Ever Vigilant (A Pharmacovigilance Book Review) - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Ever Vigilant (A Pharmacovigilance Book Review)
In a recent book, UK regulators explain how to establish a pharmacovigilance system.


Pharmaceutical Technology
Volume 33, Issue 4

The second problem, however, seems a bit more daunting. It is the authors' apparent confusion about the book's target audience. Throughout the text, the authors assume that the reader has a great understanding of the purposes, goals, and reporting structures for a pharmacovigilance professional. Yet this background information is included in Annex One, which would strike experienced readers as superfluous. A solution might have been to include the basic principles early in the book to ensure that all of readers are on the same level.

The authors' confusion is also manifest in the relative depth of the book's chapters. The basic chapters occasionally include a wealth of information, but others are somewhat sketchy. For example, the "Reference Safety Information" chapter does not include enough discussion to elucidate this complex concept. Yet the section about data management, which is largely irrelevant to new pharmacovigilance professionals, is complete and extensive. Nevertheless, new professionals would still benefit from the book because even where the information is sketchy, the text indicates areas that require investigation.

This book is highly recommended to new qualified persons for pharmacovigilance and to those who aspire to fill this important role. The value of the core material that simply and completely lays out the responsibilities for the pharmacovigilance system should not be underestimated because it can have a significant effect upon a drug company. The annexes provide information in a concise manner that will make this a valuable reference for both new and experienced pharmacovigilance professionals.

Todd L. Cecil is vice-president for compendial sciences at the US Pharmacopeia, 12601 Twinbrook Pkwy, Rockville, MD 20852-1790, tel. 301.816.8234,
. He is also a member of Pharmaceutical Technology's editorial advisory board.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
29%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
13%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here