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Regulatory Affairs Mastery

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

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Mise à jour 29.08.2024

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).

This CAS equips students with the practical skills essential for a regulatory affairs professional in the pharmaceutical and medical industries. Participants will develop skills in strategic negotiation for interactions with regulatory authorities, acquire the ability to analyse statistical data and generate meaningful documentation. They will also learn how to effectively incorporate artificial intelligence into their daily work.

Plan de la formation

  • Communication / Medical writing in Regulatory Affairs
  • Understanding and evaluating statistical statements in medicine
  • Regulation requirement in digital marketing of pharmaeuticals and medical devices

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 medical, pharmacy or science degree, an engineering education, legal studies, a higher education in material science, a degree in Business Administration or in a related field.

Target audience

Participants:

  • are planning to work in a regulated environment in the medical device- or in the life sciences industry.
  • are currently working in the areas of development, manufacturing, quality management or regulatory affairs.

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 Mastery»

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

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