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.
Factsheet
- Degree
- Certificate of Advanced Studies FHNW Pharmaceutical Project Management
- ECTS points
- 10
- Next start
- 17.9.2026
- Teaching languages
- English
- Venues
- FHNW Campus Muttenz, Hofackerstrasse 30, 4132 Muttenz
- Fee
- CHF 8 500
At a glance
- 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.
Aims and benefits
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.
Target audience
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.
Structure and programme contents
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
Lecturers
The programme is conducted by lecturers from the university as well as recognised experts in the field.
Requirements and admission
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.
Organisational matters
Format
The modules are taught on Thursdays and Fridays. All the lessons are held in person at the FHNW Campus in Muttenz.
Downloads
Advising and information events
Contact
Christoph Heinzen
- Phone
- +41 61 228 55 40 (Central office)
Information events
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Registration
CAS Pharmaceutical Project Management17 September 2026
- Date
- 17.9.2026
- Place
- Muttenz
- Course management
- Christoph Heinzen
- Final application date
- 24.7.2026