Course Content

The course begins with an introduction to the structures, areas of activity, and entities in the pharmaceutical industry, and an overview of the pharmaceutical value chain, whose complexity necessitates the cooperation of specialists working in transdisciplinary teams.

In the first module, you study the specific knowledge and abilities in personnel and project management that are required to guide these teams. Other focus areas in the first module are the highly regulated field of drug safety, ethical and ecological considerations, and their practical formulation during the development and marketing phases of a pharmaceutical product. In the last major complex of the first module, you explore the principles and methods of discovering, developing, manufacturing and controlling the quality of drugs, from small molecules to plant products and biological and bio-engineering products, and of pharmacogenomics.

The second module deals with the scientific principles, legal provisions and specific procedures in the pre-clinical and clinical research phases, and with their interdependencies.

In this module, you explore pharmaceutical topics such as the formulation and selection of suitable dosage forms, quality and stability testing, and the development of the process for manufacturing the new drug. Furthermore, you examine the methodology, management and evaluation of pharmacological, toxicological, pharmacokinetic and clinical studies of the new drug.

The third module focuses on drug approval and marketing.

You will study the principal regulatory requirements and the various approval processes, and acquire the knowledge and abilities you need to choose an appropriate approval strategy, and to prepare and draft approval documentation to conform to EU or US regulations. In addition, you will deal with aspects of patent and drug law, as well as with economic aspects of health care, as they affect successful drug marketing. You will discuss concepts of modern pharmaceutical marketing and current life cycle management strategies. In the process, you will gain a deeper insight into economic interdependencies, which enables you to bear in mind, during your professional activity, such considerations as the return on the capital invested in drug development.

This module strengthens your basic management skills, and imparts insights into key processes in the activities of modern organizations. You acquire the generalist knowledge in the areas of change management, enterprise management and controlling, and project management and practice transfer that you need to take on responsible positions in the pharmaceutical industry, government agencies and other health care institutions. Particular attention is given to ensuring the sustainability of the skills you acquire in the course, and transferring them to actual practice.

In the Knowledge Management, Leadership, Cross-cultural Communication and Practice Research courses, you strengthen your skills in those areas of personal relations that are indispensable to specialists and managers all areas of the pharmaceutical industry, government agencies and other institutions of the health care system. You will broaden and reinforce your personal abilities in dealing with knowledge, people and different cultures and roles, including expert cultures, in the context of your profession.

To conclude your course of study, you will write a scientifically grounded master’s thesis that connects theory and practice. Your thesis may be on a specific project from your own professional context, or on a general topic in the field of drug research and management. The objective in either case is to discuss an issue that is relevant to practice using the knowledge and methods you have acquired and augmented during your course of study at DUW, and to propose an answer based on your discussion.

In developing your master’s thesis, as in all other phases of your studies at DUW, you will receive academic supervision and thorough guidance counselling.