DAY 1: 26th September, 2019 Mr. Vijaykumar Srinivasan started the morning session by giving the overview of PharmaReady eCTD software. He briefed about the need of regulatory submission, their structure and difference between the various submission formats (comparison between Paper, NeeS, eCTD formats and the ACTD formats.) He discussed on the fundamentals of eCTD & its benefits, Global perspective into the market requirements; also deliberated on various Tools and Technologies for eCTD submission and explained about the components of RIMS. A demonstration on the PharmaReady software was made. The afternoon session was interactive, where Mr. Vijaykumar Srinivasan asked the students to volunteer to create an eCTD submission. He then demonstrated different steps and procedures to be followed to carry out the EU and Health Canada submissions. The session concluded by clearing the issues related to submission; emphasis was made to create submission for EU, Health Canada and US the next day in a group of two. DAY 2: 27th September, 2019 The session started by detailing the steps to login to the PharmaReady website (IP address, login ID and password on the sandbox). Later, the students had a practical and interactive session, where Mr. Bharanitharan Boominathan assisted students in the filing an US submission. The students started creating submission on the instructions of the trainers; the day continued by filing the submission for EU and Health Canada. 65 students of Dept. of Pharmaceutics took the benefit of the eCTD submission across various Regulatory bodies i.e. US, EU and Health Canada. The day was interacting and the students gained vast experience in filling submissions for regulatory bodies. The day ended with a questionnaire session and feedback was collected regarding the two-day session. The NAVITAS team also expressed their support to attend the queries/ issues related to eCTD submissions for the complete learning. They also shared the step wise procedure about eCTD submissions.