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29959-01 - Vorlesung: Regulatory Toxicology, Risk Assessment (2 KP)
| Semester | Frühjahrsemester 2015 |
| Angebotsmuster | Jedes Frühjahrsem. |
| Dozierende | Martin F. Wilks (martin.wilks@unibas.ch, BeurteilerIn) |
| Inhalt | Part I: Principles, regulatory schemes for products and substances (excluding pharmaceuticals) Week 1: Hazard evaluation, dose-response relationships (R. FitzGerald); Exposure assessment (M. Wilks) Week 2: Risk characterization (R. FitzGerald); Risk management, risk perception and risk communication (L. Aicher) Week 3: Pesticides (L. Aicher); Biocides (R. Ritter) Week 4: Cosmetics and household products, Nanomaterials (R. FitzGerald) Week 5: Chemicals (O. Depallens); Risk assessment of chemical mixtures (M. Wilks) Week 6: Air quality (R. FitzGerald; Water quality (C. Abegglen) Week 7: Endocrine disruptors: regulation, testing strategies (R. FitzGerald) Week 8: Case studies from pesticide and chemicals (R. FitzGerald, L. Aicher, M. Wilks) Part II: Regulatory requirements and risk assessment for pharmaceutical products Week 9: Human pharmaceuticals/biologics: general regulatory strategies I/II (M. Jauslin) Week 10: Human pharmaceuticals/biologics: non-clinical strategy for clinical development and registration (P. Heining); Human pharmaceuticals/biologics: impurities (S. Glowienke) Week 11: Human pharmaceuticals/biologics: regulatory requirements for clinical trials and registration in Switzerland / pharmacovigilance in Switzerland (B. Schmid) Week 12: Generics, Biosimilars (M. Heim) Week 13: Vaccines, stem cell products, gene therapy products (P. Ulrich) Week 14: Medical devices (A. Petermann), pharmaceuticals for veterinary use (R. Helbig) |
| Lernziele | 1) Understand and be able to apply methods of toxicological risk assessment and gain insight into regulatory processes for pesticides, cosmetics, industrial chemicals, and medicinal products. 2) Understand the risk assessment and regulatory requirements for a variety of medicinal products and be able to describe commonalities and differences. |
| Weblink | ADAM |
| Unterrichtssprache | Englisch |
| Einsatz digitaler Medien | kein spezifischer Einsatz |
| Intervall | Wochentag | Zeit | Raum |
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Keine Einzeltermine verfügbar, bitte informieren Sie sich direkt bei den Dozierenden.
| Module |
Modul Specific Knowledge in Toxicology (Master Toxikologie) (Pflicht) Vertiefungsmodul Toxikologie (Master Pharmazeutische Wissenschaften) |
| Prüfung | Lehrveranst.-begleitend |
| Hinweise zur Prüfung | Please refer to the list: http://pharma.unibas.ch/teaching/leistungsueberpruefungen/lluep/ |
| An-/Abmeldung zur Prüfung | Anmelden: Belegen; Abmelden: Dozierende |
| Wiederholungsprüfung | keine Wiederholungsprüfung |
| Skala | 1-6 0,5 |
| Belegen bei Nichtbestehen | beliebig wiederholbar |
| Zuständige Fakultät | Philosophisch-Naturwissenschaftliche Fakultät, studiendekanat-philnat@unibas.ch |
| Anbietende Organisationseinheit | Departement Pharmazeutische Wissenschaften |