Offered courses 'Drug Regulatory Affairs'
Certificate course
As part of the continuing education Master's degree programme ‘Drug Regulatory Affairs’, certificate courses and single modules are offered in addition to the complete degree programme. Certificate courses and single modules are suitable for further education in specific topics to build up individual competences. They can be freely selected and combined, provided that compulsory modules are included in the certificate course.
Our certificate courses 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
We offer the following certificate courses:
(1) Drug Regulatory Affairs - Basic
(2) Drug Regulatory Affairs - Basic plus (International)
(3) Drug Regulatory Affairs - Dossier/Documentation
(4) Drug Regulatory Affairs - HTA/Market Access
(5) Drug Regulatory Affairs - Individuell
Find out more about
(1) Drug Regulatory Affairs "Basic"
| 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 5 | Maintenance of Marketing Authorisations/Pharmacovigilance | Study paper, examination | 6 ECTS |
| Fee: 4,200 € | 17 ECTS |
(2) Drug Regulatory Affairs "Basic plus (International)"
| 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 5 | Maintenance of Marketing Authorisations/Pharmacovigilance | Study paper, examination | 6 ECTS |
| Fee: 6,100 € | 24 ECTS |
(3) Drug Regulatory Affairs "Dossier/Documentation"
| Module 4 | General Aspects of Module 1 (CTD),Registration of Special Medicinal Products | 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 |
| Fee: 5,600 € | 23 ECTS |
(4) Drug Regulatory Affairs "HTA/Market Access"
| 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 11 | Benefit, Efficiency, Reimbursement | Study paper | 3 ECTS |
| Module 12 | Regulatory Management/Decision Making | Study paper | 2 ECTS |
| Fee: 5,100 € | 17 ECTS |
(5) Drug Regulatory Affairs "Individuell"
You can put together a certificate according to your own interests and requirements.
Please note the following:
- a maximum of four modules may be taken in total
- at least one compulsory module must be taken
- Compulsory module: Module 2, Module 3, elective module: Module 1, Modules 4-12
- a total of at least 14 credit points (ECTS) must be achieved
- the fee is calculated from the individual prices of the modules
- Module 1, 2, 4-10: 1,400 € each
- Module 3: 1,900 €
- Module 11, 12: 900 € each
Modules 1 - 12 / Overview
| 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
- relevent 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
Recognition of certificate courses for the continuing education Master's degree programme ‘Drug Regulatory Affairs’
Have you successfully completed a certificate course 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 on the certificate course will be recognised for the complete study programme.
Apply now!
Get details of how to apply for the certificate courses and fill in the application form:
Do you have any questions?
If you have any questions about the certificate courses or your application, please contact us:
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