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Studiegids

nl en

Legislation of Production of Medicinal Products

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. Master’s students of Bio-Pharmaceutical Sciences specialization Industrial Pharmacy and other master’s students of Bio-Pharmaceutical Sciences.

Description

In the European Union a comprehensive legal framework for the authoriszation, manufacture, and distribution of human medicines is in place which should safeguard public health, while not to hinder the development of the pharmaceutical industry or trade in medicinal products within the European Union. In this course the students are familiarized with the European Directive 2001/83/EC governing medicinal products for human use in the European Union and national laws, specifically the Dutch Medicines Act. The relationship between these two sources will be discussed. Subsequently, it will be examined how the rules work out in daily practice, from the perspective of the manufacturer, importer or wholesaler, but also from the Health Care Inspectorate, and the Medicines Evaluation Board.

This course aims to:

  • Familiarize students with the European Directive 2001/83 /EC and the Dutch Medicines Act.

  • Provide an overview of standards and rules that apply in the pharmaceutical industry and that arise from national and European regulations.

  • Provide insight into how the rules work out in practice.

Course objectives

At the end of this course the student is able to:

  • Describe the relevant national and European legal frameworks for the authorizsation, manufacture, and distribution of human medicines.

  • Understand why (people in the) pharmaceutical need to comply with European and national laws and how to identify the specific legal requirements to comply with.

  • Explain how the legal frameworks ensure that medicines meet the criteria for efficacy, safety and quality in practice for application in humans.

Timetable

One day course in semester 1, period 2.
A detailed course schedule will be published on Brightspace.

Mode of instruction

Lectures, tutorials (case study and discussion), self-tuition.

Assessment method

This course requires active participation during the lectures and tutorials in which cases will be discussed. The course is concluded with an individual assignment based on which the final result (pass/no pass) will be determined.

Reading list

Will be announced during the course.

Registration

Registration via uSis for both the course and exam is mandatory. Registration for the course closes 14 days before the start of the course or earlier when the maximum number of students is reached. Registration for the exam closes 7 days before the exam date or earlier when the maximum number of students is reached.

Contact

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

Remarks

Maximum 12 students. Students of the specialization Industrial Pharmacy of the master programme Bio-Pharmaceutical Sciences have guaranteed places.

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