Quality by Design in Pharmaceutical Development – University of Copenhagen

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Quality by Design in Pharmaceutical Development

Quality by Design (QbD) is at the very heart of modern pharmaceutical development. The implementation of QbD principles provides a cost-efficient approach to delivering high quality medicines for patients. Regulatory authorities, both the European Medicines Agency (EMA) and the US 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 in a stream-lined drug development process.

This course will provide insight into the key principles of QbD covering quality risk management, formal experimental design and process analytical technology (PAT). Leading QbD experts ­ from industry, the regulatory side and the academic world ­will introduce the current knowledge on QbD and provide participants with ideas about, how this knowledge can be implemented in their companies. The course includes practical demonstrations.

""It has been a fantastic course – the best I have attended in years! All persons that gave lectures were very enthusiastic and dedicated to their work – this was so GREAT and motivating- thanks."

Birgit Sølvkær Jensen, Scientific Adviser, Leo Pharma.

Course content

The course will provide a thorough introduction to 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 chemometrics, examples of process measurements both with examples of small molecules and biopharmaceuticals.
  • Risk-based regulatory framework.

Course dates

5 days, 14 – 18 August 2017, 9:00 – 16:30 at the University of Copenhagen, Frederiksberg Campus, Bülowsvej 17, DK-1870 Frederiksberg, Denmark.

""The course was very well organised and gave an excellent mix of activities throughout each day. All guest lecturers were excellent."

Susan Fetherston, Development Engineer, QPharma AB.

Course fee:DKK 19,000. 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 receive a 15% discount on the course fee (DKK 16,000)

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 offer an excellent introduction for those less familiar with QbD
and provide those with more experience with QbD, new ideas on how to further implement the company’s QbD programme. The course is preapproved as an elective in the Master of Medicines Regulatory Affairs (MRA) programme. It 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

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 2 October 2017 at 14:00. The course has been preapproved as an elective in the MRA programmes at the University of Copenhagen. The exam is obligatory for master’s students. Read more on the examination.