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 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.
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.
- 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.
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.
|Duration:||5 days on campus|
|Dates:||14-18 August 2023|
|Frequency:||Once every year|
|Place:||University of Copenhagen, Copenhagen, Denmark
Fee includes teaching, course materials, all meals during course hours and examination.
|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