Drug Regulatory Affairs: Seminar and Workshop

As part of the Master's program Drug Research and BIGS DrugS

The course Drug Regulatory Affairs can be chosen as a compulsory course (WPB4) as part of the Master's program in Drug Research, or it is also offered as a workshop of the Bonn International Graduate School of Drug Sciences (BIGS DrugS).
The course consists of two parts, the seminar (part A) and the workshop (part B). For successful participation in both parts of the course, Master students will receive a certificate of 6 ECTS. Ideally, the two parts should be taken one after the other, but it is also possible to vary from this. Registration for WPB4 via Basis or directly by email. The teaching language is German.

Part A - Seminar

In lectures and subsequent discussions, participants are provided with basic knowledge and contexts in the field of drug regulatory affairs. Topics include European networks, regulatory frameworks for drugs and medical devices, pharmacovigilance and risk assessment.
In order to promote a professional discussion, keywords on a topic from the field of drug regulatory affairs are assigned before the module, on which the participants then give mini-lectures of about five minutes each.

Part A will take place on five dates in February/March. The exact dates for the current semester can be found on Basis or by contacting BIGS DrugS.

© Bernadett Yehdou / Universität Bonn
Eine Wissenschaftlerin und ein Wissenschaftler arbeiten hinter einer Glasfassade und mischen Chemikalien mit Großgeräten.
© Bernadett Yehdou / Universität Bonn

Part B - Workshop

In Part B, participants make their own connection to the topic of Drug Regulatory Affairs. This connection is based on the participant's previous contact with DRA, or if a particular aspect is of special interest. A presentation is given on this topic (approx. 30 min). Afterwards, the individual topics will be discussed with the participants. This workshop is intended to show the contact between Drug Regulatory Affairs and practice and to enable its integration into the regulatory context.

Part B will take place on five dates in September/October. For the exact dates of the current semester, please refer to Basis or contact BIGS DrugS.

Postgraduate Master's Degree in Drug Regulatory Affairs

The Rheinische Friedrich-Wilhelms-Universität Bonn and the Deutsche Gesellschaft für Regulatory Affairs e.V. (German Society for Regulatory Affairs) offer the postgraduate course "Master of Drug Regulatory Affairs" (MDRA) in cooperation. Director of the program is also Prof. Knöss. The program is interdisciplinary between the fields of pharmacy, law and medicine and includes a practice-oriented postgraduate education. Knowledge of chemical, pharmaceutical, pharmacological, toxicological and clinical documentation and its evaluation can be acquired.


Avatar Knöss

Prof. Dr. Werner Knöss

Head of the Drug Regulatory Affairs Department

An der Immenburg 4

53121 Bonn

Avatar Wollenhaupt

Clara Wollenhaupt

Doctoral Student and Research Assistant


An der Immenburg 4

53121 Bonn

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