A Quarterly journal researched and edited by an expert team experienced in all aspects of the safe use of medicines and medical devices.
PharmacoVigilance Review, is dedicated to the analysis of international regulations and informed comment on drug safety issues.
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- Review of the new role of the European Qualified Person
- Comparison of EU and US regulations
- Examination of the demands of pharmacovigilance inspections
- Understanding new guidelines on the Periodic Safety Updates Reports (PSUR)
- Debate on the effects of the Clinical Trials Directive
- Interpretation of the FDA's Risk Management Guidance
- Report on EMEA guideline on pharmacovigilance for paediatric medicines
- Discussion on the challenges of medical device vigilance
- Evaluation of the effects of Volume 9A on all matters of drug safety
Sample Table of Contents - Volume 9 Number 3 - 2017
3 Editorial comment
4 INTEGRATED SAFETY AND RISK MANAGEMENT SOLUTIONS – ADDRESSING THE NEEDS OF SMALL AND MEDIUM-SIZED BIOPHARMACEUTICAL COMPANIES
This article discusses the challenges facing small and medium-sized biopharmaceutical companies who may not have the resources or subject matter experts to address the many requirements of safety and pharmacovigilance requirements that span clinical trials and post-marketing activities.
David Balderson and Supriya Desai
10 WHY INTELLIGENT PEOPLE IN RESPECTED ORGANISATIONS DO IRRATIONAL THINGS
Why do respected organisations, staffed with intelligent people, do some very illogical things? This article highlights some insight into contributing factors.
13 WHAT BREXIT MEANS FOR BRITISH QUALIFIED PERSONS
British senior pharmacists who are also QPs, more anxious than enthusiastic, think Brexit has substantial implications for British QPs and has urgent questions for the British government and the Royal Pharmaceutical Society.
Malcolm E. Brown
16 LEGISLATION MAP