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        Master's degree programme Certificate course Single modules Application Student advisory service Examination board
    • In your studies
        Study plan (MDRA-26) Study modules (MDRA-26) Study modules (MDRA-25) Internship Master's thesis Lecturer Literature
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        Business Office Board of Directors Articles of Association
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In your studies 'Drug Regulator Affairs'

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    • Study plan (MDRA-26)

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)

MDRA-26 Study plan (PDF)

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


Module:
1
2
3
4
5
6
7
8
9
10
11
12

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
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