Strategic and transparent medicinal regulatory decision-making

Direct your company towards a more robust decision-making process based on scientific evidence as well as administrative and legal aspects of regulation.

Regulatory science uses scientific evidence in decision-making. The scientific approach facilitates sound and transparent regulatory decision-making and will enable you to challenge specialists and argue for clinical relevance and scientific legitimacy to ensure a strong, reliable, and quality-based storyline.

A strong regulatory storyline of a product requires competences within chemical manufacturing control, non-clinical, clinical, safety, approval procedures, regulatory science, understanding the health authority’s mindset, identification of product competitors and market access criteria.

Regulatory science and critical thinking

Regulatory science and affairs will help you to organise the regulatory work across the classic safety, clinical and quality disciplines to obtain a sound and speedy marketing authorisation and prevent delays in the innovation process.

Regulatory science teaches you to critically examine legislation on drug regulations and directives and the differences in regulatory demands globally.

The lecturers have a high standard and broad knowledge, and the other students are very experienced. This combination creates a wide perspective, interesting discussions, and a great network.

Ewa Törnqvist, owner of R-Trak Consulting, Sweden.

Programmes

Courses

Course Level Start date Duration
Citizen Science
This MSc course offers an in-depth introduction to citizen science: the involvement of the public in all levels of the scientific process. Citizen Science is an innovative method with the potential to collect large amounts of data over short time periods and is increasingly recognized for its enormous potential to make research relevant to the public by their involvement in the research process. Part of UCPH International Summer Programme.
Master July 2 weeks
Science as a cultural human right
This course will take a multidisciplinary approach to the right to science and to cultural rights in general, exposing students to fields outside their respective core disciplines of study. Among the topics focused on are scientific freedom and dissemination, the importance of international scientific collaboration, and the relationship between intellectual property and authors’ rights. Part of UCPH International Summer Programme.
Master July 2 weeks
Science Communication in Theory and Practice
Students will work together to produce high quality science communication products such as short films, podcasts, articles and complementary social media. Project groups will be interdisciplinary, giving students the chance to gain hands-on experience of research and development across disciplinary boundaries. Part of UCPH International Summer Programme.
Master August 2 weeks

Find more courses

Customised courses

Are you looking for a course on regulatory science and affairs that matches the needs of your company or organisation?

Courses can be customised and organised to enhance your employees’ skills within a specific area of your interest and that matches your reality.

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