Module 11
Supporting Rationales & Documentation
for Safety Updates
An update to a CCDS/CCSI is not effective if not accompanied by a convincing rationale and supporting documentation. Rationales and supporting documentation should be created with great care. They can have a major impact on the image of a company with regulatory authorities, and they might be used in court. They also are important elements of a company's safety knowledge base for a product.
Curriculum topics of this module include:
- Addressees of supporting rationales/documentation and how they drive style and content
- Review of common scenarios: Supporting rationales/documentation for adding an adverse reaction or interaction, for adding advice (eg, contraindication, precaution), for removing safety information
- Things that would make us look amateurish