Training Session 2: The second session of this three-part Clinical Regulatory Document Management Compliance Professional (CRDMCP) certificate program will cover the regulatory requirements for the use of Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD), plus implementation best practices and global requirements.
Register now for the entire program at a significant discount!
Learning objectives, key drivers and pain points associated with this session topic:
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
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
This session will be valuable to clinical trials and associated/related personnel looking for a foundational understanding of regulatory requirements, implementation, and best practices surrounding Electronic Document Management Systems (EDMS) And Electronic Common Technical Documents (eCTD). Anyone who needs or wants to be conversant in these areas will find this course highly useful.
Betsy Fallen - Until recently, Betsy was with Merck where she spent several years in the data, regulatory and clinical operations areas. Betsy developed expertise in Essential Document Management, Trial Master Files and eTMF/eISF along with associated metrics as at Merck and on assignment with industry organizations including Metrics Champion Consortium. She is currently engaged with industry standards and best practices organizations such as the SAFE-BioPharma Association and the DIA TMF Reference Model working group. As an RN, Betsy is dedicated to leveraging technology to improve the patient experience as a clinical trial participant.
Dan Orfe - Dan is a Leadership professional with 20+ years experience in Regulatory eSubmission production. Subject matter expert for "cloud-based" eCTD & EDMS solutions and business process analyst for efficient submission assembly, dossier management and eCTD production. He has been a key member of several industry/agency initiatives to foster electronic submission standardization and efficiency. Dan presented or chaired sessions at several DIA Annual Meetings and DIA EDM Conferences. DIA Electronic Document Management (EDM) Conference Co-chair in 2009, 2010 & 2011. Program committee member for the DIA RSIDM Conference. Directed eSubmission production groups at Merck & Co., Inc. and Datafarm Inc.