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The Scientific and Technical Knowledge domain and competencies for Medical Affairs professionals focus on understanding how drugs are developed, types of clinical trials designs usually used and the statistics and epidemiology concepts in pre and post approval phases, the role of the Target Product Profile as a tool in program design, the regulatory agencies functions to evaluate safety and quality of drugs, the knowledge needed to be critically reviewed by the relevant literature.Â
The competencies provided in this domain will enable Medical Affairs professionals to understand clinical trials and data that supports the safe and effective use of drugs that fit the business objectives of the organizations. Â