Admission requirements
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 specialisation. The course GMP voor het Middenkader has to be completed.
Description
This two-day training provides insight into the regulatory requirements for drug development from both the viewpoint of regulatory authorities as well as inspection bodies. We will explore the development of a new Active Pharmaceutical Ingredient (API), following the principles of Quality by Design.
Then non-clinical development is discussed, including toxicology, up to clinical development and manufacturing, referring to GLP, GCP and GMP requirements and regulatory guidelines.
Course objectives
After completion of this course students can:
Understand the basic concepts of quality, non-clinical 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, non-clinical and clinical data in the Common Technical Document (CTD).
Timetable
This course is offered by PCS in 2024 (specific dates are to be determinded).
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
ICH guidelines: Q6A, Q7, Q8, Q9, Q14, E6.
Registration
Enrollment via My StudyMap is not necessary for this course. Students need to enroll via the website of PCS (contact the coordinator of the specialisation for questions).
Contact
Coordinator of the specialisation Industrial Pharmacy: Drs. Judith Mathijssen, studyadvisorBPS@lacdr.leidenuniv.nl.
Remarks
This course is only available for students of the Industrial Pharmacy specialisation.
This information is without prejudice. Alterations can be made for next year.