535-0050-00L Pharmacoepidemiology and Drug Safety
| Semester | Autumn Semester 2019 |
| Lecturers | S. Russmann, A. Burden |
| Periodicity | yearly recurring course |
| Language of instruction | English |
Courses
| Number | Title | Hours | Lecturers | ||||
|---|---|---|---|---|---|---|---|
| 535-0050-00 G | Pharmacoepidemiology and Drug Safety | 2 hrs |
| S. Russmann, A. Burden |
Catalogue data
| Abstract | Introduction to the principles, methods and applications of pharmacoepidemiology and drug safety. Drug safety in the pharmaceutical industry and regulatory authorities, but also for hospital and office pharmacists. Another focus is the evaluation and interpretation of pharmacoepidemiological drug safety studies in the medical literature and the evaluation of benefits vs. risks. |
| Learning objective | Objectives: - To familiarize participants with the principle methods and applications of pharmacoepidemiology and drug safety that is relevant for industry, regulatory affairs, but also for clinical pharmacists in hospitals and office pharmacies. - Perform independently a causality assessment of suspected adverse drug reactions in patients - Study designs and biostatistics used for the quantitative evaluation of drug safety - Setup of programs that can effectively reduce medication errors and improve drug safety in clinical practice, particularly in hospitals |
| Content | - Historical landmarks of drug safety - Pharmacovigilance and causality assessment - Drug safety in premarketing clinical trials - Descriptive, cohort and case-control drug safety study designs; Data analysis and control of confounding - Pharmacoepidemiology and regulatory decision making in drug safety; Risk management plans (RMPs) - Medication errors, clinical pharmacology / clinical pharmacy - Clinical Decision Support Systems, Interventional Pharmacoepidemiology - Pharmacoepidemiological databases, 'Big Data' - Interactive discussion of many real-life examples for each topic |
| Lecture notes | This course will be a combination of formal lectures, group discussions and self-directed studies. Course material will be taught through seminars, case studies in small groups. Reading material and scripts will be provided for each week. |
| Literature | Recommended literature - Rothman: Introduction to Epidemiology - Strom, Kimmel, Hennessy: Textbook of Pharmacoepidemiology - Gigerenzer: Risk Savvy - How to Make Good Decisions |
Performance assessment
| Performance assessment information (valid until the course unit is held again) | |
Performance assessment as a semester course | |
| ECTS credits | 3 credits |
| Examiners | S. Russmann |
| Type | session examination |
| Language of examination | English |
| Repetition | The performance assessment is offered every session. Repetition possible without re-enrolling for the course unit. |
| Mode of examination | written 60 minutes |
| Written aids | English Dictionary |
| This information can be updated until the beginning of the semester; information on the examination timetable is binding. | |
Learning materials
| No public learning materials available. | |
| Only public learning materials are listed. |
Groups
| No information on groups available. |
Restrictions
| There are no additional restrictions for the registration. |
Offered in
| Programme | Section | Type | |
|---|---|---|---|
| DAS Preparation for the Swiss Federal Examination in Pharmacy | Compulsary Courses II | W |  |
| Pharmaceutical Sciences Master | Core Courses I | O | |
| Pharmacy Master | Core Courses I | O | |