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 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
Education

BRIDGE - Translational Excellence Programme

A two-year postdoctoral fellowship in translational medicine

Learning outcome

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

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

Oral
Continuous feedback during the course of the semester
ECTS
0 ECTS
Type of assessment
Continuous assessment
Course participation
Attendance and active participation
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.

Part time Master and Diploma courses

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