Development and Rational Use of Standardised MedDRA Queries SMQs Retrieving Adverse Drug Reactions with MedDRA 2nd Edition by Council for International Organizations of Medical Sciences ISBN 9789290360865 9290360860

Development and Rational Use of Standardised MedDRA Queries SMQs Retrieving Adverse Drug Reactions with MedDRA 2nd Edition by Council for International Organizations of Medical Sciences – Ebook PDF Instant Download/Delivery: 9789290360865, 9290360860

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Product details:

ISBN 10: 9290360860

ISBN 13: 9789290360865

Author: Council for International Organizations of Medical Sciences

 This publication aims to inform regulatory authorities, scientific institutions, pharmaceutical companies and other organizations or individuals involved in pharmaceutical and other medicinal product development, about the purpose and appropriate use of SMQs in safety surveillance activities.

Table of contents:

 ACKNOWLEDGEMENTS.
DEDICATION..
INITIALISMS AND GLOSSARY…
PREFACE……
DISCLAIMERS AND CLARIFICATIONS…
CHAPTER I. INTRODUCTION.
Executive summary…
I.A. Origins of SMQS..
I.B. Overview of purpose and content of this publication..
I.C. Target audience.
CHAPTER II. OVERVIEW OF SMQ CONCEPTS.
Executive summary..
II.A. SMQ definition…
II.B. SMQ benefits and limitations….
II.C. SMQ applications………
II.D. Development of SMQS
II.E. MedDRA Version Analysis Tool (MVAT).
II.F. SMQ design features…………
II.G. SMQ modifications and organization-specific queries.
II.H. SMQ maintenance..
II.I. Consideration of requests for new SMQS
II.J. Testing of SMQ…..
II.K. Summary of concepts and proposals for use of SMQS……
CHAPTER III. SEARCH STRATEGIES WITH A FOCUS ON PHARMACOVIGILANCE.
Executive summary..
III.A. Introduction…..
III.B. General considerations for search strategies.
III.C. Communication and documentation of the search strategy..
III.D. Limitations – guidelines to avoid pitfalls…..
III.E. Customized searches……….
III.F. Conclusions and recommendations..
CHAPTER IV. TECHNICAL ASPECTS OF IMPLEMENTATION..
Executive summary..
IV.A. Introduction…….
IV.B. Practical guidance for implementing SMQS.
IV.C. How to deal with algorithms……
IV.D. Algorithmic SMQs using weight factors.
IV.E. Conclusions and recommendations …
CHAPTER V. COMMUNICATION OF RESULTS…
Executive summary.
V.A. General considerations for communication of search results.
V.B. Points to consider when preparing a report with query output..
V.C. Conclusions and recommendations……….
CHAPTER VI. CURRENT CONSIDERATIONS AND FUTURE DIRECTIONS.
Executive summary..
VI.A. Current considerations.
VI.B. Future direction……….

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Council for International Organizations of Medical Sciences,Development and Rational,Use of Standardised MedDRA,Queries SMQs Retrieving