Pharma II – Drug Development – Clinical and Regulatory

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