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.

    • 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
    • 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
    • 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
    • Kick-off
    • Risk management
    • Monitoring & reporting
    • Stakeholder management, project team meetings & steering committee meetings
    • Managing project changes/deviations
    • Cost control
    • Building effective teams across departments
    • Conflict management
    • Effective communication
    • Typical pitfalls, project optimization

    Overview

    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).

    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.

    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.

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

    FHNW School of Life Sciences

    FHNW University of Applied Sciences and Arts Northwestern Switzerland
    School of Life Sciences

    Hofackerstrasse 30

    CH - 4132 Muttenz