CIOMS VIII PDF

CIOMS licence for electronic versions of its publications: Download SKU: Category: Uncategorized Description In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly. Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations. These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately. In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners.

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CIOMS licence for electronic versions of its publications: Download SKU: Category: Uncategorized Description In recent years public expectations for rapid identification and prompt management of emerging drug safety issues have grown swiftly.

Over a similar timeframe, the move from paper-based adverse event reporting systems to electronic capture and rapid transmission of data has resulted in the accrual of substantial datasets capable of complex analysis and querying by industry, regulators and other public health organizations.

These two drivers have created a fertile environment for pharmacovigilance scientists, information technologists and statistical experts, working together, to deliver novel approaches to detect signals from these extensive and quickly growing datasets, and to manage them appropriately.

In following this exciting story, this report looks at the practical consequences of these developments for pharmacovigilance practitioners. The report provides a comprehensive resource for those considering how to strengthen their pharmacovigilance systems and practices, and to give practical advice.

But the report does not specify instant solutions. These will inevitably be situation specific and require careful consideration taking into account local needs. Finally, in looking ahead, the report anticipates a number of ongoing developments, including techniques with wider applicability to other data forms than individual case reports.

The ultimate test for pharmacovigilance systems is the demonstration of public health benefit and it is this test which signal detection methodologies need to meet if the expectations of all stakeholders are to be fulfilled. This guideline was well received and has been widely distributed around the world.

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Council for International Organizations of Medical Sciences

The Council was formally constituted at a jointly-sponsored conference in Brussels in as a non-governmental organization, with financial assistance from the two parent organizations, UNESCO and WHO. The purpose of the Council was described as being to facilitate the exchange of views and scientific information in the medical sciences by securing continuity and coordination between international organizations of medical sciences, by making their work known, and by providing them with material aid where necessary. This was to be achieved through the exchange of information and by the provision of material and financial assistance to congresses and to the individuals attending them. The scope of activities of the Council was gradually broadened to include other forms of international collaboration in medical sciences in addition to the coordination of congresses. Until , the activities of CIOMS were focused on the coordination of international medical congresses; grants and loans to member societies for the preparation of congresses and the publication of their proceedings; travel grants to young scientists, especially from developing countries to attend medical congresses; organization of symposia on medical subjects; and assistance to member organizations for the standardization of nomenclature in various medical disciplines. After , various changes were made — some of which were dictated by the need for economy. Thus, the Council was forced to discontinue its grants to young scientists and to curtail its financial assistance to member organizations.

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Working Group VIII – Signal detection

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