PharmacoVigilance Review
Euromed Communications Ltd, May 2013
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, the journal dedicated to the analysis of international regulations and informed comment on drug safety issues. The subscription price is for four issues of the journal.
This publication includes:
- 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 Issues: February 2007 - Volume 1 Number 1
3 Editorial Comment
Phil Berry
4 Pharmacoepidemiological studies and risk
management
The common element – good data
John Parkinson
8 Prescription-Event Monitoring
A method of post-marketing surveillance of newly marketed
drugs in general practice
Saad Shakir, Lorna Hazell
12 New EU pharmacovigilance requirements
Joe Ridge reports on the changes in legislation as presented at
an MHRA conference in London
14 Quality management in
pharmacovigilance
New legislation emphasises the need to establish a quality
management system as an integral part of pharmacovigilance
Reinhard Nibler
18 Pulse of the States
The first edition of a series of articles on current changes in FDA
regulations and guidance
J Ambrose Van Wert
21 Pre-marketing clinical trials: Legal and
ethical considerations
The aim of the Clinical Trials Directive is to safeguard the safety
and wellbeing of trialists. This article gives detailed guidance on
its requirements and comments on its application.
Arundel McDougall, Kiran Shergill
May 2007 - Volume 1 Number 2
3 Editorial comment
Joe Ridge
4 EudraVigilance: initiatives and
achievements at five years from its launch
Report on a unique database created by EMEA to protect the EU
public health by collecting and exchanging safety reports
Sabine Brosch and Aniello Santoro
9 London School of Hygiene and Tropical
Medicine
Description of a short postgraduate course on
pharmacoepidemiology and pharmacovigilance
Stephen Evans and Ann Arscott
10 Verbal labels can increase perceived risk
and reduce likelihood of participation in
clinical trials
This study suggests that current EU-recommended verbal
descriptions make patients overestimate the risk of adverse
side-effects
Dianne Berry and Mark Hochhauser
13 Problems of maintaining a 360° view of
pharmacovigilance in a small company
Small companies need to overcome problems in complying
with the new legislation
Martin Goldman
17 Levels of vigilance – or what happens
when we think inside the box
Lessons to be learnt from the TGN1412 incident at Northwick
Park Hospital
Les Rose
21 Pulse of the States
The second of a series of articles on current changes in FDA
regulations and guidance
J Ambrose Van Wert
24 New EC guidelines on pharmacovigilance
for medicinal products in human use
A legal appraisal of the new legislation
Arundel McDougall and Andy McGregor
Editor - Dr Phillip Berry, a European Qualified Person, with an advisory panel of Elliot Brown, David Cousins, Alison Ewing and Graeme Ladds
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