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Agenda

  1.  

    Feedback Survey

    Please take a moment to complete the feedback survey for this course here

  2.  

    Training course slides

    Please find the slides for this training course available for download at the link below.

  3.  

    Handout

    Please download the handout document for this course at the link below.
    On page 8 of the document you will find a download link for the Matrix Tool.

  4. Registration

  5. Introduction

  6. 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

  7. Refreshment break

  8. Similar levels of risk and efficiacy

  9. Lunch

  10. 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

  11. Refreshment break

  12. Methodology applied on a BPF example

    • Practical BPF example 1
    • Practical BPF example 2
    • Practical BPF example 3

  13. Conclusion / Close of day

  14.  

    Course leaders:

    Nathalie Hanon Nathalie Hanon
    Executive Vice President & Head of Biocides, CEHTRA
    Cyril Durou Cyril Durou
    Executive Vice President, MD France, CEHTRA, France
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