Having spent more than a decade working in compliance, Agnès Keltie knows that she may not always be the first person her colleagues at Norgine relish hearing from. “People often view compliance as an annoying fly buzzing around their face, albeit a necessity,” says Keltie, who works as the compliance manager for global medical affairs at the European specialty pharmaceutical company. “It can sometimes be a lonely and thankless task, but I love the challenge of finding creative ways to adhere to the rules while keeping my stakeholders engaged.”
Tact and influence are key qualities needed to be successful in such a role, and indeed, they came in handy when Keltie was tasked with finding a way to streamline content approvals for Norgine. Through process simplification and new workflows set up in Veeva Vault PromoMats, Norgine was able to reduce its review and approval time while opening new opportunities to scale as the company grows.
Too many cooks in the kitchen
Sometimes old habits are hard to change. The company had been using the same medical, legal, review (MLR) process for decades, and despite evolving European regulations and new engagement tactics such as social media and dynamic content entering the marketing mix, nothing had fundamentally changed. “In some instances, it felt like we were having every member of our staff reviewing documents just because we always did it that way,” recalls Keltie.
Not only did the large number of reviewers slow down approvals and field usage, but it also sometimes led to the team losing sight of what really mattered (i.e., that copy approval is about ensuring compliance with Codes of Practice). “Reviewers would comment on all sorts of things, including personal preferences for colors, word choice, or other stylistic elements, which detracted from the primary reason of copy approval,” says Keltie. “If the law or codes require one person to be responsible for signing off on a document, then we should just have one person weigh in,” noting that the rest can be done much earlier in the process and potentially outside any copy approval system.
Keltie knew that informing some reviewers that their opinion was no longer critical to the copy approval process wasn’t going to be easy. She also knew that the company needed an MLR review tool that would be flexible enough to be configured for different countries, each with its own regional requirements—something that gave Norgine the speed, scale, and intelligence to help take its content to the next level.
New technology, new perspectives
Norgine found its solution in Vault PromoMats. “We wanted a system that was suitable for every country but didn’t have to be overly customized,” says Keltie. “Vault PromoMats gives us the global collaboration and automated audit trails we need, without having to be bolted so tight that every edge case becomes a problem.”
“We wanted a system that was suitable for every country but didn’t have to be overly customized. Vault PromoMats gives us the global collaboration and automated audit trails we need, without having to be bolted so tight that every edge case becomes a problem.” —Agnès Keltie, Compliance Manager, Global Medical Affairs, Norgine
Having the right technology in place was crucial to speeding Norgine’s MLR reviews, but the change management required in implementing the new review process was just as—if not, more—important. “People dislike being told what to do,” says Keltie. “This is where you have to be very tactful, making sure they understand you’re not creating change just to be difficult, but to help everyone work smarter and faster in the end.”
For Keltie, being able to connect with her peers through Veeva’s community forums and chat through common challenges has been particularly helpful during the transition. As an active member of Veeva’s Content Metrics, Compliance, and Content Space communities, Keltie is frequently helping drive the agenda for upcoming meetings and has even led discussions outside of Veeva-facilitated sessions. “These are really great groups of people—everyone is so open and wants to better the way we work, better Veeva products, and work together to share tips, difficulties and knowledge, without judgement,” says Keltie.
Veeva Pulse Content Metrics has also been useful in providing the Norgine team a baseline of content performance across the globe, helping them understand variations by markets across its medicines and medical devices. “We use Veeva Pulse Content Metrics to monitor where we stand compared to the industry benchmark and spot opportunities for improvement,” says Keltie.
Streamlining approvals with a leaner process
Since March 2020, Norgine has rolled out Vault PromoMats to its medical affairs, regulatory, and marketing teams in 11 regions made up of 20 countries and its global functions. With a leaner, more streamlined content approval process supported by Vault PromoMats, these teams have been able to collaborate more effectively and produce content more efficiently.
“I find that being a part of the Veeva community, coupled with the use of Veeva Pulse Content Metrics, is instrumental in shaping the future of our individual and collective efforts to improve the content approval process.” —Agnès Keltie, Compliance Manager, Global Medical Affairs, Norgine
In fact, not only has the company reduced its number of content approvers by 50%, but it has also achieved a review cycle of no more than two rounds per asset, with 82% of assets being approved in one day. “When you consider the fact that we’re producing about 8,000 pieces of content a year, these improvements can make a significant difference,” says Keltie.
For Norgine, the mere fact that it can now objectively measure and benchmark its process performance has been a huge win. While the company has its own internal dashboard it continues to use to report on certain aspects of content production, the industrywide view provided by Veeva Pulse Content Metrics has been critical to understanding and tailoring its approach based on the nuances of various markets.
“I find that being a part of the Veeva community, coupled with the use of Veeva Pulse Content Metrics, is instrumental in shaping the future of our individual and collective efforts to improve the content approval process.”
To learn more about Norgine’s approach to commercial content, read this Q&A with Agnès Keltie and Karen Timmins of Takeda.
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