Recently I attended the DIA 2018 Global Annual Meeting, which was held in Boston from June 24-28. With more than 250 sessions across 12 tracks, it’s an event that helps to drive insights into action by connecting key policy discussions to real-world knowledge in life sciences and healthcare.
I was fortunate enough to attend a session, Electronic Submissions where Accenture (Sandra Krogulski) had been invited to participate on the FDA discussion panel. Sandra's talk focused on how to manage lifecycle management submission with the Electronic Common Technical Document (eCTD). It was a lively discussion, hosted by Tessa Brown of the FDA, and joined by Julian Chun and Jonathan Resnick, also of the FDA.
When it comes to regulatory submissions, the eCTD offers a number of benefits, including enabling organizations to improve their ability to:
While the eCTD will go a long way toward helping companies manage the chaos of submissions, companies should also take the following steps to stay up to date with changes to the document and to regulations:
It was interesting to note the common desire to increase harmonization of pharmaceutical standards across the globe. Sponsors and company representatives frequently discussed the challenges of meeting changing regulatory requirements, and preparing for updates that are coming but not yet officially endorsed.
Industry meetings like the DIA offer a great opportunity to spend time with leaders in this industry and learn about best practices and innovative new approaches. I look forward to attending future events, to continue to share insights to advance discoveries in life sciences research and development.