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| Semester | spring semester 2024 |
| Course frequency | Every spring sem. |
| Lecturers |
Christian Burri (christian.burri@unibas.ch, Assessor)
Jörg Möhrle (joerg.moehrle@unibas.ch) Matthias Schwenkglenks (m.schwenkglenks@unibas.ch) Aita Signorell (aita.signorell@unibas.ch) |
| Content | 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 |
| Learning objectives | 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. |
| Bibliography | 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 |
| Comments | 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) |
| Admission requirements | No specific prior knowledge required |
| Language of instruction | English |
| Use of digital media | No specific media used |
| Course auditors welcome |
| Interval | Weekday | Time | Room |
|---|---|---|---|
| Block | See individual dates | ||
| Date | Time | Room |
|---|---|---|
| Thursday 29.02.2024 | 08.15-17.00 | Swiss TPH Neubau, Seminarraum 2 |
| Friday 01.03.2024 | 08.15-17.00 | Swiss TPH Neubau, Seminarraum 2 |
| Thursday 04.04.2024 | 08.15-17.00 | Swiss TPH Neubau, Seminarraum 2 |
| Friday 05.04.2024 | 08.15-16.00 | Swiss TPH Neubau, Seminarraum 2 |
| Modules |
Courses: Master Infection Biology (Master's Studies: Infection Biology) Doctorate Science Epidemiology: Recommendations (PhD subject: Epidemiology) Module: Advances in Epidemiology, Statistics and Global & Public Health (Master's Studies: Epidemiology) |
| Assessment format | continuous assessment |
| Assessment details | 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 |
| Assessment registration/deregistration | Reg.: course registration, dereg: cancel course registration |
| Repeat examination | no repeat examination |
| Scale | Pass / Fail |
| Repeated registration | as often as necessary |
| Responsible faculty | Faculty of Science, studiendekanat-philnat@unibas.ch |
| Offered by | Schweizerisches Tropen- und Public Health-Institut |