Check your knowledge 3 - reporting adverse events, product complaints and special reporting situations
Consider the following scenario and make a note of your responses. We’ll discuss them on the next slide.
Your company has a product that is licensed for treatment of condition A but the team want to carry out research looking at use in condition B which is not licensed.
Is this allowable market research?
- What AEs/PCs/SRSs are most likely to occur in this research?
- What concerns might this raise?
- What would you be looking for in relation to AE/PC/SRS reporting processes when reviewing the interview guide and stimulus materials?