APPLYING THE AGILE APPROACH TO PROJECT MANAGEMENT: A CASE STUDY OF A TRADITIONAL FINISHED PHARMACEUTICAL PRODUCTS MANUFACTURER
DOI:
https://doi.org/10.60078/3060-4842-2025-vol2-iss4-pp132-136Abstract
In the conditions of high regulatory and market uncertainty, export of medicines to the European Union (EU) requires flexible approaches to project management. This paper examines the possibility of applying Agile methodology, traditionally used in IT, to a project to enter the pharmaceutical market in Bulgaria. In this work case-oriented scenario is presented for the export preparation, where tasks divided into iterations (sprints) with the descriptions of the key roles and advantages of applying of flexible management. The article demonstrates the practical value of the Agile approach in the context of constantly changing regulatory requirements and a high degree of cross-functional cooperation.
Keywords:
agile project management iterations (sprints) export pharmaceuticals Bulgaria European Medicines Agency (EMA) Bulgarian Drug Agency (BDA) Scrum hybrid approach product backlog case-study Common Technical Document (CTD) waterfall project management product labeling regulatory requirementsReferences
Beck, K., Beedle, M., van Bennekum, A., et al. (2001) Agile Manifesto [Electronic resource]. – Available at: https://agilemanifesto.org/iso/ru/manifesto.html (accessed: 09.07.2025).
Egorov, A.V. (2021) Specifics of Drug Registration in EU Countries // Issues of Healthcare Organization and Informatization. – No. 2. – P. 54–60.
Highsmith, J. (2009) Agile Project Management: Creating Innovative Products. – 2nd ed. – Boston: Addison-Wesley, – 432 p.
Kozlov, S.V. (2022) Adapting Scrum and Kanban in Highly Regulated Industries // Management and Business Administration. No. 3. – P. 77–84.
PMI. Agile Practice Guide (2017). – Newtown Square, PA: Project Management Institute, – 210 p.
Shapiro, V.D., Safonova, N.A. (2020) Project Management in the Pharmaceutical Industry. – Moscow: HSE Publishing House, – 312 p.
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
