Research Areas and and PhD Projects

Here you can find the current research topics and PhD projects of the Department of Drug Regulatory Affairs. Currently, six PhD projects are supervised by Prof. Knöss. Theses in the Drug Research Master's Program can also be supervised.

Research in the field Drug Regulatory Affairs

The Department of Drug Regulatory Affairs is characterized by its interdisciplinary nature. Pharmacy and law provide the basis, as well as toxicology, chemistry and medicine. The legislations cover the various aspects of the life cycle of drugs: Pre-clinical and clinical development, manufacturing, marketing authorization, quality and vigilance. The increasingly complex regulatory frameworks, their application and impact require a deep understanding. The projects presented here are intended to specifically address problems that are of regulatory relevance.

Recent Publications

Eine Wissenschaftlerin und ein Wissenschaftler arbeiten hinter einer Glasfassade und mischen Chemikalien mit Großgeräten.

PhD Projects

Impact of the Paediatric Medicines Regulation (EC) No. 1901/2006 on Information on Off-patent Medicines.

This PhD project investigates the impact of the Paediatric Medicines Regulation (EC) No 1901/2006 on information "on the use of medicines in the different paediatric populations" (see recital 4 of the Regulation). Based on an impact model, two research questions were addressed:

1) Primary: Does each identified level of output individually result in improved information for users?
2) Secondary: Can the information be tracked across output levels?

Contact: Simona Stratil

Regulatory Perspectives for Future Combinations of Medicinal Products and Medical Devices Using the Example of Software-based Insulin Delivery Systems

Within the scope of the dissertation, the combination of medicinal product and medical device will be analyzed from a regulatory perspective using the example of software-based insulin delivery systems. It will be investigated which systems are currently available on the market in the EU and how they are certified. Based on the findings, regulatory perspectives for future systems will be developed.

Contact: Christina Morhart

Multinational Collaboration in the marketing Authorization of Biologics

In order to accelerate the market access of pharmaceuticals in as many countries as possible, multinational associations play a decisive role. One well-known associations is the European Union (EU). Besides the EU, there are other multinational associations around the world, such as the Eurasian Economic Union (EAEU). The EAEU was founded in 2015 and is an association of the 5 member states Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia. The goal of the EAEU is to facilitate the exchange of goods, capital, services and labor. This includes the regulation of pharmaceuticals, which is to be harmonized across the five member states. Within the scope of the dissertation, the EAEU association will be analyzed, especially with a focus on the approval of biological medicinal products.

Contact: Tanja Sorg

German Federalism and Global Trade Routes - An Analysis in the Context of Drug Safety

This dissertation project aims to investigate the risks to patients in Germany arising from global pharmaceutical trade routes and the impact of the German state system, with its federal division of competencies between the federal government and the states, on the security of medicines and the supply of medicines. The investigation is interdisciplinary in approach and, in addition to focusing on analysis and evaluation from a pharmaceutical perspective, also includes methods from administrative, health and legal sciences.

Contact: Dominique Busch

Personalized Medicine from a Regulatory Perspective - Analysis of Current Regulations and Possible Development of New Regulations

The aim of the PhD project is to identify and analyze the current regulatory frameworks for active ingredients from personalized medicine. In addition, the question is to be clarified whether existing regulations must be optimized to meet the requirements of personalized medicines or whether the development of new regulations is necessary.

Contact: Zohaira El Malahi

Exploratory Analysis of Regulatory Frameworks Targeting Recent Developments on Medicinal Products and Their Application.

The development of pharmaceutical innovations is a continuous process that reflects scientific research in many areas. This requires an emerging regulatory framework that is able to cover the latest developments in the pharmaceutical field. In this PhD project a concept will be developed which is able to map and analyze regulatory developments. With the help of the project, conclusions for future legislation might be drawn.

Contact: Clara Wollenhaupt

Master Student Projects

A Search Strategy and Overview of Clinical Trials Using Companion Diagostics in the EU before Applying the New In Vitro Diagnostic Medical Device Regulation

The use of Companion Diagnostics (CDx) reflects the current development in personalized medicine. They are used prior to treatment with a specific drug to identify groups of patients who may particularly benefit from a therapy or who may be at increased risk. The new regulation on in vitro diagnostic medical devices defines CDx as a separate product class for the first time, so an investigation of the relevant in vitro diagnostics, biomarkers and medicinal products, as well as their use, could provide forward-looking results for regulatory decision making.

Planning and implementation of electronic archiving for a GMP-certified analytical laboratory

In this master thesis, a model for establishing electronic archiving under GMP conditions was developed and implemented in a GMP-certified analytical laboratory. For the laboratory, the documents relevant to testing in analytics, in this case the raw data, are to be stored purely electronically rather than in paper form in the future. Electronic archiving is intended to ensure that the documents are easily and quickly accessible to specific groups of people.