Process

The working group undertook a survey of the currently existing requirements for periodic safety updates, noting the diversity and identifying the questions which needed to be addressed in defining the content and format, and what might be considered to be the essential elements. After considerable debate and compromise on several controversial issues relating to scope and content, a series of proposals was then drafted in preparation for the pilot phase. Each manufacturer representative undertook to draft a single prototype summary-report on one of their own drugs using the proposed guidelines. Each report was then sent personally to each regulator in the working group and a "sanitised" version was sent to the other manufacturer representatives. All members of the working group took part in the critical evaluation of each pilot report to examine the feasibility (data availability), resources required in compilation and utility to the regulators of the information provided. On the basis of the experiences gained in the pilot study, the guidelines were refined and used to produce a model report on a fictitious drug (Qweasytrol) for inclusion in the final report.

Was this article helpful?

0 0
Drug Free Life

Drug Free Life

How To Beat Drugs And Be On Your Way To Full Recovery. In this book, you will learn all about: Background Info On Drugs, Psychological Treatments Statistics, Rehab, Hypnosis and Much MORE.

Get My Free Ebook


Post a comment