Drug Information Association (DIA) India has kicked off its event calendar for 2013 with the e-CTD Hands on Training Workshop to held on February 4 and 5, 2013 at Sci-Tech Centre, Jogeshwari West in Mumbai.

In this regard the association has invited regulatory affairs experts from LORENZ Life Sciences Group in Germany.

The organisers said that while the e-CTD training is a day-long event, it will be conducted as a two-day session as only 20 participants with 10 laptops can be accommodated for each sitting.

The workshop is an opportunity to learn all about e-CTD. It is focused on  enabling the participants to compile, publish and validate e-CTD submissions with insights on Life Cycle Management and Study Tagging Files (STF) compilations. Hands-on training also enables participants to understand regional differences and global submission strategies. Compilation of US M1 and EU M1 is discussed in detail to empower users with updated information on these major ICH regions. This course is designed for anyone pursuing or intending to pursue regulatory affairs, regulatory operations, submissions management and electronic publishing, stated the organisers.

The main topics would cover various aspects of e-CTD compilation, publishing, validation and Life Cycle Management. It will also include compiling study tagging files (STFs), regulatory strategy, regional differences in e-CTD requirements and coordinating global e-CTD submissions.

At the conclusion of this workshop, participants will be able to compile a technically validated e-CTD for various regions. They would able to maximize the reuse of compiled content, understand e-CTD publishing and technical validation besides have a comprehension on the differences in the regional interpretations of electronic submissions. Further, they would also be able to consider the impact of various regional interpretations of e-CTD along with the specifications and guidelines on global submissions strategy.