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