ECVAM - caat.jhsph.edu

ECVAM - caat.jhsph.edu

Berlin, 31 January 2011 ECVAM as EU-RL according to 2010/63 Joachim Kreysa Berlin, 31 January 2011 Last update: 02/08/20 Author: J.Kreysa Slide Number: 1 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 02/08/20 ECVAM / J.Kreysa 2 Berlin, 31 January 2011 ANNEX VII: ECVAM shall deal with the entire lifecycle of Alternative Methods - from Research to Implementation Implementation (Industry, Regulators,

CROs) Research Regulatory Acceptance Development (EU, OECD) Optimization Validation Last update: 02/08/20 Author: J.Kreysa incl. independent review Slide Number: 3 Berlin, 31 January to 2 February 2011 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 02/08/20 ECVAM / J.Kreysa

4 Berlin, 31 January to 2 February 2011 02/08/20 ECVAM / J.Kreysa 5 Berlin, 31 January to 2 February 2011 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 02/08/20 ECVAM / J.Kreysa 6

Berlin, 31 January to 2 February 2011 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 02/08/20 ECVAM / J.Kreysa 7 Berlin, 31 January to 2 February 2011 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 02/08/20 ECVAM / J.Kreysa

8 Berlin, 31 January to 2 February 2011 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. 02/08/20 ECVAM / J.Kreysa 9 Berlin, 31 January to 2 February 2011 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) 02/08/20 ECVAM / J.Kreysa 10 Berlin, 31 January to 2 February 2011 How will ECVAM handle these requirements and link them to its validation process? 02/08/20 ECVAM / J.Kreysa 11 Berlin, 31 January to 2 February 2011 International coop. Consultation Validation Workflow ICATM: establish mutual interest EU MS / agencies: regulatory relevance

ESTAF: user relevance 1. Test submission handling, scientific/relevance assessment. Decision on entering Validation ICATM: Propose VMG members, send liaison, comment Public input on planned Validation Study (facts, Data, comments) ICATM: Propose Peer Review Group Members; ESAC observer ICATM: Comment on draft ECVAM recommendations EU MS / agencies: ESTAF Test Submission (TS) PARERE | ESTAF Input 2. Validation; Validation Study Report

Validation Announcement Validation Study Report (VSR) 3. ESAC peer review of VSR; ESAC opinion on reliability and/or scientific validity ESAC mandate ESAC Reports & Opinion 4. Draft ECVAM Recommendation 5. Right to be heard process Public input (INTERNET) 6. Public Commenting 7. Final ECVAM recommendation incl. ESAC opinion & VSR; 02/08/20 Output / Docs Transfer to policy DGs ; publication ECVAM / J.Kreysa

Draft ECVAM Recommendation Public Commenting Report ECVAM Recommendation 12 Berlin, 31 January to 2 February 2011 International coop. Consultation Validation Workflow ICATM: establish mutual interest EU MS / agencies: regulatory relevance ESTAF: user relevance 1. Test submission handling, scientific/relevance assessment. Decision on entering Validation Output / Docs Test Submission

(TS) PARERE | ESTAF Input Pre-Submission arrives at ECVAM Start Validation? Who (f (resources, capacities))? Promising? Invite full submission Consult PARERE, ESTAF, ICATM Ready for which stage of Validation? yes Organise & carry out Validation in line with modular approach in order to generate a complete dossier for peer review Back to developer 02/08/20 ECVAM / J.Kreysa 13 Berlin, 31 January to 2 February 2011

International coop. Consultation Validation Workflow ICATM: establish mutual interest EU MS / agencies: regulatory relevance ESTAF: user relevance 1. Test submission handling, scientific/relevance assessment. Decision on entering Validation ICATM: Propose VMG members, send liaison, comment Public input on planned Validation Study (facts, Data, comments) ICATM: Propose Peer Review Group Members; ESAC observer ICATM: Comment on draft ECVAM recommendations EU MS / agencies:

ESTAF Test Submission (TS) PARERE | ESTAF Input 2. Validation; Validation Study Report Validation Announcement Validation Study Report (VSR) 3. ESAC peer review of VSR; ESAC opinion on reliability and/or scientific validity ESAC mandate ESAC Reports & Opinion 4. Draft ECVAM Recommendation 5. Right to be heard process Public input (INTERNET)

6. Public Commenting 7. Final ECVAM recommendation incl. ESAC opinion & VSR; 02/08/20 Output / Docs Transfer to policy DGs ; publication ECVAM / J.Kreysa Draft ECVAM Recommendation Public Commenting Report ECVAM Recommendation 14 Berlin, 31 January to 2 February 2011 International coop. ICATM: Propose VMG members, send liaison, comment Consultation Validation Workflow

Public input on planned Validation Study (facts, Data, comments) 2. Validation; Validation Study Report Output / Docs Validation Announcement Validation Study Report (VSR) Define Validation Study VMG Validation study, generating lacking info. Public consultation, Consult ICATM Ready for which stage of Validation? Stop 02/08/20 Output: Validation Report, ready for independent peer review by ESAC. ECVAM / J.Kreysa

15 Berlin, 31 January to 2 February 2011 International coop. Consultation Validation Workflow ICATM: establish mutual interest EU MS / agencies: regulatory relevance ESTAF: user relevance 1. Test submission handling, scientific/relevance assessment. Decision on entering Validation ICATM: Propose VMG members, send liaison, comment Public input on planned Validation Study (facts, Data, comments) ICATM: Propose Peer Review Group Members; ESAC observer ICATM: Comment

on draft ECVAM recommendations EU MS / agencies: ESTAF Test Submission (TS) PARERE | ESTAF Input 2. Validation; Validation Study Report Validation Announcement Validation Study Report (VSR) 3. ESAC peer review of VSR; ESAC opinion on reliability and/or scientific validity ESAC mandate ESAC Reports & Opinion

4. Draft ECVAM Recommendation 5. Right to be heard process Public input (INTERNET) 6. Public Commenting 7. Final ECVAM recommendation incl. ESAC opinion & VSR; 02/08/20 Output / Docs Transfer to policy DGs ; publication ECVAM / J.Kreysa Draft ECVAM Recommendation Public Commenting Report ECVAM Recommendation 16 Berlin, 31 January to 2 February 2011 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 profile allows identifying best suitable lab for validation studies Ad hoc networks of expertise, work shops, conferences, ESAC-WGs, manned from ECVAM Expert Panel (EEP) 02/08/20 ECVAM / J.Kreysa 17 Berlin, 31 January to 2 February 2011 Thank you for your attention ! 02/08/20 ECVAM / J.Kreysa 18

Recently Viewed Presentations

  • The Effects of Biochar on Plant Growth

    The Effects of Biochar on Plant Growth

    The Effects of Biochar on Plant Growth. David Rice. 110110356. Dr Marcel Jansen. Professor Peter Jones. March 2014
  • Soon after the end of World War II,

    Soon after the end of World War II,

    President Truman agrees to send U. S. troops Eventually 16 nations send troops in the first U. N. military action in history; but most are from U.S. Supreme Allied Commander: General Douglas MacArthur First troops in are U. S. troops...
  • CII Assignment Techniques

    CII Assignment Techniques

    CII Marking Grid. Knowledge and UnderstandingThese are facts from the learning material derived from the learning outcomes that are relevant to the question.To score a high mark in this section a candidate will have included relevant and sufficient factual information...
  • Headline is Arial, 36pt Bold, Two Lines

    Headline is Arial, 36pt Bold, Two Lines

    Agile Practice. Benefits. Whole Team. Quality & Testing is not just a testers responsibility. Quality is more than defect counts. Testers role shifts to quality infusion throughout project life cycle
  • An Tionscnamh um Phleanil Fhorbartha Scoile Roinnphleanil dbhair

    An Tionscnamh um Phleanil Fhorbartha Scoile Roinnphleanil dbhair

    An Leas a bhaintear as an Measúnacht Úsáideann múinteoirí agus scoileanna torthaí measúnachta chun: Aiseolas a thabhairt do dhaltaí faoin dul chun cinn atá déanta acu Tuairisciú do thuismitheoirí ar dhul chun cinn na ndaltaí Gníomhaíochtaí ranga amach anseo a...
  • Principles of Interferometry - National Radio Astronomy ...

    Principles of Interferometry - National Radio Astronomy ...

    In astronomy, brightness (or specific intensity) is denoted I n,t (s). Brightness is defined as the power received per unit frequency dn at a particular frequency n, per unit solid angle dW from direction . s, per unit collecting areadA....
  • Synonymes

    Synonymes

    Times New Roman Arial Comic Sans MS Blank Presentation Synonymes rire de remuer fonder détester poltron troubler pesant croître Le dédain interdire luire entêté plus étoile la bague la fin; l'objectif jadis châtier mener épris les noces ému l'étoffe unir;...
  • Organic Chemistry

    Organic Chemistry

    Naming Alkenes & Alkynes Change suffix from -ane to -ene for base name of the alkene, or to -yne for base name of the alkyne. Number chain from end closest to the multiple bond. Number in front of main name...