Clinical Research and Regulatory Affairs - Berlin University for Professional Studies (DUW)

Clinical Research & Regulatory Affairs

Strict regulations govern the approval of new drugs entering the market. To protect not only patients, but also the environment, pharmaceutical enterprises must document the quality, efficacy and safety of a proposed drug in the approval application. Preparing such an approval application is an important transdisciplinary process. It is subject to strict regulations in every respect, and the approval application must also document the observance of the applicable regulations. Thus regulatory considerations permeate the entire research and development process of pharmaceutical products. Conformance to regulations is therefore a critical business objective for pharmaceutical enterprises before they can even think of having a marketable product.

In this situation, 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.

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.

Learning Outcomes

In the certificate programme in Clinical Research and Regulatory Affairs, you will develop a holistic view of these two central aspects of drug development. On completion of the certificate programme you will be able in the course of your work to evaluate the design choice, planning and execution of clinical trials with respect to their compatibility with regulatory considerations. You will be able to utilize the results of clinical studies in relation to the efficacy and the safety of the drug in drafting the clinical study report, the approval documentation, the patient information leaflet and the information for health professionals. You will also acquire the expertise to recognize early on the potential risks for the approval of a drug that may arise in the overall clinical research process and to intervene where necessary.

At a Glance

Final certificate:

University certificate (15 ECTS)

ZFU certification:

No: 252309

Beginning of course:

Course added in October, 2010.
Students can start the course at any time beginning in October, 2010.
Introductory seminars are held regularly for an optimum start.

Current dates

Duration:

4 months
The period of supervised study can be extended by four months without additional fees.

Prerequisites:

A first academic degree, preferably in a life science subject, such as pharmacology, biology, biochemistry, biotechnology, chemistry, or human or veterinary medicine
At least one year of related work experience

Because the certificate programme is conducted in English, good to excellent proficiency in English is required.

We recommend work experience and current employment as a prerequisite for this certificate programme. This ensures that you can directly transfer the skills you acquire to your professional practice.

Credit:

Your achievement in the Clinical Research and Regulatory Affairs certificate programme can be counted towards the master’s degree course in Drug Research and Management at DUW if you fulfil the admission requirements for that course.

Tuition Fees:

See the schedule of fees in our Info and Download Area.

Related programmes of study:

Drug Research and Mangement

Accreditation

All courses of study at DUW that lead to an academic degree are approved by the accreditation agency ACQUIN.

State Certification

All of DUW’s programs of study are approved by the German national Distance Learning Office (Zentralstelle für Fernunterricht, ZFU) in Cologne. This certifies that course content is complete, correct and appropriately presented to ensure that you can achieve your educational goal.

Target Group

The certificate programme Clinical Research and Regulatory Affairs is aimed at graduates in the life sciences, particularly pharmacology, biology, biochemistry, biotechnology, chemistry, and human and veterinary medicine who are employed in the pharmaceutical industry or in government agencies and have initial work experience in the field.

This certificate programme is especially designed for:

Employees in the areas of clinical trials, drug safety, and medical research.

Members and managers of development teams.

Employees in related service companies in the pharmaceutical industry.

Course Content

The subject matter of the certificate programme in Clinical Research and Regulatory Affairs is based on the demands placed on scientists in planning and carrying out clinical studies. The focus is on the regulatory framework, procedures and processes involved in clinical research and the authorization of new drugs for the European and US markets. In particular the course elucidates the interdependencies between clinical research and approval, and their significance in regard to your professional practice.