Certificate of Advanced Studies

Regulatory Affairs Pharma

Pharmaceutical products are developed, manufactured, controlled,

and distributed under strict regulations to ensure that they are safe,
effective and of high consistent quality. In this CAS you will gain the
skills to work in this highly regulated environment and learn how to
act as a liaison person between companies and regulatory
authorities.
Table of contents

1 Setting 3
2 Target audience 4
3 Requirements 4
4 Language 4
5 Location 4
6 Competency profile 5
7 Course overview 6
8 Course description 7
9 Competency assessment 17
10 Lecturers 17
11 Organisation 18

27.02.2024
1 Setting

Modules Content

Regulatory Affairs – History

Requirements for a Career in Regulatory Affairs

Introduction to the Topic
Overview of the Content

Introduction to the Semester Work (Living Case)

Semester work (You will work on a project or a question from your company about regulatory affairs for medicinal products for human use)

‘Global Pharma’ – An Economic Perspective

Pharma Supply Chain in a Global Context

Role of Pharmacopoeias
Global Drug Regulatory Affairs
ICH Q12 Lifecycle Management: Consequences of Non-harmonized
Implementation

Phases of Drug Development

Major Regulatory Bodies in the EU/EEA, Specific Role of the EDQM, Roles of
Structure and Function of Relevant
FDA’s CDER and CBER
Regulatory Bodies
Swissmedic

Scientific Technical Dossier to CTD Modules 1 to 5 and eCTD

Accompany a Marketing Authorisation
Regulatory Affairs Pharma

Application Scientific Technical Writing

GxP GMP, GDP, GLP and GPvP

R&D, pre-Authorisation Phase, Marketing Authorisation Procedure, Post-

Healthcare Product Lifecycle
authorisation Phase

Clinical Trial Application According to ClinO and Clinical Trials

Regulatory Affairs in Clinical Trials Regulation/Registration of a Clinical Trial

Research Ethics

Different Pathways of a Marketing Authorization

Development Phase: Tools & Obligations in EU

Introduction to EU Regulatory Framework
Changes to Marketing Authorization Application

Maintaining the Marketing Authorization Application

Post-approval Activities
Post-Registration Activities
Change Reporting

Legal Basis
Pricing and Reimbursement (CH)
Reimbursement Procedures

Scientific Advice/Protocol Assistance

Interacting with Regulators (EU)
Pre-submission Meetings

Packaging and Labelling CH, EU and US Regulatory Framework

Advanced Therapy Medicinal Products

Product Classes with Special Regulations Vaccines

Blood and Blood Products

The CAS begins with general biology knowledge and ends with the new trends and challenges module, which covers topics such as Real-
World Data (RWD)/Real-World Evidence (RWE) and Digital Transformation in the Pharmaceutical Industry.
2 Target audience
– You are interested in a career in regulatory affairs in the pharmaceutical industry.
– You work in the development, manufacturing, quality management or regulatory affairs and want
to improve your knowledge of regulatory affairs for medicinal products for human use.

3 Requirements
Ideally you have a degree in medicine, pharmacy or science, engineering education, law, material
science, business studies or a related field.

4 Language
Teaching and the course materials are in English.

5 Location
Bern University of Applied Sciences, School of Engineering and Computer Science
Continuing Education, Aarbergstrasse 46 (Switzerland Innovation Park Biel/Bienne), CH-2503 Biel
Phone +41 31 848 31 11, E-Mail [email protected].
6 Competency profile

Bloom’s taxonomy of learning objectives

1. Knowledge: Reproduce what has been learned by heart, perform routines.

2. Comprehension: Explain, reformulate, or paraphrase what has been learned.
3. Application: Apply what has been learned in a new context/situation.
4. Analysis: Break down what has been learned into components, explain structures.
5. Synthesis: Reassemble what has been learned or generate new content.
6. Judgement: Critically evaluate what has been learned according to (mostly self-)chosen
criteria.
7 Course overview

Module/Teaching Unit Lessons Lecturers

Starting Knowledge:

Introduction to RA 2 Fabienne Weiss

Bio-Principles: Nanotechnology in Medicine 4 Dr. Tino Matter

Bio-Principles: Pharmacogenetics 4 Prof. Dr. Carlo Largiadèr

Bio-Principles: Basics of the Lifecycle and Bioinformatics 4 Prof. Dr. Joachim Frey

Global Drug Regulatory Affairs + Structure and Function of Regulatory Bodies:

Structure and Function of Relevant Regulatory Bodies: EU and 4 Ogie Ahanor

USA

Structure and Function of Relevant Regulatory Bodies: CH 2 Dr. Andreas Pfenninger

(Swissmedic)

Introduction to EU Regulatory Framework 4 Speaker of the CSLB

Global Drug Regulatory Affairs 8 Ogie Ahanor

Falsified Medicines 3 Ruth Mosimann

Interacting with Regulators and How to Prepare a Scientific 4 Ogie Ahanor

Advice Meeting

Pharmaceutical Legislation & Regulations 2 Noëmi Müller

Lifecycle Management

Patient Involvement in the Lifecycle of Therapeutic Products 3 Prof. Dr. Cristiana Sessa
Sabine Rütti Roch

Research Ethics 2 Dr. Salome Adam

Healthcare Product Lifecycle + Post-registration Activities 3 Dr. Tamara Markovic

GxP: GLP 2 Salieu Jalloh

GxP: GMP 2 Salieu Jalloh

Scientific Dossier to Accompany a MAA 3 Ogie Ahanor

GxP: GVP 2 Salieu Jalloh

GxP: GDP 2 Salieu Jalloh

Packaging 6 Cathlyn Carley

Pharmacovigilance 2 Dr. Thomas Stammschulte

Pharmacovigilance: Real Life Examples 2 Diff. speakers of CSLB

Pricing and Reimbursement 4 Dr. Muriel Grämer

Labelling 4 Corinne Meier

Post-approval Change Management Protocol 2 Speaker of the CSLB

 CTA Process in EU 2 Speaker of the CSLB

New Trends and Challenges:

Real-World Data (RWD) and Real-World Evidence (RWE) 4 Dr. Salome Adam

Digital Transformation in Pharma Industry 2 Dr. Tamara Markovic

Product Classes with Special Regulations:

Human Plasma: A Special Starting Material 2 Dr. Jens Rehbein

Advanced Therapies 2 Dr. Ana Figueiredo

Vaccines 1 Speaker of CSLB

Total 93

Course/Teaching Unit Lessons Hours Lecturers

Semester work (Living Case) 24 100 Diverse Experts

Total 24 100

The CAS program consists of a total of 12 ECTS credits. Each course is designed to provide ample
time for self-study, exam preparation, and other essential activities.

8 Course description
In this chapter, each of the teaching modules will be presented in more detail.

8.1 Starting knowledge

8.1.1 Introduction to RA

Topics and content After a historical overview of why regulatory affairs in life sciences and
pharmaceuticals is so important today, you will gain an insight into the
requirement for a career in this field.

Learning goals – You understand why the field of regulatory affairs was developed and why
it is so important today.
– You know the requirements for a career in regulatory affairs in life
sciences and pharmaceuticals.
– You will get an overview of the contents of the CAS.

Teaching material Slides

8.1.2 Bio-principles

Topics and content When navigating the regulation of Advanced Therapy Medicinal Products
(ATMPs), personalised medicine, or vaccines, a basic understanding of gene
technology, pharmacogenetics, and nanotechnology is essential. The initial
modules of this CAS are designed to provide you with the necessary
knowledge in these areas.

Learning goals – You know the basics of genetics and genetic engineering and understand
the principles of personalised medicine.
– You know how to use nanoparticles to deliver a molecule of particular
interest to tumour cells.

Teaching material Slides

8.2 Global drug regulatory affairs + Structure and function of regulatory bodies

8.2.1 Falsified medicines

Topics and content The European Medicines Agency (EMA) defines falsified medicines as ‘fake
medicines that pass themselves off as real, authorised medicines’. Such
medicines my lack active ingredients, contain dangerous ingredients, have
the wrong dosage or be incorrectly labelled. This module will introduce you
to the problems caused by falsified medicines and the initiatives being taken
in Switzerland, the EU and the rest of the world to eliminate them.

Learning objectives – You know the definitions of substandard, falsified, and counterfeit
medicines.
– You are familiar with the Falsified Medicines Directive (FMD).
– You know how Switzerland, the EU and the rest of the world detect and
deal with falsified medicines.

Teaching material Slides

8.2.2 Global drug regulatory affairs

Topics and content This module begins with an economic perspective, discussing potential
conflicts in drug pricing, statistics on global sales, revenues, and
economists’ perspectives. You will then be introduced to the key milestones
in the regulatory life cycle of human medicines. In this module you will also
learn about the pharmaceutical supply chain in a global context and
understand why there is a risk of drug shortages. The final two topics of this
module are pharmacopoeias as important standards and the ICH Q12
lifecycle management as an example of a non-harmonised implementation of
an ICH guidance document and the resulting regulatory consequences for
marketing authorisation holders.
 Learning objectives – You gain an insight into the economic situation of global pharmaceutical
sales and revenues, with a focus on the pharmaceutical industry’s
problem of rising R&D costs.
– You know the general regulatory life cycle of a human medicine and its
key regulatory milestones.
– You understand the phases of drug development and the legislation that
applies in the EU, considering revisions to clinical trials provisions.
– You understand the need for international harmonisation.
– You gain an insight into the specifics of EU pharmaceutical legislation.
– You understand the challenge of regulatory compliance in a global
economy.
– You understand the risk of drug shortages in a global supply chain.
– You understand the importance of pharmacopeial standards and
compliance.
– You gain an insight into pharmacopeia harmonisation activities.
– You know what the Certificate of Suitability (CEP) is.
– You understand the implications of a non-harmonised implementation of
an ICH guidance document and the resulting regulatory consequences for
marketing authorisation holders.

Teaching material Slides

8.2.3 Pharmaceutical legislation and regulation

Topics and content In Regulatory Affairs, you are expected to work with laws, standards, norms,
and guidelines. Reading such documents can be difficult. In this module you
will learn how to read legal documents.

Learning objectives – You know the structure of legal documents and the relevance of their
passages.
– You know how to find specific information.
– You learn how to find hidden reasonings in legal documents.

Teaching material – Slides

– Exercises

8.2.4 Structure and function of relevant Regulatory Bodies (with focus on CH, EU, USA)

Topics and content In this module, you will become familiar with the structure and
responsibilities of Swissmedic, the EMA, the US FDA and other regulatory
bodies.

Learning objectives – You know the term ‘Regulatory Body’.

– You discuss the structure, responsibilities and different activities of the
EMA, the US-FDA and Swissmedic.
– You learn about the European Directorate for the Quality of Medicines
(EDQM) as a Directorate of the Council of Europe (COE) and its role in
relation to the European Pharmacopoeia (Ph. Eur.) and the Certificate of
Suitability (CEP).

Teaching material Slides

8.2.5 Pricing and reimbursement in CH

Topics and content In this module you will learn how medicines are priced and reimbursed by
the Swiss healthcare system.

Learning objectives – You are familiar with the Swiss health insurance system.
– You are familiar with the List of Pharmaceutical Specialties (SL).
– You know what the public price of medicines is made up of.
– You can explain the legal basis for the reimbursement of medicines in
Switzerland.
– You know the role of the Federal Office of Public Health (FOPH) and the
sections responsible for reimbursement and pricing.
– You can name the three kinds of reimbursement procedures in
Switzerland.
– You can explain how and why Therapeutic Price Comparison is done.
– You know why the Federal Office of Public Health (FOPH) conducts Health
Technology Assessments (HTAs) and how HTAs relates to pricing and
reimbursement.

Teaching material Slides

8.3 Lifecycle management

8.3.1 Research ethics

Topics and content Ethical standards in research are important because they promote truth and
minimise error by prohibiting the fabrication, falsification, or
misrepresentation of research data. In this module you will learn about the
ethical requirements for research projects.

Learning objectives – You understand the definition of research ethics.

– You are familiar with the ethical requirements for planning and
conducting research projects.
– You know the legal framework of research ethics (Declaration of Helsinki,
Guideline for Good Clinical Practice ICH E6 (R2), Clinical Trials on
Medicinal Products for Human Use in the EU, European Convention on
Human Rights and Biomedicine, Human Research Act, Therapeutic
Products Act, etc.)

Slides

8.3.2 Introduction to EU regulatory framework

Topics and content In the EU, medicines are covered by the principle of free movement of goods
within the single market. However, before products can be placed on the EU
market, they must have a valid marketing authorisation granted by the
relevant competent authority(ies). This module will give you an overview of
the EU regulatory framework for medicinal products for human use and the
different procedures for authorising medicinal products before they are
placed on the EU market. At the end of this module, you will learn what
needs to be done to maintain the marketing authorisation.
 Learning objectives – You gain an understanding of the regulatory framework that is required
for a medicinal product to be granted access to the EU market.
– You are familiar with the different marketing authorisation pathways
(centralized, pure national, mutual recognition, decentralized).
– You know the different procedures for post-approval changes and which
guidance documents to use.
– You will get an overview of how to maintain a marketing authorisation
(renewals, periodic safety update report, sunset clause).

Teaching material Slides

8.3.3 GxP

Topics and contents In a nutshell, the drug lifecycle starts with research and development (R&D),
the clinical trial phase, the regulatory approval phase and the launch before
the commercial (post-approval) phase begins. The lifecycle ends with the
withdrawal of the medicine from the market and the termination or
revocation of the marketing authorisation. The good practice regulations,
often abbreviated as GxPs, govern the different phases of the lifecycle. This
module will provide you with the basics of GMP, GDP, GLP and GPvP.

Learning objectives – You understand the basics of Good Manufacturing Practice (GMP) in CH,
EU and ROW (rest of the world)
– You know the basics of Good Distribution Practice (GDP)
– You know the basics of Good Laboratory Practice (GLP)
– You know the basics of Good Pharmacovigilance Practice (GVP) in CH and
EU.

Teaching material – Slides

– Hands-on exercise

8.3.4 Patient involvement in the lifecycle of therapeutic products

Topics and contents With the development of a patient-centred approach to medicine, more and
more patients can participate in their own medical decisions. In this module,
you will learn about the ways in which the level of information of patients
and society can be promoted to encourage the formation of expert patients.

Learning objectives – You will get a general introduction to the Patient and Public Involvement
(PPI) concept and Swiss landscape.
– You learn about the European Patients’ Academy on Therapeutic
Innovation (EUPATI) and EUPATI Switzerland.

Teaching material – Interactive format

– Slides
8.3.5 Healthcare products lifecycle + post-authorisation activities

Topics and contents The regulatory lifecycle of a medicinal product for human use consists of
different phases. In this module you will gain a detailed insight into how
each of these phases is regulated.
A medicinal product for human use requires a marketing authorisation
which, once granted, is valid for five years from the date of notification. It is
renewable and, once renewed, is valid indefinitely. This module also focuses
on the purpose and regulatory tools required for post-authorisation
activities.

Learning objectives – You understand the different stages of drug development before and
after marketing authorisation and be able to describe the key regulatory
milestones.
– You understand basic pharmaceutical concepts and terminology in
relation to post-authorisation licence maintenance.
– You understand the product life cycle from an RA point of view and its
importance.
– You get overview of the stages of Life Cycle Management (LCM) and the
core activities at each stage.
– You gain an awareness of the close links between the RA and the quality
systems.
– You understand the importance of, and activities involved in the change
management process.
– You get introduced to the Chemistry, Manufacturing and Control (CMC)
dossier sections and how to maintain them.

Teaching material – Slides

– Hands-on exercise

8.3.6 Pharmacovigilance

Topics and content According to the European Commission, pharmacovigilance (PV) is ‘the
process and science of monitoring the safety of medicines and taking action
to reduce their risks and increase their benefits’. Since the Thalidomide
disaster in the early 1960s, the detection of adverse reactions occurring
after a product has been placed on the market has been systematic. This
module addresses the requirements and standards of pharmacovigilance.

Learning objectives – You get a brief background on pharmacovigilance.

– You become familiar with the regulations and directives that define EU
and CH requirements.
– You learn about the processes using product examples.

Teaching material Slides

8.3.7 Interacting with regulators and how to prepare a scientific advice meeting (focus EU)

Topics and content For companies seeking authorisation to market a medicine use in the EU,
effective communication with the EMA throughout the product development
process is important. In the months leading up to the submission of a
Marketing Authorisation Application (MAA), there are several opportunities
 to engage with the EMA and receive valuable input. It is essential that
companies have a solid understanding of the different types of meeting
procedures and know how to prepare carefully for these important
interactions. By the end of this module, you will be familiar with the different
types of advice available to developers and applicants of (new) medicines in
the European Union.

Learning objectives – You know the different types of European Medicines Agency (EMA)
meetings that support the submission of a marketing authorisation
application (e.g. Scientific advice, protocol assistance and pre-submission
meeting).
– You know the ITF briefing meetings for innovative medicines.

Teaching material – Slides

– Hands-on exercise

8.3.8 Packaging

Topics and content Product packaging and labelling is an important part of product
development. This module will give you with an overview of packaging
processes in Switzerland, the EU and the USA.

Learning objectives You are familiar with the CH, EU, and USA packaging regulatory frameworks

Teaching material Slides

8.3.9 Labelling

Topics and content Labels provide information about the known profile and proper use of a
drug, and for the packaging materials it is crucial to choose those that
support the quality of the product. In this module you will become familiar
with the labelling processes in CH, the EU and the USA.

Learning objectives You are familiar with the legal framework of labelling in CH, the EU, and the
USA.

Teaching material – Slides

– Labelling examples based on practical exercises.

8.3.10 Scientific technical dossier to accompany a marketing authorisation application

Topics and content A marketing authorisation application must be prepared and submitted in
the Common Technical Document (CTD) format. The CTD has been
developed by the International Council on Harmonisation (ICH). It is a format
for the preparation of well-structured applications, divided in five modules.
This course will provide you with the knowledge required to work on a CTD
or eCTD.

Learning objectives – You are familiar with the structure and the content of the ICH Common
Technical Document (CTD).
 – You know the national/regional different CTD modules and are familiar
with the specific requirements for the EU-CTD Module 1.
– You understand the general characteristics of an Electronic Common
Technical Document (eCTD) and the national/regional differences in eCTD
validation criteria and electronic submission gateways.
– You are familiar with the elements of a ‘good dossier’ in terms of
compliance, design and content as well as the characteristics of technical
(regulatory) writing for submissions to regulatory authorities.

Teaching material – Slides

– Hands-on exercise
– E-Learning course

8.3.11 Post-approval change management protocol

Topics and content A Post-Approval Change Management Protocol (PACMP) outlines the changes
a company plans to make to a product over time and how to prepare and
check these changes, allowing for a gradual assessment process.

Learning objectives – You know the importance and activities of the change management
process.
– You know the benefits of using PACMPs.
– You know the limitations of using PACMPs.
– You know which countries currently accept PACMPs.
– You know how a PACMP submission works.

Teaching material – Slides

8.3.12 CTA process in EU

Topics and content The EU Clinical Trials Regulation came into force on 31 January 2022. It aims
to ensure that the EU provides an attractive and favourable environment for
the conduct of large-scale clinical research, with high standards of public
transparency and safety for clinical trial participants.

Learning objectives – You get a brief overview of the clinical trials taking place in the EU.
– You are familiar with the EU Clinical Trials Regulation the differences
between the Directive 2001/20/EC and the EU Clinical Trials Regulation
(key changes).
– You know the Clinical Trial Information System (CTIS)
– You get a real-life example of the challenges faced by a sponsor of a
clinical trial.

Teaching material – Slides

8.4 Product classes with special regulation + New trends and challenges

8.4.1 Product classes with special regulation

Topics and content In this module you become familiar with regulatory requirements that apply
for specific medicinal product classes.

Learning objectives You are familiar with the basic EU regulatory requirements of
– orphan drugs
– paediatric medicines
– advanced therapy medicinal products (ATMPs)
– vaccines
– blood and blood products with focus on blood plasma

Teaching material – Slides

8.4.2 Real-world data and real-world evidence

Topics and content Health-related data collected and stored by computers, mobile devices,
wearables, and other biosensors are playing an increasing role in healthcare
decisions. Real-World Data (RWD) and Real-World Evidence (RWE) are used to
monitor post-marketing safety and are also involved in other regulatory
decisions.

Learning objectives – You can explain what RWD and RWE means.
– You understand how RWE can support regulatory decision making and the
efficacy of medicinal products.
– You know how electronic health records are used in clinical trials.

Teaching material – Slides

8.5 Semester work (Living Case)

The semester work (Living Case) is carried out as a group work within the context of your professional
environment. On average, each group member invests approximately 100 working hours, but this
may vary depending on the preparation phase and the complexity of the task.
If necessary, semester projects can be treated confidentially. The framework is determined by the
study regulations. It is important to stress that, while maintaining confidentiality, it is imperative to
respect the pedagogical framework. This means that presentations and in-depth discussions on the
chosen topic should remain possible in the classroom.

Objectives and topic In the semester work (Living Case), you carry out a project or a question
from your company on the topic of regulatory affairs.
Instead of a question from the company, you can also define and work on
topics of your own interest.
The semester work should cover the entire cycle of a typical Master’s thesis,
from formulating the question to evaluating the results. However, you may
choose to focus on specific steps in the process.
Procedure The semester work includes the following milestones:
1. You look for a topic within the company and preferably find a contact or
supervisor within the company.
2. You prepare a proposal (2 to 4 pages)
2.1 Title and information on the persons concerned (title page)
2.2 Initial situation and motivation
2.3 Objective or question
2.4 Material and methods
2.5 Limits
2.6 Framework conditions
2.7 Deliverables/Results
2.8 Supplements
2.9 Annex
3. You present the topic to a panel of lecturers. 5-10' for the presentation,
5-10' for questions/discussion.
4. You revise the proposal if necessary, according to the feedback.
5. You will be assigned to an expert by the head of the CAS programme.
6. You do the work required for the semester work according to your own
schedule.
7. You organise two or three meetings with your expert.
8. In a review, you present the state of your work to the experts and to the
class. 10' presentation, 5-10' questions/discussion.
9. You submit the report to the experts and upload it to Moodle.
10. You give a final presentation to the class, experts, and lecturers. 15' for
the presentation, 10' for the discussion.
11. You will be available to answer questions from interested participants in
a poster session following the final presentation.

Result and The report is to be sent to the experts in electronic form as a PDF document
assessment and posted on the Moodle platform.
Report: approx. 20-30 pages.
The semester work (Living Case) will be assessed according to the following
criteria:
− Submission of the topic and topic presentation
− Review
− Methodology and execution
− Results
− Report, documentation
− Final presentation

You will receive a detailed evaluation sheet at the beginning of the CAS.
9 Competency assessment
For the 12 ECTS credits to be recognised, successful completion of the competency assessment is
required (exams, project work), according to the following list:

Competency assessment Weight Type of assessment Student’s

success rate
Multiple Choice Exam 2.5 Online exam, closed book 0 – 100 %
Multiple Choice Exam 2.5 Online exam, closed book 0 – 100 %
Semester work 5 Living Case 0 – 100 %

Weight overall 10 0 – 100 %

ECTS-Note A-F

The exams cannot be repeated.

The weighted average of the pass rates of the individual competency assessments is converted into a
grade between 3 and 6. Grade 3 (averaged success rate is less than 50%) is insufficient.
Grades 4, 4.5, 5, 5.5 and 6 (averaged pass rate between 50% and 100%) are sufficient.

10 Lecturers

Name/Prename Company E-Mail

Adam Salome IQVIA [email protected]
Ahanor Ogie Astellas Pharma [email protected]

Borges Figueiredo Ana Rocket Pharmaceuticals, Inc. [email protected]

Carley Cathlyn Sobi [email protected]

Frey Joachim Vetsuisse, Universität Bern [email protected]

Grämer Muriel Bundesamt für Gesundheit BAG [email protected]
Jalloh Salieu GxP GmbH [email protected]
Largiadèr Carlo R. Universitätsinstitut für Klinische Carlo.Largiadè[email protected]
Chemie (UKC), Inselspital Bern

Markovic Tamara CSL Behring [email protected]

Matter Tino anavo medical [email protected]

Meier Corinne GxP GmbH [email protected]

Mosimann Ruth Swissmedic [email protected]

Müller Noëmi Pharmalex GmbH [email protected]

Pfenninger Andreas Swissmedic [email protected]
Rehbein Jens CSL Behring [email protected]
 Rütti Roch Sabine Swiss Clinical Trial Organisation [email protected]

Sessa Cristiana Ente Ospedaliero Cantonale [email protected]

Stammschulte Thomas Swissmedic [email protected]

Weiss Fabienne Berner Fachhochschule BFH [email protected]

+ Further experts and supervisors for the semester work.

11 Organisation
Head of the CAS:
Fabienne Weiss
Phone: +41 31 848 32 15
E-Mail: [email protected]

CAS-Administration:
Miriam Patwa
Phone: +41 31 848 58 68
E-Mail: [email protected]
During the CAS there may be adaptations concerning content, learning objectives, lecturers, and
competency assessments. It is up to the lecturers and the CAS management to make changes to the
CAS programme, based on current developments in a particular field, participants’ current prior
knowledge and interests as well as for teaching and organisational reasons.

Bern University of Applied Sciences

School of Engineering and Computer Science
Continuing Education
Aarbergstrasse 46 (Switzerland Innovation Park Biel/Bienne)
CH-2503 Biel

Phone: +41 31 848 31 11

E-Mail: [email protected]

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