Synchrogenix was well represented at DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Forum held earlier this month. One of the reasons RSIDM is such a valuable meeting for Regulatory Operations professionals is because it is so well attended by U.S. FDA staff members who participate both as speakers and fellow attendees. We particularly look forward to the “Ask the Regulators” sessions, where FDA representatives answer questions directly from the attendees. Following are highlights from the ‘Ask the Regulators’ sessions.
Nowadays the word “scan” is a bad word. Scanned documents are more difficult to read and often the quality is lower. Further, scanned documents do not allow search or copy and paste text. During an electronic review, the ability to search and cut and paste text are very useful. Sponsors are reporting more and more rejections if scanned documents are submitted.
If history is any indication, the China Food and Drug Administration’s (CFDA) adoption of eCTD will also outpace anything previously seen at other regional health agencies. Moving to eCTD submissions is just one of many initiatives currently underway in China as part of an effort to reform regulation of the pharmaceutical industry.
The DIA conference most attuned to our segment of the industry returns to the East Coast this year September 22-24 at the Omni Shoreham Hotel in Washington, DC. GlobalSubmit will have a healthy presence at DIA EDM and ERS – exhibiting on the show floor and presenting during a number of educational sessions. We encourage you to visit us at Booth #201 during the conference or schedule a time to meet with the GlobalSubmit team on or off...
Submission publishers face a number of challenges as they perform the day-to-day tasks associated with compiling and inspecting the quality of an eCTD. Innovations in technology are easing the burden in terms of actions publishers must perform manually. Streamlining publishing tasks saves time, effort, resources and in the end, produces a higher-quality submission. Susceptibility to error is a corollary to the number of labor-intensive, manual actions performed by your publishing team. Manual processes also extend the publishing time frame, induce extra effort and require greater resources for quality assurance.