Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT).
The regulatory and technical landscape of the pharmaceutical field is rapidly evolving from one focused predominantly on development of small molecules, using well established manufacturing technologies towards an environment in which biologicals and complex modalities are being developed using advanced science and technology coupled with the application of modern Quality by Design (QbD) principles. In order that Europe keeps pace with these changes and sustains its position as major player in the development and commercialization of medicines, it is essential that measures are put in place to maintain a highly skilled workforce. A number of challenges however exist to equipping academic, industrial and health agency staff with the requisite knowledge, skills and experience to develop the next generation of medicines. In this regard, the EUFEPS QbD and PAT Sciences Network has proposed a structured framework for education, training and continued professional development, which comprises a number of pillars covering the fundamental principles of modern pharmaceutical development including the underpinning aspects of science, engineering and technology innovation. The framework is not prescriptive and is not aimed at describing specific course content in detail. It should however be used as a point of reference for those institutions delivering pharmaceutical based educational courses, to ensure that the necessary skills, knowledge and experience for successful pharmaceutical development are maintained. A positive start has been made and a number of examples of formal higher education courses and short training programs containing elements of this framework have been described. The ultimate vision for this framework however, is to see widespread adoption and proliferation of this curriculum with it forming the backbone of QbD and PAT science based skills development.
Seda Pharmaceutical Development Services, The BioHub at Alderley Park, Alderley Edge, Cheshire, SK10 4TG, UK,. Electronic address: marcel.dematas@sedapds.com.
Marcel
M
de Matas
Faculty of Pharmaceutical Sciences, Department of Pharmaceutical Analysis, Ghent University, Belgium.
Thomas
T
De Beer
Pharmaceutical Technology & Development, AstraZeneca Gothenburg, SE-43183 Mölndal, Sweden.
Staffan
S
Folestad
School of Pharmacy, Faculty of Health Sciences, University of Eastern Finland, Kuopio Campus, Kuopio, Finland.
Jarkko
J
Ketolainen
European Federation for Pharmaceutical Sciences (EUFEPS), Veddesta Business Center, SE-17572, Järfälla, Sweden.
Hans
H
Lindén
Research Institute for Medicines (iMed.ULisboa), Faculdade de Farmácia, Universidade de Lisboa, Av. Prof. Gama Pinto, 1649-003 Lisbon, Portugal.
João Almeida
JA
Lopes
Pharmaceutical Science and Tehnology, Abbott Laboratories, The Netherlands.
Wim
W
Oostra
Sanofi, R&D LGCR, Frankfurt, Germany.
Marco
M
Weimer
European Federation for Pharmaceutical Sciences (EUFEPS), Veddesta Business Center, SE-17572, Järfälla, Sweden.
Per
P
Öhrngren
Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.
Jukka
J
Rantanen
D004345:Drug Industry / Q000193:education* / Q000592:standards; D011786:Quality Control; D013678:Technology, Pharmaceutical / Q000193:education* / Q000592:standards
Continuing professional development; Education; Process analytical technology; Quality by Design; Training