Σχεδιασμός επιχειρηματικής διαδικασίας και μοντέλου προτεραιοποίησης για τη διεθνοποίηση φαρμακευτικής εταιρείας γενοσήμων
Business process design and prioritization model for the internationalization of a generic pharmaceutical company
View/
Keywords
Generic pharmaceuticals ; Regulatory submissions ; Multi-criteria decision analysis ; Business process management ; Project managementAbstract
This thesis examines the design of an integrated regulatory submission management framework for a hypothetical generics pharmaceutical company expanding outside the European Union, with Australia, Canada, the United Arab Emirates and Taiwan as target markets. The objective is to develop a structured business process and prioritisation model that translates the internationalisation strategy into an actionable execution plan. The methodological framework is a case study combining qualitative as-is process mapping, quantitative modelling through Multi-Criteria Decision Analysis (MCDA), and process redesign based on the principles of Business Process Management (BPM) and Project Management.
The as-is analysis identified four structural findings: i. absence of standardised regulatory requirements collection, ii. lack of objective prioritisation criteria, iii. absence of structured scheduling, and iv. the additive nature of the internationalisation project as supplementary workload on existing teams. In response, a prioritisation model was developed with five criteria — regulatory feasibility, commercial priority, intellectual property status, dossier readiness and regulatory cost — producing a Priority Index per country-product combination. Sensitivity analysis confirmed the overall robustness of the ranking, identifying dossier readiness and IP constraints as the most differentiating factors. The redesigned process introduces a structured ten-phase workflow with milestone-driven hybrid scheduling, a governance framework and implementation in a project management tool environment.
The findings demonstrate that effective regulatory submission management is primarily an operational rather than a regulatory challenge, requiring simultaneous intervention in prioritisation methodology, process structure and organisational governance.
Postgraduate Studies Programme
Βιομηχανική Διοίκηση και ΤεχνολογίαDepartment
Σχολή Ναυτιλίας και Βιομηχανίας. Tμήμα Βιομηχανικής Διοίκησης και TεχνολογίαςNumber of pages
123Language
GreekCollections
Except where otherwise noted, this item's license is described as
Αναφορά Δημιουργού-Μη Εμπορική Χρήση-Όχι Παράγωγα Έργα 3.0 Ελλάδα
Αναφορά Δημιουργού-Μη Εμπορική Χρήση-Όχι Παράγωγα Έργα 3.0 Ελλάδα