CAS Pharmaceutical Project Management

Hochschule für Life Sciences

Do you want to master complex projects in the pharmaceutical sector? This programme combines project management with scientific expertise – equipping you to successfully lead complex projects across drug development, regulatory affairs, maintenance, supply chain and GMP manufacturing.

Steckbrief

Abschluss: Certificate of Advanced Studies FHNW Pharmaceutical Project Management
ECTS-Punkte: 10
Nächster Start: 17.9.2026
Unterrichtssprache(n): Englisch
Durchführungsort(e): FHNW Campus Muttenz, Hofackerstrasse 30, 4132 Muttenz
Preis: CHF 8 500

Auf einen Blick

Master project management methodologies and tools tailored to the needs of pharmaceutical projects.
Confidently navigate regulatory requirements and ensure compliance throughout all stages of the project lifecycle.
Design and implement effective risk management strategies that address the specific challenges of the pharmaceutical industry.
Engage with industry experts and expand your professional network in pharma.
Study alongside your job – in a compact, five-module format with direct practical relevance.

Ziele und Nutzen

Upon completing this programme, you will be able to:

Understand the pharmaceutical development lifecycle and its impact on project management.
Apply specialised project management methodologies and tools for pharmaceutical projects.
Navigate regulatory requirements and ensure compliance within project management frameworks.
Develop and implement effective risk management strategies tailored to the pharmaceutical industry.
Communicate seamlessly with cross-functional teams, including R&D, regulatory affairs, marketing and manufacturing.

You complete the programme with an individual thesis – enabling you to apply your knowledge directly in your professional setting.

Zielpublikum

This part-time programme is for current project managers in pharmaceutical companies, professionals aspiring to enter project management roles within the pharmaceutical industry, R&D professionals, regulatory affairs specialists and quality assurance managers.

Aufbau und Inhalte

This programme is designed in a modular format. In the five focused modules of the programme you will gain in-depth knowledge and acquire practical skills to apply directly in your professional practice.

Module 1: Introduction to Pharmaceutical Project Management

Overview of the pharmaceutical industry, Regulatory & GMP frameworks
Key drug development phases: discovery, preclinical, clinical, regulatory and post-market
Types of projects, ISO 21502
Agile, waterfall and hybrid approaches
Tools and software for project management
Roles and responsibilities of project team members (RACI) and other stakeholders

Module 2: Regulatory affairs, quality & legal compliance

FDA, EMA and other regulatory bodies
Quality management systems and key quality processes
Quality assurance agreement
Master service agreement / product agreement, shipment agreement
User requirement specification / statement of work

Module 3: Project initiation

R&D, manufacturing, maintenance
Project structuring: checklists, SOPs, work packages, milestones
Establishing a quote, preparing a budget, time schedule
Supply chain: procurement, ordering equipment & materials
Resource planning: materials, equipment and individuals
Introduction of new equipment, IQ/OQ/PQ, validation/verification, commissioning

Module 4: Project monitoring & controlling

Kick-off
Risk management
Monitoring & reporting
Stakeholder management, project team & steering committee meetings
Managing project changes/deviations
Cost control

Module 5: Team building & project optimization strategies

Building effective teams across departments
Conflict management
Effective communication
Typical pitfalls, project optimization

Throughout the course, you will also gain insights into evidence synthesis methods and how to advise researchers effectively.

Dozierende

The programme is conducted by lecturers from the university as well as recognised experts in the field.

Christoph Heinzen

Voraussetzungen und Zulassung

At least one of the following admission requirements must be met:

Tertiary educational qualification (at least Bachelor’s degree level) and relevant professional experience.
Federal Diploma of Higher Education (from a Swiss “Höhere Fachschule” or “eidg. HFP” or “eidg. BP”) and at least 3 years’ professional experience in a subject relevant to the programme.
At least 5 years’ professional experience in a subject relevant to the programme and successful completion of continuing education courses (in-company or CAS/MAS/DAS), or partially completed tertiary education (> 50%).

As the instruction and educational materials are in English, proficiency in English (minimum level C1) is a prerequisite.

Organisatorisches

Format

The modules are taught on Thursdays and Fridays. About half the lessons take place online, while the other half are held in person at the FHNW Campus in Muttenz.

Downloads

Programme specific

General Documents

All general documents can be found here.