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.



Courses

NumberTitleHoursLecturers
541-0007-00 GModule 7: Clinical Development
Block course
03.09 .- 05.09.2019
10.09. - 11.09.2019
40s hrs
03.09.09:15-18:00LEE D 101 »
04.09.09:15-18:00LEE D 101 »
05.09.09:15-18:00LEE D 101 »
10.09.09:15-18:00LEE D 101 »
11.09.09:15-18:00LEE D 101 »
R. Furegati Hafner, R. Schibli

Catalogue data

AbstractModule 7 gives an overview about the several steps that have to be followed during the process of clinical development.
Learning 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

Performance assessment

Performance assessment information (valid until the course unit is held again)
Performance assessment as a semester course
ECTS credits2.5 credits
ExaminersR. Schibli, R. Furegati Hafner
Typeungraded semester performance
Language of examinationEnglish
RepetitionRepetition possible without re-enrolling for the course unit.

Learning materials

No public learning materials available.
Only public learning materials are listed.

Groups

No information on groups available.

Restrictions

There are no additional restrictions for the registration.

Offered in

ProgrammeSectionType
CAS in Pharmaceuticals - From Research to MarketModulesWInformation