Management of Reference Safety Information
Below is the list of different Reference Safety Information (RSI) used during Drug Safety and Pharmacovigilance activities.
- Company Core Data Sheet (CCDS)
- Summary of Product Characteristic (SmPC)
- US Prescribing Information (USPI)
- Canada Product Monograph
- Package Leaflet
- Patient Leaflet, and
- Investigator Brochure (IB) etc.
AllyWorth, supported by the team of experienced professionals, provides below services related to the Management of Reference Safety Information (RSI).
- Preparation of the Company Core Data Sheet (CCDS).
- Comparison of Summary of Product Characteristic (SmPC) with the SmPC of Reference Product with a defined frequency as per client requirement.
- Comparison of Investigator Brochure (IB) of test product with the IB of reference product.
- Significant safety updates of RSI, based on the ground of Pharmacovigilance data or based on the authority request.