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Quality Management in Pharma and Biotech. Module 2 - Drug development: from ‘Quality by Design’ to Clinical Studies

Vak
2021-2022

Admission requirements

Completed the first year of the master Bio-Pharmaceutical Sciences. Research Project 1 must be completed with at least an average of 7.5 for the components Practical work, Report, and Oral presentation. Only available to students of the Industrial Pharmacy specialization.

Description

The course follows quality assurance from the development of an active pharmaceutical ingredient (API) in R&D, through quality by design that meets GMP guidelines, to preclinical development, toxicology and GLP, to clinical development that meets GCP requirements.

Course objectives

After completion of this course students will have:

  • Knowledge and understanding of the importance of quality management in drug development, from quality in lead finding and lead optimization, to large scale production, formulation, and clinical development

Timetable

September 14-16, 2021.

Mode of instruction

Lectures, self-tuition, discussion.

Assessment method

This course will be concluded by a written exam and an assignment. Each counting for 50% of the final grade.

For each individual exam, the grade is expressed by using a decimal integer between 1.0 and 10.0 that should be ≥ 5.5. The final grade is expressed using an integer between 1 and 10 and can be rounded off/up to a half integer, with the exception of the grade 5.5. Final grades between 5.50 and 5.99 will be rounded up to 6.0. The final grade should be 5.5 to successfully complete this course.

Reading list

Will be announced during the course.

Registration

Registration via the provider of the course. Registration via uSis is not necessary.

Contact

Coordinator for the Industrial Pharmacy specialization: Emily Ouwehand MA (email: studyadvisorBPS@lacdr.leidenuniv.nl).

Remarks

This course is only available for students of the Industrial Pharmacy specialization.

This information is without prejudice. Alterations can be made for next year.