'Requirements: None. Description: The course has two parts. In the first part, the course will cover the fundamentals of clinical pharmacology as a translational scientific discipline focused on rational drug development and utilization in therapeutics. The course focuses on the following core principles of pharmacology: pharmacokinetics, pharmacodynamics and toxicology; drug discovery and development and clinical study protocol design. The second part of the course will cover advanced clinical trial concepts like medical device development, advanced therapeutical medicinal products (e.g. gene therapy), clinical trial and sofware development in clinical trials, and basics of pharmacovigilance. This course intends to complement the other courses of the translational research teaching program so that participants will have a broad and in-depth overview of the mainstream methodologies of clinical research. Courses part I: 1. Pharmacokinetics 2. Pharmacodynamics and toxicology 3. Drug development 4. Clinical study protocol design Courses part II: 5. Medical Devices. 6. Clinical developments, clinical trials in the field of medical devices and medical softwares. 7. Advanced therapy medicinal products 8. Pharmacovigilance'
'Requirements: None. Description: The course has two parts. In the first part, the course will cover the fundamentals of clinical pharmacology as a translational scientific discipline focused on rational drug development and utilization in therapeutics. The course focuses on the following core principles of pharmacology: pharmacokinetics, pharmacodynamics and toxicology; drug discovery and development and clinical study protocol design. The second part of the course will cover advanced clinical trial concepts like medical device development, advanced therapeutical medicinal products (e.g. gene therapy), clinical trial and sofware development in clinical trials, and basics of pharmacovigilance. This course intends to complement the other courses of the translational research teaching program so that participants will have a broad and in-depth overview of the mainstream methodologies of clinical research. Courses part I: 1. Pharmacokinetics 2. Pharmacodynamics and toxicology 3. Drug development 4. Clinical study protocol design Courses part II: 5. Medical Devices. 6. Clinical developments, clinical trials in the field of medical devices and medical softwares. 7. Advanced therapy medicinal products 8. Pharmacovigilance'
