Key Topic 1: Legitimate Business Need
Here are some examples of activities or materials where there could be a legitimate business need to include off label information:
- Advisory Boards
- Clinical trial documentation or meeting
- HTA (health technology appraisal) submission
- Development partnership
- Business development enquiry
- Market research
- Regulatory submissions
- Information for prospective employees
Some of these, such as regulatory submissions, will not require nominated signatory review. However within a medical function you are most likely to be involved with materials and activities related to ‘scientific exchange’.
