EPAA WG5 Validation and Acceptance

1
EPAA WG5 Validation and Acceptance

• Presentation by
• Odile de Silva (lOréal)
• Magda Chlebus (EFPIA)
• Laura Gribaldo/Thomas Hartung (ECVAM)

2
WG5 Membership

• Activity Leaders/Co-chairs
• S. Breier DG Enterprise (Cosmetics)
• L. Gribaldo ECVAM
• O. de Silva LOréal
• M. Chlebus EFPIA

• Team Members
• AstraZeneca
• BASF
• Bayer
• Covance
• DG Enterprise (Pharma)
• DG Enterprise (Reach)
• DG Environment
• DG Sanco
• ECOPA
• GlaxoSmithKline
• Henkel Phenion
• Intervet
• Pfizer
• Unilever

3
Objectives of WG5

• To facilitate and accelerate validation of
  existing methods relevant for industry use
• To overcome barriers to validation and regulatory
  acceptance.

4
How? Three Actions

• Support to Validation of priority methods in the
  ECVAM pipeline
• Criteria for prioritising studies of industry
  interest
• List of methods to be supported by industry with
  data and substances
• Procedure and timelines for provision of data and
  substances
• Overcoming barriers to validation
• Case studies and inventory of barriers
• Discussion document on potential solutions and
  strategy
• Overcoming barriers to regulatory acceptance
• Start of implementation scheduled for Q1 2007

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Interlinkage of Working Group Activities
Map and evaluate past and current 3R activities
Identify, disseminate implement 3R best practice
Evaluation of the regulatory drivers for animal
use
Prioritise and implement research based on 3Rs
Validate and accept alternative methods and
strategies
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WG5 Process and Timelines
Action1 Action 2 Action 3
Criteria and list of Priority studies Definition
of needs
Provision of data and/or substances
Case studies Definition of barriers Strategy
Implementation of agreed strategy
Case studies Definition of barriers Strategy
Implementation of agreed strategy
06Q3 06Q4 07Q1 07Q2 07Q3
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Activities in 2006
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Action 1
9
ECVAM pipeline reduction replacement
41
59
Potential for replacement within testing
strategies
10
The methods in the ECVAM pipeline for which there
is a need for data /substances
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ECVAM and validation status
Implementation
Research
Regulatory Acceptance
Development
Endocrine modulators Systemic toxicity
24 methods
ESAC Review
Prevalidation
Carcinogenicity Eye irritation
Validation
ECVAM
Duration of the validation process 2 to 7 years

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Prioritisation of the methods of relevance to
industrial use

• Based on an agreed list of criteria defined in
  the September 2006 stakeholders workshop
• Purpose to pilot a few projects with relevance
  to regulatory testing and where needs are well
  defined
• Profiles of the prioritised methods prepared in
  close collaboration with ECVAM and different
  sectors experts

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Prioritisation criteria (1)

• Ethics
• Overall (in vivo/in vitro) impact on numbers of
  animals and severity,
• increased level of safety
• Regulatory relevance
• Regulatory requirement,
• full replacement or tiered strategy,
• legislative timelines

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Prioritisation criteria (2)

• Industrial incentive
• Regulatory acceptance,
• across sector applicability,
• transferability,
• frequency of use,
• applicability across a range of molecules
• Development status
• Relevant positive and negative references
  response,
• high advancement of the test,
• clear purpose,
• availability of data,
• relevance to the best scientific knowledge,
• high probability for success

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Action 2
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Barriers to validation where can the EPAA help?
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EPAA framework for collaboration to facilitate
successful validation

• Industry contact points equipped with validation
  SOPs
• Standard operating procedures
• ECVAM elements to be included in an information
  request
• Industry how to process validators
  data/substance request
• Confidentiality agreement for provision of data
  substances
• Finalisation expected in early 2007

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Other recommendations

• Adding a regulatory review module to the
  validation process
• Involvement of industry at the stage of study
  design
• Involvement of regulators in early stages of the
  procedure to support regulatory acceptance
  process
• Applicability of approaches to be revisited with
  regulators after 5 years in order to consolidate
  the relevance of the method.

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Suggested Expanded Modular Approach to Validation
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Next steps and conclusions
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Next Steps

• Reflection on
• the role of validation and assessment for
  different purposes/sectors and by different
  bodies
• regulatory requirements vs. levels of confidence
  and acceptance of the validation of methods and
  strategies.
• criteria and prerequisites for efficient and
  robust validation as well as legal acceptance of
  alternative methods and testing strategies
• Promotion and fostering the regulatory acceptance
  and the use of new testing strategies
• Guidance on validation of strategies
• Continuous support to the validation process in
  ECVAM.

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Conclusions

• EPAA has a great potential to make the process of
  validation more efficient
• by enhancing the collaboration between ECVAM,
  industry and regulators
• in order to overcome administrative barriers and
• to ensure that priority is given to validation of
  methods, which will ultimately be accepted and
  used.
• This unprecedented cross-sectoral dialogue is
  helping to build common understanding of
  different parties needs and processes
• All actions on validation and acceptance have a
  medium to long term perspective. Clear
  milestones will help to assess progress made