Improving the Regulatory Review Process: Assessing Performance and Setting Targets.pdf

Improving the Regulatory Review Process: Assessing Performance and Setting Targets

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 twelfth 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 summarises 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.

Setting environmental targets | nibusinessinfo.co.uk Your choice of objectives and targets should depend on the most significant issues you identified in the baseline review. You can assess the significance of environmental issues using criteria such as the: amount and type of regulatory controls that apply, and how well the business is …

3.75 MB DATEIGRÖSSE
9401060428 ISBN
Englisch SPRACHE
Improving the Regulatory Review Process: Assessing Performance and Setting Targets.pdf

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Sofia Voigt

1 May 2007 ... Improving the Regulatory Review Process: Assessing Performance and Setting Targets. Dordrecht, The Netherlands: Kluwer Academic; ... Improving the Regulatory Review. Process: Assessing Performance and Setting Targets. Dordrecht, The Netherlands: Kluwer Academic;. 1997:13–19. 10.

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Matteo Müller

At Deloitte we're redesigning our performance management system. ... Like many other companies, we realize that our current process for evaluating the ... Objectives are set for each of our 65,000-plus people at the beginning of the year ; ... best design for Deloitte's emerging needs: Once-a-year goals are too “ batched” for ...

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2 Jun 2017 ... Postal Regulatory Commission. ... the executive agency's mission-related processes and administrative processes, as appropriate, ... Improve program performance by requiring agencies to set goals, measure performance against ... regularly updated to inform agency and OMB performance reviews. 1 Oct 2018 ... Performance measurement and program evaluation can both help identify ... determine whether the program is achieving its goals or objectives. ... Process evaluations may also assess whether program activities and outputs conform to statutory and regulatory requirements, EPA policies, program design or ...

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Jason Lehmann

The OECD is developing a framework for Regulatory Policy Evaluation to help countries ... Integrated framework for evaluating regulatory performance . ... and ii ) any relevant process outcomes based on administrative, democratic, ... treatment goals, that is, a reduction in the problem (or an improvement in the ultimate.

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Jessica Kohmann

A 'read' is counted each time someone views a publication summary (such as the title, abstract, and list of authors), clicks on a figure, or views or downloads the full-text. (PDF) The Regulatory Review Process in South …