Quality by Design (QbD) in Pharmaceutical Development

The course will introduce the underlying principles and tools required for QbD-based pharmaceutical development and manufacturing:

• Basic risk analysis techniques
• Constructing the Quality Target Product Profile (QTPP)
• Identification of Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
• Design of Experiments (DoE): Basic screening designs and expanded designs
• Process Analytical Technologies (PAT): Basic principles of multivariate data analysis (chemometrics), looking at examples of process measurements applied to both small molecules and biopharmaceuticals, and for batch and continuously operating processes
• Risk-based regulatory framework

After the course, you will be able to

• Summarize the principles of the QbD approach in pharmaceutical development and manufacturing
• Demonstrate basic knowledge of risk management, Design of Experiments (DoE) and Process Analytical Technology (PAT)
• Demonstrate basic knowledge of how the QbD approach can be applied in design space and further in the regulatory framework
• Apply basic risk analysis and experiment with design techniques using practical case studies
• Identify and suggest suitable process analytical tools for a given manufacturing environment
• Work in a multidisciplinary risk management team
• Plan and implement a basic DoE approach
• Suggest a QbD approach for constructing a design space

Professionals in need of interdisciplinary overview

The course is intended for professionals in the pharmaceutical industry, particularly in production, regulatory affairs and quality functions. The course serves as an excellent introduction for those less familiar with QbD, while participants who have more experience with QbD will gain new insight into how to further implement the company's QbD programme.

Participants must

• Hold a relevant bachelor degree or equivalent
• Have a minimum 2 years of relevant job experience in drug development
• Be proficient in English

Find detailed information about the admission criteria.

Course directors
Jukka Rantanen, Professor, Department of Pharmacy, University of Copenhagen
Poul Bertelsen, Honorary Associate Professor/Principal Scientist, University of Copenhagen/LEO Pharma

Other course teachers
Staffan Folestad, Professor, Senior Principal Scientist, AstraZeneca, Sweden
Wim Oostra, PhD, Technical manager, Abbott Healthcare, the Netherlands
Øyvind Holte, PhD, Scientific officer, Norwegian Medicines Agency, Norway
Erik Skibsted, PhD, Principal Scientist, Novo Nordisk A/S, Denmark
Morten Allesø, PhD, Pharmaceutical Scientist, NNE, Denmark

Additional speakers may be included. 

This course is offered as an elective course in Master of Industrial Drug Development and in Master of Medicines Regulatory Affairs.

Priority is given to students enrolled on Master of Industrial Drug Development and Master of Medicines Regulatory Affairs. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.