Regulatory affairs are not simply the responsibility of an approval manager. Rather, the quality of an approval application — and hence the approval of the new drug — depends critically on all the participants in drug research and development, in every department, observing and conforming to the rules and necessities of the regulatory process in their work. The interplay of clinical research and approval is especially important, since clinical studies are very complex and expensive, and their results determine what indications and usage the drug will be approved for. Accordingly, there is a high demand in the pharmaceutical industry for expertise in the design, conduct, and evaluation of clinical studies that fully and sufficiently meet the requirements for approval. The subject matter of the Certificate Program in Clinical Research and Regulatory Affairs is oriented after the requirements that confront scientists in planning and carrying out clinical studies.
Clinical Research and Regulatory Affairs - DUW Certificate Program
Bringing Drugs to Approval
As an expert for clinical research and regulatory affairs, you work in a pharmaceutical company or a public health agency, taking responsibility for documenting and verifying the quality, effectiveness and safety of drugs in approval applications. You assess and document the conformance of clinical studies to regulatory requirements. You issue pertinent specifications for the planning, performance and evaluation of clinical studies to the departments concerned. You use the results of such studies in the clinical study report, the approval dossier, the medical documentation and the patient information leaflet. You recognize potential risks for the approval of a drug early on and can intervene if necessary.
The Certificate Program in Clinical Research and Regulatory Affairs teaches you the parameters, methods and procedures of clinical research, and of new drug approval in the European and American markets. The program focuses on the interfaces and interdependencies between clinical research and approval.
Clinical Research and Regulatory Affairs
Final certificate
- University certificate (15 ECTS units)
Type of course
- Distance education with in-class units
Duration
- 4 months (standard course duration)
Beginning of course
- Students can start at any time
Distance Education at DUW
- Practical, relevant curriculum
- Flexible academic model
- Up-to-date learning on the Online Campus
- Individual supervision
The course focuses on the framework conditions, methods and procedures of clinical research and the approval of new drugs for the European and American markets, with attention to the interfaces and interdependencies between clinical research and approval, and their implications for your professional practice. In the Certificate Program on Clinical Research and Regulatory Affairs, you will acquire a holistic view of these two core facets of drug development, largely through individual study, learning where and when you want. After completing the course, you will be able to assess the design choice, the planning and the performance of clinical studies in reference to the approval and subsequent marketing of a drug. You will be able to use the results of clinical studies in regard to the effectiveness and safety of the drug in compiling the clinical study report, the approval dossier, the physicians’ information and the patient information leaflet. Furthermore, you will have the expertise to recognize potential risks that the overall clinical research process involves for the approval of a drug, and to intervene if necessary.
To enroll in the Certificate Program in Clinical Research and Regulatory Affairs, you must have:
- An undergraduate degree, preferably in a life sciences subject, such as pharmacology, biology, biochemistry, chemistry, human or veterinary medicine, and
- At least 1 year’s related work experience.
- Good to excellent language skills in German and English are also necessary.
You’ll find further information on the Certificate Program in Clinical Research and Regulatory Affairs in our Information and Download Center. You can request free, direct online access to detailed information including:
- Tuition fees and application forms
- The syllabus
- Study and examination regulations
- The timetable of in-class units