Practical Approaches To Risk Minimisation For Medicinal Products: Report Of Cioms Working Group Ix by M. C. World Health OrganizPractical Approaches To Risk Minimisation For Medicinal Products: Report Of Cioms Working Group Ix by M. C. World Health Organiz

Practical Approaches To Risk Minimisation For Medicinal Products: Report Of Cioms Working Group Ix

byM. C. World Health OrganizEditorWorld Health Organiz

Paperback | March 2, 2015

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Risk management of medicines is a wide and rapidly evolving concept and practice, following a medicine throughout its lifecycle, from first administration in humans through clinical studies and then marketing in the patient population at large.

Previous reports from CIOMS I - VIII provided practical guidance in some essential components of risk management such as terminology and reporting of adverse drug reactions, management of safety information from clinical trials, and safety signal detection. Beyond the detection, identification, and characterization of risk, "risk minimization" is used as an umbrella term for the prevention or mitigation of an undesirable outcome.

Risk management always includes tools for "routine risk minimization" such as product information, the format depending on the jurisdiction, to inform the patient and the prescriber, all of which serve to prevent or mitigate adverse effects. Until this current CIOMS IX document, limited guidance has been available on how to determine which risks need "additional risk minimization," select the appropriate tools, apply and implement such tools globally and locally, and measure if they are effective and valuable. Included in the report is a CIOMS framework for the evaluation of effectiveness of risk minimization, a discussion of future trends and developments, an annex specifically addressing vaccines, and examples from real life.
World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based polic...
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Title:Practical Approaches To Risk Minimisation For Medicinal Products: Report Of Cioms Working Group IxFormat:PaperbackDimensions:184 pages, 8 × 6 × 0.68 inPublished:March 2, 2015Publisher:WHO PUBLICATIONSLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:9290360844

ISBN - 13:9789290360841

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