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20458-01 - Lecture with practical courses: Essentials in Drug Development & Clinical Trials (2 CP)
| Semester | spring semester 2026 |
| Course frequency | Every spring sem. |
| Lecturers |
Matthias Schwenkglenks (m.schwenkglenks@unibas.ch)
Aita Signorell (aita.signorell@unibas.ch, Assessor) |
| 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. 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 |
| 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 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 |
| Comments | 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 | ||
Dates
| Date | Time | Room |
|---|---|---|
| Thursday 26.02.2026 | 08.15-17.00 | Swiss TPH Neubau, Seminarraum 2 |
| Friday 27.02.2026 | 08.15-17.00 | Swiss TPH Neubau, Seminarraum 2 |
| Thursday 26.03.2026 | 08.15-17.00 | Swiss TPH Neubau, Seminarraum 5 |
| Friday 27.03.2026 | 08.15-17.00 | Swiss TPH Neubau, Seminarraum 5 |
| Modules |
Doctorate Science Epidemiology: Recommendations (PhD subject: Epidemiology (Start of studies before 01.08.2025)) Module: Advances in Epidemiology, Statistics and Global & Public Health (Master's Studies: Epidemiology) Module: Electives in Infection Biology (Master's Studies: Infection Biology) |
| Assessment format | continuous assessment |
| Assessment details | Satisfactory homework assignment (rectification may be required if classified as unsatisfactory) 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 |