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0:00
Hello, I'm Dian Turnheim.
I'm currently Head of the Environment,
Health and Safety Division.
And I would like to begin by setting the
framework and the history of the work of
OECD on Good Laboratory Practice and
compliance monitoring.
0:16
This slide is an overview slide of
what my presentation today will cover.
First of all, I'll give you a general
overview of all the talks to be covered in
this series, and then a brief
discussion of the Organisation for
Economic Cooperation and Development and
its work on the safety of chemicals and
chemical products for the past 40 years.
Then I will go into the first council
decision on the Mutual Acceptance of
Data in the assessment of chemicals,
the MAD council decision of 1981, and
I will briefly touch upon the development
and revision of the OECD principles of
Good Laboratory Practice, which
are an integral part of that decision, and
finally, briefly,
the role of the working group on GLP.
1:01
This slide presents an overview of
all of the talks in this series which
I have put together.
The first section, and by far the longest,
is that on the OECD principles
of Good Laboratory Practice,
beginning with history and framework in
OECD, which I will present to you today.
That is followed then by two talks
on the scope of application of
Good Laboratory Practice.
First of all, 'What is Safety' study?
Second, the relationship between
Good Laboratory Practice principles and
ISO standards.
The third and by far the longest section
is that on the OECD principles of GLP.
This will begin with a long
talk on the philosophy of GLP,
followed by several talks on
the various aspects of GLP: planning,
performing, recording, reporting,
archiving, quality assurance, facilities.
Then: several talks on the application and
interpretation of the principles of GLP,
with talks on multi site studies and
field studies, in vitro and
term studies, the application
of GLP to computerised systems,
the application of GLP principles
to analytical chemistry, and
the role and responsibilities
of the sponsor in GLP studies.
The second section of
talks is on monitoring for
compliance with Good Laboratory Practice.
Once again,
we'll begin by setting out the history and
the OECD framework on this work, followed
by several talks on the OECD guidance for
national compliance monitoring programmes,
and
then some specific talks on specific
National Compliance Monitoring systems.
The third and last section deals
with the international aspects of
data acceptance through OECD,
starting with a talk on the history and
OECD context of this work,
followed by a talk on the programme for
peer review of national compliance
monitoring programs, and
then finally on the participation
of non-member economies in
the OECD's system for
mutual acceptance of data.
