Problem 1: Demonstrate an understanding of the key principles of pre-approval safety science and pharmacovigilance including nonclinical safety pharmacology/toxicology and clinical trial safety data (e.g., adverse event single and aggregate data, laboratory and clinical safety data, etc.)
Problem 2: Demonstrate an ability to describe/analyze safety information for a combination product that is in development and not yet approved for use
Problem 3: Demonstrate an understanding of the importance of the Investigator's Brochure as the physician-facing document containing cumulative knowledge of an investigational drug's safety at any given time during pre-approval
Problem 4: Demonstrate an understanding of the role of the Investigator's Brochure in drug/biologic development and how this document evolves to form the basis for many safety elements of the final approved product labelling
Problem 5: Demonstrate an ability to analyze and report on complicated safety events in clinical trials
Problem 6: Demonstrate deep understanding of SUSAR events, the regulatory reporting requirements, and their role in the benefit: risk profile of novel drugs/biologics in development.