14 August 2023

Quality by Design (QbD) in Pharmaceutical Development

Gain insight into the key principles of QbD including quality risk management, formal experimental design and process analytical technology (PAT).

Quality by Design (QbD) in Pharmaceutical Development

Quality by Design lies at the very heart of modern pharmaceutical development. The implementation of QbD principles provides a cost-effective approach to delivering high quality medicines to patients.

Regulatory authorities, such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), are placing increasing importance on the QbD component as a part of regulatory filing. QbD has become a crucial element in a streamlined drug development process.

Leading QbD experts from industry, from the regulatory side and from the academic world provides the current knowledge on QbD and offer ideas about how this knowledge can be applied in your company. The course includes practical demonstrations.


















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


























































Course details

Duration: 5 days on campus
Dates: 14-18 August 2023
Frequency: Once every year
Place: University of Copenhagen, Copenhagen, Denmark
Course fee:

22,500 DKK

Fee includes teaching, course materials, all meals during course hours and examination.
Payment conditions

Level and credit: Master course; 3 ECTS
Examination date: Please consult the exam schedule
Application deadline: 31 May 2023

To be admitted, you must meet the admission criteria for Master of Industrial Drug Development

Course dates and application deadlines are announced via the  programme newsletter.
Download course curriculum