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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 | This lecture provides an overview of the operational and decision-making processes involved in modern drug development. Using real-world examples, students learn how unmet medical needs and burden of disease shape target product profiles and influence development strategies. The course covers key stages of drug development, including preclinical and clinical phases, clinical trial design, risk management and safety monitoring, chemistry, manufacturing and controls (CMC), and post-development considerations such as access, affordability, and effectiveness in real-world settings. 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. The homework assignment will be a group activity to develop a written information and PPT presentation on various current regulatory topics. Topics covered: Health priorities and product development Transition from pre-clinical to clinical development Introduction to Pharma Market & R&D The drug development process Trial design Research ethics Regulations and authorities Patient safety and pharmacovigilance Risk assessment- and management Clinical data management Trial documentation Quality system and SOPs Chemistry, Manufacturing, and Controls (CMC) in drug development Access From efficacy to effectiveness 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. As English is the language of instruction, participants are expected to be competent in written and spoken English. |
| 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 |