Programme
Regulatory affairs managers in the life sciences industry need strategic as well as technical and regulatory knowledge. The CAS in Regulatory Affairs Management focuses on the strategic requirements. In the first part, you will develop communication and negotiation skills, as well as digital skills, particularly in the area of artificial intelligence. The second part of the programme focuses on clinical trial design and the statistics behind it, as well as the development of regulatory strategies that not only meet current requirements but also incorporate green initiatives. Knowledge of marketing analytics and marketing regulations completes the programme.
In this CAS, you gain strategic knowledge. Knowledge, that involves communication and negotiations with stakeholders and authorities, process optimization through AI, sustainable regulatory strategies, and effective interface management. This programme emphasises communication (speaking and writing) as a critical skill, particularly for regulatory professionals who interact with a global audience, including manufacturers, authorities, and Notified Bodies.
To develop clinical trials, an understanding of statistical methods and data interpretation is essential. You will learn the language of statistics and what questions to ask the statistician when you need to write your documents. The integration of artificial intelligence (AI) is transforming the regulatory landscape. This CAS explores how AI can streamline processes, enhance data analysis, and improve decision making.
In this CAS, you gain strategic knowledge. Knowledge, that involves communication and negotiations with stakeholders and authorities, process optimization through AI, sustainable regulatory strategies, and effective interface management. This programme emphasises communication (speaking and writing) as a critical skill, particularly for regulatory professionals who interact with a global audience, including manufacturers, authorities, and Notified Bodies.
To develop clinical trials, an understanding of statistical methods and data interpretation is essential. You will learn the language of statistics and what questions to ask the statistician when you need to write your documents. The integration of artificial intelligence (AI) is transforming the regulatory landscape. This CAS explores how AI can streamline processes, enhance data analysis, and improve decision making.
Fabienne Weiss Head of the CAS
Students at Bern University of Applied Sciences (BFH) benefit from our interdisciplinary approach and our international orientation. Our eight departments teach and research a wide range of subjects, and our students and staff come from a wide range of different countries. The university has sites in Bern, Burgdorf, Biel, Zollikofen and Magglingen.