Algemene informatie
Vakcode | AM_1180 |
---|---|
Studiepunten | 3 EC |
Periode | P3 |
Vakniveau | 500 |
Onderwijstaal | Engels |
Faculteit | Faculteit der Bètawetenschappen |
Vakcoördinator | drs. ing. E.M. Janse |
Examinator | prof. dr. H.J.H.M. Claassen |
Docenten |
prof. dr. H.J.H.M. Claassen |
Praktische informatie
Voor dit vak moet je zelf intekenen.
Voor dit vak kun je last-minute intekenen.
Werkvormen | Hoorcollege, Werkgroep |
---|
Doelgroepen
Dit vak is ook toegankelijk als:
Dit vak wordt in het Engels aangeboden. Omschrijvingen kunnen daardoor mogelijk alleen in het Engels worden weergegeven.
Doel vak
- To gain knowledge and insight into the function clinical trials intoday's healthcare system
- To gain knowledge and insight into the design of clinical trials
- To gain knowledge and insight into the conduct of clinical trials,
including the applying rules and regulations (including ICH-GCP)
- To gain knowledge and insight into and critically reflect on the
roles, tasks and responsibilities of the stakeholders involved in
clinical trials
- To gain insight into challenges in clinical development as well as in
strategies to deal with these challenges
- To learn where and how to look up rules and regulations
Inhoud vak
In today’s healthcare system, clinical trials have gained the status ofgolden standard to test the safety and efficacy of newly developed
drugs. For new drugs to enter the market, clinical trials must be passed
and as a consequence, clinical trial outcomes have major effects on our
healthcare system. While our healthcare system currently is under
pressure to remain affordable and available to all, at the same time,
clinical trial regulations are increasingly tightened and the prominence
of clinical trials in our healthcare system is being criticized. For
that matter, it is of great importance to learn about and reflect on the
role of clinical trials in today’s healthcare system.
The Clinical Development & Clinical Trials course will elaborate on the
function, design and conduct of clinical trials, as well as the relevant
stakeholders involved. The course consists of a theoretical part and an
important practical part (e.g. gaining knowledge on clinical trial
regulations). Classes include for example: ‘Life Cycle of a Clinical
Trial’, ‘Clinical Trial Methodology’, ‘ICH-GCP Principles’, ‘The Ethics
Committee’, ‘Safety Considerations in Clinical Trials’, ‘Quality Control
& Quality Assurance’, ‘Compliance, Misconduct & Fraud’.
The gained knowledge and skills will be evaluated by means of a written
exam at the end of the course.
Onderwijsvorm
Lectures: +-35 hSelf study: +- 40 h
Toetsvorm
Written exam: 100%Literatuur
Ray, S., Fitzpatrick, S., Golubic, R. & Fisher, S. (2016). OxfordHandbook of Clinical and Healthcare Research. Oxford University
Press,Oxford, UK.
(Additional reading will be provided via Canvas and will serve as
background reading for the lectures).
Doelgroep
Optional course for Master students Management, Policy Analysis andEntrepreneurship in Health and Life Sciences (MPA), Societal
differentiation of the Health, Life & Natural Sciences.
Overige informatie
Guest lecturers, organisations/companies:• Eric Klaver, FourPlus Clinical