Definition and Application of Terms for Vaccine Pharmacovigilance PDF Download

Author: Council for International Organizations of Medical Sciences (CIOMS)
Publisher:
ISBN: 9789290360834
Category : Drug Monitoring
Languages : en
Pages : 0

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Book Description
This report from the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with WHO covers the activities and outputs of the CIOMS/WHO Working Group on Vaccine Pharmacovigilance (2005-2010). This working group brought together experts from both industrialized and emerging countries representing regulatory agencies, vaccine industry, national and international public health bodies including WHO and CIOMS, academia and clinical care, contributing from their different perspectives. The report covers general terms and definitions for vaccine safety and discusses the application of such harmonized tools in vaccine safety surveillance and studies. As well, the report highlights case definitions for adverse events typically reported for vaccines. The report is addressed to those engaged in vaccine safety data collection and evaluation, and will also make a useful reading for others who want to familiarize themselves with vaccine safety terminology.

Author: Patrick Waller
Publisher: John Wiley & Sons
ISBN: 1119289742
Category : Medical
Languages : en
Pages : 194

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Book Description
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.

Author: Luke Y. Tsai
Publisher: Future Horizons
ISBN: 9781885477804
Category : Health & Fitness
Languages : en
Pages : 404

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Book Description
A medical doctor and academic pens a book about medication therapy for those on the autism spectrum, delineating the critical principles and treatments to ensure proper medication. Dr. Tsai enumerates the impact of drugs on behavior and various forms of pervasive developmental disorders.

Author: Mira Harrison-Woolrych
Publisher: Springer
ISBN: 3319124064
Category : Medical
Languages : en
Pages : 624

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Book Description
In this definitive new text, the major medicines, devices and vaccines used by women worldwide are brought together for the first time in a single volume. Written and edited by international experts with an evidence-based approach, the book offers a comprehensive summary of all the key areas of women’s medicines. In the first part, issues relating to female drug exposure and considerations for prescribing for subgroups of women - for example during pregnancy and lactation - are presented in the context of contemporary clinical practice. In the second part, specific groups of pharmaceutical products are reviewed, including oral contraceptives, emergency contraception, treatment of chronic pelvic pain, hormone replacement therapy, bisphosphonates, herbal medicines for women, contraceptive devices and human papilloma virus (HPV) vaccines. Every chapter reviews and summarises the efficacy and safety of each group of products and concludes with a useful set of clinical take home messages. In the third part, broader perspectives are presented - from a primary care overview of prescribing for women, through to regulatory, political and religious aspects, including issues with women’s medicines in developing countries. The final two chapters focus on risk communication and conclude that women themselves should be placed at the centre of all discussions about their medicines. The book is aimed at prescribers, other healthcare professionals and students in the field of women’s health throughout the world. It is an extremely valuable resource for all in clinical practice, for students of medicine, nursing, pharmacy and related sciences, and also for those in medicines regulation, pharmacovigilance and the pharmaceutical industry.

Author: Lynn Kern Koegel, Ph.D.
Publisher: Penguin
ISBN: 0698157435
Category : Family & Relationships
Languages : en
Pages : 434

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Book Description
There have been huge advances in our ability to diagnose autism and in the development of effective interventions that can change children’s lives. In this extraordinary book, Lynn Kern Koegel, a leading clinician, researcher, and cofounder of the renowned Autism Research Center at the University of California at Santa Barbara, combines her cutting-edge expertise with the everyday perspectives of Claire LaZebnik, a writer whose experience with a son with autism provides a rare window into the disorder. Together, they draw on the highly effective “pivotal response” approach developed at the center to provide concrete ways of improving the symptoms of autism and the emotional struggles that surround it, while reminding readers never to lose sight of the humor that lurks in the disability’s quirkiness or the importance of enjoying your child. From the shock of diagnosis to the step-by-step work with verbal communication, social interaction, self-stimulation, meltdowns, fears, and more, the answers are here-in a book that is as warm and nurturing as it is authoritative.

Author: Moira Stewart
Publisher: CRC Press
ISBN: 1909368032
Category : Medical
Languages : en
Pages : 310

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Book Description
This long awaited Third Edition fully illuminates the patient-centered model of medicine, continuing to provide the foundation for the Patient-Centered Care series. It redefines the principles underpinning the patient-centered method using four major components - clarifying its evolution and consequent development - to bring the reader fully up-to-

Author: World Health Organization
Publisher:
ISBN: 9789290360841
Category : Drugs
Languages : en
Pages : 0

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Book Description
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.

Author: Nathan I. Cherny
Publisher: Oxford University Press, USA
ISBN: 0199656096
Category : Medical
Languages : en
Pages : 1281

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Book Description
Emphasising the multi-disciplinary nature of palliative care the fourth edition of this text also looks at the individual professional roles that contribute to the best-quality palliative care.

Author: Don Hellriegel
Publisher:
ISBN: 9780324069563
Category : Beslutningstagning-ledelse
Languages : en
Pages : 0

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Book Description
Organizational Behavior is designed to help students, professionals, and managers develop the competencies and skills that are needed to effectively contribute to an organization. This proven text's strengths lie in its classic research, coverage of contemporary and emerging OB topics, and excellent case selection. Throughout the text, seven core competencies-Managing Self, Managing Diversity, Managing Ethics, Managing Across Cultures, Managing Teams, Managing Communications, and Managing Change-are emphasized and illustrated for the student.

Author: Charles S. Carver
Publisher:
ISBN: 9789353067854
Category : Personality
Languages : en
Pages : 0

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Book Description
"Perspectives on Personality describes a range of viewpoints that are used by personality psychologists today, and helps students understand how these viewpoints can be applied to their own lives. Authors Charles Carver and Michael Scheier dedicate a chapter to each major perspective, presenting an overview on the perspective's orienting assumptions and core themes and concluding with a discussion of problems within that theoretical viewpoint and predictions about its future prospects. The Eighth edition incorporates several important recent developments in the field, including genetics and genomics and the biological underpinnings of impulsiveness"--Back cover