ECVAM as EU-RL according to 2010/63

Last update: 04/19/23 Author: J.Kreysa Slide Number: 1

Berlin, 31 January 2011

ECVAM as EU-RLaccording to 2010/63

Joachim KreysaBerlin, 31 January 2011

04/19/23 ECVAM / J.Kreysa 2

Berlin, 31 January to 2 February 2011

ECVAM as Union Reference Laboratory

1. Art 47: Alternative Approaches; Role of MS & COM

2. Art 48: The EU – RL

3. Annex VII: defining the tasks of ECVAM

Last update: 04/19/23 Author: J.Kreysa Slide Number: 3

Berlin, 31 January 2011

incl. independent reviewValidation

Optimization

Development

Research

Implementation

(Industry, Regulators, CROs)

Regulatory Acceptance

(EU, OECD)

ANNEX VII: ECVAM shall deal with the entire lifecycle of Alternative Methods - from Research to Implementation



ECVAM as Union Reference Laboratory

New elements:

- The EU-RL may collect charges (rules need to be fixed)

- promote 3R also in basic & applied research



ECVAM: coordinating and promoting the development & use of 3R including in basic & applied research and regulatory testing;

Development:• Identify 3R research needs (DG RTD, other funding bodies)• Participation in RTD projects and in-house projects• Scientific dialog (Workshops, conferences,..)• Produce guidance for test developers and test validators

Use:• Provide a quality control (validation, peer review, confirmation) of

alternative methods and their capabilities & limitations• Make info on 3R available (in coop. with MS)• Inform users of test methods (industry) and of test data (regulators)• Training in validated methods



ECVAM: coordinating the validation of alternative approaches at Union level

• Others than ECVAM may carry out validationECVAM • Offers Guidance & advice, (guidance docs, helpdesk, VMGs)

• Carries out independent peer review of validation studies (ESAC)

• Prepares recommendation to policy DGs • clear indication of capabilities & limitations of

validated 3R-methods• suggestions on possible regulatory uses



ECVAM: exchange of information & running databases & information systems on alternative approaches & their state of development

• Conferences & workshops & publications

• State of the art reports

• Maintain and improve DB-ALM, incl. INVITOX protocols, and ECVAM web-site, interlink with other sites, search guide



ECVAM: promoting dialogue between legislators, regulators, and all relevant stakeholders

ESTAF – the ECVAM STAkeholder Forum • is being set up; first meeting in 2011• representation of stakeholders with EU wide reach• relevance of test methods proposed for validation

AD HOC events bringing together• legislators, regulators, industry, biomedical scientists,

consumer organisations and animal-welfare groups, • to discuss on the development, validation, regulatory

acceptance, international recognition, and application of alternative approaches.



Art.47 : Alternative Approaches

Member States shall• identify & nominate laboratories for validation

studies• promote 3R approaches and disseminate info thereon• nominate a single point of contact (PARERE,

coordinated by ECVAM)

The Commission (policy DGs & ECVAM) shall• set the priorities for validation studies• allocate tasks to the laboratories• take appropriate action for international acceptance

of 3R approaches (OECD, ICATM, ICCR)



How will ECVAM handle these

requirements and link them to its

validation process?



1. Test submission handling, scientific/relevance assessment. Decision on entering Validation

7. Final ECVAM recommendation incl. ESAC opinion & VSR;

Transfer to policy DGs ; publication

6. Public Commenting

2. Validation; Validation Study Report

3. ESAC peer review of VSR; ESAC opinion on reliabilityand/or scientific validity

4. Draft ECVAM Recommendation 5. ‘Right to be heard’ process

• Public input on planned Validation Study (facts, Data, comments)

• EU MS / agencies:• ESTAF

• Public input (INTERNET)

• EU MS / agencies: regulatory relevance• ESTAF: user relevance

Test Submission(TS)

ValidationAnnounce-

ment

ValidationStudy Report

(VSR)

ESAC mandate

Draft ECVAM Recommendation

ECVAM Recommendation

ESAC Reports& Opinion

PARERE |ESTAF Input

Public Commenting

Report

ICATM: Propose VMG – members, send liaison, comment

ICATM: Propose Peer Review Group Members; ESAC observer

ICATM: Commenton draft ECVAM recommendations

ICATM: establish mutual interest

International coop. Consultation Validation Workflow Output / Docs





Test Submission(TS)

PARERE |ESTAF Input



Pre-Submission arrives at ECVAM

Promising?

Invite full submissionConsult PARERE, ESTAF, ICATM

Ready for which stage of Validation?

Start Validation?Who (f (resources,

capacities))?

Back to developer

Organise & carry out Validation in line with modular approach

in order to generate a complete dossier for peer review

yes














Test Submission(TS)

ValidationAnnounce-

ment


(VSR)

ESAC mandate




PARERE |ESTAF Input

Public Commenting

Report









Define Validation Study

Public consultation, Consult ICATM

Ready for which stage of Validation?

Validation study,generating lacking

info.

Stop

Output: Validation Report, ready for independent peer

review by ESAC.



ValidationAnnounce-

ment


(VSR)


VMG














Test Submission(TS)

ValidationAnnounce-

ment


(VSR)

ESAC mandate




PARERE |ESTAF Input

Public Commenting

Report








ECVAM as EU-RL thrives with its networks

PARERE – Preliminary Regulatory Relevance Assessment, single points of contact, MS competent authorities

COM services and EU agencies ESTAF – ECVAM STAkeholder Forum (Ind, NGOs, Academia) ECVAM network of Validation Laboratories

not yet set up, waiting for MS nominations will include all MS-nominated labs with clear capacity profileallows identifying best suitable lab for validation studies

Ad hoc networks of expertise, work shops, conferences,

ESAC-WGs, manned from ECVAM Expert Panel (EEP)



Thank you for your attention

!

ECVAM as EU-RL according to 2010/63

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