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Programme

REACH and Registration Processes

  1.  

    Course leader:

    Alex Paul Alex Paul
    Principal: Chemical Regulatory Services, Yordas Group, UK
  2.  

    Supporting Trainer:

    Dr Rémi Vacherot is a toxicologist with a comprehensive background in pharmacy. At Yordas Group Rémi is responsible for developing Data Gap Assessments (DGA) and Intelligent Testing Strategies (ITS) relating to toxicology, and providing technical expertise and advice for human hazard and exposure. In addition, Rémi is IUCLID Dossier manager for REACH Lead Registrations and the co-ordinator for the commission of toxicological and ecotoxicological tests required for regulatory purpose.

     

  3. Coffee and registration

  4. Introduction

    • Overview of the main features of REACH and experience over the last 10 years
    • Brief introduction to the main protocols: Registration, Evaluation, Authorisation and Restriction
    • Definitions and exemptions from registration

  5. Refreshment break

  6. Registration

    • Roles and responsibilities in the supply chain (including exercises)
    • Joint and Lead Registration processes
    • Managing registrations after the phase-in period
    • Tonnage tracking exercise
    • Inquiry Process

  7. Lunch

  8. Data Management

    • Data Gap Assessment
    • Integrated Testing Strategies
    • Use of alternative endpoint fulfilment methods
    • Data costs

  9. Data Sharing

    • SIEFS post REACH 2018
    • Data Sharing Objectives and Obligations
    • Data sharing disputes

  10. Refreshment break

  11. Ensuring ongoing compliance

    • Obsolescence / continuity of supply
    • Due diligence
    • Enforcement
    • Reporting / record keeping

  12. Close of day one

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