Part A – eCTD: A 50 thousand foot overview
The electronic Common Technical Document (eCTD) is not going anywhere anytime soon, and will be the only method by which firms can submit clinical data to FDA for review. While the eCTD has been in place since 2000, by March of 2018 the FDA will require nearly all regulatory deliverables to CDER and CBER be in eCTD format (NDA, BLA, ANDA, IND, DMF). The eCTD is based upon the Common Technical Document (CTD), which provided for the “harmonization” of scientific content to the participants (US, EU, Japan) of the International Conference on Harmonization (ICH) and other observer regulatory agencies. The eCTD is comprised of the following
- Module 1 Regional Specific Admin & Label
- Module 2 Summaries
- Module 3 Chemistry Manufacturing and Controls
- Module 4 Safety-Animal Studies
- Module 5 Clinical-Human Studies
We will provide a brief overview of the eCTD construct, document level publishing, and submission level publishing. Additionally, options for eCTD production: “on premise publishing tools” versus “cloud publishing tools” versus “outsource publishing” will be detailed.
Part B – EDMS: A 50 thousand foot overview
Electronic Document Management Systems (EDMS) have been used for well over a decade. These have provided significant benefit for the biopharmaceutical industry but not without some challenges driven by significant resource investment. EDMS have primarily been leveraged by large organizations for the benefit of their research and development activities. This limited adoption has been due to the substantial expertise needed to manage these systems, and financial investment. Lower cost “cloud-based” EDMS providers leveraging standards and industry best practices have expanded EDMS use within the life sciences community, covering the full range of company scale from small and emerging firms through the largest of enterprises.
We will discuss a high level overview of EDMS, exploring best practices in use and benefit. Additionally, we will provide an overview of the changes to systems driving broader adoption including “on-premise” versus “cloud” and “own” versus “lease” options.
Part C – Looking Forward: What regulations, standards and industry trends are underway and/or anticipated?
There are a number of recently released and upcoming regulations, regulatory guidelines, standards and industry trends. We will briefly outline these and what their impact has been and could be going forward.
Examples: US eCTD Mandates, US Module 1 Advertisement/Promotional Material Delivery, Active Substance Master File for EU, US Data Standards à Clinical Data Interchange Standards Consortium – CDISC, Analysis Data Model – ADaM, Standard for Exchange of Nonclinical Data – SEND
Learning objectives, key drivers and pain points associated with this session topic:
- FDA March 2018 mandated delivery of submission documentation of NDAs, BLA, INDs, and DMFs in eCTD format
- Cloud based EDMS and eCTD toolsets: How they are changing industry standards for document storage and publishing
- Required eCTD deliverables for US, EU, Japan, and Canada