Accelerating Drug Development Through Efficient Regulatory Documents
Tanja Jensen and Matilde Thye Kveiborg from Aixial Group delivered an in-depth presentation at COG Nordics on April 9th, 2024, titled "Accelerating your drug development through efficient regulatory documents". As a Senior Medical Writer and Director of Medical Writing respectively, Tanja and Matilde brought their expertise to the forefront, highlighting the critical role that well-crafted regulatory documents play in the drug development process.
The presentation underscored the importance of document quality, citing that 9 in 10 reviewers say poor document quality impedes their ability to perform regulatory reviews, and that 80% of submissions are delayed due to poor document quality. Tanja and Matilde emphasised the need for clear, concise, and well-structured documents to facilitate the review process and avoid unnecessary delays.
Using relatable examples, such as the fictional character "Martha," a regulatory reviewer, the presenters demonstrated the challenges faced by reviewers when navigating poorly written protocols. They also showcased the power of plain language summaries, which not only fulfil legal requirements but also serve as an important avenue for patient engagement.
Aixial Group's presentation served as a timely reminder of the vital role medical writers play in the drug development process. By ensuring the quality and clarity of regulatory documents, medical writers can help accelerate drug development, ultimately benefiting patients in need of innovative therapies.
Missed this one? Join our next European meeting in Amsterdam this November, full details here: https://www.thepbcgroup.com/cog-europeÂ