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20458-01 - Vorlesung mit Übungen: Essentials in Drug Development & Clinical Trials (2 KP)
| Semester | Frühjahrsemester 2026 |
| Angebotsmuster | Jedes Frühjahrsem. |
| Dozierende |
Matthias Schwenkglenks (m.schwenkglenks@unibas.ch)
Aita Signorell (aita.signorell@unibas.ch, BeurteilerIn) |
| Inhalt | The lecture will combine teaching on drug development and clinical trial regulations (pathway of drug development, ethical principles, ICH-GCP, regulatory requirements) as well as practical exercises. Topics covered: Health priorities and product development Transition from pre-clinical to clinical development Introduction to Pharma Market & R&D The drug development process Research ethics Regulations and authorities Drug development process Risk assessment- and management Patient safety and pharmacovigilance Trial design Chemistry, Manufacturing, and Controls (CMC) in drug development Clinical data management Quality system and SOPs Trial documentation Monitoring & auditing Trial operations and practical aspects Insight into real clinical trials (examples) Insight into real drug development (example) Jobs around clinical research |
| Lernziele | To know the development pathway of a drug: to be familiar with the theoretical principles of good clinical practice (GCP) and research ethics with special attention to developing countries; to acquire basic knowledge on clinical trial operations including practical skills to draft the content of a clinical trial protocol and document patient information. |
| Literatur | Helsinki Declaration, Version 2024 Helsinki - detailed pre-reading required Guideline ICH E8(R1) General Considerations for Clinical Trials - detailed pre-reading required Guideline ICH E6(R3) GCP - superficial reading sufficient; please focus on glossary and principles sections |
| Bemerkungen | Workload: 60 hours - 32 lessons, 28 hours of homework assignment (group task) |
| Teilnahmevoraussetzungen | No specific prior knowledge required |
| Unterrichtssprache | Englisch |
| Einsatz digitaler Medien | kein spezifischer Einsatz |
| HörerInnen willkommen |
| Intervall | Wochentag | Zeit | Raum |
|---|---|---|---|
| Block | Siehe Einzeltermine | ||
Einzeltermine
| Datum | Zeit | Raum |
|---|---|---|
| Donnerstag 26.02.2026 | 08.15-17.00 Uhr | Swiss TPH Neubau, Seminarraum 2 |
| Freitag 27.02.2026 | 08.15-17.00 Uhr | Swiss TPH Neubau, Seminarraum 2 |
| Donnerstag 26.03.2026 | 08.15-17.00 Uhr | Swiss TPH Neubau, Seminarraum 5 |
| Freitag 27.03.2026 | 08.15-17.00 Uhr | Swiss TPH Neubau, Seminarraum 5 |
| Module |
Doktorat Epidemiologie: Empfehlungen (Promotionsfach: Epidemiologie (Studienbeginn vor 01.08.2025)) Modul: Advances in Epidemiology, Statistics and Global & Public Health (Masterstudium: Epidemiologie) Modul: Electives in Infection Biology (Masterstudium: Infektionsbiologie) |
| Prüfung | Lehrveranst.-begleitend |
| Hinweise zur Prüfung | Satisfactory homework assignment (rectification may be required if classified as unsatisfactory) Multiple choice test (70% correct responses); 1 repetition |
| An-/Abmeldung zur Prüfung | Anm.: Belegen Lehrveranstaltung; Abm.: stornieren |
| Wiederholungsprüfung | keine Wiederholungsprüfung |
| Skala | Pass / Fail |
| Belegen bei Nichtbestehen | beliebig wiederholbar |
| Zuständige Fakultät | Philosophisch-Naturwissenschaftliche Fakultät, studiendekanat-philnat@unibas.ch |
| Anbietende Organisationseinheit | Schweizerisches Tropen- und Public Health-Institut |