LWF23 – Efficiency in Medical Writing: The Lean Approach – From Protocol to Submission

Description

Objective
Participants will gain insight into the advantages of lean medical writing and its alignment with regulatory expectations, thereby emphasizing the importance of efficient and concise documentation. Participants will be introduced to various opportunities for lean writing, such as use of cross-references, deductive writing, reducing appendices, and avoiding descriptive text and redundancies in favour of result interpretation.

Content
Lean writing techniques: The principles of lean writing and its application in medical writing will be presented. We will utilize applicable templates (e.g. the TransCelerate CSP/CSR templates) with practical examples and case studies to illustrate the benefits and impact on regulatory compliance.
Efficient cross-referencing and redundancy mitigation: We will explore effective cross-referencing techniques across clinical documents within the specified scope. Our focus will be on minimizing redundancies, reducing the number of appendices, and consequently reducing document size.
Reviewer and regulatory emphasis: Participants will gain insights into concentrating on essential information necessary for approval, while learning to avoid unnecessary details. This approach aims to facilitate a more straightforward review process for assessors. Strategies for managing an excess of (exploratory) analyses will also be discussed.
Expanding lean writing opportunities: We will introduce opportunities for employing deductive medical writing in CSRs and Module 2 documents, emphasizing result interpretation over descriptive writing, and providing practical strategies for implementation.

Participant profile: This workshop is intended for medical writers who are relatively new to preparing clinical documents, as well as for more advanced writers. Participants should have a basic understanding of the drug development process and its clinical documents such as CSPs, CSRs, summaries, and overviews, and how they relate to each other.