SBRI19009U Pharma II - Drug Development and Regulation

On completion of the course, the participants should be able to:

Knowledge
•    Give a comprehensive overview of the preclinical efficacy tests in animals and clinical phase of development of medicines
•    Identify correct professional terms in clinical development of medicines
•    List major steps and elements of the preclinical efficacy tests in animals and clinical drug development process
•    Outline definitions of key concepts and the fundamentals of the major disciplines in clinical development
•    Identify the important transition points that require involvement of authorities

Skills
•    Appraise the integration of the various basic disciplines into the process of preclinical efficacy tests in animals and clinical development of medicines
•    Analyse the sequence and flow of the various steps in the process of clinical drug discovery and development
•    Plan a development process within the regulatory framework

Competences
•    Liaise with 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 of a medical product
•    Communicate professionally with the various specialist groups within the area of development of medicines