1st Regulatory Risk Assessors' Summit

On the road towards an animal free regulatory system: CHIASMA Next Generation Safety Assessment 0.9

*** ONLINE Workshop ***

13. March 2025, 10:00 – 15:30 CET

Scope and Objectives: Collect input from regulatory and standardisation stakeholders on the current regulatory-science needs for the transition towards and sustainable, animal free regulatory system and how CHIASMA best can contribute to this. 

Target audience: Regulators from regulatory agencies and industry, regulatory experts from nongovernmental organisations: EURL ECVAM Network for Preliminary Assessment of Regulatory Relevance (PARERE), European Food Safety Authority Plant Protection Products and their Residues (EFSA-PPR) panel & EFSA scientific committee, European Chemical Agency Committee for Risk Assessment (ECHA-RAC), European Chemical Agency Committee for Socio-Economic Analysis (ECHA-SEAC), Organisation for Economic Co-Operation and Development Emerging Science in Chemical Assessment advisory group (OECD -ESCA), regulatory experts from the concurrent European Research projects dealing with Non-Animal Methods, NGRA within the Green Deal policy framework: the ASPIS cluster (RiskHunt3R, ONTOX, PrecisionTox) and the Green Deal Health cluster (ALTERNATIVE, LIFESAVER, PANORAMIX, PROMISCES, SCENARIOS and ZeroPM), and Social Scientists working on the societal challenges for change. 

Preliminary Agenda

Time

Topic

Speaker

10:15 – 10:30

Opening of the meeting and establish the agenda

  • Welcome by the Meeting Host (LIST)
  • Brief introduction to, and agreement on, the day’s agenda and the Terms of Engagement

Martin Paparella (MUI)

10:30 – 10:50

European Roadmap towards an animal free regulatory system 

Georg Streck (European Commission, DG for Internal Market, Industry, Entrepreneurship and SMEs)

10:50 – 11:10

Societal hurdles on the road towards an animal free regulatory system 

Ingrid Visseren-Hamakers

11:10 – 11:25

Regulatory-Science input to the roadmap by other European Research Projects  

Andrew Worth (European Commission DG JRC, EURL-ECVAM)

11:25 – 11:40

Update on the OECD efforts for the revision of the OECD Guidance document on validation 

Joao Barroso (European Commission DG JRC, EURL-ECVAM)

11:40 – 11:55

NAMs progressed for technical readiness and the approach to validation taken within CHIASMA 

LIST/RIVM (TBC)

11:55 – 12:10

NGRA & LCA concepts progressed within CHIASMA  

EMPA/MUI (TBC)

12:10 – 12:15

Introduction of the Breakout Sessions

Martin Paparella (MUI)

12:15 – 13:15

Lunch Break

13:15 – 14:15

Breakout rooms for participants to discuss three questions

  1. What are the further needs for CHIASMAs experimental method validation? 
  2. What are the further needs for the advancement/specification of the NGRA & LCA? 
  3. What are the societal hurdles for the roadmap and how could CHIASMA help to overcome them? 

14:15 – 14:45

Presentation of results from the breakout groups 

Breakout Room Rapporteurs (TBC)

14:45 – 15:30

Panel Discussion

  • Feedback from Speakers & General Discussion 

Moderator (TBC)

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