SAS Pharmaceutical Risk, R&D and Portfolio Management, FHNW School of Life Sciences

Develop the competencies to manage risk, R&D, and portfolio activities effectively within pharmaceutical operations and regulatory environments.

After completing the SAS, you will be able to:

• Perform structured risk assessments, including FMEA, to support sound project decision-making in pharmaceutical environments.
• Manage project changes, deviations, and complexity effectively across multi-project portfolios.
• Apply tools and methods to evaluate, prioritize, and monitor projects within portfolio and PMO frameworks.
• Apply knowledge of R&D project management, including clinical development, cost control, and regulatory requirements.
• Understand how quality management systems and regulatory authorities such as FDA and EMA influence pharmaceutical project execution.

This SAS is for you if you are currently working as a project manager in a pharmaceutical company, aspiring to enter a project management role within the pharmaceutical industry, or working in R&D, regulatory affairs, or quality assurance management.

This SAS is the fourth of four modules within the CAS Pharmaceutical Project Management. It is offered in presence over four days.

The main learning is how to manage pharmaceutical R&D and operational portfolios by systematically assessing risks, ensuring regulatory and quality compliance, and effectively prioritizing and controlling multiple projects.

Additionally, the following topics are covered:

• Perform project risk analysis, FMEA
• Managing project changes/deviations
• Tools for evaluating multiple projects
• Cockpits for project management office
• Commercial GMP manufacturing projects
• R&D projects including clinical development
• Cost control within R&D projects
• FDA, EMA and other regulatory bodies
• Quality management systems and key quality processes
• Quality assurance agreement

At the end of the module, a multiple-choice questionnaire (pass/fail) is available, if you would like to receive ECTS credits. The module can be allocated to the CAS Pharmaceutical Project Management within three years. If you have successfully completed all SAS of this CAS programme and wish to receive the Certificate of Advanced Studies (CAS), please contact us for the final written assignment.

• Dr. Christoph Heinzen, Programme management
• Reto Brügger, eidg. dipl. Apotheker, EMBA, Standortleiter Basel und Mitglied der GL bei pixon engineering AG
• René Marty Ph.D. PMP, Senior R&D Program Manager
• Dr. Christian Schärer, Leiter Inspection Management Swissmedic

The following programme admission requirements apply:

• Tertiary A: Higher education qualification (at least a Bachelor’s degree) and at least 2 years’ practical experience relevant to the programme,
• Tertiary B: Colleges of Higher Education Diploma (HF), Advanced Federal Diploma of Higher Education (HFP) or Federal Diploma Higher Education (BP), and at least 5 years’ practical experience relevant to the programme,
• Individuals without a Tertiary A or B qualification may be admitted if they cumulatively meet the following admission criteria:
• at least 10 years’ professional experience in a field relevant to the programme, of which at least 5 years in a managerial or senior specialist role
• additional qualifications (various non-formal, extensive further training courses or partial completion (>50%) of a tertiary qualification)
• evidence of knowledge of academic work or a willingness to acquire this in advance.