In your studies 'Drug Regulator Affairs'
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Study plan
MDRA-27 (academic year 2025/2026)
Study plan of the Master's degree programme 'Drug Regulatory Affairs'
MDRA-27 academic year 2025/2026 (subject to change)
Written examination, Thursday 16 April 2026, 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 2026
Modul 1
Definition and Scope of Drug Regulatory Affairs and Good Regulatory Practice
| Part 1 | ||
|---|---|---|
| Wednesday | 17.09.2025 from 12:00 to 18:30 | |
| Thursday | 18.09.2025 from 08:00 to 18:30 | |
| Friday | 19.09.2025 from 08:00 to 18:30 | |
| Saturday | 20.09.2025 from 08:00 to 16:00 | |
| Location | Pharmazeutisches Institut | |
| Submission of study paper: Monday, 20.10.2025 | ||
Modul 2
Pharmaceutical Law
| Part 1 | ||
|---|---|---|
| Friday | 10.10.2025 from 08:30 to 18:30 | |
| Saturday | 11.10.2025 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 24.10.2025 from 08:30 to 18:30 | |
| Saturday | 25.10.2025 from 08:00 to 16:00 | |
| Location | Online | |
| Submission of study paper: Monday, 24.11.2025 | ||
Modul 3
International Registration Procedures
| Part 1 | ||
|---|---|---|
| Friday | 07.11.2025 from 08:30 to 18:30 | |
| Saturday | 08.11.2025 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 21.11.2025 from 08:30 to 18:30 | |
| Saturday | 22.11.2025 from 08:00 to 16:00 | |
| Location | Online | |
| Part 3 | ||
|---|---|---|
| Friday | 12.12.2025 from 08:30 to 18:30 | |
| Saturday | 13.12.2025 from 08:00 to 16:00 | |
| Location | Online | |
| Submission of study paper: Saturday, 03.01.2026 | ||
Modul 4
General Aspects of Module 1 (CTD), Registration of Special Medicinal Products
| Part 1 | ||
|---|---|---|
| Friday | 09.01.2026 from 08:30 to 18:30 | |
| Saturday | 10.01.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 23.01.2026 from 08:30 to 18:30 | |
| Saturday | 24.01.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Submission of study paper: Monday, 23.02.2026 | ||
Modul 5
Maintenance of Marketing Authorisations / Pharmacovigilance
| Part 1 | ||
|---|---|---|
| Friday | 06.02.2026 from 08:30 to 18:30 | |
| Saturday | 07.02.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Pharmacovigilance | ||
| Part 2 | ||
|---|---|---|
| Friday | 20.02.2026 from 08:30 to 18:30 | |
| Saturday | 21.02.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Maintenance of Marketing Authorisations | ||
| Submission of study paper: Monday, 23.03.2026 | ||
Modul 6
Information Management, e-CTD
| Part 1 | ||
|---|---|---|
| Friday | 06.03.2026 from 08:30 to 18:00 | |
| Saturday | 07.03.2026 from 08:30 to 18:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 20.03.2026 from 08:30 to 18:30 | |
| Saturday | 21.03.2026 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 | 17.04.2026 from 13:00 to 18:30 | |
| Saturday | 18.04.2026 from 08:00 to 16:00 | |
| Location | Pharmazeutisches Institut | |
| Quality Management, Medical Devices | ||
| Part 2 | ||
|---|---|---|
| Friday | 24.04.2026 from 08:30 to 18:30 | |
| Saturday | 25.04.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Medical Devices, Quality Management | ||
| Submission of study paper: Tuesday, 26.05.2026 | ||
Modul 8
Chemical Pharmaceutical Documentation
| Part 1 | ||
|---|---|---|
| Friday | 08.05.2026 from 08:30 to 18:30 | |
| Saturday | 09.05.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 15.05.2026 from 08:30 to 18:30 | |
| Saturday | 16.05.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Submission of study paper: Monday, 15.06.2026 | ||
Modul 9
Pharmacology and Toxicology Documentation
| Part 1 | ||
|---|---|---|
| Friday | 29.05.2026 from 08:30 to 18:30 | |
| Saturday | 30.05.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 12.06.2026 from 08:30 to 18:30 | |
| Saturday | 13.06.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Submission of study paper: Monday, 13.07.2026 | ||
Modul 10
Clinical Documentation
| Part 1 | ||
|---|---|---|
| Friday | 26.06.2026 from 08:30 to 18:30 | |
| Saturday | 27.06.2026 from 08:00 to 18:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 10.07.2026 from 08:30 to 18:30 | |
| Saturday | 11.07.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Submission of study paper: Monday, 10.08.2026 | ||
Modul 11
Benefit, Efficiency, Reimbursement
| Part 1 | ||
|---|---|---|
| Thursday | 23.07.2026 from 14:00 to 18:45 | |
| Friday | 24.07.2026 from 08:30 to 18:30 | |
| Saturday | 25.07.2026 from 08:00 to 16:00 | |
| Location | Online | |
| Submission of study paper: Monday, 24.08.2026 | ||
Modul 12
Regulatory Management / Decision Making
| Part 1 | ||
|---|---|---|
| Friday | 07.08.2026 from 08:30 to 18:30 | |
| Saturday | 08.08.2026 from 08:00 to 16:00 | |
| Location | Pharmazeutisches Institut | |
| Submission of study paper: Monday, 07.09.2026 | ||