Pharma II - Drug Development and Regulation

Course content

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
Education

BRIDGE - Translational Excellence Programme

Learning outcome

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 into the 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 discussions.

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 of the BRIDGE - Translational Excellence Programme.

Oral
Continuous feedback during the course of the semester
ECTS
0 ECTS
Type of assessment
Continuous assessment
Requirement to attend classes
Type of assessment details
Attendance and active participation.
Exam registration requirements

Participants are automatically registered for the examination upon admission to the BRIDGE - Translational Excellence Programme.

Aid
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

  • Category
  • Hours
  • Lectures
  • 20
  • Theory exercises
  • 15
  • English
  • 35

Kursusinformation

Language
English
Course number
SBRI19009U
ECTS
0 ECTS
Programme level
Part Time Master
Ph.D.
Placement
Spring
Schedulegroup
See course dates and course programme in Absalon
Capacity
15 participants
Studyboard
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
  • Siv Annegrethe Hjorth   (9-7b717e7072777a7c70487b7d766c36737d366c73)
  • Henriette Elisabeth Autzen   (16-77747d8178748383743d70848389747d4f82847d733d7a843d737a)
  • Mette Rosenkilde   (10-7b787c6e777472756d6e497c7e776d37747e376d74)
Saved on the 23-04-2024

Are you BA- or KA-student?

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Courseinformation of students