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
   • Presentation
3. Summary on feedback received on reference list
   • Q&A
   • Presentation
4. Accessing the database
   • Presentation 
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
   • Presentation
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
   • Presentation
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
   • Notification 32c1 and 32b
   • Q&A
   • Presentation
8. Discussion of case studies and trainings
9. Second day wrap-up and conclusions