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3rd meeting of the EFSA Technical group on Notification of Studies Database

Agenda

Participants

Report

Agenda

Day 1

  1. Welcome and Apologies for absences
    Adoption of the agenda
  2. Where we are today: status of progress of the TG
  3. Summary on feedback received on reference list
  4. Accessing the database
  5. Case study 1: Enabling third party to notify on behalf of BO a study:
    • Registration of third parties
    • Delegation of third parties
    • Notification of studies
    • Q&A
  6. Case study 2: Third party notifies a study commissioned to a laboratory not registered in the system:
    • Notification of studies to a new laboratory
    • Invite of a new laboratory
    • Notification from laboratory
    • Presentation
  7. Overall discussion on first day

Day 2

  1. Welcome second day Karine Lheureux
  2. Subject of application, test item and components
  3. Case study 3: Specification of subject of application, test items and its components in pre-application-id and in study notifications
    • Creation of pre-application-id
    • Notification of study on the subject of the application
    • Notification of a study with a test item different from the subject of the application
    • Q&A
  4. Notification from laboratory
  5. Case study 4: Notification from a laboratory and its inclusion in a pre-application-id of a business operator
    • Laboratory sends notification
    • BO adds notification to pre-application-id
    • BO reuse a notified study for other pre submission activities
  6. Case study 5: Pesticides Renewals
    • Joint applications renewals
    • List of intended studies for renewal according to article 32c1
    • Adding new BOs
    • Notification according to article 32b
    • Q&A
    • Presentation
  7. Case study 6: Renewal procedures under tight timeline
  8. Discussion of case studies and trainings
  9. Second day wrap-up and conclusions