Apart from the well-documented issues of heartbreak and overconsumption of alcohol, nothing gives a RegOps professsional the year-end blues like scrambing to finish a submission the last week of December. Here are some suggestions for how to avoid the blues this year. (Sorry, you’ll have to work out the heartbreak and alcohol issues elsewhere.)
Avoiding the Year-End Blues
Module 3 Project Management
Module 3 is usually the most complicated part of an eCTD submission for Regulatory Operations. It contains a lot of complex documents, and small companies that may have a medical writing group usually don’t have a similar group for CMC documents. Finalizing CMC documents is often very challenging due to the nature of the documents themselves and the number of parties who have to sign off. Regulatory Operations groups can take a few steps to increase the predictability of this effort, as outlined below.
Strategic Partnerships: A Regulatory Operations Perspective
Strategic partnerships play a big role in today’s biopharmaceutical industry. Most of these partnerships involve a relatively small company with an interesting molecule partnering with a larger company with cash to invest. The partners come together with a shared goal to develop and market a product, but often differences in company cultures, processes, and technology get in the way. Regulatory Operations usually has a few key roles to play in partnerships, including due diligence activities, setting up collaboration platforms, and managing document reviews.
eCTD Submission Project Management
Managing eCTD submission projects involves balancing a complex set of conflicting requirements. The role of Submission Project Manager is often vaguely defined and ends up defaulting to someone in Regulatory Operations, who may be more skilled as a publisher than project manager. While every project is different, there are key elements that will be part of every submission project. The right approach can minimize stress by outlining the process and identifying the key handoff points between functions.
Final Submission QC
Quality Control is an important part of any submission project. While there are many aspects of an overall submission QC program, this post focuses on the final QC process for eCTD submissions that takes place after the submission is published and the publishers have done their QC. This effort is the last chance to catch errors and omissions before submissions go to the agency. I generally refer to this process as Team QC, since it brings all the authors and content owners back to check the submission. A well-designed Final QC process can run through a large submission in 1-2 days.
eCTD Leaf Titles
Leaf titles are an important part of eCTD submissions, but they are rarely considered outside of Regulatory Operations. While authors tend to focus on what their file is called, reviewers look at leaf titles, not file names. Putting meaningful information into leaf titles makes submissions easier to navigate, and makes reviewers’ jobs easier.
The Importance of eCTD Viewers
It’s hard for most people to grasp important eCTD concepts like lifecycle and granularity until they’ve seen them in action. The best way I’ve found to teach these concepts is by using an eCTD viewer. There are a number of viewers on the market, ranging from free desktop applications to large scale web-based viewers. While I have my favorites, any of them will serve to educate authors, project teams, and Regulatory staff about granularity and document lifecycles. I’m not exaggerating when I say that getting a viewer in front of people is probably the best thing you can do to help your company successfully adopt the eCTD.
Study Report Formats
The eCTD allows companies to submit clinical and nonclinical study reports in either legacy or granular format. The legacy format requires assembly of all sections of the report into one document, while the granular format allows each section of the report to stand as a separate document. Most companies submit clinical reports (in m5) using the granular format and nonclinical reports (in m4) using the legacy format. The granular format makes it easier to publish clinical study reports, but it requires planning and coordination between Medical Writing and Regulatory Publishing to achieve those efficiencies.
FDA Fillable Forms
Implementing the FDA’s fillable forms has been challenging for many small companies. While the advantages of using the forms are clear, many companies find the process daunting. Fortunately, there are some easy paths to implementation that do not require large-scale process or system changes.
Responding to FDA Questions
Responding to FDA questions can be a challenge in the eCTD world. Companies often have a goal to respond to questions within a certain time frame. Short turnaround cycles force people to focus on content, and as a result, lifecycle management is often ignored. Over time this can lead to a messy submission with lots of appended information and orphaned responses.
It’s often challenging to figure out best practices under time pressure, so I’ve outlined some strategies to address this situation before it arises.