Clinical Research & Regulatory Affairs — DUW Certificate Program

Bringing Drugs to Approval

Berufsbegleitendes Fernstudium in Clinical Research & Regulatory Affairs

As an expert for clinical research and regulatory affairs, you work in a pharmaceutical company, in a hospital or medical practice, 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.

In the certificate program on Clinical Research and Regulatory Affairs you learn about parameters, methods and procedures of clinical research and of new drug approval in the European and American markets. You pay particular attention to the interfaces and interdependencies between clinical research and marketing authorisation and acquire strategies to identify regulations applicable to the complex practice in both signature fields of this program.

Infoflyer in deutscher Sprache - Information in German

Clinical Research & Regulatory Affairs

Final certificate

  • University certificate (15 ECTS)

Type of course

  • Distance study with in-class units

Duration

  • 4 months (standard course duration)

Beginning of course

  • Semiannual enrollment

Tuition Fees

  • 3,800.- € (four monthly installments of 950.- € each)

Distance Studies at DUW

  • Practical, relevant curriculum
  • Flexible study model
  • Up-to-date learning on the Online Campus
  • Individual supervision
    Course Content

    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 programme on Clinical Research and Regulatory Affairs is oriented after the requirements that confront scientists in planning and carrying out clinical studies.

    Course Goals

    The study program 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 programme 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 contribute to quality assurance of clinical research. You will know how 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 recognise potential risks that the overall clinical research process involves for the approval of a drug, and to intervene if necessary. Last but not least, you will be able to identify the regulations and requirements which apply to particular practical cases and know where to search for the most recent legislation.

    Admission Requirements

    To enrol in the certificate programme on 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;
    • At least one year’s related work experience;
    • Good to excellent language skills in English.
    Tuition Fees

    You will find further information on the certificate programme on 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 course syllabus;
    • Study and examination regulations;
    • The timetable of in-class units.
    Schedule
    Schedule Q1 2016

    Not applicable.

    Schedule Q2 2016

    Start of study: 18.04.2016

    Deadline of registration: 13.03.2016 - extended to 03.04.16

    Online unit
    Applied Biostatistics (O-BSTAT-D)
    30.05.2016 - 26.06.2016

    In-class seminar
    Selected Issues of Clinical Trials and Regulatory Affairs (S-WCRRA-D)
    Sa, 07.05.2016, 09.00 – 18.00 Uhr

    In-class seminar
    Quality Assurance of Clinical Trials (S-QACTR-D)
    Fr, 29.07.2016, 09.00 – 18.00 Uhr

    In-class seminar Best Practice of Clinical Trials (S-BPCTR-D)
    Sa, 30.07.2016, 09.00 – 18.00 Uhr

    Schedule Q3 2016

    Not applicable.

    Schedule Q4 2016

    Start of study: 17.10.2016

    Deadline of registration: 11.09.2016

    Online unit
    Applied Biostatistics (O-BSTAT-D)
    21.11.2016 - 18.12.2016

    In-class seminar

    Selected Issues of Clinical Trials and Regulatory Affairs (S-WCRRA-D)
    Sa, 05.11.2016, 09.00 – 18.00 Uhr

    In-class seminar
    Quality Assurance of Clinical Trials (S-QACTR-D)
    Fr, 03.02.2017, 09.00 – 18.00 Uhr

    In-class seminar
    Best Practice of Clinical Trials (S-BPCTR-D)
    Sa, 04.02.2017, 09.00 – 14.30 Uhr

     

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