Regulatory Affairs Pharma
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.
- 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.
- Degree/Certificate Certificate of Advanced Studies (CAS)
- Duration Week 17 to week 40
- Schedule Friday: 1pm to 7.30pm
- Application deadline Deadline: One month before the start of the semester
- ECTS credits 12 ECTS credits
- Costs CHF 7500
- Teaching language English
- Location Biel, Aarbergstrasse 46
- School School of Engineering and Computer Science
- Next session Spring semester 2024
Regulatory Affairs Pharma
Objectives + Skills
- 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.
- 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.
The individual modules that make up this programme are named below.
- Global drug regulatory affairs + 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)
Levels of competence
- Knowledge of terms, definitions, and regulations; factual knowledge.
- Understanding the context, ability to explain complex matters.
- Applying knowledge in simple situations.
- Analysing one’s own solution method.
- Synthesis of new solutions and application in complex situations.
- Assessing applicability for specific problems and situations, evaluating of methods and of alternatives, connections with other fields of expertise.
A module may include a variety of teaching methods such as lectures, seminars, case studies, practical labs, assignments, etc.
Proof of proficiency
For the 12 ECTS credits to be recognized, successful completion of the competency assessment is required (exams, semester work).
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 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.
Degree + Titel
Certificate of Advanced Studies (CAS) in «Regulatory Affairs Pharma»