Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Benefits of Structured Content Management for Labeling Compliance in the Pharmaceutical Industry

Dr. Mahsa Rahbari (Abschlußjahr: 2024)

Summary
Language: English
Pharmaceutical companies face regulatory challenges due to the generation of extensive information throughout a drug's life cycle, including labeling, CMC, and clinical data. The complexity arises from diverse data sources, regional variations, and the production of content by various individuals over an extended period, leading to significant data variability. These challenges are increased by unstructured content and the continuous need for updates, especially in response to safety-related events. Managing unstructured data poses difficulties in tracking information, timely submission compilation, and maintaining transparency in the regulatory process.
Structured content management (SCM) addresses these regulatory challenges by streamlining document authoring, review, and translation through reusable, approved content components. SCM ensures regulatory compliance, minimizes risks, and accelerates time-to-market by organizing content into libraries, facilitating consistent updates across documents when changes are made, and providing a digital data trail for tracking changes. SCM serves as a strategic tool, reducing errors and improving efficiency, accuracy, transparency, and compliance across the entire drug life cycle in the face of evolving regulatory requirements.
In this thesis, the author presents a real-life SCM implementation project in a global pharmaceutical company's labeling department, providing first-hand insights into the business case and benefits. This strategic initiative aims to enhance content quality, streamline processes, and ensure pharmaceutical industry compliance. The implementation entails crucial steps, including meticulous planning, stakeholder engagement, and ongoing monitoring, all focused on optimizing labeling content workflows. This thesis explores the implementation project from a procedural standpoint, concluding with considerations of challenges, open issues, and prospects for SCM tools in the pharmaceutical industry.
Pages: 53
Annexes: 0, Pages: 0