An Introduction to Pharmacovigilance 2nd Edition by Patrick Waller, Mira Harrison Woolrych 9781119289784 1119289785

An Introduction to Pharmacovigilance 2nd Edition by Patrick Waller, Mira Harrison Woolrych – Ebook PDF Instant Download/Delivery: 9781119289784, 1119289785

Full download An Introduction to Pharmacovigilance 2nd Edition after payment

Product details:

• ISBN 10:1119289785 

• ISBN 13:9781119289784

• Author:Patrick Waller, Mira Harrison Woolrych 

An Introduction to Pharmacovigilance
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.

An Introduction to Pharmacovigilance 2nd Table of contents:

 List of Abbreviations
1 What is Pharmacovigilance and How Has it Developed?
Origins and Definition of Pharmacovigilance
Scope and Purposes of Pharmacovigilance
Development of Pharmacovigilance
Development of Pharmacoepidemiology
Oral Contraceptives and ‘Pill Scares’
Hormone Replacement Therapy (Menopausal Hormone Therapy)
Selective Serotonin Re‐uptake Inhibitors
COX‐2 Inhibitors
Glitazones
Pandemrix
Conclusions
2 Basic Concepts
Adverse Drug Reactions
The Concept of Safety
Causation – Was the Drug Responsible?
Conclusions
3 Types and Sources of Data
Pre‐clinical Studies
Human Volunteer Studies (Phase I)
Clinical Trials (Phase II and III Studies)
Post‐marketing Surveillance (Phase IV Studies)
Spontaneous ADR Reporting Systems
Pharmacoepidemiological Studies
Prescription‐Event Monitoring
Registries
Systematic Reviews and Meta‐analysis
Conclusions
4 The Process of Pharmacovigilance
Overview – A Risk Management Process
Signal Detection
Evaluation and Investigation
Taking Action
Communication
Measuring the Effectiveness of the Risk Minimisation Process
Crisis Management
Conclusions
5 Regulatory Aspects of Pharmacovigilance
Legislation and Guidelines
Key Elements of European Legislation
Guidelines
Regulatory Pharmacovigilance Systems
Obligations of Pharmaceutical Companies
Company Pharmacovigilance Systems
ADR Reporting
Periodic Safety Update Reporting
Post‐authorisation Safety Studies
Risk Management Planning
Conclusions
6 International Collaboration
International Regulatory Collaboration
World Health Organization
Council for International Organizations of Medical Sciences
International Council on Harmonisation
International Scientific Collaboration
International Professional Societies
Conclusions
7 Clinical Aspects of Adverse Drug Reactions
Clinical Burden of ADRs
Important ADRs and Minimising Risk
Common Clinical Scenarios
Important Patient Populations
Improving Patient Safety in Clinical Practice
Conclusions
8 Ethical and Societal Considerations
Stakeholders and Their Perspectives
Ethical Principles
Informed Consent
Privacy and Confidentiality
Ethical Issues for the Pharmaceutical Industry
Ethical Safeguards in Relation to Safety
Transparency
Conflicts of Interest
Conclusions
9 Future Directions
Current Limitations
Meeting the Challenges
Education
Public Health and Policy
Conclusions
10 Learning More About Pharmacovigilance
Books
Journals
The Internet
Courses
International Societies
Final Conclusions
Glossary
Index
End User License Agreement

People also search for An Introduction to Pharmacovigilance 2nd:

an introduction to pharmacovigilance
    
an introduction to pharmacovigilance patrick waller wiley publishers
    
an introduction to pharmacovigilance pdf free download
    
an introduction to pharmacovigilance patrick waller
    
an introduction to pharmacovigilance patrick waller pdf