In your studies 'Drug Regulator Affairs'
Study plan
MDRA-28 (academic year 2026/2027)
Study plan of the Master's degree programme 'Drug Regulatory Affairs'
MDRA-28 academic year 2026/2027 (subject to change)
Written examination, Thursday 8 April 2027, 13 o'clock (Module 2, 3 and 5)
University of Bonn, lecture hall X
Oral examination (Module 8, 9 and 10) - Time period: September - November 2027
Modul 1
Definition and Scope of Drug Regulatory Affairs and Good Regulatory Practice
| Part 1 | ||
|---|---|---|
| Wednesday | 16.09.2026 from 12:00 to 18:30 | |
| Thursday | 17.09.2026 from 08:00 to 18:30 | |
| Friday | 18.09.2026 from 08:00 to 18:30 | |
| Saturday | 19.09.2026 from 08:00 to 16:00 | |
| Location | Pharmazeutisches Institut | |
| Submission of study paper: Monday, 19.10.2026 | ||
Modul 2
Pharmaceutical Law
| Part 1 | ||
|---|---|---|
| Friday | 09.10.2026 from 08:30 to 18:30 | |
| Saturday | 10.10.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 16.10.2026 from 08:30 to 18:30 | |
| Saturday | 17.10.2026 from 08:00 to 16:00 | |
| Location | Online | |
Modul 3
International Registration Procedures
| Part 1 | ||
|---|---|---|
| Friday | 06.11.2026 from 08:30 to 18:30 | |
| Saturday | 07.11.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 20.11.2026 from 08:30 to 18:30 | |
| Saturday | 21.11.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Part 3 | ||
|---|---|---|
| Friday | 04.12.2026 from 08:30 to 18:30 | |
| Saturday | 05.12.2026 from 08:00 to 16:00 | |
| Location | Online | |
Modul 4
General Aspects of Module 1 (CTD), Registration of Special Medicinal Products
| Part 1 | ||
|---|---|---|
| Friday | 15.01.2027 from 08:30 to 18:30 | |
| Saturday | 16.01.2027 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 29.01.2027 from 08:30 to 18:30 | |
| Saturday | 30.01.2027 from 08:00 to 16:00 | |
| Location | Online | |
| Submission of study paper: Monday, 01.03.2027 | ||
Modul 5
Maintenance of Marketing Authorisations / Pharmacovigilance
| Part 1 | ||
|---|---|---|
| Friday | 12.02.2027 from 08:30 to 18:30 | |
| Saturday | 13.02.2027 from 08:00 to 16:00 | |
| Location | Online | |
| Pharmacovigilance | ||
| Part 2 | ||
|---|---|---|
| Friday | 26.02.2027 from 08:30 to 18:30 | |
| Saturday | 27.02.2027 from 08:00 to 16:00 | |
| Location | Online | |
| Maintenance of Marketing Authorisations | ||
Modul 6
Information Management, e-CTD
| Part 1 | ||
|---|---|---|
| Friday | 12.03.2027 from 08:30 to 18:00 | |
| Saturday | 13.03.2027 from 08:30 to 18:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 19.03.2027 from 08:30 to 18:30 | |
| Saturday | 20.03.2027 from 08:30 to 14:00 | |
| Location | Pharmazeutisches Institut | |
| Submission of study paper: Saturday, 21.03.2026 | ||
Modul 7
Quality Management / Medical Devices
| Part 1 | ||
|---|---|---|
| Friday | 09.04.2027 from 13:00 to 18:30 | |
| Saturday | 10.04.2027 from 08:00 to 16:00 | |
| Location | Universitätsclub Bonn e.V.. | |
| Quality Management, Medical Devices | ||
| Part 2 | ||
|---|---|---|
| Friday | 23.04.2027 from 08:30 to 18:30 | |
| Saturday | 24.04.2027 from 08:00 to 16:00 | |
| Location | Online | |
| Medical Devices, Quality Management | ||
| Submission of study paper: Monday, 24.05.2027 | ||
Modul 8
Chemical Pharmaceutical Documentation
| Part 1 | ||
|---|---|---|
| Friday | 07.05.2027 from 08:30 to 18:30 | |
| Saturday | 08.05.2027 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 21.05.2027 from 08:30 to 18:30 | |
| Saturday | 22.05.2027 from 08:00 to 16:00 | |
| Location | Online | |
Modul 9
Pharmacology and Toxicology Documentation
| Part 1 | ||
|---|---|---|
| Friday | 04.06.2027 from 08:30 to 18:30 | |
| Saturday | 05.06.2027 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 18.06.2027 from 08:30 to 18:30 | |
| Saturday | 19.06.2027 from 08:00 to 16:00 | |
| Location | Online | |
Modul 10
Clinical Documentation
| Part 1 | ||
|---|---|---|
| Friday | 02.07.2027 from 08:30 to 18:00 | |
| Saturday | 03.07.2027 from 08:30 to 18:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 16.07.2027 from 08:30 to 18:00 | |
| Saturday | 17.07.2027 from 08:30 to 16:15 | |
| Location | Online | |
Modul 11
Benefit, Efficiency, Reimbursement
| Part 1 | ||
|---|---|---|
| Thursday | 29.07.2027 from 14:00 to 18:45 | |
| Friday | 30.07.2027 from 08:30 to 18:30 | |
| Saturday | 31.07.2027 from 08:00 to 16:00 | |
| Location | Online | |
| Submission of study paper: Monday, 30.08.2027 | ||
Modul 12
Regulatory Management / Decision Making
| Part 1 | ||
|---|---|---|
| Friday | 06.08.2027 from 08:30 to 18:30 | |
| Saturday | 07.08.2027 from 08:00 to 16:00 | |
| Location | Universitätsclub Bonn e.V.. | |
| Submission of study paper: Monday, 13.09.2027 | ||