PARERE

The Preliminary Assessment of Regulatory Relevance (PARERE)

PARERE is a network of national regulators that provides the European Union Reference Laboratory for alternatives to animal testing (EURL ECVAM) with upstream input and preliminary views on the potential regulatory relevance of methods or approaches submitted for validation and/or peer review.

Through this network all regulatory sectors, including those for pharmaceuticals and chemicals, can provide input on the potential regulatory relevance and suitability of proposed test methods and testing strategies. Furthermore this network facilitates the information flow between EURL ECVAM and regulators regarding the development and validation of methods; in identifying areas that need specific attention and in identifying regulatory experts to participate in specific EURL ECVAM project groups.

PARERE’s main roles include:

• Provide upstream input on potential regulatory relevance and suitability of proposed test methods and testing strategies.
• Facilitate information flow between EURL ECVAM and regulators regarding the development and validation of methods and to identify areas that need specific attention.
• Identification of regulatory experts to participate in specific EURL ECVAM project groups (e.g. ITS design, validation management groups, expert workshops etc.).
• Provide comments on draft EURL ECVAM recommendations following ESAC peer review of validation studies.
• Support and promote the role of EU-NETVAL laboratories to facilitate their participation as a testing and/or lead laboratory in EURL ECVAM led validation studies.

PARERE contributes to the validation of NAMs through several key initiatives:

• Validation Studies: PARERE ensures the optimal design and conduct of validation studies to support national and international regulatory decisions on the usefulness and limitations of alternative methods proposed for regulatory testing.
• Independent Peer Review: The framework promotes high-quality independent scientific peer reviews of alternative test methods, ensuring consistency in transparency and stakeholder involvement.
• Harmonized Recommendations: PARERE supports the development of harmonized recommendations by national validation organizations on the regulatory use of alternative test methods. This helps enhance the likelihood of global acceptance of NAMs.
• Efficiency and Effectiveness: By avoiding duplication of effort and leveraging limited resources, PARERE achieves greater efficiency and effectiveness in the validation process.
• International Adoption: The framework supports the timely international adoption of alternative methods, ensuring that new NAMs provide equivalent or improved protection for people, animals, and the environment while replacing, reducing, or refining animal use.