A04 – Substantiation of Listed Medicines Claims

This workshop style session will lead you through the claims and indications substantiation for medicines that can be listed on the ARTG. We will take a step wise approach from looking at the formulation, guidance documents and literature to the writing of the claims and indications. We will also take a look at how to compile a supporting package to use for listing as well as artwork purposes.

The papers being discussed in this session are available for download here and here. If possible, please bring your own copies to the session, preferably electronically on your device.

Chairperson: Gabrijela Matanovic, Team Leader – Regulatory Affairs, Apotex