Pharma II - Drug Development and Regulation
The purpose of the Pharma II course is to equip participants with a broad understanding of how to develop a drug candidate once identified. Each theme will be dedicated to an important aspect of this development and you will be guided through each topic by experts within the respective fields.
The topics taught are:
- Preclinical efficacy tests in animal models
- Preclinical safety assessment in animal models
- Intellectual Property Rights and their role in starting up a company
- Regulatory affairs
- Clinical trials
BRIDGE - Translational Excellence Programme
On completion of the course, the participants should be able to:
- have an understanding of how to develop and maintain large animal models of disease. What the pros and cons of such models are and the key elements of preclinical efficacy testing.
- list major steps and elements of the preclinical efficacy and safety assessments in animals that enable the clinical drug development process
- identify correct professional terms and key concepts in clinical development of medicines and the major disciplines that are involved in clinical development
- understand the framework of intellectual property rights and how to safeguard the innovative potential of one’s discoveries
- appraise the integration of the various basic disciplines into the process of preclinical efficacy tests in animals and clinical development of medicines
- analyze the sequence and flow of the various steps in the process of clinical drug development
- have an overview of the regulatory framework enabling clinical development
- Govern ones research and associated IPR in a way that enables future activities within an innovative framework
- liaise within all steps of clinical drug development
- identify critical factors and bottlenecks that influence the preclinical efficacy tests in animals and clinical drug development process
- promote and state milestones for the progress of the clinical development
- communicate professionally with the various specialist groups within the area of development of medicines
The course is organized as an intensive 5-day course and comprises lectures, group discussions, case studies, presentations and discussions.
Course literature is published on Absalon.
Participants must meet the admission criteria in BRIDGE - Translational Excellence Programme
The BRIDGE – Translational Excellence Programme offers a few
select graduated PhDs a two-year postdoctoral fellowship in
translational medicine. The courses are only available to the
fellows enrolled in the programme. Fellows are automatically
enrolled in the courses upon appointment in the programme.
For further information: https://bridge.ku.dk/about/
- 0 ECTS
- Type of assessment
Continuous assessmentCourse participation
- Type of assessment details
- Attendance and active participation
- All aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
Criteria for exam assessment
Active contribution and course participation according to the BRIDGE Guidelines.
Part time Master and Diploma courses
- Theory exercises
- Course number
- 0 ECTS
- Programme level
- Part Time Master
See course dates and course programme in Absalon
- 15 participants
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
- Department of Biomedical Sciences
- Faculty of Health and Medical Sciences
- Mette Rosenkilde (10-7774786a73706e71696a45787a736933707a336970)
- wbf943 wbf943 (4-69707b7d487b7d766c36737d366c73)
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