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 each field.
The topics taught are:
- Preclinical tests using large animal models
- Pharmacokinetics and biostatistics
- Intellectual Property Rights - biotech and corporate perspective
- Regulatory affairs in drug development
- Clinical trials – design and execution
BRIDGE - Translational Excellence Programme
Upon completing the course, participants should:
Have knowledge of:
- A comprehensive overview of the major disciplines in clinical phases of drug development.
- Critical steps in the clinical drug development process.
- The framework of intellectual property rights.
- The rationale for using large animal models in pre-clinical drug development.
- Definitions of key concepts and correct professional terms in clinical drug development.
Acquire the analytical skills to:
- Appraise the various basic disciplines integrated in
tothe process of clinical drug development.
- Analyse the flow of the various steps in the process of clinical drug development.
- Recognise the importance of the regulatory framework enabling clinical development.
- Identify and manage IPR opportunities.
Acquire the ability to:
- Liaise professionally with stakeholders and specialists from all steps of clinical drug development.
- Identify critical factors and bottlenecks that influence the clinical drug development process.
- Promote and state critical milestones for the progress of clinical drug development.
- Govern IPR associated with one’s own research to enable progression of activities within an innovative framework.
The course is organized as an intensive 5-day course and
comprises lectures, group discussions, case studies, one full day
visit and work at a patent attorney’s office, presentations, and
The course will end with an evaluation where participants must reflect on course learning outcomes and give feedback for course development.
Course literature will be published on Absalon.
Participants must meet the admission criteria in BRIDGE - Translational Excellence Programme.
The BRIDGE – Translational Excellence Programme offers a few selected 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 admission to the programme.
For further information about the programme, please go to the BRIDGE website: www.bridge.ku.dk
- 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 and Practicalities.
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 (10-7a777b6d767371746c6d487b7d766c36737d366c73)
- Siv Annegrethe Hjorth (9-7a707d6f7176797b6f477a7c756b35727c356b72)
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Courseinformation of students