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PharmacoVigilance Review - Product Image

PharmacoVigilance Review

  • ID: 1199926
  • November 2014
  • Region: Global
  • Euromed Communications

PharmacoVigilance Review is a quarterly journal reporting on the safety of medicines and medical devices and helping the reader to comply with the complex regulations for risk assessment, pharmacovigilance planning and surveillance.

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.

*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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