Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Standardization as Key for Global Digital Health Regulatory Affairs Improvement ***

Fabian Witzel (Abschlußjahr: 2019)

Summary
Language: English
The thesis analyses why standardisation is key to further improve digital health regulatory affairs. Therefore, the thesis is divided into three parts.
First, the thesis will analyse the current development status of global digital health regulatory affairs. While this part starts with demarking stakeholders in the way the thesis understands them, the primary goal of this section is to outline typical information steps between industry and health agencies during the medicinal product lifecycle and examine which digital standards are used for each step. Digital standards will be explained in detail in this section.
Second, after having analysed the communication points and their digital formats to transfer information, potential improvement areas will be captured from a regulatory, industry, public, and technical perspective.
Third, improvement potentials for findings of the analysis will fuel the general discussion of why it is important to globally harmonise and standardize communication steps and standards used in the lifecycle, cross-disciplinary and - regionally.
The discussion and thesis concludes with a high-level recommendation of actions to further improve standardisation efforts for global digital health regulatory affairs today.
Pages: 57, Annexes pages: 43