WHO Drug Information Vol. 20, No. 4, 2006 - World Health ...

WHO Drug Information Vol 20, No. 4, 2006
Pharmaceutical policy
analysis conference in 2007
A conference on pharmaceutical policy
analysis, including sociocultural, economic,
regulatory and epidemiological
aspects of pharmaceuticals and international
health will be held from 19–21
September 2007, in Zeist, Netherlands.
Everybody who comes to the conference
will be asked to submit a paper which will
be discussed in groups during the conference.
The first stage of attending is to
submit a 300 word abstract.
Pharmaceutical policy analysis is increasingly
acknowledged as an important
driver of evidence-based policy making
on pharmaceuticals. In a world with
ample diversity in perspectives and
opinions about how to prioritize and
regulate pharmaceutical policies, and
where to intervene in daily practice,
robust data and valid research methodologies
can, and should, make a difference.
However, despite all the enthusiasm
and support for pharmaceutical
policy research, the scientific quality of
the field is yet rather limited in terms of
impact on policy makers and visibility in
high-impact journals. The objectives of
the Conference on Pharmaceutical Policy
Analysis are to:
• Build knowledge on the basis of a
discussion of Pharmaceutical Policy
Analysis papers submitted and reviewed
in advance of the meeting.
• Focus on methods for Pharmaceutical
Policy Analysis as a long-term outcome
to fuel the field.
• Create commitment to deliver publications
in high-impact journals.
The theme for the conference will be
broadly interpreted to encourage submission
of a range of papers on various
topics related to international policy
Recent Publications, Information and Events
aspects of pharmaceuticals. These could
include: prioritizing in and barriers to
pharmaceutical innovation. Drug utilization
aspects, regulatory issues, economical
questions, cross-cultural aspects of
medicines’ efficacy, safety and usage,
quality indicators, methods of pharmaceutical
policy analysis, effectiveness of
rational use interventions, promotional
practices, role of consumers, access to
medicines, and international health.
Ultimately, it will be the quality of the
papers which determines the content of
the meeting.
Reference: Enquiries and abstracts to Pieter
Stolk: pharmapolicy2007@pharm. uu.nl. P.O.
Box 80082, 3508 TB Utrecht, Netherlands.
Final guidance on
quality systems
The US Food and Drug Administration
(FDA) has released the final version of
their Guidance for industry: quality
systems approach to pharmaceutical
CGMP regulations. This version finalizes
the draft which was published in October
2004. The October 2nd Federal Register
announcement notes that the Agency
considered all comments received on the
draft as they established the final version;
however no substantive changes were
made.
The final version contains a number of
clarifying edits. The guidance is intended
to encourage the use of modern quality
management system principles by the
regulated industry and to foster innovation
and continuous improvements in
pharmaceutical manufacturing. Alternative
approaches may be used so long as
they satisfy the requirements of the
applicable statutes and regulations.
Reference: The Federal Register, Vol. 71, No.
190; pp. 57980 and 57981. 2 October 2006.
http://www.fda.gov/cder/guidance/index.htm or
http://www.fda.gov/ohrms/dockets/default.htm.
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