SBRI19009U Pharma II - Drug Development and Regulation
BRIDGE - Translational Excellence Programme
A two-year postdoctoral fellowship in translational medicine
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
On completion of the course, the participants should be able to:
Knowledge
- 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
Skills
- 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
Competences
- 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
Course literature is published on Absalon.
- Category
- Hours
- Lectures
- 20
- Theory exercises
- 15
- Total
- 35
Automatic registration upon appointment in the Translational Excellence Programme
- Credit
- 0 ECTS
- Type of assessment
- Continuous assessmentCourse participationAttendance and active participation
- Exam registration requirements
Participants are automatically registered for the Examination upon course registration.
- Aid
- All aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
Criteria for exam assesment
Active contribution and course participation according to the BRIDGE Guidelines.
Course information
- Language
- English
- Course code
- SBRI19009U
- Credit
- 0 ECTS
- Level
- Part Time Master
- Duration
- Placement
- Spring
- Schedule
- See course dates and course programme in Absalon
- Course capacity
- 15 participants
- Course is also available as continuing and professional education
- Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Biomedical Sciences
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Mette Rosenkilde (10-7c797d6f787573766e6f4a7d7f786e38757f386e75)
- wbf943 wbf943 (4-656c77794477797268326f7932686f)