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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
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Improving the Regulatory Review Process - Assessing Performance and Setting Targets (Hardcover, illustrated edition)
Loot Price: R2,548
Discovery Miles 25 480
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Improving the Regulatory Review Process - Assessing Performance and Setting Targets (Hardcover, illustrated edition)
Series: Centre for Medicines Research Workshop
Expected to ship within 12 - 17 working days
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At a time when it is becoming usual for medicines to be developed
for a global market and pharmaceutical companies are endeavouring
to expedite the drug development process, Regulatory authorities
are concentrating on improving their efficiency and effectiveness.
Therefore, it is not surprising that questions are being asked as
to how performance might be measured and compared between different
authorities who are now often in receipt of dossiers that have been
submitted to several agencies at the same time. Issues such as
"what target should be set for the review of new medicines?" and
"how can quality be assured?" are now considered to be of critical
importance. The 12th CMR International Workshop, held in January
1997, provided the opportunity for regulatory authority and
industry personnel from Europe, North America, Australia and Japan
to openly discuss experiences and exchange views on how to improve
the review process. The proceedings of this meeting provide a
comprehensive overview of the current review process in different
countries and the need for performance measures and targets. This
volume summarizes the many suggestions that were debated at the
workshop, and includes chapters on measuring performance, and on
the integration of quality into the review process.
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