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 Pharmacovigilance - Facts, Challenges, Limitations and Opportunity

ISBN: 978-0-85466-562-4

ISSN: 3033-3318

Part of the Book Series "Pharmaceutical Science"

Series Editor: Rosario Pignatello

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Pharmacovigilance - Facts, Challenges, Limitations and Opportunity

ISBN: 978-0-85466-562-4

ISSN: 3033-3318

Part of the Book Series "Pharmaceutical Science"

Series Editor: Rosario Pignatello

Academic editor

Farid A. Badria

Academic editor

Farid A. Badria

Mansoura University, Egypt

Prof. Farid A. Badria was listed among the top 2% of most-cited scientists in medicinal and biomolecular chemistry by Stanford University, USA, in 2019 and 2020. He is the recipient of numerous awards, including The World Academy of Sciences Prize for Public Understanding of Science, the World Intellectual Property Organization Gold Medal, and the Khawrazmi International Award, Iran. He has more than 250 publications, including 12 books, 20 patents, and several marketed pharmaceutical products.

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Clinical Safety Reporting Regulations Pharmaceutical Industry Investment in Pharmacovigilance Standardize Pharmacovigilance Processes

About the book

Pharmacovigilance (derived from Pharmakon and Vigilare) or drug safety may be defined as a science related to the "collection, detection, assessment, monitoring, and prevention" of side/adverse drug effects. It is also essential to monitor for adverse effects even after a drug or therapy has been on the market for some time, as new ones may emerge. It is noteworthy to state, "An adverse reaction, in contrast to an adverse event, is characterised by the fact that a causal relationship between a medicinal product and an occurrence is suspected. Moreover, pharmacovigilance may go through three phases: pre-clinical, clinical trial, and post-marketing. Each phase has its implication in ensuring the safety of medicines. On the other hand, the process of pharmacovigilance may go through the following processes; stage 1: Detection. Collection of Individual Case Safety Reports (ICSRs), stage 2: Assessment, stage 3: Understanding the drug safety profile, stage 4: Prevention of adverse effects. This book intends to present good pharmacovigilance practices (GVPs) guidelines for pharmaceutical companies to follow to help prevent harm to humans caused by adverse drug reactions (i.e., ADRs) from approved pharmaceutical drugs. One approach to accomplish these guidelines is a Periodic Safety Update Report (PSUR) which may provide an update of the worldwide safety experience of a drug/medicinal product to regulatory authorities at defined time points post-authorization.
Pharmacovigilance (derived from Pharmakon and Vigilare) or drug safety may be defined as a science related to the "collection, detection, assess...
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Topics

The following topics illustrate the target subject areas and scope of the project. These keywords are not definitive but can be used as the basis for the chapter content. We accept theoretical and applied scientific papers which can be presented as original research papers and review papers. The required length of the full chapters is 10-20 pages.

Subject areas and keywords

Clinical Safety

Pharmaceutical Industry

Standardize Pharmacovigilance Processes

COVID-Linked Drugs

Drug Development

Safety Monitoring of Digital Therapeutics

Reporting Regulations

Investment in Pharmacovigilance

Pharmacovigilance Post COVID-19

Pharmacokinetics

Pharmacoepidemiology

Artificial Intelligence in Pharmacovigilance

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Publishing process

Book initiated and editor appointed

Date completed: 07 May 2024

Chapter proposals submitted and reviewed

Deadline for chapter proposals: 09 June 2024 Register to participate

Approved chapters written in full and submitted

Deadline for full chapters: 06 August 2024

Full chapters peer reviewed

Review results due: 05 October 2024

Book compiled, published and promoted

Expected publication date: 24 December 2024

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Gerard’t Hooft
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Publishing Services
  • UK ISBN, DOI

  • Peer Review

  • Indexing in all major repositories like Web of Science, Google Scholar, DOAB

  • Free-to-read online access to your work

  • Creative Commons licences: you keep the rights to your work

  • Your dedicated Publishing Process Manager who will support you through the publishing process

  • Online First - Your chapter is published after review, even before the entire book is ready for publication, ensuring your research is made available to the scientific community without delay.

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  • XML Typesetting and pagination - web (PDF, HTML) and print files preparation

  • IntechOpen collaborates with Enago, and Authors who wish to use translation services before submission are eligible for a 20% discount.

Readership Reporting Of Your Chapter
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  • Email notification of each 500 downloads

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Promotion Of Your Chapter
  • Engagement with our scientific community

  • Outreach and promotion of your work through news and social media

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Open Access Books Published

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50% More Citations
Than Non-OA Books

Community Community

+73,000
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Research Institutions

Platform Platform

+185M
Total Downloads

1 Chapter Downloaded
Every 2 Seconds
Worldwide*

*Based on data collected from 2019-2020

Scientists Scientists

186,000
Authors And Editors

12.2 %
Come From World
Top 500 Universities

Content Content

6,900
Open Access Books Published

Citations

+184,650

+259,915

+115,661

50% More Citations
Than Non-OA Books

Community Community

+73,000
Monthly User Registrations

+7,140
Research Institutions

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Utrecht University, Netherlands

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