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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. - PowerPoint PPT Presentation
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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
04/19/23 ECVAM / J.Kreysa 4
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
04/19/23 ECVAM / J.Kreysa 5
Berlin, 31 January to 2 February 2011
04/19/23 ECVAM / J.Kreysa 6
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
04/19/23 ECVAM / J.Kreysa 7
Berlin, 31 January to 2 February 2011
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
04/19/23 ECVAM / J.Kreysa 8
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
04/19/23 ECVAM / J.Kreysa 9
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.
04/19/23 ECVAM / J.Kreysa 10
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)
04/19/23 ECVAM / J.Kreysa 11
Berlin, 31 January to 2 February 2011
How will ECVAM handle these
requirements and link them to its
validation process?
04/19/23 ECVAM / J.Kreysa 12
Berlin, 31 January to 2 February 2011
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
04/19/23 ECVAM / J.Kreysa 13
Berlin, 31 January to 2 February 2011
1. Test submission handling, scientific/relevance assessment. Decision on entering Validation
• EU MS / agencies: regulatory relevance• ESTAF: user relevance
Test Submission(TS)
PARERE |ESTAF Input
ICATM: establish mutual interest
International coop. Consultation Validation Workflow Output / Docs
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
04/19/23 ECVAM / J.Kreysa 14
Berlin, 31 January to 2 February 2011
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
04/19/23 ECVAM / J.Kreysa 15
Berlin, 31 January to 2 February 2011
International coop. Consultation Validation Workflow Output / Docs
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.
2. Validation; Validation Study Report
• Public input on planned Validation Study (facts, Data, comments)
ValidationAnnounce-
ment
ValidationStudy Report
(VSR)
ICATM: Propose VMG – members, send liaison, comment
VMG
04/19/23 ECVAM / J.Kreysa 16
Berlin, 31 January to 2 February 2011
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
04/19/23 ECVAM / J.Kreysa 17
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 profileallows identifying best suitable lab for validation studies
Ad hoc networks of expertise, work shops, conferences,
ESAC-WGs, manned from ECVAM Expert Panel (EEP)
04/19/23 ECVAM / J.Kreysa 18
Berlin, 31 January to 2 February 2011
Thank you for your attention
!