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, 10:15 – 15:45 CET

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

Target audience: 

  • Regulatory experts from regulatory agencies, OECD and industry
  • Experts for method standardization and validation
  • Nongovernmental organizations and other experts for One Health, animal welfare, environmental and human health protection
  • Scientists working on Non-Animal Methods, Next Generation Risk Assessment, Safe and Sustainable by Design and Life Cycle Assessment
  • Social Scientists working on the societal challenges for change towards the reduction and replacement of animal testing

Preliminary Agenda

Time

Topic

Speaker

10:15 – 10:30

Opening of the meeting and establishing 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 (Medical University Innsbruck, AT)

10:30 – 10:50

European Roadmap towards an animal free regulatory system 

Georg Streck (DG GROW, EC)

10:50 – 11:10

Societal hurdles on the road towards an animal free regulatory system 

Ingrid Visseren-Hamakers ((Radboud University, NL)

11:10 – 11:25

Transitional Initiatives in the context of the European Roadmap  

Andrew Worth (EURL-ECVAM, DG JRC, EC)

11:25 – 11:40

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

Joao Barroso (EURL-ECVAM, DG JRC, EC)

11:40 – 11:55

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

Tommaso Serchi (Luxembourg Institute of Science and Technology, LU)

11:55 – 12:10

NGRA & LCA concepts progressed within CHIASMA  

Roland Hischier (EMPA, CH) & Martin Paparella (MUI, AT)

12:10 – 12:15

Introduction of the Breakout Sessions

Martin Paparella (MUI, AT)

12:15 – 13:15

Lunch Break

13:15 – 14:15

Breakout groups 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 reduction & replacement of animal tests 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 

Steffi Friedrichs (AcumenIST, BE)

15:30 – 15:45

Wrap-Up & Next Steps

Martin Paparella (MUI, AT)

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