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CAS Regulatory Affairs Pharma (CAS RA PHARMA)

Organisation:
Berner Fachhochschule Technik und Informatik
City, country:
Bern, Bern area, Switzerland
Type:
part-time
Certificate:
CAS (Certificate of Advanced Studies)
Duration:
1 semester(s)

Programme

Pharmaceutical products are developed, manufactured, controlled and distributed in compliance with strict statutory regulations to make sure that they are safe, effective and of high consistent quality. In this CAS you will achieve the key skills to work in this highly regulated environment and learn how to act as a liaison person between companies and regulatory authorities.

This CAS:
  • is aimed at people who are planning to work in the field of regulatory affairs in the pharmaceutical industry or who are currently working in the areas of development, manufacturing, quality management or regulatory affairs,
  • provides the knowledge to successfully operate in this environment,
  • teaches the general framework: structure and function of EU bodies, marketing authorization procedures and legal framework, labelling, GXP, life cycle management.
Fabienne Weiss CAS Management

Target Audience

  • You are planning to work in the field of regulatory affairs in the pharmaceutical industry.
  • You are currently working in the areas of development, manufacturing, quality management or regulatory affairs and want to improve your knowledge.

Training objectives

  • General framework (structure and function of EU bodies, marketing authorization procedures and legal framework, labelling, GXP, life cycle management)
  • Clinical development, safety
  • Quality (control of drug substance, data requirements and practical guidance, control of medicinal product)
  • Market (market access, promotion, parallel import)
  • Special regulation for different product classes e.g. biologics, Advanced Therapy Medicinal Products ATMP, blood products

Entrance requirements

A university degree and practical experience are usually required. People with a high vocational training can apply provided they have sufficient professional experience and prior scientific and methodological knowledge.

Costs: CHF 7500.-

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Organisation

Students at Bern University of Applied Sciences (BFH) benefit from our interdisciplinary approach and our international orientation. Our eight departments teach and research a wide range of subjects, and our students and staff come from a wide range of different countries. The university has sites in Bern, Burgdorf, Biel, Zollikofen and Magglingen.

BFH is a university of applied sciences. In addition to teaching, our core competencies include continuing education, research and development and consulting services.

Further Information

Berner Fachhochschule Technik und Informatik
Continuing education

Wankdorffeldstrasse 102
3014 Bern
Switzerland