Meet the employers – University of Copenhagen

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Master of Medicines Regulatory Affairs > Meet the employers

Meet the employers

Merete Schmiegelow and Vibeke Bjerregaard of the regulatory department at Novo Nordisk find that there is a great potential for graduated Master of Regulatory Affairs students:

"Development, marketing authorisation , and life cycle  management of medicines take place on a global scale. There is a need for highly skilled employees to manage the regulatory requirements ensuring that medicines are developed, approved and kept up to date, fulfilling the regulatory requirements.  Furthermore global health authorities requests for documentation of quality, efficacy and safety of medicines increase constantly. The  regulatory staffs must therefore have a thorough understanding of the global regulatory environment.

The global development unfolds in collaboration between academia, pharmaceutical companies, health care professionals as well as  patients. It includes the quality of medicines, global clinical protocols, and studies. This contributes to an increased understanding of global health aspects to the benefit of patients’ health (efficacy and safety) and the global societies’ health development.  The regulatory staff works on a daily basis with these complex issues in order to guarantee that the development and continued market access  of the medicines comply with international standards for quality, efficacy and safety. This has resulted in a growing demand for employees with high regulatory competences especially in eg. the pharmaceutical industry, health authorities and academia.

Continuing professional development in Regulatory disciplines including Regulatory Science is therefore high on the wish list within the pharmaceutical industry and health authorities . To cover this need, the University of Copenhagen in collaboration with other European universities, the pharmaceutical industry, the Danish health authority, and three independent organisations (Medicademy, Topra and DIA), has established the Master of Medicines Regulatory Affairs. We welcome this initiative.