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CAS Regulatory Affairs Pharma

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

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 skills to work in a 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 Head of CAS

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 in regulatory affairs for medicinal products for human use.

Training objectives

  • You get insight into global regulatory strategies e.g. ICH (International Harmonization).
  • You gain knowledge about the structure and function of relevant Regulatory Bodies.
  • You learn the different regulatory pathways for the Marketing Authorization.
  • You know how to develop the Scientific Technical Dossier to accompany a Marketing Authorization Application.
  • You become familiar with GxP.
  • You learn how post-approval changes are regulated and how pharmacovigilance is performed.
  • You learn about product classes that are subject to special regulation.
  • You learn how to interact with regulators e.g. how meetings between applicant and regulator take place.
  • In a case study you work on a real project or question from your company or from your own interest.

Entrance requirements

study fees:
CHF 7500.-

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. 

Requirements
Ideally you 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.

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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

Aarbergstrasse 46 (Switzerland Innovation Park Biel/Bienne)
2503 Biel/Bienne
Switzerland