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Agenda

  1.  

    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.

  2.  

    Training course slides

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

  3.  

    Feedback Survey

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

  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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