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20458-01 - Vorlesung mit Übungen: Essentials in Drug Development & Clinical Trials (2 KP)
| Semester | Frühjahrsemester 2025 |
| Angebotsmuster | Jedes Frühjahrsem. |
| Dozierende |
Christian Burri (christian.burri@unibas.ch, BeurteilerIn)
Jörg Möhrle (joerg.moehrle@unibas.ch) Matthias Schwenkglenks (m.schwenkglenks@unibas.ch) Aita Signorell (aita.signorell@unibas.ch) |
| 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. The homework assignment will be a group activity to develop a written information and PPT presentation on various current regulatory topics. Topics covered: Introduction to Pharma Market & R&D Research ethics Regulations and authorities Drug development process Risk assessment- and management Patient safety Trial design Study statistics 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 2013 Fortaleza - detailed pre-reading required Guideline ICH E8(R1) General Considerations for Clinical Trials - detailed pre-reading required Guideline ICH E6(R2) GCP - superficial reading sufficient; please focus on glossary and principles sections |
| Bemerkungen | Thu 29 February 2024 08:15 – 17:00 Fri 1 March 2024 08:15 – 17:00 Period for homework assignment; Submission of homework Wed 27 March 2024 18:00 (CET) Thu 4 April 2024 08:15 – 17:00 Fri 5 April 2024 08:15 – 16:00 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 06.03.2025 | 09.15-17.00 Uhr | Swiss TPH Neubau, Seminarraum 2 |
| Freitag 07.03.2025 | 09.15-17.00 Uhr | Swiss TPH Neubau, Seminarraum 2 |
| Donnerstag 03.04.2025 | 09.15-17.00 Uhr | Swiss TPH Neubau, Seminarraum 2 |
| Freitag 04.04.2025 | 09.15-17.00 Uhr | Swiss TPH Neubau, Seminarraum 2 |
| Module |
Doktorat Epidemiologie: Empfehlungen (Promotionsfach: Epidemiologie) Lehrveranstaltungen Masterstudium Infektionsbiologie (Masterstudium: Infektionsbiologie (Studienbeginn vor 01.08.2024)) 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) - Submission of homework Wed 27 March 2024 18:00 (CET) 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 |