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Author: Dr. Pradeep K. Agarwal
Publisher: Lulu.com
ISBN: 1304172996
Category : Science
Languages : en
Pages : 144
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Book Description
An Insight to Pharmacovigilance: A Global Perspective is a step-by-step guide for beginners and personnel involved in this field to give them comprehensive insight about various aspects involved in drug safety departments. The book gives the readers about an in-depth knowledge on the following topics of Pharmacovigilance: Basics of Pharmacovigilance, Global Bodies Governing Pharmacovigilance, Regulatory and Legal Aspects, Reporting Requirement and Reporting Forms, Public Safety Update Report, Individual Case Safety Report, Signal Detection, PV Inspections, Expedited Reporting Requirements, MedDRA, PV Glossary etc
Author: Dr. Pradeep K. Agarwal
Publisher: Lulu.com
ISBN: 1304172996
Category : Science
Languages : en
Pages : 144
Get Book Here
Book Description
An Insight to Pharmacovigilance: A Global Perspective is a step-by-step guide for beginners and personnel involved in this field to give them comprehensive insight about various aspects involved in drug safety departments. The book gives the readers about an in-depth knowledge on the following topics of Pharmacovigilance: Basics of Pharmacovigilance, Global Bodies Governing Pharmacovigilance, Regulatory and Legal Aspects, Reporting Requirement and Reporting Forms, Public Safety Update Report, Individual Case Safety Report, Signal Detection, PV Inspections, Expedited Reporting Requirements, MedDRA, PV Glossary etc
Author: Neeru Agarwal
Publisher: CreateSpace
ISBN: 9781499721812
Category : Medical
Languages : en
Pages : 142
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Book Description
Pharmacovigilance Insight & Global Perspective is a step by step guide for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, government and legal professions. It discussed about evolution of pharmacovigilance, ICH guidelines, Partners in Pharmacovigilance, Regulatory and Legal Aspects, Reporting Requirement and Reporting Forms, Public Safety Update Report, Individual Case Safety Report, Signal Detection, PV Inspections, Expedited Reporting Requirements, Global Perspective of Pharmacovigilance and Adverse Drug Reaction (ADR) Reporting, List of Technical Assistance providers in Pharmacovigilance, MedDRA, PV Glossary etc. The text provides exemplary coverage of all the relevant issues. The definitive book on the subject.
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: Ed Schoonveld
Publisher: Gower Publishing, Ltd.
ISBN: 9781409420521
Category : Business & Economics
Languages : en
Pages : 384
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Book Description
The Price of Global Health is the first book of its kind: an in-depth but straightforward exploration of the pharmaceutical pricing strategy process, its underlying market access, general business and ethical considerations, and its implications for payers, physicians and patients. It is a much needed and invaluable resource for anybody interested, involved in or affected by the development, funding and use of prescription drugs. In particular, it is of critical importance to pharmaceutical company executives and other leaders and professionals in commercialization and drug development, including marketing, business development, market access and pricing, clinical development, drug discovery, regulatory affairs, health outcomes, market research and public affairs.
Author: Andrew Bate
Publisher: Humana
ISBN: 9781493988167
Category : Medical
Languages : en
Pages : 0
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Book Description
This book examines insights into the latest thinking and core concepts in areas of key methodological endeavor in Pharmacovigilance (PV), which strives to ever more effectively protect patients from harm caused by the medicines they need. Each book chapter tends to have a clear quantitative or clinical slant and an aim to provide an overview of methodological insights within a specific topic, while also providing a perspective on how the area is anticipated to develop in the future. Quantitative chapters focus more on statistical and epidemiological strategies and the thinking that underpins core developments in Pharmacovigilance, whereas clinical chapters focus on clinical methods for detecting hypotheses for and determining side effects of medicinal products as well as misdiagnosis pitfalls. Examples of areas of importance include signal detection, risk management, and risk benefit assessment. Vital and authoritative, Evidence-Based Pharmacovigilance: Clinical and Quantitative Aspects aims to provide readers with a sense of the advances that have occurred in pharmacovigilance methods and approaches, as well as inspiration and motivation to advance the field of pharmacovigilance with a strong sense that there is much more work to be done in ensuring the safe use of medications by patients.
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: Mukesh Nandave
Publisher: Springer Nature
ISBN: 9819989493
Category :
Languages : en
Pages : 478
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Book Description
Author: Abdul Kader Mohiuddin
Publisher: Universal-Publishers
ISBN: 1627343083
Category : Medical
Languages : en
Pages : 690
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Book Description
The goal of a high quality, cost-effective and accessible health care for patients is achieved through constructing a team-based and patient-centered health care delivery system. The expanded role of pharmacists uplifts them to patient care from dispensing and manufacturing or marketing of drugs. Along with doctors and allied health professionals, pharmacists are increasingly recognized as an integral part of the patient care team. Furthermore, colleges of pharmacy need to revise and up-date their curricula to accommodate the progressively increasing development in the pharmaceutical education and the evolving new roles of practicing pharmacists in patient care settings. This book focuses on the expanded role of the pharmacists in total patient care including prescribing, dispensing, compounding, administering and monitoring of drugs at home, hospital, community, hospice, critical care, changeover and other care settings. The sector is emerging in both developed and under-developed countries. Overburdened by patient loads and the explosion of new drugs physicians turned to pharmacists more and more for drug information especially within institutional settings. And today’s patient care pharmacists are taking more interests in medication review and reconciliation, patient education and counseling, creating drug therapy regimen and monitoring compliance. The purpose of this book is to guide the pharmacists in their daily interactions with patients and to ensure collaboration with other health professionals. The contents are mostly based on recently published articles related to patient care, with most recent ideas and activities followed by the patient care pharmacists around the globe. However, a pharmacist implements the care plan in collaboration with other health care professionals and the patient or caregiver. Along with professional guidelines, the book discusses the concepts and best practices of patient interaction, patient rights, and ethical decision-making for the professional pharmacist, apprentice and student. In every chapter, the role of pharmacists in that chapter specific issues are detailed explicitly so that a professional pharmacist or a student can figure out his or her do’s and don’ts in that specific situation. Moreover, further reading references are listed as future recommendations. So, the book is an archive of potential references too. Among so many books about patient care, either doctors’ or nurses’ roles are highlighted. The proposed book highlights the pharmacists’ roles and responsibilities to the most, separated from those of doctors and nurses, with the most recent information obtained from most publications in several journals, books, bulletins, newsletter, magazines etc.
Author: Thao Doan
Publisher: Elsevier Health Sciences
ISBN: 032358117X
Category : Medical
Languages : en
Pages : 229
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Book Description
Written by experts in the field of pharmacovigilance and patient safety, this concise resource provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. Drs. Thao Doan, Fabio Lievano, Mondira Bhattacharya, and Linda Scarazzini provide essential information for health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance. - Covers the evolving regulatory landscape, as well as current and future use of digital technologies. - Uses case studies to ensure content is relevant to everyday practice. - Discusses behavioral science and patient perspectives, risk communication, and new frontiers in pharmacovigilance. - Consolidates today's available information on this timely topic into one convenient resource.
Author: Evangel Sarwar
Publisher: Springer Nature
ISBN: 303128593X
Category : Philosophy
Languages : en
Pages : 239
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Book Description
This book presents the promises of Precision Medicine (PM) and the challenges of its implementation in daily clinical routine, while addressing the anticipated ethical and social implications. It is the first book that critically analyzes the potential and the dilemmas relevant to genomics and precision medicine from healthcare, public health and global perspectives. The nine chapters presented in this book elaborate on pharmacogenomics' crucial role in maximizing the potential benefits and minimizing medication's potential risks in groups of people, especially in cancer treatment and other health conditions. Infectious and non-communicable diseases (NCDs) are also discussed in this book by identifying challenges and ways to overcome them. Essential concepts are addressed, such as health-related benefits and harm to individuals and the broader community, including threats to individual privacy and autonomy, which warrant just distribution of scarce resources. The book also identifies and addresses the lack of competency in the healthcare workforce in the era of PM and discusses the path to laying the ethical foundation for the implementation of PM in healthcare organizations.
