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Studiegids

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Regulation of Drug Safety

Vak
2021-2022

Admission requirements

Master students of Bio-Pharmaceutical Sciences, Biomedical Sciences, Life Science & Technology, Molecular Science & Technology.

Description

Are you sure that the little pill you take each morning is really safe?

The goal of this lecture series is to provide a thorough understanding of several socially very relevant aspects of drug development. This subject is an essential link between science, industry, government and patients.

Subjects to be handled:

  • General considerations of regulating safety of drugs (and related health products) such as: what are the general principals and structure of the law/regulations, how is safety ensured/verified/monitored, what is the role of different stakeholders (government, authorities, manufacturers, etc.).

  • How is the safety of drugs (and related products) evaluated/tested/proven/documented? What must be as minimum tested, document and present to authorities in order to prove that a new drug (developed product) is safe and to get it approved?

  • What are the most important aspects of nonclinical toxicology/safety testing? What is the adequacy of different tests in specific cases (e.g. biotech-derived proteins, vaccines, regular small molecules, etc.)?

  • Next Generation Risk Assessment (NGRA) and New Assessment Methodologies (NAMs): what is the future of toxicology and risk assessment?

  • Challenges with natural and botanical products safety: How safe are herbal medicines and alike products? Should everything bearing a label “natural” be regarded as safe?

  • Environmental impact of drugs: What is the environmental impact of drugs? How does manufacturing and use of drugs impacts the environment? What can we do about it?

  • Quality and safety “management” of drugs at manufacturing: How do we ensure safety and quality at manufacturing level? Who is responsible for that?

Course objectives

At the end of the course the students have knowledge about:

  • Basic principles of regulating safety of drugs and comparable products.

  • Structure and requirements of main EU regulations that apply to human pharmaceuticals and comparable health products.

  • Differences between safety testing of small molecules, biotechnology-derived proteins and vaccines.

  • Basic principles of post-market monitoring (pharmacovigilance).

  • Basic principles of the NGRA.

  • Most important aspects of Environmental Risk Assessment of pharmaceuticals.

  • Quality assurance and process of market release of manufactured drugs (incl. the main responsibilities and tasks of the QP).

Students are expected to have a thorough understanding of regulatory aspects of drug development in comparison with other regulatory areas as well. This subject is an essential link between science, industry, government, and patients.

Timetable

The duration of the lecture series is 6 days spread over 3 weeks (September/October 2021). Each day includes a lecture/presentation in the morning and presentation or activity in the afternoon (literature research and discussion, a guest speaker or a visit, discussion or a debate on actual cases and examples). Attention of all days is obligatory, as the exam will be based on presentations and discussions. The form may be adjusted to actual situation in relation to COVID-19 pandemic and online education tools.

Examination: October 2021.

The specific schedule for this course will be published on Brightspace.

Mode of instruction

Lectures, literature research, case studies and discussions.

Assessment method

Oral group presentations during the course and written examination (open as well as multiple choice questions), depending on the number of participants.

Reading list

The reading list will be given on the Brigthspace per topic just a few weeks before the start of the course. These are given as presentations and pdf files. There is no need to purchase literature, as the presented material is not commercialized.

Registration

Application via uSis. Registration closes 14 days before the start of the course. After this date only with approval of course coordinator.

Contact

Coordinators:
Dr. J.W. van der Laan, Division of Toxicology, LACDR, and Medicines Evaluation Board, Utrecht.
E-mailaddress: jw.vd.laan@cbg-meb.nl.

Drs. Z. Gavrić, The Regulatory Company, The Hague.
E-mailadress: z.gavric@theregcom.com)

Remarks

There is a limit of max. 24 students for this course. Placement is based on the registration date.

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