Reference no: EM133254822

1. Title and purpose of the report 
   • Briefly describe why you are developing this document and how you think it might help your new colleagues to better understand SUSAR reporting requirements.
2. Description of FDA and ICH descriptions of SUSAR reporting
   • The following are examples of some content you might include:
     • Key safety definitions and terms (e.g., Adverse Event (AE), Expectedness, Severity/Seriousness, Causality, Serious Adverse Event (SAE), etc.)
     • Definition of SUSAR
     • Description of expedited reporting requirements
     • EXAMPLES of each kind of safety event (HINT: Do some original research to find examples of Adverse Events in other drug/biologic development programs)
3. Description of the safety profile of ITCA-650 
   • Use the IB to guide your discussion of the current phase of development of ITCA-650
   • What type of drug is contained within ITCA-650? How does ITCA-650 (both drug and the device) work to address T2D (Diabetes Type II)?
   • What does the nonclinical safety data of ITCA-650 suggest about the overall safety profile? (HINT: Look at ADME data)
   • What does the clinical safety data tell you about the safety profile of ITCA-650? What are the expected adverse events? (HINT: there are 3 key Gastrointestinal (GI)-related AEs that are top of the expected AE list for this drug class)
4. Analysis of 3 ITCA-650 safety events 
   • You will use the ITCA-650 Safety Case Generator "Quiz" in Canvas to generate 3 randomly selected case studies for you to discuss in this section.
   • For each safety case, determine the following:
     • Analyze the event based on the 3 primary AE assessment tools (Expectedness, Severity/Seriousness, Causality)
       • HINT: You should reference the ITCA-650 IB in your analysis
     • Describe what type of AE category the event fits
     • Describe what the appropriate means of reporting is for this event (e.g., expedited? DSUR/IND annual report only?)
5. Conclusions (~1-2 paragraphs)
   • Use this section to provide your audience with an overview of the role of AE/SAE/SUSAR reporting in drug/biologic development (HINT: you should consider tying this part of the discussion to the concept of Benefit: Risk).