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DAS Regulatory Affairs

BFH

DAS Regulatory Affairs

Overview

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3 semesters

Duration

Biel, Aarbergstrasse 46 / Online

Location

36 ECTS

Credits

from CHF 22'500

Cost

Registration deadline

23. September; 24. March

Online

English

Language

Food service: Yes

Sports option: Yes

Diplomas of Advanced Studies (DAS)

Degree type

Requirements

As a rule, a university degree and practical experience are required for admission. 
People with a high vocational training can apply, provided they have suitable professional experience and prior scientific and methodological knowledge.

More information

1

Portrait

The healthcare industry evolved greatly over the last 10 years. As a result, the tasks of Regulatory Affairs Professionals have changed accordingly. New technologies such as artificial intelligence and machine learning (e.g., decision support systems), home virus detection kits, wearable patient monitoring devices, companion diagnostics and precision medicine are already being used today. In the wake of such innovations and the resulting revision or creation of new regulations, Regulatory Affairs Professionals must continually expand their knowledge.

To obtain and maintain regulatory approval of healthcare products, Regulatory Affairs Professionals must fulfill the following core tasks:

  • Regulatory strategies

  • Implementing regulatory measures

  • Adhering to quality management

  • Solving trade-related issues

  • Negotiating/communicating with authorities

  • Crisis management

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