Document 1485717

DRAFT - ICCVAM Participation on ECVAM Test Method Evaluations - DRAFT
For Discussion Purposes Only
................................
U)
c
0
·ai
:J
~
~
"tl
c(
.
Greenscreen
(GeneTox)
• Yeast
Androgen
Screen (ED)
Gard (Skin
Sensitization)
.
...................................
...........................................................................................
..
..
• VITOSENS (Skin Sensitization)
CAMVA (Eye Irritation)
Ocular lrritection (Eye Irritation)
MELN (ED)
CYS/LYS Peptide Binding (Skin Sensitization)
• AR CALUX (ED)
SENS-IS (Skin Sensitization)
PALM Cell Assay (ED)
.
.
..............................................................................................
..............................................
.
.
hCLAT(Skin
Sensitization)
EpiOcular EIT (Eye
Irritation)
...............................................
~
~
(.)
w
1. Assess Submission
U)
U)
~
0
r1.
.
.
Scientific and
regulatory
aspects
Stakeholder
relevance
3. ESAC Review
_,.......
..
.
2. Validation Study
Planning (Validation Project Plan)
Performing study
Preparing report (Validation Study Report)
.,
~
.
Conduct of validation study
• Validation study report
~
conclusions
·~
-
'
Pre11m1n t:.va1uat1on
U)
c.
:J
e
(!)
Cl
c;
:Si!
~
I
~
~
(.)
z
I
:::!:
~
~
- Pepare l\.,;\.,;VAM
briefing
- Add to next TC
Agenda
Distribute
materials
-
ICCVAM EVal
i--.
-
Detennine level
of interest
Identify
stakeholder
agencies
Nominate VMT
liaisons
~'
Feedback
- VMT liasons
update ICCVAM
and Working
Group
- Provide feedback
on draft validation
project plan and
study report
,
ICCVAM Nomination
- Nominate experts
for ESAC working
group
Review ESAC Results
- Review and
provide feedback
on ESAC Report
and Opinion
4. ECVAM
Recommendation
Draft -- ICCVAM Participation on ECVAM Test Method Evaluations -- Draft
For Discussion Purposes Only
I
.................................................
!!!
0
•
•
•
•
DPRA(Skin Sensitization)
Bhas CTA (Cardinogenicity)
ZFET (Embryotoxicity)
Keratinosens (Skin
Sensitization)
• 3T3 NRU (Acute Tox)
"j
:J
~
~
"8
<(
................................................
~
~
u
w
ill
Gl
u
e
a.
4. ECVAM Recommendations
4.2 Public commenting
• Develop draft ECVAM recommendations
Negotiate harmonized recommendation with
ICATM partners
4.1 "Right to be heard" process
• Public input on draft
ECVAM
recommendation
.
~
4.3 Publication
Lr-
• Final ECVAM
Recommendation
• ESAC Report and Opnion
• Validation Stud Report
j
·~
Negotiate Harmonized Recommendations
ICCVAM Statement
Ill
c.
:J
e
(.!)
Cl
c:
• Assess relevance of ECVAM draft
recommendation to US regulatory agencies
• Identify additional activities needed for US
aoption
• Identify and plan ICCVAM response to
ECVAM Recommendation
- Publish on website and through ICCVAM-All email list
- Relevance of recommendation to US regulations
- Announce any further ICCVAM activities
Additional Validation (Optional)
.....
~
~
z
-
Other Activities (Optional)
~
'
:::!:
- Testing of additional substances (expand domain
or compare to other methods)
Additional analysis (e.g. using US categorization)
- Testing at additional laboratories (transferability)
workshops
.................................... -- Collect
additional data (FR notices)
u
'
:::!:
~
u
Formal ICCVAM Recommendation (OptionaQ
~
.....................................
- Recommendation and transmittal to agencies
- Only used when required
- New peer review required if additional data or
analysis used in developing recommendation