Professionals in pharmaceutical, biotechnological and medical device industries, Professionals in institutions and Contract Research Organizations (CRO’s), Hospital pharmacists and Postgraduate students. The course is aimed at (young) professionals in non-clinical and clinical development of new medicinal products, manufacturing, packaging, Quality Control, Quality Assurance or Regulatory Affairs who are dealing with complex quality systems. The target audience needs to gain an in-depth understanding of these systems to improve quality management in their own organization. The course is an international training program in English and requires, at minimum, a Bachelor’s Degree level.

Expert knowledge and real-life case studies are combined to form an ideal learning experience. Professionals from industry, academia and national regulatory authorities such as Dutch IGJ will share their wealth of experience and knowledge during the course. The course is highly interactive. The program is offered as a combination of self-study, theory, and practical case studies.

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After having followed this course, you will be able to:
Understand the basic concepts of quality, nonclinical- and clinical drug development.
Find, interpret, and understand relevant GxP guidelines and identify the key regulatory requirements for products in development.
Identify the location of quality, nonclinical- and clinical data in the Common Technical Document (CTD).

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Content;
API – Profile of lead compound: R&D steps and R&D data
Medicinal chemistry - Quality in lead finding and optimization
Pharmaceutical formulations (incl. development, quality management and GMP)
Drug development in Dutch hospital pharmacies
Regulatory requirements - quality, clinical and nonclinical (incl. CTD, Clinical Trial Applications)
GLP and nonclinical development program
Execution of a GLP compliant study
GMP during nonclinical and clinical development
Clinical development and GCP
Clinical phase I, II and III
Perspective of the Dutch Inspectorate for Healthcare and Youth (IGJ)
Real-life case studies

Ineke Jonker-Hoogerkamp
Jan-Jaap Scherpbier
Mieke van der Meulen (IGJ)
Jac Wijkmans
Erik Frijlink
Katja van Rij
Wim Oostra
Peter Vis
Chris Mitchell
Eveline Krijger
Lisette Vromans
Leo de Leede

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