Live compliance conferences are back! And organizers of the 2022 Pharmaceutical Compliance Congress hit the ground running with an impressive array of industry and government speakers presenting to an audience of eager compliance professionals. The return to some sense of “normalcy” was certainly refreshing as attendees, presenters, and vendors exchanged experiences, anecdotes, and ideas for building more effective compliance programs.
After two years of virtual conferences, this one felt different in terms of content as well, with presenters and audience members discussing, and even debating a range of topics (if you were there, you know all about the discussion around the OIG Special Fraud Alert on Speaker Programs). Below are some comments that stood out in terms of industry lessons, along with my thoughts on what these lessons could mean for your curriculum as you strive to reduce risk with better compliance training.
1. The Lesson: Good enough training is not nearly good enough.
What Was Said: “Having a healthy compliance program is not enough. The Department of Justice has made it clear they expect your program to evolve.”
When It Was Said: Why and How You Can EVOLVE Your Compliance Program
What It Means for Your Curriculum: Your training curriculum must evolve with your program. In fact, the agency’s 2020 Evaluation of Corporate Compliance Programs document is clear when it calls for “more targeted training to enable employees to identify and raise issues,” and it instructs prosecutors to ask, “has the company evaluated the extent to which the training has an impact on employee behavior or operations?” So, how does a busy compliance officer demonstrate that he or she is deploying training that “has an impact on behavior?”
It begins with a continuous learning approach to your curriculum. As I have written in previous posts on this blog, the Ebbinghaus Forgetting Curve demonstrates that learners will forget up to 90% of what they have learned seven days after the event. So, if you’re not continuously evolving by deploying nuggets of compliance training, your chances of demonstrating impactful training when the regulators come calling are dangerously slim. Have you integrated microlearning covering high-risk topics into your curriculum? Are you supporting your field team with just-in-time interactive PDFs and messaging in the field when they need it most?
2. The Lesson: Medical Science Liaisons need to know more than medical affairs.
What Was Said: “Don’t assume people in medical affairs have been trained the right way.”
When It Was Said: A Look at Commercial and Medical Affairs to Understand Changes to An Organization’s Evolving Compliance Needs
What It Means for Your Curriculum: Everyone in your organization, from the top down, including the medical affairs staff, needs to be trained in the rules, polices, and nuances of compliance. Don’t make the mistake of focusing mostly on the field staff.
MSLs, for example, are trained extensively in the science associated with a company’s products and therapeutic areas. However, they need a baseline of knowledge on commercial interactions with HCPs to understand what separates their activities from those of field staff and what defines scientific exchange versus promotion. A more compliant and ethical culture is formed when MSLs and sales representatives understand what divides their roles and what they can expect of one another in their daily business activities.
3. The Lesson: Assess it, build it, test it, repeat.
What Was Said: “Your compliance program needs to be proactive and well-tested.”
When It Was Said: Keynote Enforcement Panel — Stay on the Pulse of Emerging Trends
What It Means for Your Curriculum: It’s not as much what was said, but in which session it was said, that piqued my interest. I’ve heard savvy and respected industry professionals espouse the need for a more proactive approach to compliance for years, but now the regulators have joined the “time for a change” chorus and that should be a signal to the entire industry.
A regularly scheduled curriculum analysis will help ensure your program is viewed as one that is “proactive and well-tested.” We help our clients evaluate where they are in the product development process and what training they’re already delivering on which topics, in what form, and at what frequency. Gaps and redundancies are delineated using our Compliance Curriculum Analysis Tool (CCAT), allowing for opportunities to effectively address any identified risks through a stream of continuous training. It’s a comprehensive process that often reveals surprises in terms of what is and isn’t covered sufficiently. Don’t raise your risk level by assuming you know.
4. The Lesson: Speaker programs, speaker programs, and, did I mention, speaker programs.
What Was Said: A lot, especially about alcohol (more on that later).
When It Was Said: Often, but I will focus on the Oversight and Best Practices for Speaker Programs, HCP Engagement and Sales Interaction session.
What It Means for Your Training: Where do I begin? Not surprisingly, speaker programs were an intended and unintended oft-repeated topic. In the Oversight and Best Practices for Speaker Programs, HCP Engagement and Sales Interaction presentation, presenters offered valuable tips in consideration of the regulatory focus on the programs by corporate integrity agreements and the OIG Special Fraud Alert. As an example, a significant amount of time was spent discussing the necessity for a needs assessment for each program as justification for the topic, speaker, and invitees. And, of course, meals and alcohol were addressed at length, with panelists weighing in on how their companies handle the management of both.
The advent of the pandemic and subsequently, virtual speaker programs, has led the government to raise questions about the need for live programs. And the OIG’s Special Fraud Alert clearly continues to reverberate across the bow of the industry. It’s a hot topic and diligence is needed more than ever to establish justification for the programs, as well as for training on the changing details around the programs. If you have not updated your speaker program training (for field staff as well as HCPs), the newly updated, Managing Speaker Program Risk, from our Compliance Foundations library of off-the-shelf eLearning modules, covers topics like program logistics, virtual programs, speaker criteria, attendee management, and responding to off-label questions. Just send me a note if you’d like to see a demo.
5. The Lesson: Cover the important details but don’t get caught up in the minutia.
What Was Said: “As compliance professionals, it’s a shame we have to spend so much time on whether or not alcohol should be served, when the core purpose should be that you have to run an educational event.”
When It Was Said: Chairperson’s Review of Day 1
What It Means for Your Training: If there was an unintended theme to the conference, it was alcohol (and I am not referring to any activity at the hotel bar). In light of the Special Fraud Alert and recent changes to the PhRMA Code, the presence of alcohol at speaker programs took center stage. It was discussed by presenters and audience members throughout the conference. Do you serve it? Do you allow it? Can attendees bring it in from another room? Can they leave and get a drink? Eventually, multiple presenters emphatically pointed out that attendees are much too focused on this one narrow topic and getting caught up in details like this is a waste of time and energy.
The almost obsessive attention to alcohol did lead one presenter to raise a compelling question though, “How does a company make sure important issues are addressed while not spending too much time on the logistics?” It’s a critical consideration for your curriculum as well, and the secret is in the planning. Taking the time to map your highest risks against the levels and frequency of training is the first step to ensuring that necessary topics are covered appropriately. And, just as importantly, that time and resources are not misspent obsessing over topics that don’t represent a high level of risk for your company.
6. The Lesson: It’s a small world after all.
What Was Said: “We are looking to France and other countries for ideas.”
When It Was Said: Compliance Top 10 — Clear and Concise Overview of the Top Areas of Concern for the Compliance Professional
What It Means for Your Training: If your company does business overseas, training needs to be extended and tracked to those responsible for that business, even if its solely third-party vendors. Do you understand the tenants of regulations like Loi Bertrand (French Sunshine Act) and the EFPIA Disclosure Code? Also, do your global third-party vendors have access to the same training you are utilizing for your employees? Can they access your internal learning management system? If not, you need to find a cost-effective solution like PharmaCertify’s Access LMS.
Even if your company’s business is solely based in the US, you need to have an awareness of global trends. As demonstrated in recent conferences, presenters from US agencies like the DOJ have made it clear they are partnering with other governments to investigate corruption and non-compliance. They’re identifying trends around the world and using those to inform their own activities. Are you doing the same in consideration of your program and your curriculum?
7. The Lesson: Don’t assume people know the basics.
What Was Said: “You have to remember that a lot of people there have not been with a commercial company.”
When It Was Said: Emerging and Small Company
What It Means for Your Training: No matter the size of your company or the nature of its products, an effective and proactive training curriculum begins with an analysis of who needs what training and an awareness of the topic knowledge of your audience. Does your audience have previous experience with the commercial aspects of the business? Are you hiring non-tenured employees? Do they understand the industry as a whole? These are all questions you need to consider.
For example, building a training module around field-based scenarios might seem like an instructionally sound idea in general, but if your learners have been with a pre-commercial company for most, if not all, of their careers, you may want to rethink your approach. A fundamental module covering topics such as the state of the industry, why compliance is everyone’s concern, what employees can say about products in general, and the nature of the company’s relationship with healthcare professionals will ground them in the basics they need to succeed.
8. The Lesson: A values-based approach and data-driven approach are not mutually exclusive.
What Was Said: “Do not strive to have a data-driven compliance program; strive to have a values-driven program supported by data.”
When It Was Said: CCO Innovation Panel
What It Means for Your Training: Perhaps the debate over whether a values-based approach to compliance provides the right level of data to drive an appropriate level of valuable data has reached the point at which we can acknowledge both are possible. The same holds true for training. Yes, learners want and need to know the answers and information they need to compliantly conduct their activities, (e.g., how much can they spend on meals to HCPs). However, having the data to show who has been trained on what concepts and at what frequency is necessary to demonstrate a level of adherence to compliant practices — and frankly — to help you sleep better at night.
I have written on this blog about the successful formula for compliance training:
core + reinforcement + performance support = integration (C+R+PS = I). The first two components of that equation provide ample opportunities to gather the data necessary to demonstrate an effective level of training and steer future training in an even more effective direction. The third component, performance support, which includes tools such as videos on the company intranet, posters, and electronic banners, raises the awareness level of training campaigns with opportunities to communicate the intention behind the training: to foster an overall sense of “doing the right thing,” and “remembering why we are here.”
The First Step Back
Kudos to Informa and the presenters for creating a successful first step back to in-person conferences. The excitement among attendees was palpable and it extended to the exhibit hall as we enjoyed countless opportunities to showcase how we help clients build better compliance training.
If you attended the conference, Dan O’Connor and his panel of industry professionals, presented great examples of how they utilize a continuous approach to training to reduce risk. It, along with some of the other sessions, is still available for conference attendees. If you didn’t attend and would like to see the demos, contact me at firstname.lastname@example.org to schedule a brief meeting.
Thanks for reading. I look forward to seeing you at the next conference!
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