A 1-day targeted training workshop examining the regulatory requirements for PI/PIL submissions and amendments.
- The Law and Regulations 11 and 12
- Professional Information Guideline 2.16
- Applying the SAHPRA PI guideline requirements. Creating a SAHPRA SmPC from an approved PI
- The requirements of the PIL guideline 2.14
- Applying the SAHPRA amendment guideline 2.08 to variations to the PI