Recent Articles on Preparing Submission Documents
Ross N Raymond, October 22, 2011
The eCTD specifications for electronic submissions include detailed guidance on exactly which specific scientific-regulatory content should be included and where. The XML backbone structure defines this association and helps insure compliance with eCTD specifications during the assembly phase of e-publishing. The result is that an eCTD submission, if compared to a similar filing compliant with the FDA's 1999 Guidance, is comprised of an increased number of smaller, interrelated files.
These changes have impacted the pharmaceutical sponsor's process of authoring, reviewing, editing, approving and ultimately publishing submission-related documents. This article describes required changes to the processes, and examines how these changes may impact the quality of individual documents and the submission as a whole. Solutions to mitigate risks associated with the changes and in order to avoid non-compliance of these complex electronic regulatory filings are also discussed.
Raising the Bar for Regulatory Submission Document Quality: A Collaborative, Transitional Approach – Part 1 of 2
Mauricha Marcussen, January 17, 2011
Regulatory Affairs Operations teams rely heavily upon the Medical Writing Community for the delivery of comprehensive, quality content to be used in various marketing applications. The Medical Writers may be in-house or external, or the documents may have been acquired through a partnership, merger, or acquisition.
Regardless of the quality of the content, there exists a great risk to the success of the overall submissions process when the Microsoft Word documents themselves are improperly formatted or the documents contain unknown formatting issues.
This is the first article in a two-part series exploring the needs of authors, identifying the challenges of the formatting process, and defining the business drivers necessary to support an optimal environment alleviating this potential risk in the submission cycle.
Raising the Bar for Regulatory Submission Document Quality: A Collaborative, Transitional Approach – Part 2 of 2
Mauricha Marcussen, March 21, 2011
Part two of this article focuses on establishing a Quality Control Gateway between the Medical Writing Community and Regulatory Affairs, and positions a plan for how to effectively leverage improvements in the quality process upstream, through reporting, feedback, analysis and understanding of the document quality challenges.
Meeting Agency eCTD Expectations for Efficient Navigation
The move by the FDA, EMA and ICH to eCTD submission implies a faster review process and response, but the added responsibilities and burden of precise formatting guidelines may lengthen the time it takes for a sponsor to author, review and publish a Clinical Study Report and other large submission documents.
Published July 13, 2010.
Consistent Format Leads to Efficient Review
Providing the regulatory authorities with clear, easy to ready, easy to navigate and consistent documents is essential to ensure an efficient review process. In this article Ed Tripp, President of Edward S. Tripp and Associates, details formatting considerations to guide the development of an internal style guide.
Published August 17, 2010.
A Symbols Tale
Don't risk a submission delay due to uncontrolled font use. This tale is based on a true story that cost a company over $40 million in future revenue. Fortunately, now that you are aware of the potential problem you can stop, verify the problem doesn't exist at your company or set in place the plans for corrective action.
Published October 20, 2010.
Managing Content Received from Outside Sources
Pressures from the current economic environment to reduce operational costs and the inability to generate a full product pipeline using only internal sources is driving pharmaceutical companies to re-think their business model and processes. This article provides insights into how internal processes and using metrics improves the quality of submission documents.
Published December 7, 2010