New Age Regulatory Operations:

How the eCTD has Changed Submission Teams

 

In May of this year, regulatory operations leaders will finally begin preparing therapy submissions under one standardized format. The eCTD’s compliance deadlines will force organizations to move completely beyond clerical data formation and into the world of electronic submissions. Major filings submitting New Drug Applications (NDA), Abbreviated NDA’s (ANDA), and Biologics License Applications (BLAs), and Master Files (MF) will be adhering to a deadline of May 5, 2017, while companies submitting Commercial Investigational New Drug Applications will be adhering to a deadline of May 5, 2018. For companies which have continued to submit paper applications, this move could really impact regulatory operations teams – freeing time and energy to focus on other areas of submission management and planning. In addition to expanding the role of regulatory operations, the eCTD’s module requirements and changes may indicate an increase of operations employment.

To learn more about the expanding role of regulatory operations, industry changes resulting from adoption of  eCTD, and the future of regulatory operations and automated submission production, we turned to Craig Gassman. Gassman, Associate Director of Regulatory Operations at Karyopharm Therapeutics, and key speaker at this year’s Regulatory Operations and Submissions Conference, detailed how the upcoming eCTD  use requirement  impact both the role and the management of submission.

Document formatting, structuring and styling have been time-consuming aspects of the regulatory operations field. The eCTD has changed that. Gassman explains, “At a document level, the content is able to be easily structured and formatted using third-party authoring templates. We’re spending less time fighting with document processing software, and more time working on submission management for multiple deliverables over many applications.” The ability to work on multiple submissions at one time allows companies to streamline development and efficiently plan for product launch activities.

The focus on submission efficiency is supporting regulatory operations teams in optimizing their own procedures and ensuring submission workflow, which greatly aids in submission timeline planning. This is expanding the responsibilities of regulatory operations from preparing submissions to analyzing and streamlining business processes within and adjacent to Regulatory departments.

The eCTD mandate will further increase this efficiency and the need for eCTD –familiar professionals to successfully execute submission management, “The benefit of this standardized format is immediately noticeable. But to dutifully transition a company from paper to eCTD format, regulatory operations teams and medical writers must already be familiar with the eCTD module structure coupled with compliant document publishing standards. This ensures that a team can successfully compile, structure, and transmit a submission without a costly transition period.”

 

Furthermore, updated versions of the FDA Module 1 require these experienced professionals to quickly adapt processes to comply with guidance and associated technical conformance guides. Gassman explained that understanding both eCTD format needs and FDA Guidance requirements is a crucial aspect of preparing a team for format updates and changes. In addition to this, vendors must also constantly prepare for upcoming eCTD and regional requirement updates to best serve their clients’ needs.

For organizations which outsource submission building, ensuring that the vendor or service provider has the ability, knowledge, and technology to guarantee compliant, validated submission content. This includes updating eCTD software to adhere to new structural requirements of submissions.

Beyond document changes, the eCTD and modules have expanded the regulatory operations field. Previously, regulatory operations responsibilities had been confined to document preparations which included tedious editing, stylizing, and formatting. With the inclusion of automated eCTD specifications, to Craig Gassman the role has greatly expanded, “Standards put in place have driven regulatory operations to continually evolve both the core and ancillary skillset. Understanding the different types of submissions and individual challenges from a submission planning perspective, especially for special conditions for certain submissions, has largely transitioned the role from submission preparation to submission management. I see many operations teams expanding their scope beyond the classic regulatory operations skillset to better serve organizations from a much deeper, strategic level.”

Therapy submissions can be a long and complicated process, but with the right tools and experienced professionals, this system can be streamlined for any regulatory operations team. The eCTD is optimizing submissions and helping regulatory operations professionals expand their responsibilities and skills. To hear more from Craig Gassman, or learn more about the eCTD, register for the Regulatory Operations and Submissions Conference, May 22-23 in Philadelphia or email marketing@q1productions.com to reserve your space.