Unlike other information sources, PharmacoVigilance Review is dedicated to helping the reader to understand and keep up with the often jargon-ridden regulations which are being continually introduced by the regulatory agencies. Thus this journal does not simply list new regulations - each item comes with analysis and comment on their effect on you and your company.
Other topics covered include reviews on drug safety, risk management, quality management, pre-clinical and post-marketing studies, new EU and FDA requirements, prescription event monitoring, and highlights of relevant conferences.
- 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
3 Editorial comment
4 Non-clinical and clinical safety assessment of biosimilar products
To gain regulatory approval, a biosimilar product not only has to be compared with an approved reference product, but has to undergo both clinical and non-clinical studies, together with a pharmacovigilance plan.
Rakesh Dixit and Joerg Bluemel
8 Managing concomitant medications in clinical trials
This article highlights the need for better management of the issue of concomitant medications in the interest of patient safety in global multicentre clinical trials. Many drug interactions are avoidable.
11 Priority PASS
Post-authorisation safety studies (PASS) now have to take into account the new EU Good Pharmacovigilance Practices (GVP) legislation.
Miranda Dollen and Kosta Cvijovic
14 Reporting safety data electronically
More timely reporting of potential serious effects, coupled with the reduction of unnecessary reports, can best be done using modern analytical and visualisation tools in order to increase patient safety and reduce costs.