Unlisted Brochures, Flyers, and Reprints on Group Discussion PDF Download
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Author:
Publisher:
ISBN:
Category : Forums (Discussion and debate).
Languages : en
Pages : 438
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Author:
Publisher:
ISBN:
Category : Forums (Discussion and debate).
Languages : en
Pages : 438
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Author:
Publisher:
ISBN:
Category : Psychological warfare
Languages : en
Pages : 340
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Author:
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ISBN:
Category : Adult education
Languages : en
Pages : 576
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Author:
Publisher:
ISBN:
Category : Congresses and conventions
Languages : en
Pages : 262
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Author: CIOMS Working Group III
Publisher: World Health Organization
ISBN: 9789290360704
Category : Drugs
Languages : en
Pages : 98
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Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher: Cioms
ISBN: 9789290360827
Category : Drug monitoring
Languages : en
Pages : 0
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Book 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. However, the CIOMS Working Group VIII is convinced that the combination of methods and a clear policy on the management of signals will strengthen current systems. 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.
Author: World Health Organization
Publisher:
ISBN: 9789290360742
Category : Medical
Languages : en
Pages : 381
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Book Description
In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals.
Author: Daniel J Solove
Publisher: NYU Press
ISBN: 0814740375
Category : Computers
Languages : en
Pages : 295
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Book Description
Daniel Solove presents a startling revelation of how digital dossiers are created, usually without the knowledge of the subject, & argues that we must rethink our understanding of what privacy is & what it means in the digital age before addressing the need to reform the laws that regulate it.
Author: Estados Unidos. President's Commission on the Assassination of President Kennedy
Publisher:
ISBN:
Category :
Languages : en
Pages : 982
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Author: Gregory Fontenot
Publisher:
ISBN:
Category : History
Languages : da
Pages : 578
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Book Description
Den amerikanske hærs første officielle historiske beretning om operationerne i den anden Irakiske Krig, "Operation Iraqi Freedom", (OIF). Fra forberedelserne, mobiliseringen, forlægningen af enhederne til indsættelsen af disse i kampene ved Talil og As Samawah, An Najaf og de afsluttende kampe ved Bagdad. Foruden en detaljeret gennemgang af de enkelte kampenheder(Order of Battle), beskrives og analyseres udviklingen i anvendte våben og doktriner fra den første til den anden Golf Krig.
