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Regulatory Affairs Management

CAS

Haute école spécialisée bernoise (HESB)

Categorie
Luogo di formazione

Biel/Bienne (BE)

Lingua di insegnamento

inglese

Tipo di formazione

Perfezionamento: formazioni lunghe - Scuole universitarie professionali SUP

Modalità temporali

Tempo parziale

Ambiti

Elettronica, microtecnica

Indirizzi di studio

Scienze e tecnologie biomediche - Tecnica medica

Swissdoc

7.555.33.0

Aggiornato il 06.08.2025

Descrizione

Descrizione della formazione

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)

Ammissione

Condizioni d'ammissione

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.

Link verso l'ammissione

Iscrizione

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

Costi

CHF 7'500.-

Diploma

  • Certificate of Advanced Studies CAS

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

Informazioni pratiche

Luogo / indirizzo

  • Biel/Bienne (BE)

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

Svolgimento temporale

Inizio

Autumn

Durata

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

Modalità temporali

  • Tempo parziale

Lingua di insegnamento

  • inglese

Link

Informazioni / contatto

Berner Fachhochschule Technik und Informatik
Weiterbildung

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

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