Autumn Semester 2020 takes place in a mixed form of online and classroom teaching.
Please read the published information on the individual courses carefully.

541-0007-00L  Module 7: Clinical Development

SemesterAutumn Semester 2019
LecturersR. Furegati Hafner, R. Schibli
Periodicitytwo-yearly recurring course
Language of instructionEnglish
CommentOnly for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.

AbstractModule 7 gives an overview about the several steps that have to be followed during the process of clinical development.
Objective• Preclinical bridge to clinical development
• Strategy for clinical development
• Regulatory aspects of clinical development
• Good clinical practice (GCP) and quality assurance
• First in human studies (Phase I), Proof of concept studies (Phase II), Registration studies (Phase III), Post-registration studies (Phase IV)
• Monitoring
• Organizational and financial aspects of clinical development
• Portfolio and life cycle management
• Data management and simulation of a clinical study
• Personalized medicine