On successful completion of this module, the student should be able to:
- Justify the emerging relevance of the Medical Affairs functions as an effective interface with external stakeholders to ensure the right medicines are available for patient access and proper use.
- Describe the process of drug development based upon a target product profile (TPP) and identify the critical factors and decision points to meet expectations of customers and stakeholders
- Describe the principles of clinical pharmacology and the practical applications of pharmacokinetics and pharmacodynamics
- Describe the molecular and cellular basis of adverse and toxic reactions and influence of genetic factors in drug development and drug response
- Describe the principles of translational research and application of statistics in medicines development
- Conclude the importance of the patient in drug development
- Discuss the background to the development of medicines regulation and the role of the competent authorities
- Outline the principles of drug safety and risk management
- Justify the principles of medical-marketing and health economics