developments in regulatory science Claudia Heppner Senior science - PowerPoint PPT Presentation

76 th Advisory Forum meeting Virtual meeting, 1-2 July 2020 Preparedness for verification studies: integrating latest scientific developments in regulatory science Claudia Heppner Senior science coordinator

Background: SPIDO and other initatives EU Risk assessment agenda (EU RAA) Partnering projects Science Studies and Project Identification EU Research Agenda & Development Office (SPIDO) (Horizon Europe)

Background: Aim, tools & means  Establish process to identify scientific themes , and develop their roadmaps for action , requiring multi- annual cooperative arrangements with Member States, EU Agencies and, if relevant, international partners  Fill knowledge gaps that can benefit regulatory processes/science to ensure - preparedness to address possible divergencies on sensitive matters (“verification studies”) - preparedness for future risk assessment requirements due to new scientific developments Science Studies and Project Identification & Development Office (SPIDO)  Tools: multi-annual, multi-partner and high-value scientific grants (co-funding) and procurements projects Transparency Regulation (EU) 2019/1381 (Art. 32d)  Means (planned, pending on MFF 2021-2027): 2021: 8 mio € ; from 2022 onwards 16 mio € annually 3

Status  Engagement and alignment with DG SANTE, Member States (AF), EU Agencies  DG SANTE recommended a framework document (FWD) outlining  Process and criteria for selecting scientific themes  Mechanism for preventing duplication of work  Mechanism to ensure budget availability in case a mandate for a specific verification study is submitted to EFSA  Draft FWD was shared with DG SANTE on 11 June.

Process – draft Aim: Gain full understanding on e.g. ongoing activities, • knowledge gaps, societal interests/concerns and collaboration opportunities and partners Provide basis for prioritisation and decision making for project • Roadmap calls (multi-annual, high value) (EFSA/DG SANTE) for action Consultation with Member States , EU Agencies • Theme EFSA ´ s 2027 strategy • Paper Future of science themes • • Preparedness for possible verification Scientifc studies Theme • Knowledge gaps in EU research projects Selection Aim: Outline vision, scope, opportunities, cooperation • • EU strategies and impact for EFSA and its partners Alignment with DG SANTE • • Serve as basis for roadmaps • Consultation with Member States, EU Consultation (phased approach) of draft paper with wide • Agencies and other bodies range of bodies such as DG SANTE, Member States , EU Agencies, Scientific Committee, international partners

2020: First wave of scientific themes  Selected based on previous work (e.g. future of science, EFSA’s 2027 strategic developments).  Themes discussed with Member States at the Advisory Forum.

Next steps  Ongoing consultation process on framework document with DG SANTE (June-July)  Ongoing consultation process (phased approach) on first four theme papers with DG SANTE and collaborating EU Agencies; Member States Scientific Committee, and other bodies to follow (June-Sep)  Launching a call on roadmaps for actions related to these four themes (autumn 2020) aiming to start implementing the roadmaps from 2022 onwards.  In parallel to the ongoing roadmap activities, first project calls related to SPIDO activities might be already launched in 2020 (e.g. case study NAMs and chemicals) and 2021.

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