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ECVAM as EU-RL according to 2010/63

ECVAM as EU-RL according to 2010/63. Joachim Kreysa Berlin, 31 January 2011. ECVAM as Union Reference Laboratory. Art 47: Alternative Approaches; Role of MS & COM Art 48: The EU – RL Annex VII: defining the tasks of ECVAM.

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ECVAM as EU-RL according to 2010/63

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  1. ECVAM as EU-RLaccording to 2010/63 Joachim Kreysa Berlin, 31 January 2011 Author: J.Kreysa

  2. ECVAM as Union Reference Laboratory • Art 47: Alternative Approaches; Role of MS & COM • Art 48: The EU – RL • Annex VII: defining the tasks of ECVAM ECVAM / J.Kreysa

  3. ANNEX VII: ECVAM shall deal with the entire lifecycle of Alternative Methods - from Research to Implementation Implementation (Industry, Regulators, CROs) Research Regulatory Acceptance (EU, OECD) Development Optimization incl. independent review Validation Author: J.Kreysa

  4. 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 / J.Kreysa

  5. How will ECVAM meet the requirements of 2010/63? ECVAM / J.Kreysa

  6. 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 / J.Kreysa

  7. ECVAM: coordinating the validation of alternative approaches at Union level • Others than ECVAM may carry out validation • ECVAM • 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 / J.Kreysa

  8. 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 / J.Kreysa

  9. 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. ECVAM / J.Kreysa

  10. Art.47 : Alternative Approaches Member States shall • identify & nominatelaboratories 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) ECVAM / J.Kreysa

  11. How will ECVAM handle these requirements and link them to its validation process? ECVAM / J.Kreysa

  12. International coop. Consultation ValidationWorkflow Output / Docs ICATM: establish mutual interest • EU MS / agencies: regulatory relevance • ESTAF: user relevance 1. Test submission handling, scientific/relevance assessment. Decision on entering Validation Test Submission(TS) PARERE |ESTAF Input ICATM: Propose VMG – members, send liaison, comment • Public input on planned • Validation Study (facts, • Data, comments) 2. Validation; Validation Study Report ValidationAnnounce- ment ValidationStudy Report(VSR) 3. ESAC peer review of VSR; ESAC opinion on reliability and/or scientific validity ICATM: Propose Peer Review Group Members; ESAC observer ESAC mandate ESAC Reports& Opinion ICATM: Comment on draft ECVAM recommendations 4. Draft ECVAM Recommendation 5. ‘Right to be heard’ process • EU MS / agencies: • ESTAF Draft ECVAM Recommendation 6. Public Commenting • Public input (INTERNET) Public CommentingReport 7. Final ECVAM recommendation incl. ESAC opinion & VSR; Transfer to policy DGs ; publication ECVAM Recommendation ECVAM / J.Kreysa

  13. International coop. Consultation ValidationWorkflow Output / Docs ICATM: establish mutual interest • EU MS / agencies: regulatory relevance • ESTAF: user relevance 1. Test submission handling, scientific/relevance assessment. Decision on entering Validation Test Submission(TS) PARERE |ESTAF Input Pre-Submission arrives at ECVAM Start Validation? Who (f (resources, capacities))? Promising? Priority ? Invite full submission Consult PARERE, ESTAF, ICATM Organise & carry out Validation in line with modular approach in order to generate a complete dossier for peer review Ready for which stage of Validation? yes Back to developer ECVAM / J.Kreysa

  14. International coop. Consultation ValidationWorkflow Output / Docs ICATM: establish mutual interest • EU MS / agencies: regulatory relevance • ESTAF: user relevance 1. Test submission handling, scientific/relevance assessment. Decision on entering Validation Test Submission(TS) PARERE |ESTAF Input ICATM: Propose VMG – members, send liaison, comment • Public input on planned • Validation Study (facts, • Data, comments) 2. Validation; Validation Study Report ValidationAnnounce- ment ValidationStudy Report(VSR) 3. ESAC peer review of VSR; ESAC opinion on reliability and/or scientific validity ICATM: Propose Peer Review Group Members; ESAC observer ESAC mandate ESAC Reports& Opinion ICATM: Comment on draft ECVAM recommendations 4. Draft ECVAM Recommendation 5. ‘Right to be heard’ process • EU MS / agencies: • ESTAF Draft ECVAM Recommendation 6. Public Commenting • Public input (INTERNET) Public CommentingReport 7. Final ECVAM recommendation incl. ESAC opinion & VSR; Transfer to policy DGs ; publication ECVAM Recommendation ECVAM / J.Kreysa

  15. International coop. Consultation ValidationWorkflow Output / Docs ICATM: Propose VMG – members, send liaison, comment • Public input on planned • Validation Study (facts, • Data, comments) 2. Validation; Validation Study Report ValidationAnnounce- ment ValidationStudy Report(VSR) Define Validation Study VMG Validation study, generating lacking info. Public consultation, Consult ICATM Ready for which stage of Validation? Output: Validation Report, ready for independent peer review by ESAC. Stop ECVAM / J.Kreysa

  16. International coop. Consultation ValidationWorkflow Output / Docs ICATM: establish mutual interest • EU MS / agencies: regulatory relevance • ESTAF: user relevance 1. Test submission handling, scientific/relevance assessment. Decision on entering Validation Test Submission(TS) PARERE |ESTAF Input ICATM: Propose VMG – members, send liaison, comment • Public input on planned • Validation Study (facts, • Data, comments) 2. Validation; Validation Study Report ValidationAnnounce- ment ValidationStudy Report(VSR) 3. ESAC peer review of VSR; ESAC opinion on reliability and/or scientific validity ICATM: Propose Peer Review Group Members; ESAC observer ESAC mandate ESAC Reports& Opinion ICATM: Comment on draft ECVAM recommendations 4. Draft ECVAM Recommendation 5. ‘Right to be heard’ process • EU MS / agencies: • ESTAF Draft ECVAM Recommendation 6. Public Commenting • Public input (INTERNET) Public CommentingReport 7. Final ECVAM recommendation incl. ESAC opinion & VSR; Transfer to policy DGs ; publication ECVAM Recommendation ECVAM / J.Kreysa

  17. ECVAM as EU-RL thrives with its networks • PARERE – Preliminary Regulatory Relevance Assessment, single points of contact, MS competent authorities • COM servicesandEU 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 profile • allows identifying best suitable lab for validation studies • Ad hoc networksof expertise, work shops, conferences, ESAC-WGs, manned fromECVAM Expert Panel (EEP) ECVAM / J.Kreysa

  18. EUROPEAN CENTRE FOR THE VALIDATION OF ALTERNATIVE METHODS Thank you for your attention ! ECVAM / J.Kreysa

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