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Establishing Effective Review Practices For Regulatory Documents

Professional Techniques
Workshop profile:
Regulatory medical writers involved in coordinating document review as well as those interested in establishing and improving best document review practices with their clinical teams or their organisations. Familiarity with the general principles of clinical development and regulatory documents (including clinical CTD modules, e.g. Module 2.7 Clinical Summaries and Module 2.5 Clinical Overviews) is assumed.
To give participants practical, easy-to-implement solutions that they can 1) integrate during lead writer coordination of review cycles and 2) use to establish and improve review practices with their clinical teams or organisations. Participants will learn how to better clarify review expectations and systematically train reviewers to ensure a smooth collaboration, whether working on individual documents or establishing and improving organisation-level processes.
This will be a highly interactive workshop with a lot of practical advice, discussion and group exercises. This workshop will: · provide practical advice on how to coordinate review cycles by training reviewers; · identify common problem areas in the review of regulatory documents; · define review, highlighting features of an effective review for developing fit-for-purpose documents, in contrast to cases when no review training is offered; · present types of review and discuss how a review changes by document type/purpose, document review stage, and the reviewer’s functional role; · provide specific examples of bad review comments and how to improve them; · provide practical advice on how to best set up review processes (including advice on timelines, reviewers, comments resolution meetings, and electronic tools) and create a long-lasting “review culture” shift; · provide a “reviewer’s checklist” that regulatory medical writers can use in their future cross-functional trainings on effective review practices.