PARERE - EURL ECVAM Network for Preliminary Assessment of Regulatory Relevance

PARERE is a network of national regulators that provides EURL ECVAM with upstream input and preliminary views on potential regulatory relevance of methods or approaches submitted to EURL ECVAM for validation and/or peer review.

Find out about the role of PARERE, representation in PARERE, its meetings and operation and finally a list of meetings with agendas and minutes below.

Role of PARERE

PARERE has a number of roles to fulfil:

To 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.

Representatives in PARERE

In order to expedite the process of regulatory acceptance of alternative methods, it is considered that regulators should be involved as early as possible in providing a preliminary view on the potential regulatory relevance of methods submitted to EURL ECVAM for validation and/or peer review.

The EU Directive on the protection of animals used for scientific purposes (2010/63/EU) states that:

''Member States shall nominate a single point of contact to provide advice on the regulatory relevance and suitability of alternative approaches proposed for validation''.

Following an invitation from the Commission to nominate such single points of contact, Member States have nominated representatives that now form PARERE.

In addition, it was considered important to involve EU regulatory agencies and relevant Commission services, and requests for nominations from EFSA ECHA, and EMA were also made. All of them together constituted the Preliminary Assessment of Regulatory Relevance Network, or simply PARERE.

List of Members of PARERE

In summary, there are around 30 representatives of member countries that are members of PARERE.

Meetings and Operation

PARERE typically meets once a year
The working language is English
Requests, input and collaborative activities are addressed through written procedure and an internet-based forum for information exchange.
The first meeting was held on 26 May 2011
A list of meetings with agendas and minutes is provided below