EPAA WG 4 Workshop Pharmaceuticals October 12, 2006 Bruxelles Siegfried Breier DG ENT Gernot Klotz B

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EPAA WG 4Workshop PharmaceuticalsOctober 12,
2006 Bruxelles Siegfried Breier (DG
ENT)Gernot Klotz (Bayer AG)
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EPAA WG 4Concept

• reduce number of animals
• improve animal welfare

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WG 4 in EPAA

• I. Action Programme
• EPAA-Working Group 4 was set up to implement the
  following activities identified in the Action
  Programme in the area of
• Implementation of the 3Rs in Regulation and
  Decision Making

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Timeframe Short-term

• Identification of hot spots for animal use and
  welfare in current legislation and guidance via
  an inventory of regulatory requirements leading
  to animal use and impacting animal welfare.
• Identification of potential hot spots for
  animal use and welfare in upcoming legislation
  and guidance via mapping of relevant activities.

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Timeframe Medium and long-term

• Identification and evaluation of drivers (e.g.,
  safety, liability, precaution, risk acceptance
  etc.) for regulatory testing requirements.
• Assessment of current and evolving practice and
  criteria for reporting of animal use, including
  recommendations for improving implementation,
  where appropriate.
• Identification and consideration of appropriate
  (sector specific) measures to implement 3Rs in
  legislation and to avoid redundant testing of
  animals particularly in hot spots.

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EPAA WG 4Areas

• Existing legislation
• Up-coming legislation
• Implementation
• Global requirements

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Workprogramme 4
background paper WS report finalized
road map
-
v
v
WS Cosmetics
September 6
v
WS Pharmaceuticals
October 12
v
WS Chemicals
October 23
v
WS Crop Protection
October 26
v
WS Biotechnology
in preparation
early November
WS horizontal integration
planned
early November
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Timeline WG 4
1. Cycle 2006
2. Cycle 2007 ff
EPAA conference December 18th, 2006

• common understanding of status quo

ongoing
in depth evaluation of critical areas

• first evaluation of critical areas

reality check, added value

• description available 3R proposals

• scoping and description of various drivers

in depth evaluation (e.g. specific interviews)
identification and promotion of appropriate
measures for implementation

• first integration and evaluation across sectors

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Optimization of systemreduce and refine and
replace net benefit
it is about
it is not

• common understanding of the current status and
  reasoning within and across several sectors

• peer-review of existing / planned regulations and
  their implementation

• Use combined practical experience

• challenging the regulatory authority of EU
  Commission, EU Parliament and EU member states

• identify and describing drivers incl. competing
  targets by open dialogue

• robust proposals to focus ressources

• offer pragmatic solutions as guidance for further
  work
• Built on existing work

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EPAA WG 4Members

• Astra Zeneca
• BASF
• Bayer AG
• Covance
• DG ENTR
• DG ENV
• DG JRC
• DG SANCO
• EFSA
• EFPIA

EMEA Eurogroup for Animals GSK Henkel Johnson
Johnson Pfizer Syngenta