5. work program 2018 and other developments

Coordination of calls and designation of EURLs Role of Desk Officers Developments in EURL work program 2018 Development of dedicated performance indicators for EURL Modernized suggested protocol underperformance NRL Coordination of calls and designation of EURLs Satisfaction survey for NRLs on EURLs postponed SANTE Website+Database with EURLs, NRLs, work programs

DG SANTE Directorate G EURL Coordination of OCR – SANTE G.3

What to expect from Desk Officers? Set priority areas for their EURL/C Guide, asses, agree EURL work program Ensure regular/daily contact with EURL Evaluation of EURL/C report and performance These are some aspects of the activities done by EC regarding EURLs. -EC organizes the annual Directors meeting and address horizontal issues and improvements. The last directors meeting was in 2014. Due to internal reorganisation we were not able to schedule a meeting in 2015. So now we pick up the routine from 2016. -all EURLs are linked through the desk officer to their specific policy area in DG SANTE; -the work programme and reports are evaluated by these policy areas on the technical aspects; the financial aspects are coordinated by the financial unit. -new calls are managed by the relevant policy area and the coordinating unit; -DG SANTE manages currently a database with details of the different EURL and their NRLs, data protection rules do not allow us to share these data for instance in the contact details. Since granting direct access to the database to EURLs for adding modifications is not possible, EURLs should send alerts to DG SANTE for updating the database.

Developments in EURL work programme On-line submission Harmonized structure It should be noted that the different programs have a high quality, but they differ from each other by including the same information in different sections. The activity report involves answering the work programme, so the structure would be similar with a list of task scoring and a time planning scoring. An harmonised presentation/a template regarding the EURLs work programmes and their technical interim and final reports would be useful. It would allow an easier comparison for standardised activities, for instance. It would allow an easier and better reading and understanding of all WPs/TRs. For next year is expected the on-line submission of financial and technical aspects. A uniform structure for Work Programme and Activity report are been developed.

WORK PROGRAME TEMPLATE

Work Program template 2018 New harmonized work program template ! 4 chapters directly related to Article 94 new OCR 1 chapter related to other legal requirements (mainly animal diseases) Deadline WP 2018 was 30 November Evaluation by Desk Officers and Financial Unit Final work programmes available on website

Where to find the work programs? a Link box to Work Programmes

Work Programmes page

Tasks in new OCR for EURLs, art 94 1. To ensure availability of high quality methods and to ensure test methods of analyses (PT) Providing NRLs with details and guidance Providing references materials Proficiency Tests Cooperation to develop new methods 2. To ensure availability of scientific and technical assistance for NRLs (workshop) Coordinating practical arrangements Conducting training courses Providing information

Tasks in new OCR for EURLs art 94 3. To ensure scientific and technical assistance for cooperation with COM and other organisations Providing assistance to the Commission Collaborating with 3rd countries, EFSA, EMA and ECDC Diagnosis Outbreaks 4. Reference materials Tests to verify reagents and lots of reagents Where relevant: - Collections plant pests and material - Lists of reference substances and reagents

Dedicated Performance indicators DG SANTE process To ensure availability and use of high quality methods and ensure testing of NRL methods of analyses (PT) To ensure availability of scientific and technical assistance to NRLs (workshop, evaluation of EURLs by NRLs) To ensure scientific and technical assistance to COM and other organisations -internal DG SANTE process -results of 3 groups of tasks from work program template -to be evaluated by Desk Officer;

Underperformance of NRL's Art 101 (EC) 2017/625: NRLs shall collaborate with EURLs participate in training courses and in inter-laboratory comparative tests organised by EURLs 2007: 'Suggested protocol for management of underperformance in comparative testing and/or lack of collaboration of NRLs with EURLs activities' 2017: Modernized suggested protocol for underperformance of NRLs Phase 1 EURL to assist NRL, confidential Phase 2 EC to be informed, EC will inform CA Underperformance in comparative testing i.e. failure in proficiency test Lack of collaboration with EURL activities as no participation in the proficiency test or a workshop Draft update of the protocol available in July 2017 In CIRCABC and/or via SANTE desk officer To be discussed in EURL-dir-meeting 2017

Underperformance of NRL in:. -comparative testing and/or Underperformance of NRL in: -comparative testing and/or -lack of collaboration EURL Communicate the results to NRL Ask for clarification NRL Clarify this underperformance Repetition of comparative test Assist or take corrective measures In case of repetitive underperformance: Officially inform EC + report main findings EC EC to inform Competent Authority Requirement of appropriate actions by CA Underperformance in comparative testing i.e. failure in proficiency test Lack of collaboration with EURL activities as no participation in the proficiency test or a workshop Draft update of the protocol available in 2017 In CIRCABC and/or via SANTE desk officer 'Protocol for management of underperformance in comparative testing and/or lack of collaboration of NRLs with EURLs activities'

questionnaire for NRLs on functioning EURLs will be postponed why? timing …. because of changing to new Official Control regulation in April 2018 for EURLs and NRLs will probably be part of a new EURL review strategy (to be developed)

EURLs/NRLs on website DG SANTE All general information about EURLs in one tab in "Horizontal Topics": List of all EURL with links to the website of the EURL the connected NRL network Link to EURL work programmes of the last years Newly updated

EURLs web section

Link to EURLs and NRLs network on DG SANTE web NRL list EURL web Link to EURLs and NRLs network on DG SANTE web

To get access to CIRCABC-EURL group Link to EURL Interest Group in CIRCABC Create an ECAS account Enter in CIRCABC and join EURL Group https://circabc.europa.eu/

Thanks for your attention!