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Regulatory Affairs Pharma

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

Droit - Électronique, microtechnique

Filières d'études

Droit - Sciences et technologie biomédicales - Technique médicale

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7.555.33.0 - 7.623.3.0

Mise à jour 23.10.2024

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).

Students achieve the skills to work in a highly regulated environment and learn how to act as a liaison person between companies and regulatory authorities.

Plan de la formation

  • Global drug regulatory affairs and structure and function of regulatory bodies
  • Lifecycle Management (from R&D to Clinical Development)
  • Lifecycle Management (from marketing authorization and launch to pharmacovigilance and withdrawal from the market)
  • Product classes with special regulations
  • New trends and challenges
  • Semester work (Living Cases)

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 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 the field of regulatory affairs in the pharmaceutical industry.
  • are currently working in the areas of development, manufacturing, quality management or regulatory affairs and want to improve your knowledge in regulatory affairs for medicinal products for human use.

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 Pharma»

Infos pratiques

Lieu / adresse

  • Biel/Bienne (BE)

Berner Fachhochschule
Aarbergstrasse 46
2503 Biel

Déroulement temporel

Début des cours

Spring

Durée de la formation

Week 17 to week 40

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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