Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT)
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Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT). / de Matas, Marcel; De Beer, Thomas; Folestad, Staffan; Ketolainen, Jarkko; Linden, Hans; Lopes, Joao Almeida; Oostra, Wim; Weimer, Marco; Ohrngren, Per; Rantanen, Jukka.
In: European Journal of Pharmaceutical Sciences, Vol. 90, 30.07.2016, p. 2-7.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Strategic framework for education and training in Quality by Design (QbD) and process analytical technology (PAT)
AU - de Matas, Marcel
AU - De Beer, Thomas
AU - Folestad, Staffan
AU - Ketolainen, Jarkko
AU - Linden, Hans
AU - Lopes, Joao Almeida
AU - Oostra, Wim
AU - Weimer, Marco
AU - Ohrngren, Per
AU - Rantanen, Jukka
PY - 2016/7/30
Y1 - 2016/7/30
N2 - 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.
AB - 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.
KW - Process analytical technology
KW - Quality by Design
KW - Training
KW - Education
KW - Continuing professional development
U2 - 10.1016/j.ejps.2016.04.024
DO - 10.1016/j.ejps.2016.04.024
M3 - Journal article
C2 - 27112991
VL - 90
SP - 2
EP - 7
JO - Norvegica Pharmaceutica Acta
JF - Norvegica Pharmaceutica Acta
SN - 0928-0987
ER -
ID: 173318891