Offered courses 'Drug Regulatory Affairs'
Single modules
As part of the continuing education Master's degree programme ‘Drug Regulatory Affairs’, single modules and certificate courses are offered in addition to the complete degree programme. Single modules and certificate courses are suitable for further education in specific topics to build up individual competences. They can be freely selected and combined.
Our single modules offer you
- Relevant knowledge, from basics to in-depth specialised knowledge
- Practical examples, in-depth understanding of legal frameworks
- Acquisition of competences (analysis/critical evaluation/strategic planning/etc.)
- Knowledge transfer by our experts from authorities, universities and industry
- part-time training in online and classroom format
- An introduction to various areas of regulatory affairs
- a certificate after successful completion
Modules 1 - 12 / Overview
All 12 modules of the Master's degree programme can be completed as individual modules according to your own interests and wishes.
| Module 1 | Definition and Scope of Drug Regulatory Affairs and Good Regulatory Practice | Study paper | 5 ECTS |
| Module 2 | Pharmaceutical Law | Study paper, examination | 6 ECTS |
| Module 3 | International Registration Procedures | Study paper, examination | 7 ECTS |
| Module 4 | General Aspects of Module 1 (CTD),Registration of Special Medicinal Products | Study paper | 5 ECTS |
| Module 5 | Maintenance of Marketing Authorisations/Pharmacovigilance | Study paper, examination | 6 ECTS |
| Module 6 | Information Management, e-CTD (electronic Common Technical Document) | Project work | 3 ECTS |
| Module 7 | Quality Management/Medical Devices | Study paper | 5 ECTS |
| Module 8 | Chemical Pharmaceutical Documentation | Study paper, examination | 6 ECTS |
| Module 9 | Pharmacology and Toxicology Documentation | Study paper, examination | 6 ECTS |
| Module 10 | Clinical Documentation | Study paper, examination | 6 ECTS |
| Module 11 | Benefit, Efficiency, Reimbursement | Study paper | 3 ECTS |
| Module 12 | Regulatory Management/Decision Making | Study paper | 2 ECTS |
You can find a more detailed overview of the contents of the single modules at: Study modules
Admission requirements
- A professionally qualifying university degree (pharmacy/biology/medicine/life science or similar. The examination board decides on the recognition of other relevant degrees.
- Professional experience: at least 1 year (relevant to the university degree)
- Language skills: English B2 (classification see Common European Framework of Reference for Languages)
or
- relevant professional experience: at least 1 year
(The professional experience includes fields of activity defined in Annex 1-3 of our selection regulations (Auswahlordnung vom 18.07.2018, German) dated 18 July 2018. The examination board will check on a case-by-case basis whether the criteria are met.) - Language skills: English B2
or
- no admission requirements needed for anyone who do not wish to take examinations and do not want to be enrolled as a student. Admission as an auditor is possible within the limitations of available places. Please get in touch with our study advisory service team for further information and your application as an auditor!
Recognition for the continuing education Master's degree programme ‘Drug Regulatory Affairs’
Have you successfully completed single modules and are thinking about taking the complete Master's degree programme 'Drug Regulatory Affairs'? If you fulfil the admission requirements for the degree programme, you can apply. The modules you have completed will be recognised for the complete study programme.
Single module fees
How much does a single module cost?
The costs for participation in a single module are calculated according to the type of module.
The current tuition fee is per module:
- € 700 for modules 11 und 12,
- € 1,100 for modules 1, 2, 4, 5, 6, 7, 8, 9, 10 and
- € 1,500 for module 3
From MDRA-27 (start of winter semester 2025/2026):
- € 900 for modules 11 und 12,
- € 1,400 for modules 1, 2, 4, 5, 6, 7, 8, 9, 10 and
- € 1,900 for module 3
In addition, a social contribution of € 115 per semester must be paid directly to the University of Bonn (as of 09/2024).
Apply now!
Get details of how to apply for single modules and fill in the application form:
Do you have any questions?
If you have any questions about single modules or your application, please contact us:
Your study advisory service team