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The Investigator’s Brochure

Level:
Foundation
Area:
Drug Development
Code:
DDF2a
Duration:
03:00:00
Workshop profile:
Medical writers with at least 1 year of experience in the pharmaceutical industry.
Objective:
• Learn what the ICH and regulatory guidelines say about the Investigator’s Brochure (IB) • Learn useful tools and advice for the actual writing, compiling, and managing of an IB project • Experience the dynamics of team writing and editing as it pertains to an IB
Content:
The IB is definitely the poor cousin in the pharmaceutical industry document family, as it rarely gets the resources and time required to do it properly. It can also be the bane of the freelancer’s life, as ‘quick update’ projects often turn out to involve excruciating re-formatting and consistency checks. In the first part of the course, participants will learn the ‘theory’ of IB writing, i.e. what the ICH and regulatory guidelines say, as well as tools to be used in successful IB writing gleaned from the extensive experience of the workshop leader. In the second part of the course, participants will work in teams to prepare a mini-brochure based on actual data and compare their results to those of the other teams.