Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

A Comparative Overview of the Regulatory Landscapes Around Real-World Data/Real-World Evidence in the USA and the EU, and the Wider Perspective ***

Karla Peters (Abschlußjahr: 2022)

Summary
Language: English
The ongoing digitalization, accompanying technological advancements and emerging trends such as the shift in the nature of medicinal products towards more individualized treatments have triggered increasing interest in recent years among regulators, researchers and other stakeholders in exploiting the potential of Real-Word Data (RWD)/ big data and Real-World Evidence (RWE) for regulatory and public health purposes. In the wake of the COVID-19 pandemic, the concepts around RWD/ RWE moved in the focus of a wider public and there is widespread consensus today to the effect that the pandemic has enhanced awareness and adoption of RWD/ RWE and spurred progress in the science of RWD/ RWE. This thesis provides a comprehensive overview and a comparison of the regulatory landscapes around RWD/ RWE in the USA and the EU, a brief overview of RWD/ RWE related guidance available in other countries and some insight into harmonization efforts with relation to RWD/ RWE ongoing on ICH level. Furthermore, basic definitions and terminology around RWD/ RWE are covered. The information presented in this thesis makes apparent that there is great interest among regulators around the globe in leveraging RWD/ RWE to support regulatory decision-making throughout the drug product lifecycle. RWD/ RWE related initiatives are not only ongoing in the USA and the EU. In recent years, guidance documents and/ or position papers on the use of RWD/ RWE for regulatory purposes have been issued in many of the leading industry nations and numerous international fora exist that are dedicated to this topic. Also, a number of countries have established or are interested in building the infrastructures for secure RWD networks and associated analysis platforms allowing for the generation of reliable RWE on the use, safety and effectiveness of medicines to support better, evidence-based regulatory and public health decision-making. However, as addressed in this thesis, there are still some challenges to be overcome for the full potential of RWD/ RWE to be realized and RWD/ RWE is also not regarded as suitable to support all possible kinds of regulatory use cases.
Pages: 88
Annexes: 0