Veterinary Pharmacovigilance Adverse Reactions to Veterinary Medicinal Products

by Woodward, Kevin

• ISBN13: 9781405169684
• ISBN10: 1405169680
• Edition: 1st
• Format: Hardcover
• Copyright: 2009-06-22
• Publisher: Wiley-Blackwell

Summary

Veterinary Pharmacovigilance: Adverse Reactions to Veterinary Medicinal Products is an in-depth examination of veterinary pharmacovigilance, looking at the scientific methodologies involved, the role of regulatory agencies and legislation, and the underpinning science. Edited by a renowned expert with over 20 years of experience in the field, it draws together the expertise of authors from around the world.

Author Biography

Dr K.N. Woodward is Director of International Regulatory Affairs at Intervet/Schering-Plough Animal Health in the UK and has been involved in veterinary pharmacovigilance for over 20 years. He was formerly the Director of Licensing at the Veterinary Medicines Directorate (VMD) in the UK. He has also worked for the Health and Safety Executive on the regulation of industrial chemicals and non-agricultural pesticides and for the Department of Health where he was Scientific Secretary to the Committee on Carcinogenicity and held responsibilities for the safety of veterinary drugs. A toxicologist, he was Chairman of the Working Group on the Safety of Residues of the Committee for Veterinary Medicinal Products (CVMP, now the Committee for Medicinal Products for Veterinary Use) for over 5 years and a member of the CVMP. He was the leader of the UK delegation to the Codex Committee on Residues of Veterinary Drugs in Food in Washington for 3 years and a member of the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

Table of Contents

Introduction

Elements of Veterinary Pharmacovigilance

Veterinary Pharmacovigilance in the European Union

Pharmacovigilance and the European Medicines Agency: Conduct of Pharmacovigilance Activities

Veterinary Pharmacovigilance in France

Pharmacovigilance in Germany

Veterinary Pharmacovigilance - the UK Experience

Veterinary Adverse Drug Reporting in the United States, Australia and Canada

Veterinary Pharmacovigilance: A South African Perspective

Pharmacovigilance Inspections in the European Union

Essential Elements of Veterinary Pharmacovigilance and the Role and Duties of the Qualified Person

Veterinary Pharmacovigilance in an Industry Setting - The EU

Pharmacovigilance in the US - Industry Perspective

Practical Veterinary Pharmacovigilance

Preclinical Safety Testing and Assessment of Veterinary Pharmaceuticals and Pharmacovigilance

Safety Assessment of Veterinary Vaccines

Microbiological Assessment of Veterinary Medicinal Products and Potential Adverse Effects

Adverse Effects of Veterinary Pharmaceutical Products in Animals

Adverse Drug Reactions in Dogs - Toxic Hepatic Responses

Adverse Reactions to Vaccines

Adverse Reactions in Humans Following Exposure to Veterinary Drugs

Medicines Used to Control and Treat External Parasites of Sheep - Toxicology and The Phenomenon of Reported Adverse Human Responses to Organophosphorus Sheep Dips

User Safety Assessment of Veterinary Medicinal Products

Maximum Residue Limits

Determination of Withdrawal Periods for Pharmaceutical Products Used in Food Animals

Surveillance for Veterinary Residues

Adverse Environmental Effects and Veterinary Medicinal Products

Causality in Pharmacovigilance and Expectedness of Adverse Reactions

Quantitative Aspects of Veterinary Pharmacovigilance

Veterinary Adverse Reactions and Crisis Management

The Role of Veterinary Pharmacovigilance in Risk Analysis and the Influence of Risk Perception on Veterinary Pharmacovigilance

The Role of Quality Assurance in Veterinary Pharmacovigilance

Concordance Between Results from Animal Toxicology Studies and Adverse Reactions in Animals

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