Regulatory Affairs & Regulatory Operations: The Air Traffic Control Tower of Life Sciences

Is your job in regulatory operations 
similar to that of a control tower operator?
When describing the role of Regulatory Operations I have found that one of the best analogies of their role and responsibilities is to be the “air traffic control tower for interactions between a life sciences organization and a regulatory authority.” By no means is that their only role but it is an essential role that involves constant communication with various parties both internally as well as externally. Regulatory Operations personnel coordinate resources and documentation essential for filing of global applications such as INDs, NDAs, BLAs and MAAs for pharma/biotech organizations and of 510k and PMAs for medical device organizations.
It is often a misconception by many outside of Regulatory Operations that document management is not important for regulatory affairs and electronic submissions because all of the documents used in regulatory submissions are approved long before they make it into a submission but that couldn’t be farther from the truth.  Content generated by various functional areas such as clinical, pharmacology, toxicology, manufacturing and even marketing must all make their way through regulatory operations to be submitted to the appropriately agency for a particular product in order to gain approval.  It can be overwhelming when one contemplates the management of documents coming from multiple functional areas internally (new and revised) and multiply that by product, then by indication, by agency/country and you get a sense of why coordination and transparency can be critical.  Many of those same documents have strict reporting requirements such as safety reports, periodic safety updates and annual reports, to name a few.

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Document management for regulatory operations becomes a task of not only managing versions and revisions of standalone documents but also where and when those documents were submitted to regulatory agencies for various applications.  For example, a clinical study report (CSR) is finalized and with positive results showing that the investigational product is safe and effective and the organization is ready to begin filing marketing applications globally for the approval of the product. This single CSR may be submitted globally to 20+ countries to various regulatory authorities over a 3+ year period, perhaps for one or more different indications.  During this time, as regulatory agencies are revising this document there may be questions requesting clarification on data that may trigger the need for revisions of the original CSR, resulting in new versions being submitted.  The diligent coordination of identifying where this CSR has been submitted, what impact the changes have on the application and if resubmission is required.  The implementation of electronic common technical document (eCTD) format as a standard for regulatory submissions for pharmaceutical and biotech companies has significantly improved their ability to manage the lifecycle of an application to an authority; however, it does not address the question of “where was this document used?"

MasterControl's document management solution provides the
functionality Regulatory Operations requires.

The ideal document management solution for regulatory operations will provide the following functionality:
Document Management of Source Documents
The adoption of eCTD as a standard format for pharmaceutical and biologics marketing applications has enabled organization to implement a standard granularity to documentation utilized in electronic submissions globally.  Organizations such as the Drug Information Associates (DIA) have released recommended configurations for document management systems to organize eCTD documents called the “DIA EDM Reference Model."  This recommended standard is an ideal starting point for the configuration of a document management system and should be adopted as it will speed up implementations and minimize adoption time as it is a common and well known structure.
Submission Compilation Management & Change Notifications
Long before the regulatory electronic submission is ready to be “published” decisions are made as to what content will be used as part of a major application (i.e., IND, NDA, BLA).  Also, it is critical that Regulatory be informed of when critical documents change so that they may plan amendments and updates to applications in a timely manner.  Notification of changes and the ability to choose which documents and who gets notified are essential, as well as the relationship the document has to applications so as to know which applications need updates. The current solution for many companies is to manage this information using Microsoft Excel spreadsheets.
Electronic Submission PDF Rendering
Most document management systems provide PDF rendering capabilities; however, for regulatory, the requirements go a step further than simply generating a PDF.  The PDF renditions of submission documents must adhere to a standard outlined by regulatory agencies such as the FDA “Guidance for Electronic Submissions."
Bulk Exporting Functionality
Whether an organization is publishing submissions in house or outsourcing, the content being published (unless there is an integration) must be bulk exported content out of the document management system and placed onto a file system (or FTP server, if outsourcing submission publishing to an external vendor) in order to place it in a location where the submission publishing tool can then pull in the files for the compilation and electronic publishing of the submission.
Integration Capabilities
For organizations looking to leverage an integration between a document management system and publishing tool, it is critical that the one or both vendors have an integration or have the appropriate connectors (APIs which stand for Application Programming Interface) that will allow for easy access to information being exchanged between the two tools.
Electronic Regulatory Submission and Correspondence Archiving
Once the electronic submission (i.e., eCTD) is published and submitted to the regulatory agency, regulatory maintains a final copy of what is submitted.  This official copy is often referenced and requested by multiple functional areas throughout the organization, which means that having a centralized controlled access electronic copy of the final regulatory archive is efficient and convenient for organizations.  Ideally, the document management should maintain all electronic navigation of the submissions (i.e., external hyperlinks, and index.xml navigation) as well as enable cross-referencing of regulatory agency correspondence and submission mapping to maintain a documentation relationship of all correspondence to and from a regulatory agency regarding an application.

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Patricia Santos-Serrao is a life sciences professional with almost two decades of experience in regulatory affairs and clinical areas of the pharmaceutical industry.  She is currently MasterControl's Market Segment Manager, Global Pharmaceutical, Blood & Biologics.

Prior to joining MasterControl, Patricia held the position of manager, Global Regulatory Safety for QUMAS, a company specializing in quality and compliance management software for life sciences, where she helped drive the development, sales, marketing and implementation of solutions for the R&D areas of the pharmaceuitcal industry with a particularl focus on submission document management for regulatory affairs and clinical trial master files (CTMF) for clinical.

She's worked for several Tier 1 pharmaceutical companies, including Schering-Plough and Boehringer Ingelheim, both in regulatory affairs and clinical.  She has assisted various pharmaceutical, biotechnology and medical device companies in implementing electronic document management and submission solutions, and in compiling electronic common technical documents (eCTDs) and other submission format filings worldwide.  

A graduate of Western Connecticut State University and University of Phoenix, Patricia holds a Bachelor of Science degree in Business Administration. Patricia is a member of the Regulatory Affairs Professional Society (RAPS) and Drug Information Association (DIA). She has also earned her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) and the Regulatory Affairs Certification Board (RACB).