SBRI19009U Pharma II – Drug Development – Clinical and Regulatory

Volume 2025/2026
Education

BRIDGE – Translational Excellence Programme

Content

The purpose of the Pharma II course is to equip participants with a broad understanding of how to develop a drug toward approval once a drug candidate has been identified. Each theme of the course 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
  • Artificial intelligence – applications and opportunities in clinical and regulatory phases of drug development
  • Intellectual Property Rights (IPR) and patents – primarily from the biotech and corporate perspective
  • Regulatory affairs in drug development
  • Design and execution of clinical trials
Learning Outcome

Upon completing the course, participants should:

 

Have knowledge of:

  • The major disciplines in clinical phases of drug development
  • The 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 basic disciplines essential to 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 the progression of activities within an innovative framework

The course literature will be listed on Absalon.

Participants must meet the admission criteria of the BRIDGE – Translational Excellence Programme.
The course is organised as an intensive 5-day course and comprises lectures, group discussions, case studies, one full day visit to a patent attorney’s office, and presentations.

The course will end with an evaluation, where participants must reflect on the course learning outcomes and provide feedback for course development.
  • Category
  • Hours
  • Lectures
  • 24
  • Exercises
  • 2
  • Excursions
  • 4
  • Total
  • 30
Oral
Continuous feedback during the course of the semester
Credit
0 ECTS
Type of assessment
Continuous assessment
Requirement to attend classes
Type of assessment details
Attendance and active participation are required.
Examination prerequisites

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 assesment

Active contribution and course participation according to the BRIDGE Guidelines and Practicalities.