New Concept for Article 36 Networking and Management of the List

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1 New Concept for Article 36 Networking and Management of the List Kerstin Gross-Helmert, AFSCO 28 th Meeting of the Focal Point Network EFSA, MTG SEAT 00/M08-09

2 THE PRESENTATION Why a new concept? What does the new project entail? How will FPs be involved? 2

3 Why is a new concept needed to implement Article 36? 3

4 CURRENT ISSUES Very lengthy procedures Procedural changes High administrative burden Large involvement of EFSA in MS assessment preparation Old items on the List Large number of non-active organisations Scientific networks of competent organisations separate from the List Conceptual changes Few grants to allocate tasks Notions in legislation not being used 4

5 BOUNDARIES Networking of Competent Organisations more efficient and effective Supported by new procedures & new IT tool Lead to a newly drawn up List 5

6 EFSA STRATEGY 2020 Specific Objective 3 build the EU s scientific assessment capacity and knowledge community A key activity of SO3 the role of the Article 36 network will be reviewed and strengthened to implement common risk assessment priorities 6

7 ARTICLE 36 OF FOUNDING REGULATION 28 th Meeting of the Focal Point Network Article 36 List of Competent Organisations Burden Opportunity 7

8 What does the new project entail? 8

9 AIM OF PROJECT Overall aim to strengthen European networking and collaboration amongst competent organisations and with EFSA Specific Objectives 1. Establish a more agile up-to-date List 2. Enhance engagement of MS and competent organisations in networking and collaboration 9

10 28th Meeting of the Focal Point Network Parma, 15th 16th September 2016 PHASES OF PROJECT Phase 1: Development of the new concept (Inform MB: 12/2016) Phase 2: Development of a new solution to manage the List and support networking (Inform MB: 12/2017) Phase 3: Drawing-up newly the List of Competent Organisations (MB newly draws-up the List of Competent Organisations: 12/2018). 10

11 INVOLVEMENT Focal Points are main actors in Managing the Article 36 List and Fostering networking of organisations Gathered much experience over the past 8 years In the project, Focal Points : will be informed regularly of developments can engage in a Task Force 11

12 28th Meeting of the Focal Point Network Parma, 15th 16th September 2016 How will the Focal Points be involved? 12

13 FOCAL POINT TASK FORCE Activities Proof-of-concept October-November 2016 Input to new Article 36 solution June-September 2017 Simulation October-November 2017 Training materials, etc. October 2017-January 2018 Workshops Beginning 2018 Members 4-6 FPs Need: high experience with current processes & assessing organisations (i.e. good understanding of criteria) 13

14 28th Meeting of the Focal Point Network Parma, 15th 16th September 2016 PROJECT PHASES 1 & 2 Charter approved Focal Point Meeting Focal Point Task Force Sep Oct MB Meeting MB Meeting Focal Point Meeting Focal Point Meeting 2017 Nov Dec Jan Phase 1 Information to MB Advisory Forum Meeting Advisory Forum Meeting Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Phase 2 Information to MB Proof-of-Concept simulation (FPs) AF & FP Mtg documents MB documents Training material dev. with FPs 14

15 28th Meeting of the Focal Point Network Parma, 15th 16th September 2016 PROJECT PHASE 3 MB Meeting Launch procedures IT tool Go-Live 04/ /2018 Designation Deadline 30/09/2018 Publication of New Art.36 List 12/ Jan Feb Mar Apr May Jun Jul Aug Sep Oct Phase 3 Training workshops (incl. preparation) Launch preparation Nov Dec MB draws up new List of Competent Organisations MS assess org.s EFSA supports MS EFSA ensures compliance MB documents 15

16 28th Meeting of the Focal Point Network TASK FORCE MEMBERS Who would you like to have as Task Force members? 16

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