Pharma II - Drug Development and Regulation

Upon completing the course, 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