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| Semester | fall semester 2024 |
| Course frequency | Every fall sem. |
| Lecturers | Christian Burri (christian.burri@unibas.ch, Assessor) |
| Content | Compact two day introductory course to the Good Clinical Practice guideline (GCP) designed according to the requirements of Swissethics (level of investigators and sub-investigators). The course provides a compact insight into the ICH E6 GCP regulation and related topics. It is ideal for Investigators, study personnel and people involved and/or interested in clinical research. It serves as beginners as well as refresher training. Content: Principles of the ICH-GCP guideline and its historical background; Legal and regulatory requirements of clinical research; Role of ethics committees and regulatory authorities; Quality and data management in clinical trials; Study documentation, incl. structure and content of study protocol; Study design and basic statistical principles; Outlook to upcoming new regulations |
| Learning objectives | Understanding the basic principles of research involving humans Knowing the fundamental principles of Good Clinical Practice |
| Bibliography | Mandatory reading Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects Version 2012 (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/) - detailed pre-reading required Guideline ICH E8(R1) General considerations for clinical studies (https://www.ema.europa.eu/en/ich-e8-general-considerations-clinical-studies-scientific-guideline) - detailed pre-reading required Guideline ICH E6(R2) Good Clinical Practice (https://www.ema.europa.eu/en/ich-e6-r2-good-clinical-practice) - familiarizing is of an advantage |
| Comments | Please note the exceptional lecture times ! Wed 22 January 2025: 08:45 - 12:00 / 13:00 - 17:00 Thu 23 January 2025: 09:00 - 12:30 / 13:30 - 16:00 A certificate of participation will be handed out Film and sound recordings during the course are strictly forbidden (recorders may be confiscated) |
| Weblink | Department of Pharmaceutical Sciences |
| Admission requirements | Pre-registration by writing an email to studienkoordination-pharma@unibas.ch is mandatory. Enrolled student at the Department of Pharmaceutical Sciences. |
| Course application | Due to a limited number of seats a pre-registration by writing an email to studienkoordination-pharma@unibas.ch is mandatory. |
| Language of instruction | English |
| Use of digital media | No specific media used |
| Interval | Weekday | Time | Room |
|---|---|---|---|
| täglich | See individual dates | ||
| Date | Time | Room |
|---|---|---|
| Wednesday 22.01.2025 | 08.00-17.00 | Pharmazentrum, Hörsaal 2 |
| Thursday 23.01.2025 | 08.00-17.00 | Pharmazentrum, Hörsaal 2 |
| Modules |
Module: Clinical Drug Development: the Basis for Market Approval (Master's Studies: Drug Sciences) |
| Assessment format | continuous assessment |
| Assessment details | Complete participation and 70% correct answers in the Multiple choice test (self-checking of acquired knowledge) at the end of the seminar |
| Assessment registration/deregistration | Reg.: course registration, dereg: cancel course registration |
| Repeat examination | no repeat examination |
| Scale | Pass / Fail |
| Repeated registration | as often as necessary |
| Responsible faculty | Faculty of Science, studiendekanat-philnat@unibas.ch |
| Offered by | Departement Pharmazeutische Wissenschaften |