Regulatory Affairs Mastery

This CAS equips you with the practical skills essential for a regulatory affairs professional in the pharmaceutic and medical industries. You will develop skills in strategic negotiation for interactions with regulatory authorities, acquire the ability to analyse statistical data and generate meaningful documentation. Additionally, you will learn how to effectively incorporate artificial intelligence into your daily work.

This CAS:

  • is directed towards individuals within the pharmaceutical, life sciences or medical device industry and in development, manufacturing, quality management, and would like to improve your skills in:
    • communication and medical writing in regulatory affairs.
    • the principles of clinical design and understanding and evaluating statistical claims in medicine.
    • the use of AI in the day-to-day work of a regulatory affairs professional.
    • regulation of the marketing of medicinal products and medical devices.
    • sustainability and ethics in the life cycle of medicines and medical devices.
Regulatory Affairs Mastery

Factsheet

  • Degree/Certificate Certificate of Advanced Studies (CAS)
  • Duration Week 17 to week 40
  • Schedule Friday: 1pm to 7.30pm
  • Application deadline 24 march
    8–24 participants
  • ECTS credits 12 ECTS credits
  • Costs CHF 7500
  • Teaching language English
  • Location Biel, Aarbergstrasse 46 / Online
  • School School of Engineering and Computer Science

Contact

Structure + Content

Setting

This programme emphasises communication as a critical skill, particularly for regulatory professionals who interact with a global audience, including manufacturers, authorities and Notified Bodies. Communication skills are essential for discussing issues with internal management and effectively navigating due diligence processes.

A strong understanding of statistical methodologies and data interpretation are essential. You will learn the language of statistics, identify the right questions to ask and use the resources available to answer them. Mastering the use of (bio)statistics ensures consistency in documents and clarity in messaging, fostering confidence in your contributions to clinical development.

The integration of Artificial Intelligence (AI) is transforming the regulatory landscape. This programme explores how AI can streamline processes, enhance data analysis and improve decision making. You'll learn how to use AI to automate routine tasks, allowing you to focus on strategic activities and increase productivity. However, the use of AI in healthcare presents challenges such as privacy, ethical considerations and regulatory compliance, which are also covered.

Ethics is the foundation of laws and regulations. This course addresses the ethical challenges faced by regulatory affairs professionals and the importance of ethical practices in clinical trials, product development and regulatory compliance. Linked to ethics is sustainability: You will also learn about environmental management, recycling and waste disposal as well as best practices for sustainability and environmental compliance.

Marketing principles and marketing regulation are also included in this programme.

  • You are interested in a career in regulatory affairs in the pharmaceutical, life sciences or medical device industry.
  • You work in development, manufacturing, quality management or regulatory affairs and would like to improve your skills in
    • communication and medical writing in regulatory affairs.
    • the principles of clinical design and understanding and evaluating statistical claims in medicine.
    • the use of AI in the day-to-day work of a regulatory affairs professional.
    • regulation of the marketing of medicinal products and medical devices.
    • sustainability and ethics in the life cycle of medicines and medical devices.

Ideally you have a degree in medicine, pharmacy or science, engineering education, law, materials science, business studies or a related field and a basic education in regulatory affairs.

Communication / Medical writing in Regulatory Affairs

  • Developing a communication strategy
  • Effective communication techniques
  • Communication with internal and external stakeholders
  • Medical writing for regulatory affairs professionals
  • Medical writing: Medical devices
  • Medical writing: Pharmaceuticals

Understanding and evaluating statistical statements in medicine

  • Principals of clinical design / phases of clinical studies
  • Statistical Methodologies
  • Application of artificial intelligence (AI) in the healthcare industry
  • Challenges of using AI in the healthcare industry
  • AI for regulatory affairs professionals
  • AI for regulatory affairs (examples from industry and government)
  • Regulation requirement in the marketing of pharmaceuticals and medical devices:
  • Delivery, consulting and presales roles

Regulation requirement in digital marketing of pharmaceuticals and medical devices

  • Sustainability & ethics in the development, production and disposal of medicinal products and medical devices
  • Sustainability and ethics in the lifecycle management of pharmaceuticals
  • Sustainability and ethics in the lifecycle management of medical devices
     

Levels of competence

  1. Knowledge of terms, definitions, and regulations; factual knowledge.
  2. Understanding the context, ability to explain complex matters.
  3. Applying knowledge in simple situations.
  4. Analysing one’s own solution method.
  5. Synthesis of new solutions and application in complex situations.
  6. 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.

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 Mastery»

Infoevent and Course guidance

Location

Classes are held at Aarbergstrasse 46 in the new building of the Switzerland Innovation Park Biel/Bienne (SIPBB), which is withing easy reach of Biel/Bienne railway station.

A location with many advantages

  • Classrooms within two minutes walking distance from Biel/Bienne railway station
  • Ideal train connections from Bern’s main railway station (every 15 minutes) and from Bern Wankdorf (every 30 minutes)
  • State-of-the-art infrastructure in the new SIPBB building
  • Various catering options in the immediate vicinity
  • Innovation and networking events

And that’s not all! Biel/Bienne is…

  • an innovation hotspot,
  • a university city,
  • an industrial and service city with numerous major players in the watchmaking, mechanical engineering, precision engineering and medical technology industries and major representatives of the communications and telecommunications sectors,
  • bordered by Lake Biel and its wide range of sports and leisure facilities,
  • a city that embodies bilingualism,
  • a town with a vibrant cultural life.

Biel Aarbergstrasse 46 (Switzerland Innovation Park Biel/Bienne)

Biel, Aarbergstrasse 46

Bern University of Applied Sciences

Engineering and Computer Science
Switzerland Innovation Park Biel/Bienne
Aarbergstrasse 46
CH 2503 Biel