Regulation of Drug Safety

Course description Regulation of Drug Safety
Year: 2017-2018
Catalog number: 4323LSRDSY
Teacher(s):
  • Dr. J.W. van der Laan
  • Z. Gavric MSc
  • Guest speakers
Language: English
Blackboard: Yes
EC: 4.0
Level: 500
Period: Semester 1, Block I
Hours of study: 42:00 hrs
  • Yes Elective choice
  • No Contractonderwijs
  • Yes Exchange
  • No Study Abroad
  • No Evening course
  • No A la Carte
  • No Honours Class

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:

• “Safe? Says who?!?” When is a product, like e.g. a drug, safe? Who decides that? Based on what?
• Once on the market, is it safe during broad use? We try to make sure that no dangerous drugs (products) enter the market? But once a large population uses it, is it still save? Who is responsible for monitoring
• “Don’t worry, it’s safe! I’ve tested it on guppies…(or guinea pigs).” How do we make sure that no dangerous drugs (products) enter the market? Who is responsible for that? How do you prove that?
• “I need to test it on what???” Data mining: How do we develop safe drugs? How do you prove that? How much more do we need to know? What can we do with all the existing data? Structure-activity relationship, metabolism and exposure models, etc...
• “Off course it’s safe, it’s NATURAL!” How safe are the traditional herbal preparations? Should everything bearing a label “natural” be regarded as safe? What do we actually know about the “naturals”, being made as biotechnological compounds?
• “Well, we’ve proven it is safe for human use, are we done now…?” What about the non-functioning water treatment plants due to high levels of antibiotics in sewage water? What about the impaired fertility of aquatic organisms due to high levels of anti-conception (pill) residues in local waters?
• Safety of “medical devices” How are Medical devices (e.g. implants) regulated? How do we ensure safety and quality at manufacturing level? Who is responsible for that?
• Quality and safety “management” How do we ensure safety and quality at manufacturing level? Who is responsible for that?
• How do all these safety requirements impact the availability of drugs and innovation?

Coordinator

Dr. J.W. van der Laan, Division of Toxicology, LACDR, and Medicines Evaluation Board, Utrecht
Drs. Z. Gavrić, The Regulatory Company, The Hague

Admission requirements

Master’s Students of Bio-Pharmaceutical Sciences, Biomedical Sciences, Life Science & Technology, Molecular Science & Technology.

Mode of instruction

Lectures, literature research, case studies and discussions.

Course objectives

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

  • General regulatory principles for pharmaceuticals, herbal medicines, medical devices, cosmetic products, food supplements.
  • In depth requirements with regard to regulation of safety of human pharmaceuticals
  • General aspects of Environmental Risk Assessment of pharmaceuticals
  • Differences between safety testing of small molecules, biotechnology-derived proteins and vaccines.



    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.

Assessment method

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

Timetable

The duration of the lecture series is 6 days spread over 4 weeks. 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.
Examination: October/November 2017

Registration

Application via uSis. Registration closes 1 month before the start of the course. After this date only with approval of course leaders and the study adviser.

Languages