Webinar overview

Australia (AU- TGA) now recommeds eCTD submissions

The AU-TGA is looking towards moving to submit applications in electronic format to enter registered medicines into the Australian Register of Therapeutic Goods (ARTG)

The webinar focuses on submitting the dossier in eCTD format in Australia for all sponsors and Regulatory professionals involved with eCTD to impart an accurate and deep understanding about eCTD submission.

The underlining fact is Pharmaceuticals and other life science companies’ faces challenges while making regulatory submissions in the electronic Common Technical Document format because of revolution in new global regulatory enviorment, So Sarjen’s Regulatory experts would address all such challenges in creating eCTD Submissions in this webinar. 

• Introduction and Evolution-eCTD in AU-TGA
• Business protocol for preparing eCTD transaction
• Publishing challenges in Australia
• Baseline submission for paper to eCTD
• Lifecycle management concept of eCTD Submission
• Suggestions for PDF properties
• eCTD Australia-Points to Remember
• eCTD Preparation Tools

Webinar, participants will have a comprehensive overview of eCTD including the basics and terminology to rules and regional standards to submission output and solutions for Australia.

Support: corp.comm@sarjen.com 
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