Prospectus

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Quality Management in Pharma and Biotech. Module 2 - Quality Management in Drug Development

Course
2025-2026

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 Good Manufacturing Practice (GMP) for Middle Management 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. Following the journey of product development from drug discovery to non-clinical and clinical studies, the course touches upon the Registration Dossier and will discuss the GLP, GCP and GMP requirements and guidelines. Understanding regulatory expectations will ensure professionals minimize delays and clarify the decisions made along the way.

After having followed this course, you will be able to:

  • To enhance knowledge of regulatory requirements and best practices for the development of a pharmaceutical product and its quality to be able to comprehend the regulatory landscape and apply that knowledge to ensure product quality, patient safety and compliance with standards.

  • To create an understanding of concepts and principles in pharmaceutical development to understand the risks, manage and mitigate them in the different stages of development.

  • To be able to apply tools and strategies for the development and testing of a product.

  • A basic understanding of the clinical and non-clinical studies to understand their impact on product development, the risks and to manage and mitigate them in relation to product quality.

  • To be able to assess the right and relevant information about the product to be able to release it for its use in a non-clinical or clinical study.

Course objectives

  • Awareness of the difference between the GxPs and regulatory expectations.

  • Understanding of your role in the drug product development.

  • Knowledge on how to identify gaps in the data package to be submitted for regulatory approval.

Timetable

This course will take place on 3 & 4 June 2025 in Van Der Valk Breukelen.

Mode of instruction

Lectures, self-tuition, discussion.

Assessment method

This course will be concluded by a written exam (counts 1/3) and an assignment (counts 2/3).

The student has passed with a final score of at least 6.0.

Reading list

Will be announced during the course.

EU GMP Directives

Organisation for Economic Co-operation and Development (OECD)

International Council of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Suggested reading:

We suggest you to read the headlines of (or at least look over) the following guidelines.
Knowing these (exist) could be useful during the course.

Registration

Enrollment via MyStudymap 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.

Software
Starting from the 2024/2025 academic year, the Faculty of Science will use the software distribution platform Academic Software. Through this platform, you can access the software needed for specific courses in your studies. For some software, your laptop must meet certain system requirements, which will be specified with the software. It is important to install the software before the start of the course. More information about the laptop requirements can be found on the student website.