Programme

  1. Registration

  2. Introduction

  3. Similarity of uses

    • Data requirements
    • Assessment criteria and decision tree
    • Uses matrix and exceptions

    Similarity of composition and grouping of co-formulants

    • Data requirements
    • Backbone composition
    • Grouping of co-formulants
  4. Refreshment break

  5. Similar levels of risk and efficiacy

  6. Lunch

  7. Best practices for BPF pre-submission meetings

    • Timelines and organisation
    • eCA agreement
    • Communication and meeting with eCA

    Splitting of families for ongoing applications

    • IT issues
    • Timelines
    • Fees
  8. Refreshment break

  9. Methodology applied on a BPF example

    • Practical BPF example 1
    • Practical BPF example 2
    • Practical BPF example 3
  10. Conclusion / Close of day

  11.  

    Course leaders:

    Nathalie Hanon Nathalie Hanon
    Manager CEHTRA SL - EVP, CEHTRA, Spain
    Cyril Durou Cyril Durou
    Consultant, CEHTRA