Quality by Design (QbD) in Pharmaceutical Development
Quality by Design (QbD) is at the very heart of modern pharmaceutical development. The implementation of QbD principles provides cost-efficient approach for delivering high quality medicines for patients. Regulatory authorities - both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) - are placing great emphasis on the QbD component as a part of regulatory filing. QbD has become a crucial element of a stream-lined drug development process.
This course will provide an insight into the key principles of QbD covering quality risk management, formal experimental design and process analytical technology (PAT). Leading QbD experts - from industry, regulatory and academic side - will introduce the current knowledge on QbD and provide participants with ideas how this knowledge can be implemented in your company. Practical demonstrations are included in the course.
What you will learn
After the course, you will be able to:
- summarize the principles of the QbD approach in pharmaceutical development and manufacturing
- demonstrate basic knowledge about risk management, design of experiments and PAT
- demonstrate basic knowledge about the relationship of the QbD approach into design space and further, into the regulatory framework.
- apply basic risk analysis and design of experiments techniques into practical cases
- identify and suggest suitable process analytical tools for a given manufacturing environment
- work in a multidisciplinary risk management team
- plan and implement basic design of experiments (DoE) approach
- suggest a QbD approach for constructing a design space.
Course content
The course will give a thorough introduction to the underlying principles and tools needed 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, expanded designs
- Process Analytical Technologies (PAT): basic principles of chemometrics, purpose of process measurements in pharmaceutical development and manufacturing, examples of process measurement techniques
- Risk based regulatory framework.
Participants
The course is intended as continuing professional development (CPD) for professionals in the pharmaceutical industry, particularly in production, regulatory affairs and quality functions. The course will be an excellent introduction for those less familiar with QbD and will provide those with more experience on QbD with new ideas on how to further implement the company's QbD programme.
The course is preapproved as an elective in the Master of Industrial Drug Development (MIND) programme and in the Master of Pharmaceutical Regulatory Affairs(MPRA) programme. The course has been developed in co-operation with the Steering Committee of the EUFEPS QbD and PAT Sciences Network (EUFEPS, European Federation for Pharmaceutical Sciences).
Participants must:
- hold a relevant bachelor degree or equivalent,
- have a minimum of 2 years of relevant job experience,
- have proficiency in English.
Course dates
5 days, 13 - 17 August 2012, 9.00 - 17.00 at the University of Copenhagen, Frederiksberg Campus.
Course directors
Jukka Rantanen, Professor, Department of Pharmaceutics and Analytical Chemistry, University of Copenhagen.
Poul Bertelsen, Honorary Associate Professor/Associate Principal Scientist, University of Copenhagen/Takeda.
Other course teachers
Staffan Folestad, Professor, Senior Principal Scientist, Astra Zeneca, Sweden
Wim Oostra, PhD, Section Head Oral Dosage Form, MSD, The Netherlands
Thomas de Beer, Professor, University of Ghent, Belgium
Øyvind Holte, PhD, Scientific officer, Norwegian Medicines Agency, Norway
Erik Skibsted, PhD, Principal Scientist, Novo Nordisk A/S, Denmark
Morten Allesø, PhD, Pharmaceutical Scientist, H. Lundbeck A/S, Denmark
Additional speakers may be included.
Course fee
DKK 18,500/EUR 2,500. Fee includes teaching, course materials, and all meals during course and examination. Participants already enrolled in a Master's programme at the Faculty of Health and Medical Sciences, University of Copenhagen will get a 15% discount on the course fee.
Examination
An optional examination is provided (3 ECTS credits at Master's level) if an essay (case story), based on an extended literature list, is handed in before 28th September 2012 at 16.00. The course has been preapproved as an elective in the MIND and MPRA programmes at the University of Copenhagen.
