Monthly Archives: June 2015

eSubmissions in Australia

Kent  BriggsThe presentation “eSubmissions in Australia” was given by Kent Briggs, Lead Senior Consultant at LORENZ Life Sciences Group, at LORENZ userBridge.14 in Milan, Italy.

In September, I presented the status of eSubmissions in Australia on behalf of the TGA. Since then, the TGA has been busy ensuring a quick and successful implementation of eCTD and setting the foundation for electronic review across all formats.

From the beginning, the TGA “pilot” was kept open allowing anyone to take part that expressed interest. As a result, the first eCTD applications began arriving in October and the first lifecycle sequences in the early parts of 2015.

Continue reading