| Enhancing Strategic Document Review Practices Webinar |
Future Session Dates Will Be Announced Soon
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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:
- Correctly
sizing the timeline for reviews in project plans
- Using
staged reviews with focus of review based on stage of document development
- Using
review instructions to formalize the structure of review
- Using
review checklists as heuristic prompts to guide reviewers
- 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.
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