Passer au titre

Recherche

Regulatory Affairs Management

CAS

Haute école spécialisée bernoise (HESB)

Catégories
Lieu de formation

Biel/Bienne (BE)

Langue d'enseignement

anglais

Type de formation

Formation continue: formations longues - Hautes écoles spécialisées HES

Modalités temporelles

À temps partiel

Thèmes de formation

Électronique, microtechnique

Filières d'études

Sciences et technologie biomédicales - Technique médicale

Swissdoc

7.555.33.0

Mise à jour 06.08.2025

Description

Description de la formation

Certificate of Advanced Studies is a postgraduate qualification awarded by universities and corresponds to at least 10 ECTS (credit points).

The CAS in "Regulatory Affairs Management" focuses on the strategic requirements. In the first part, students 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.

Structure:

  • Communication / Medical writing in Regulatory Affairs
  • Understanding and evaluating statistical statements in medicine
  • Applications of artificial intelligence (AI) in everyday working life of a regulatory affairs professional
  • Ethics and sustainability in the development, product and disposal of pharmaceuticals and medical devices
  • Marketing analysis and regulation
  • Semester project (Living Case)

Admission

Conditions d’admission

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. 

Ideally you students have a degree in in medicine, pharmacy, chemistry or life sciences, engineering, law, materials science, business studies or a related field, together with a basic understanding of regulatory affairs in the medical device or pharmaceutical industry.

Target audience

Participants:

  • work in regulatory affairs and don’t want to miss out on the latest developments in the field, such as artificial intelligence (AI).
  • work in the medical device or pharmaceutical industry and would like to learn more about topics like “Green Hospital” and sustainability.

Lien sur l'admission

Inscription

See the provider's website. Registration takes place online.

Coûts

CHF 7'500.-

Diplôme

  • Certificate of Advanced Studies CAS

Certificate of Advanced Studies (CAS) in «Regulatory Affairs Management»

Infos pratiques

Lieu / adresse

  • Biel/Bienne (BE)

Berner Fachhochschule, Aarbergstrasse 46, 2503 Biel, On-site and online

Déroulement temporel

Début des cours

Autumn

Durée de la formation

Week 43 to week 14
Schedule: Friday 1pm to 7.30 pm

Modalités temporelles

  • À temps partiel

Langue d’enseignement

  • anglais

Liens

Renseignements / contact

Berner Fachhochschule Technik und Informatik
Weiterbildung

Tel. +41 (0)31 848 31 11
E-Mail: office.ti-be@bfh.ch

orientation.ch