Pitfalls in compiling a dossier : a module 3 marketing authorisation dossier

Abstract

Various pitfalls are encountered within daily tasks in a Regulatory Affairs department, one of them being the process of compiling the Module 3 of the dossier. The main objective of this dissertation is identification of pitfalls encountered when Module 3 of the Common Technical Document (CTD) is compiled, with a secondary objective being to explore solutions to minimise the gravity of the pitfalls identified. The setting for the thesis is a pharmaceutical industry based in Malta, within an international scenario, specifically personnel engaged in the Regulatory Sciences aspects. The Research design was split into three phases, being Data Collection, Data Processing, and Issue Investigation. For the Data Collection phase, the aim was to collect as much data as possible, via a questionnaire, from personnel who were currently working within Regulatory Affairs, with responsibility for updating or reviewing Module 3. For the Data Processing phase, pitfalls were identified individually from responses and frequencies for each question totalled. The Drug Substance Information was noted to be the most typically challenging to obtain. Three to six personnel or departments are normally required for collaboration to compile data for Module 3. There is room for improvement in communication between departments to obtain the required information. For the Issue Investigation phase, mitigation measures were suggested for each obstacle encountered, to achieve the goal of minimising effect of pitfalls or eliminating them completely. Main strategies obtained include: holding regularly scheduled meetings to establish priorities and workloads between departments, which does not come with a financial burden; regularly updating old products’ contents in the dossier, to keep the product updated and to have the product in-line with the latest regulations and guidelines at all times and not only when required or requested, revisiting the dossiers in its entirety; and to explore the implementation of Artificial Intelligence (AI), not only specifically for this process and for Regulatory Affairs, but for all process areas and departments as it can aid sites greatly.