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.
| Mualliflar | Murodova , Feruzakhon, Муродова , Ферузахон, Муродова , Ферузахон |
|---|---|
| Jurnal | Илғор иқтисодиёт ва педагогик технологиялар |
| Nashr sanasi | 2025-07-24 |
| Jild | 2 |
| Son | 4 |
| Betlar | 132-136 |
| Til | O‘zbek |
| DOI | 10.60078/3060-4842-2025-vol2-iss4-pp132-136 |
DOI: 10.60078/3060-4842-2025-vol2-iss4-pp132-136 · Maqolaning asl sahifasi
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 requirements, Agile, проектное управление, итерации (спринты), экспорт, фармацевтика, Болгария, Европейское агентство по лекарственным средствам (EMA), Болгарское агентство по лекарственным средствам (BDA), Scrum, гибридный подход, бэклог продукта, практическое исследование, Общий технический документ (CTD), каскадное управление проектами, маркировка продукта, нормативные требования, Agile, лойиҳа бошқаруви, итератсиялар (спринтлар), экспорт, фарматсевтика, Болгария, Европа дори воситалари агентлиги (ЕМА), Болгария дори воситалари агентлиги (BDA), Scrum, гибрид ёндашув, маҳсулот беклоги, амалий тадқиқот, умумий техник ҳужжат (CTD), каскадли лойиҳа бошқаруви, маҳсулот маркировкаси, меъёрий талаблар
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