In your studies 'Drug Regulator Affairs'
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Study plan
MDRA-26 (academic year 2024/2025)
Study plan of the Master's degree programme 'Drug Regulatory Affairs'
MDRA-26 academic year 2024/2025 (subject to change)
Oral examination (Module 2, 3 and 5) - Time period: March - June 2025
Written examination, Thursday 31 July 2025, 13 o'clock (Module 8, 9 and 10)
University of Bonn, lecture hall X
Modul 1
Definition and Scope of Drug Regulatory Affairs and Good Regulatory Practice
| Part 1 | ||
|---|---|---|
| Friday | 13.09.2024 from 08:30 to 18:30 | |
| Saturday | 14.09.2024 from 08:00 to 16:00 | |
| Location | Universitätsclub Bonn e.V. | |
| Part 2 | ||
|---|---|---|
| Friday | 27.09.2024 from 08:30 to 18:30 | |
| Saturday | 28.09.2024 from 08:00 to 16:30 | |
| Location | Universitätsclub Bonn e.V. | |
| Submission of study paper: Monday, 28.10.2024 | ||
Modul 2
Pharmaceutical Law
| Part 1 | ||
|---|---|---|
| Friday | 11.10.2024 from 08:30 to 18:30 | |
| Saturday | 12.10.2024 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 25.10.2024 from 08:30 to 18:30 | |
| Saturday | 26.10.2024 from 08:00 to 16:00 | |
| Location | Universitätsclub Bonn e.V.., Universitätsclub Bonn e.V. | |
| Submission of study paper: Wednesday, 04.12.2024 | ||
Modul 3
International Registration Procedures
| Part 1 | ||
|---|---|---|
| Friday | 08.11.2024 from 08:30 to 18:30 | |
| Saturday | 09.11.2024 from 08:00 to 16:00 | |
| Location | Universitätsclub Bonn e.V. | |
| Part 2 | ||
|---|---|---|
| Friday | 22.11.2024 from 08:30 to 18:30 | |
| Saturday | 23.11.2024 from 08:00 to 16:00 | |
| Location | Online | |
| Part 3 | ||
|---|---|---|
| Friday | 06.12.2024 from 08:30 to 18:30 | |
| Saturday | 07.12.2024 from 08:00 to 16:00 | |
| Location | Universitätsclub Bonn e.V.. | |
| Submission of study paper: Monday, 13.01.2025 | ||
Modul 4
General Aspects of Module 1 (CTD), Registration of Special Medicinal Products
| Part 1 | ||
|---|---|---|
| Friday | 17.01.2025 from 08:30 to 18:30 | |
| Saturday | 18.01.2025 from 08:00 to 16:00 | |
| Location | Universitätsclub Bonn e.V. | |
| Part 2 | ||
|---|---|---|
| Friday | 24.01.2025 from 08:30 to 18:30 | |
| Saturday | 25.01.2025 from 08:00 to 16:00 | |
| Location | Online | |
| Submission of study paper: Monday, 24.02.2025 | ||
Modul 5
Maintenance of Marketing Authorisations / Pharmacovigilance
| Part 1 | ||
|---|---|---|
| Friday | 07.02.2025 from 08:30 to 18:30 | |
| Saturday | 08.02.2025 from 08:00 to 16:00 | |
| Location | Online | |
| Pharmacovigilance | ||
| Part 2 | ||
|---|---|---|
| Friday | 21.02.2025 from 08:30 to 18:30 | |
| Saturday | 22.02.2025 from 08:00 to 16:00 | |
| Location | Universitätsclub Bonn e.V. | |
| Maintenance of Marketing Authorisations | ||
| Submission of study paper: Monday, 24.03.2025 | ||
Modul 6
Information Management, e-CTD
| Part 1 | ||
|---|---|---|
| Friday | 07.03.2025 from 08:30 to 18:00 | |
| Saturday | 08.03.2025 from 08:30 to 18:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 14.03.2025 from 08:30 to 18:30 | |
| Saturday | 15.03.2025 from 08:30 to 14:00 | |
| Location | Pharmazeutisches Institut | |
| Submission of study paper: Saturday, 15.03.2025 | ||
Modul 7
Quality Management / Medical Devices
| Part 1 | ||
|---|---|---|
| Friday | 28.03.2025 from 08:30 to 18:30 | |
| Saturday | 29.03.2025 from 08:00 to 16:00 | |
| Location | Online | |
| Quality Management, Medical Devices | ||
| Part 2 | ||
|---|---|---|
| Friday | 04.04.2025 from 08:30 to 18:30 | |
| Saturday | 05.04.2025 from 08:00 to 16:00 | |
| Location | Online | |
| Medical Devices, Quality Management | ||
| Submission of study paper: Monday, 05.05.2025 | ||
Modul 8
Chemical Pharmaceutical Documentation
| Part 1 | ||
|---|---|---|
| Friday | 02.05.2025 from 08:30 to 18:30 | |
| Saturday | 03.05.2025 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 16.05.2025 from 08:30 to 18:30 | |
| Saturday | 17.05.2025 from 08:00 to 16:00 | |
| Location | Universitätsclub Bonn e.V.. | |
| Submission of study paper: Monday, 16.06.2025 | ||
Modul 9
Pharmacology and Toxicology Documentation
| Part 1 | ||
|---|---|---|
| Friday | 30.05.2025 from 08:30 to 18:30 | |
| Saturday | 31.05.2025 from 08:00 to 16:00 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 13.06.2025 from 08:30 to 18:30 | |
| Saturday | 14.06.2025 from 08:00 to 16:00 | |
| Location | Universitätsclub Bonn e.V. | |
| Submission of study paper: Monday, 14.07.2025 | ||
Modul 10
Clinical Documentation
| Part 1 | ||
|---|---|---|
| Friday | 27.06.2025 from 08:30 to 17:50 | |
| Saturday | 28.06.2025 from 08:00 to 16:10 | |
| Location | Online | |
| Part 2 | ||
|---|---|---|
| Friday | 11.07.2025 from 08:30 to 18:00 | |
| Saturday | 12.07.2025 from 08:00 to 16:00 | |
| Location | Universitätsclub Bonn e.V. | |
| Submission of study paper: Monday, 11.08.2025 | ||
Modul 11
Benefit, Efficiency, Reimbursement
| Part 1 | ||
|---|---|---|
| Thursday | 24.07.2025 from 14:00 to 18:45 | |
| Friday | 25.07.2025 from 08:30 to 18:30 | |
| Saturday | 26.07.2025 from 08:00 to 16:00 | |
| Location | Wissenschaftszentrum Bonn | |
| Submission of study paper: Monday, 25.08.2025 | ||
Modul 12
Regulatory Management / Decision Making
| Part 1 | ||
|---|---|---|
| Friday | 01.08.2025 from 08:30 to 18:30 | |
| Saturday | 02.08.2025 from 08:00 to 16:00 | |
| Location | Wissenschaftszentrum Bonn | |
| Submission of study paper: Monday, 08.09.2025 | ||