Did you miss the circuit of promotional review committee (PRC) conferences in late 2016? We had the opportunity to see colleagues and clients and soak in a lot of information at the Exl PRC conferences in both Chicago and New Jersey this year. Here’s a recap of a few hot topics that came up at both forums and some of our key takeaways.
2253 Submissions
In the Misery Loves Company category, the FDA mandate for transitioning to the electronic common technical document (eCTD) format for 2253 submissions was a subject on many attendees’ minds. There was discussion about who has the changeover to eCDT figured out—a few—and how people plan to get there despite the lack of a definitive date from the FDA thus far. Despite the gnashing of teeth, everyone generally agreed that there is a positive side to the new regulation: a single electronic submission will ultimately be easier than paper submissions in triplicate.
Social Media
It’s a whole new world of standard operating procedures (SOPs) as it relates to social media. Life science companies are still tentative when it comes to using social media because of FDA regulations and reporting complexities. Some marketers are simply staying away from these channels since their organizations haven’t yet established SOPs around them, while others are navigating the waters cautiously by creating their own controlled social media environments—proprietary portals for physicians, for example.
Referencing and Claims Compendiums
Many folks don’t have a system for how they load and approve references, but everyone agreed they could use one. Marketers and their teams have processes for managing references, but the processes are not always driven by SOP. The same is true for claims compendiums, which are relatively new. We heard plenty of discussion about who should create and own claims compendiums and how these “living and breathing” documents should be managed.
Responsive vs. Adaptive Websites
We heard multiple conversations about how to handle responsive and adaptive websites in the review process and how to submit them. A responsive website uses a single layout that changes according to the viewer’s screen size, whether a desktop, tablet, or mobile—one layout, so one review. An adaptive website uses a different layout for each screen size—multiple layouts, so multiple reviews. The general consensus was that responsive sites are significantly easier to review, while adaptive sites can be a nightmare because reviewers are forced to review very similar web content several times. For large sites, adaptive design just isn’t practical.
For adaptive sites, it seems most companies are submitting desktop, tablet, and mobile sizes to the FDA. For responsive sites, the general recommendation is to submit one job for review, using one job number to represent all versions of the site. Reviewers use the desktop to review content and tablet/mobile to review layout only since all content is the same.
Creating Efficiencies
Many conversations centered on the general topic of creating greater efficiencies in the long and winding PRC process. Here are some of the consistent subtopics:
- Adapting communications—in other words, the what, how, and when people should communicate
- Providing consistent, formalized training for new employees on PRC and SOPs (not just when a new system initially rolls out)
- Optimizing the roles of Medical/Legal – include them upfront where appropriate to streamline specific projects later in the review cycle
- Establishing when to take content offline and when to escalate
- Obtaining metrics that gauge performance, both in terms of process and content
- Considering the possibility of outsourcing the PRC process and partners who offer those services.
These conferences represent great opportunities to meet like-minded folks from across the industry who are attempting to slay the same marketing operations dragons. Here are some upcoming forums that we think will be worth attending in 2017 for any life sciences marketing operations folks or for those involved in the review process:
- DIA Marketing Pharmaceuticals
- Promotional Review Committee and Client Best Practices (both Chicago and NJ options)
- Food Drug Law Institute (FDLI) Advertising and Promotions
If you’d like to learn more about Pepper Flow, a promotional review platform, and how it can help streamline your promotional review process, contact us at hello@vodori.com.