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EURL ECVAM's Network for Preliminary Assessment of Regulatory Relevance (PARERE)

Role, operation and output of PARERE

 

Role of the PARERE

The PARERE's roles will be:

  • 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 …)
  • Commenting on draft EURL ECVAM Recommendations following ESAC Peer Review of validation studies.
  • Support and promote the role of NETVAL laboratories in MS to facilitate their participation as a testing and/or lead laboratory in EURL ECVAM led validation studies

 

Representatives to the PARERE

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

The revised 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 form the network of Member States. In addition, it was also considered important to involve the EU regulatory agencies, and requests for nominations from EFSA, ECHA, EMA and the DG SANCO Scientific Committees were also made. All of them together constituted the Preliminary Assessment of Regulatory Relevance network, known as PARERE.

 

Meetings & Operation

  • PARERE will typically meet once a year.
  • Working language will be English.
  • Requests, input and collaborative activities will be addressed also through written procedure and using an internet-based forum for information exchange.
  • The first meeting was held on 26 May 2011
  • A first joint meeting of PARERE and the ESTAF networks was held on 25-26 September 2012.
  • The PARERE and ESTAF joint meeting of 5-6 June 2013 in Ispra, Italy included a dedicated workshop on the theme "Establishing the Relevance and Ensuring the Acceptance of Alternative Methods for regulatory Safety Assessment".
  • The joint PARERE and ESTAF meeting of 5-6 June 2014 included a 360° question and answer session on issues relating to validation and acceptance.
  • The joint PARERE and ESTAF meeting of 20-21 October 2016 included a dedicated workshop on Integrated approaches to testing and assessment (IATA): method validation; testing strategy development, evaluation and acceptance.
  • The joint PARERE- ESTAF meeting on 8-10 November 2016 included a session on 3Rs uptake in basic, applied, and translational research and education and training and a workshop to explore the possible regulatory use of alternative (non-animal) approaches for systemic toxicity that are intended for the hazard and safety assessment of chemicals used in a variety of sectors.
 

List of Meetings

 

Meeting

Agenda

Minutes/Summaries

 

PARERE Meeting 26 May 2011

pdf icon Agenda pdf icon Executive summary
 

Joint PARERE/ESTAF Meeting 25-26 Sept. 2012

 pdf icon Agenda pdf icon Executive summary
 

PARERE Meeting 4 June 2013

 pdf icon Agenda  pdf icon Summary record
 

Joint PARERE/ESTAF Meeting 5-6 June 2013

pdf icon Agenda of the meeting

pdf icon Agenda of the workshop
 pdf icon Summary records
PARERE Meeting 5 June 2014 pdf icon Agenda pdf icon Summary record

Joint PARERE/ESTAF Meeting 5-6 June 2014

pdf icon Agenda

pdf icon Summary record

PARERE meeting 20 October 2015

pdf icon Agenda

pdf icon Summary record

Joint PARERE/ESTAF Meeting 20-21 October 2015

pdf icon Agenda

pdf icon Summary record

PARERE meeting 8 November 2016

pdf icon  Agenda

pdf icon Summary record

Joint PARERE/ESTAF Meeting 8 November 2016

pdf icon  Agenda

pdf icon  Summary record