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 that will be handled:
General considerations: When is a product, like e.g. a drug, safe? Who decides that? Based on what? How do we make sure that no dangerous drugs (products) enter the market? Who is responsible for that? How do you prove that?
Safety of chemicals and consumer products: How are “non-pharma” products regulated? Similarities and differences with drugs regulations and safety assessment approach.
Next generation risk assessment (NGRA): is there a better way to assess a product safety? Where do the regulators stand on animal testing for safety assessment? What is the roadmap to achieve the NGRA?
NGRA in practice: How can we collect the needed information? Can we use existing data? Structure-activity relationship, metabolism and exposure models, etc...
NAMs - Advanced Non-Animal Methods/Approaches: Which methods are available? How can they be applied in NGRA?
NGRA in practice: how do we integrate different source of data to provide evidence of low risk? NAMs data integration and IATA concept.
Conclusions: How do all these safety requirements impact the availability of drugs and innovation?
Note that these are expert lectures series and that hence the content might change every year.
Course objectives
At the end of the course the students have knowledge about:
General regulatory principles for pharmaceuticals, chemicals, consumer products, food supplements.
In depth requirements about regulation of safety of human pharmaceuticals
General principles of classical (current) safety assessment approaches
General principles of NGRA
General principles of non-animal approaches/methodologies (NAMs) and their regulatory acceptance for risk assessment
In depth theoretical knowledge of different NAMs: in vitro and in silico models, PBPK models, the Adverse Outcome Pathway concept
Practical experience on how to use and combine different NAMs for NGRA: Threshold of Toxicological Concern, Read-Across, Tiered approach for cosmetic safety assessment.
Post market product safety survailance (Vigilance)
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
This course is scheduled for semester 2, period 3.
You will find the timetables for all courses and degree programmes of Leiden University in the tool MyTimetable (login). Any teaching activities that you have sucessfully registered for in MyStudyMap will automatically be displayed in MyTimeTable. Any timetables that you add manually, will be saved and automatically displayed the next time you sign in.
MyTimetable allows you to integrate your timetable with your calendar apps such as Outlook, Google Calendar, Apple Calendar and other calendar apps on your smartphone. Any timetable changes will be automatically synced with your calendar. If you wish, you can also receive an email notification of the change. You can turn notifications on in ‘Settings’ (after login).
For more information, watch the video or go the the 'help-page' in MyTimetable. Please note: Joint Degree students Leiden/Delft have to merge their two different timetables into one. This video explains how to do this.
A detailed schedule of the course will be published on the Brightspace course module.
Mode of instruction
Lectures, tutorials, practical work, self-tuition.
Assessment method
The course will be completed with case-studies and a presentation (20%) and exam (80%):
case-studies presentations: each group indicates who contributed and the other groups scores the presenters (0, 3 or 5 points)
exam: each question counts 0-3 or 0-5 points depending on question weight and completeness of the answer
Extra assignments: mindmaps/infographics (2 extra points), report after the agencies discussions (3 extra points)
For each individual exam, the grade is expressed either with pass or fail, or 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 6.0 to successfully complete this course.
The time and manner of the inspection and of the feedback session on the examination are specified in the Brightspace module of the course.
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
Every student has to register for courses with the enrollment tool MyStudyMap. There are two registration periods per year: registration for the fall semester opens in July and registration for the spring semester opens in December. Please see this page for more information.
Please note that it is compulsory to both preregister and confirm your participation for every exam and retake. Not being registered for a course means that you are not allowed to participate in the final exam of the course. If you want to retake of the exam of the course without following the lectures, you have to contact the coordinator of the course to see if this is possible (you would have to passed the other assignments of the course in the earlier year).
Confirming your exam participation is possible until ten days before the exam.
Extensive FAQ's on MyStudymap can be found here.
Contact
Coordinators: Giulia Callegaro, PhD, Assistant Professor, LACDR, Leiden University
E-mail address: g.callegaro@lacdr.leidenuniv.nl
Dr. Z. Gavrić, The Regulatory Company, The Hague.
E-mailadress: z.gavric@theregcom.com OR z.gavric@lacdr.leidenuniv.nl)
Remarks
A minimum of 5 students and a maximum of 40 master students applies to this course. Placement is based on the registration date in MystudyMap.
This information is without prejudice. Alterations can be made for next year.