CAS Pharmaceutical Project Management

Advanced training in pharmaceutical project management – designed for professionals in regulatory, quality assurance, drug development and compliance

Key data

Degree: FHNW Certificate of Advanced Studies in Pharmaceutical Project Management
ECTS points: 10
Next start: 15.1.2026
Final application date: 18.11.2025
Teaching language: English
Place: Muttenz
Fee: CHF 8'500

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The programme blends project management skills with scientific expertise, empowering professionals to lead complex projects in the pharmaceutical sector. It covers important topics such as project management methods, regulatory requirements and the challenges of drug development, maintenance, supply chain logistics and GMP manufacturing. It's ideal for professionals who want to succeed in the fast-changing pharmaceutical industry, providing the tools and knowledge to excel in project management.

Content

The part-time programme consists of five modules, combining theoretical inputs with practical components and real-world case studies.

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 system 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 meetings & 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

Overview

Target audience

The part-time training course is suitable 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.

The admission criteria are outlined in the programme description (see downloads).

Learning Outcomes

Upon completion of this programme, participants will be able to:

Understand the pharmaceutical development lifecycle and its impact on project management.
Apply specialized 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.

Format

The modules are taught on Thursdays and Fridays. About half of the lessons take place online, while the other half are held in person at the FHNW campus in Muttenz. The programme concludes with an individual written thesis, followed by a presentation and defence.

Lecturers

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

Downloads

Programme specific

General Documents

Online info event, Thursday, 21.8.2025

CAS Pharmaceutical Project Management

Key data

Content

Overview

FHNW School of Life Sciences