislation and a view from different angles (European Medicines Agency (EMA), industry, others)

Lead:

  • Infarmed

    		•
     

    14:10 – 14:50

    		Networking break
      14:50 – 16:20

    HM2: Case studies (ice breaker amongst delegates)

    Leads:

  • Carlos Langezaal, Senior Director, Global Regulatory Affairs, BMS, USA
  • Fred Senatore, Medical Officer, Clinical Team Leader Division of Cardiology and Nephrology Office of New Drugs, Center of Drug Evaluation Research, U.S. Food and Drug Administration (FDA), USA 

    		•
     

    16:20 – 17:00

    		Networking break
      17:00 – 18:30

    HM3: Fireside chat with EMA, Infarmed, FDA

    Lead: 

  • Francesca Buttigieg, Associate Director Regulatory Affairs, PTC Therapeutics, Switzerland

    		•

     

    24 October

      All times GMT
      9:00 – 10:30

    HM4: The evolving clinical trial landscape

    Lead: 

  • Head of Clinical Trials at Infarmed

    		•
     

    10:30 – 11:00

    		Networking break
      11:00– 11:45

    TOPRA Annual Lecture - TBC
      11:45 – 12:30

    TOPRA Annual Review - TBC
      12:30 –  13:30 Lunch break
      14:00 – 15:30

    HM5/MD1/IVD1: Process for regulations and implications of different legislation – how to follow and decide which regulation will impact your product development (for MD and IVD)

    Lead:

  • Bjørg Hunter, Department Affairs Director, Regulatory Affairs Digital Health, Novo Nordisk, Denmark

    • Global perspectives and learnings will be provided by looking at the US, UK and EU.
     

    15:30 – 16:00

    		 Networking break
      16:00 – 17:40

    HM6: Real world evidence (RWE) and the use of big data for regulatory decision making; DARWIN EU 

    Leads:

  • Maren Koban, Director Global Regulatory and Scientific Policy, Merck, Germany
  • Almath Spooner, Director of Regulatory Policy and Intelligence, Abbvie, Ireland

    		•

     

    25 October

      All times GMT
      9:00 – 10:30

    HM7: Paediatric investigational plans

    Leads:

  • Andrea Laslop, AGES  
  • Sandra Lourenço, Head of Regulatory Affairs, Arriello, Ireland
  • Francesca Buttigieg, Associate Director Regulatory Affairs, PTC Therapeutics, Switzerland

    		•

    PS1: Health technology assessments – the new EU regulation 

    Lead: 

  • Infarmed; Carlos Langezaal, Senior Director, Global Regulatory Affairs, BMS, USA



    		•
     

    10:30 – 11:00

    		Networking break
      11:00 – 12:30 HM8: Patient intervention in the decision-making process


    Lead:     

  • TBC – contributors will be from the EMA and FDA

    		•
     

    12:30 – 13:30

    		 Lunch break
      13:30 – 15:00

    HM9: Regulatory mechanisms to expedite drug development and patient access (e.g. PRIME)

    Leads:

  • Marie Uguen, Chief Regulatory officer & QA, Lysogen, France
  • Francesca Buttigieg, Associate Director Regulatory Affairs, PTC Therapeutics, Switzerland
  • Fred Senatore, Medical Officer, Clinical Team Leader Division of Cardiology and Nephrology Office of New Drugs, Center of Drug Evaluation Research, FDA, USA

    		•
        End of the Human Medicines Symposium

     

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    TOPRA Symposium 2023
    Lisboa Congress Centre, 
    Praça das Indústrias 1,
    1300-307, Lisbon, Portugal

    Contact us
    meetings@topra.org
    +44 (0)20 7510 2560

    #TOPRASym23

    Exhibition / Sponsorship
    Call +44 (0)20 7510 2573
    or email erik@topra.org