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CIOMS
Working Group X
on
"Considerations for applying good
meta-analysis practices to clinical data
within the biopharmaceutical regulatory
process"
NEW CIOMS WORKING GROUP!
Meta-analyses have been increasingly used
in the scientific evaluation of efficacy
and safety in benefit-risk assessments, as
well as for pricing and the reimbursement
of biopharmaceutical products. Over the
last few years, the outcome of
meta-analyses have been both debated and
used as evidence within the regulatory
process for human medicinal products and
their interpretation has sometimes
contributed to different regulatory
actions for the same product.
Working Group X was established based on
suggestions from several parties and
consists of senior scientists from drug
regulatory agencies, the biopharmaceutical
industry and academia. The objective is to
develop a consensus on scientific and
methodological criteria that represent
good practices when applied to
meta-analyses of clinical data within the
regulatory process. The aim is that these
criteria will then be used by both
industry and regulators.
The
first two meetings were held in Geneva on
30 June and 1 July 2011 on 3-4 November
2011. The third meeting will be held at
the FDA, Washington in March
2012.
Full
details........Click
Here
STAKEHOLDERS
SESSION BY CIOMS AT THE 24th
ANNUAL EURODIA MEETING, 28 MARCH 2012 IN
COPENHAGEN
CIOMS is in
charge of the panel session "Risk(y)
Business! Stakeholders Interactive Input
into Risk Minimization Planning" under the
theme "Benefit/Risk Management and
Lifecycle Approach" during the meeting.
The session will take place on
Wednesday,
28 March, 09:00-10:30 at Bella Center.
CIOMS Working Group IX is to develop a
pragmatic consensus publication containing
a harmonized list of tools for managing
risks of medicinal products intended for
human use as well as the potential
application of these tools. One of the
main purposes of the session is to reflect
on and receive stakeholders input about
how risk minimization can be designed and
implemented.
The session will be in the form of a
roundtable panel discussion and
interactive with the audience using
technical equipment.
Members of CIOMS WG IX and the
Secretary-General will participate in the
discussion together with invited experts.
PRESENTATON BY THE PRESIDENT OF
CIOMS
MEETING IN NEW YORK ON THE PROTECTION OF
HUMAN PARTICIPANTS IN
RESEARCH:
On 18-19 May 2011, the Presidential
Commission, USA convened a meeting in New
York on "Human Subjects Protection", at
which 13 experts provided testimony and
were interrogated by members of the
Commission on the subject. CIOMS was
invited and was represented by its
President, Professor Johannes J.M. van
Delden, who is a Professor of Medical
Ethics at the University of Utrecht, in
the Netherlands. Other stakeholders
represented included UNESCO, the World
Medical Association, the European
Commission's European Group on Ethics in
Science and New Technologies (EGE), and
the Brussels-based Good Clinical Practice
Alliance -- Europe.
Further information on the meeting and other relevant aspects,
including a full transcript of the
proceedings,
can be accessed on the Presidential Commission's
website,www.bioethics.gov,
under the heading "Meeting 5, Session 7,
Transnational Standards". Those interested
may also wish to read a commentary on the
meeting on blog.Bioethics.gov. This
introductory narrative is based on the
information provided in these
sources.
To
view the Power Point slides of Professor
van Delden's
presentation,
click
here
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