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Enhancing Strategic Document Review Practices Webinar
Future Session Dates Will Be Announced Soon


 
                                                                                 

Overview
It is difficult to overestimate the importance of sound document review methods for the pharmaceutical and medical device industries. Much time is given to document review, yet review practices remain remarkably frustrating to participants, as they are frequently inefficient and poorly managed. This session is designed to discuss cause and effect of poor review practice, suggest solutions to enhance the value and increase the efficiency of reviews, and offer a case-study of review tools used in several organizations.

Problems with Current Practice
We will begin the webinar with a brief discussion of current review practices with an emphasis on what research tells us about best practice. We will look at some problems with document review in the realm of clinical research—document reviews almost always engage a team of professionals, entail multiple reviews, and are often fraught with second guessing on issues of representation above and beyond a document’s perceived “content.” We will discuss how document review practices observed across industries tend to reinforce non-productive organizational behaviors.

Recommendations for Improved Review Practices

Professionals working in the life sciences need to come to a better understanding of the multiple functions and the value of review activities, become more reflective and evaluative of their own work practices, and take a page from review best practice as applied in other professional workplaces. We will present a set of recommendations designed to encourage efficient and productive review practices. The recommendations are as follows:
  1. Correctly sizing the timeline for reviews in project plans
  2. Using staged reviews with focus of review based on stage of document development
  3. Using review instructions to formalize the structure of review
  4. Using review checklists as heuristic prompts to guide reviewers
  5. Creating a language for review to improve the quality of review commentary

The Use of Review Tools in Several Pharmaceutical Companies

We will offer a case study on the development and application of review tools principally used on clinical study protocols and research reports and discuss how the tools are applied and how they impact outcomes in terms of document communication quality and efficiency of review.



This is a free webinar, though we have limited the number of attendees to encourage questions and discussion following the presentation.