Welcome to the next installment of our series on using ADDIE to build better compliance training. So far, we’ve discussed how to analyze your training needs, and best practices to apply when approaching the design process. Now we move onto the second D, development, and for this post, we focus on the development of online training (eLearning), though this process can be applied no matter the deliverables.
Once all the groundwork has been completed and you’re ready to start the development process, the five development phases detailed below will help avoid errors along the way and ensure your training meets the expectations you’ve established and the quality your learners deserve. You will notice there is overlap with elements of the design process, but to present development absent this context would be like building a house without referring to the blueprint.
Phase 1: Discovery
It begins with a discovery phase, when you set aside time with all the stakeholders, including management and any potential vendors, to finalize the instructional goals, learning objectives, content scope, and duration of the individual training program. In addition to communicating the overall concepts and designs, this is the time to ensure a comprehensive project plan, with a timeline detailing the completion of all deliverables, is established and approved by all involved in the project.
Phase 2: Outline Development
Before a complete storyboard with narration, on-screen text, and graphic elements is developed, we suggest you create a content outline to list the overarching topics, and, if possible, subtopics. This is the time for the instructional designer to dig into your content source documents and interview your subject matter experts. If you’re working with an outside vendor, look for one that brings a background in instructional design combined with a familiarity with life sciences compliance. Trust me, you don’t want a vendor over-relying on you for compliance expertise when you are busy 8+ hours a day with your day job.
Phase 3: Storyboard Development
The storyboard is a screen-by-screen guide for the programmer and graphic artist to follow when creating the course. Once the initial storyboard is completed, you should have the opportunity to make modifications in “tracked changes” and consult with the instructional designer to resolve any changes you request. Upon completion, you will be asked to “sign off” on the content and give approval to move forward. There should be no surprises or remaining questions for the development team once the storyboard is completed and approved. It should clearly delineate all content and creative requirements for the module, as well as the production notes necessary to guide the decisions made by the developer.
Phase 4: Alpha Course Build
Any reliable vendor or in-house developer should also offer you the opportunity to review an alpha version of the course, without audio added. Think of it as the “rough cut.” During this phase, you’ll ideally review the course, usually on a secure portal, and log comments for anything that looks incorrect or not up to the approach discussed and the specifications in the storyboard. Although there should be no surprises after the storyboard approval, seeing the course in its “close to” final form can sometimes reveal nuances you may have missed earlier. Don’t be afraid to ask for minor changes. It’s why the alpha stage exists.
Phase 5: Beta Course Build
You’re in the homestretch! During the beta build, your team (internal or vendor) will finalize any remaining changes from the alpha review and incorporate any remaining elements, including narration, into the course. You should still expect to review the beta course and request minor changes, but the changes should be rare at this stage. The development team will also conduct a final quality assurance (QA) check upon your final approval, and before the start of the implementation stage…which, by the way, will be the subject for our next post.
Conclusion
The development stage of eLearning development is wrought with the potential for pitfalls and mistakes. Beware the temptations of shortcuts in the schedule and the resources. There are no shortcuts to success and the path to less risk requires numerous checkpoints along the way. Better compliance training demands diligence and by using the process detailed above, you’ll be one step closer to launching training that reduces risk across your company. And who knows, it may even solidify your organizational reputation as a compliance training hero.
For this installment of our series on using the ADDIE model to build better compliance training, I talked to NXLevel’s Senior Art Director, Mike Mandracchia, to get his perspective on the importance of visual design when developing compliance training for the life sciences. Here are the highlights from our discussion.
Why do you think visual design matters for compliance training?
It starts with the learner’s perception. Compliance training isn’t usually something learners look forward to. It’s not like we often hear, “Oh boy, I get to take the compliance training now!” So, we face the challenge of changing their attitude right from the start. And the only way we’re going to do that is to think of visual design as more than just graphics.
It’s how it all comes together. How the on-screen content, the audio narration, and the user interface all align with the graphics in a complete package. It all needs to be visually attractive and easy to digest.
Let’s stay on that idea of “visually attractive.” Do you equate that with a modern approach to design?
I stay away from a term like “modern,” and I try to stick to classic, established concepts of design. That begins with a clean and timeless look. You can look at design from any era and know whether it’s good or not. The year, or even the decade, it was created doesn’t matter. Good design is good design, and we don’t want to run the risk of chasing fads or trends.
You led the push for the use of illustrated characters instead of stock photos or even custom-produced photos in NXLevel’s Compliance Foundations off-the-shelf eLearning courses. Why?
Multiple reasons. From a look and feel standpoint, they add more personality. The characters we use give the training a more light-hearted look, which goes back to my previous point about changing the perception of compliance training. I also recommend the use of illustrated characters because of the flexibility. It’s so much easier to find images that support the key messages and modifying them to fit the content is much simpler.
Stock photos are limited and frankly, they look like stock photos. As for custom photography, that can be expensive and is often not reusable. Illustrated images are more affordable, and you can change anything. And you can make your characters as diverse as the learners that are going to take the training.
Let’s talk about that diversity. How do you address diversity when you are designing a course?
Diversity is about the total human experience. That includes gender, ethnicity, physical appearance, religion, physical abilities, etc. It’s important that people see themselves in the training they take, and that extends to making sure the training reflects their own company too. It’s our job to research details about the company. What is the dress code? What do their buildings look like? The training should look like it came from their company. And that’s easy to modify with illustrations, whether we are customizing our off-the-shelf courses or creating custom training from the ground up.
How do you go about creating the visual design for a training deliverable?
It involves us (me and my design colleagues) working with everyone on the team, from the project managers to the instructional designers and developers and the client. There’s a reason our graphic artists are often part of on-going client meetings. I need to understand the details and regularly talk to the ID and development team to understand the goals of the project, the audience, how the content is going to be organized…whether it’s an electronic course or a workshop. It all helps me think about the learner’s experience.
What should people avoid when designing compliance training?
Well, this isn’t as much about what they should avoid as much as what they should think about. That gets back to your last question. It really matters how the content is presented. Sometimes, less is more. Cramming too much content and too many graphics into the program is a problem. That’s just going to disengage the learner and the training won’t stick.
Your point gets back to the idea of respecting the learner, doesn’t it?
Yes. It also gets back to our conversation about the use of illustrated characters instead of stock photos. The context is more meaningful when the images reflect the reality of their world. Think about it. No one is ever going to be fooled into thinking the stock photos they see in a training course are people from their company. And that’s fine. But, when we use illustrations, we can easily modify the broader details to align with the learners’ reality. For example, if we need a scene with a sales representative meeting with a healthcare professional in a specific type of office setting, we can do that easily and quickly. That type of context is less limiting and pulls the learners into the training. And the more they relate to it, the more they are engaged with it, and the more they will retain. Our goal is to remain as true as possible to that reality and to the content and always value the learner.
If you are interested in seeing some more of the visual design work Mike and his team have created, contact us at info@nxlevelsolutions.com and we’ll be happy to share some examples. Meanwhile, our next blog post turns to the I in ADDIE – Implementation. How you implement your training plan is as important as the plan itself.
This is the second post in a series about using the ADDIE learning model as a framework for building a better compliance training curriculum.
In our last post, we began with the first step in the ADDIE model, A (Analyze), and explored a way to analyze your compliance training needs so you can obtain a clear picture of those needs. The result was a list of the activities your employees engage in that contain some form of compliance risk, with columns indicating the risk level and frequency of each activity for each employee group. For example:
With this information in hand, it’s time to move on to the first D in the ADDIE model – Design. Now that you have identified your training needs, how are you going to meet them? How do you decide whether to create eLearning modules, live workshops, microlearning, performance support tools, etc.?
Several factors should help drive your design decisions.
Activity Risk
Make sure you address high-level risks first. This doesn’t necessarily mean all high-level risks need to receive the same level of resources or attention (other factors are at play), but it does mean that you need to implement a solution that properly addresses each high-level risk activity.
Select the chart to see examples of how various activities might be mapped in terms of risk and frequency.
Activity Frequency
Employees who perform an activity more frequently will tend to remember the steps involved (and the associated compliance guidance), while the opposite will be true of those activities performed less frequently.
For example, sales representatives may call on doctors almost every day. It’s a high-risk activity, but repetition breeds familiarity. However, the same sales representatives may only occasionally plan and host a speaker program. So, a quick reference guide or refresher training to remind them of their responsibilities would be helpful.
Regardless of the frequency of an activity, all learners benefit from a training solution that includes spaced reinforcement and that does not rely on just one crowded learning event. But for less frequent activities, reinforcement and reference materials are even more critical.
Learner Characteristics
Also take into account the characteristics of your learners. Think about these questions:
How many people engage in each activity? Some training modalities, like live workshops and coaching, are well suited for smaller populations but may not be practical for larger groups.
How many groups engage in the same activity? Are there groups who can receive the same training on a topic?
What are your learners’ levels of experience? Foundational training may be more important for new learners, whereas experienced learners may need more reinforcement or training that goes deeper into specific issues.
Where are your learners located? In-person training events may not be an option for a dispersed group.
Other Considerations
Here’s a quick review of other factors to consider.
Which activities can be addressed through common solutions? For example, can all transfers of value and transparency concerns be addressed through a single learning solution?
How stable is the subject matter? Are regulations, policies, or practices changing soon? You may want to hold off on an elaborate learning solution until the dust settles.
What resources do you have available? What’s your training budget? How many employees can you dedicate to training initiatives? Some solutions will be more practical and economical than others.
DOJ Recommendations
As you consider your choices, don’t forget to review the training recommendations found in the US Department of Justice’s Evaluation of Corporate Compliance Programs. Along with recommending timely, periodic, risk-based training that is appropriately tailored, the guidance notes that “Other companies have invested in shorter, more targeted training sessions to enable employees to timely identify and raise issues to appropriate compliance, internal audit, or other risk management functions.”
Possible Solutions
Weighing all the factors discussed above should help you narrow down the approaches that would help you best meet your learners’ training needs.
For example, low-risk, low-frequency activities might be best addressed by requiring learners to read the relevant policy and electronically sign an attestation. You can also provide job aids and other performance support tools learners can reference at the point of need, ie, when they are about to engage in the activity.
The Compliance Foundations eLearning module, Compliant Product Promotion, is a great starting point for all sales employees.
Likewise, when training on a high-risk activity, consider blending core training with reinforcement and performance support tools. For example, you could deploy a foundational eLearning module on promotional interactions for all sales employees, supplemented by live Q&A sessions for individual brand teams and micro-learning videos that periodically reinforce of key risks.
And don’t forget the value of communication. Website banners, short emails, and physical posters can all be used to remind employees of important principles and practices.
No Matter the Solution, Follow Good ID
Once you settle on a specific solution, remember to follow sound instructional design principles. Focus on the learning objectives, ie, what people need to know and be able to do, rather than chunks of content. Remember the goal is not to turn your employees into junior compliance experts; it’s to help them perform their jobs in compliance with your company’s policies and procedures and thereby reduce your company’s compliance risk. If nothing else, put yourselves in the learner’s shoes as you make your design decisions.
Conclusion
While this post merely scratches the surface, we hope it’s given you some practical design considerations to think about when creating or refreshing your compliance training curriculum.
In our next post, we’re going to stay with the topic of design a little longer, but this time we’ll discuss visual design and the role it plays in creating effective learning experiences.
This is the first post in our series on using the ADDIE learning model as a framework for building a better compliance training curriculum. We begin with the A (Analysis) stage of the model as a first step for creating or refreshing a curriculum.
With so many compliance concerns piling up in your inbox, it can be hard to take the time to pause and analyze your training needs without rushing towards solutions. But until you have a clear picture of your needs, how can you be sure the solutions you are deploying really address them?
Whether you are creating your company’s first compliance training plan or working with a mature plan that has evolved over time, don’t skimp on the analysis. Otherwise, you risk creating a convoluted curriculum with redundancies, gaps, and an uneven emphasis on content over risk. And while analysis is an ongoing task, taking the time to conduct a formal analysis that looks at the big picture and gives you a foundation to build (or rebuild) from is important.
Start with the Risks
One way to begin your analysis is to list all of the activities your employees engage in that contain some form of compliance risk. After all, if your ultimate goal is to reduce risk, why not put those risks front and center in your planning?
We’re all familiar with the annual risk assessments that virtually all life science companies perform. They provide an overview of macro areas of risk and are therefore good overall guidance for compliance professionals. However, it is important to also consider the “risks within the risks.” The key here is to be granular enough so that you build an informative picture of the risks your company faces – one that gives you the flexibility to address risks that apply to different audiences, in different ways, and at different frequencies.
For example, to simply list “speaker programs” as a risk glosses over the individual activities involved in a speaker program that expose different people to various types, levels, and frequencies of risk. These could include speaker selection, attendee tracking, program meals, and the handling off-label questions.
Identify Your Learners
Next, it’s time to identify the groups of individuals who are potentially exposed to the risks you have listed. You could create these groups as columns that bisect your rows of risk activities. Again, it’s important to achieve the right level of specificity. Under the commercial umbrella, for example, you’ll want to break out field sales, sales operations, marketing, etc. so you can recognize the different needs for each function.
Add Risk Levels and Frequency
Not all risks are created equal; nor do they occur with the same frequency for the same groups of employees. It’s important to recognize both of these factors when analyzing your training needs.
The value of distinguishing activities that present higher levels of risk is obvious, but frequency is just as important. Someone who engages in a high-risk activity on a frequent basis has a different learning need than someone who engages in the same activity on a less frequent basis.
Since risk level and frequency can vary for each learner group, you can further divide your columns and assign risk levels and frequency, as shown in this example.
Next Step: Design
Completing the activity described above is not necessarily a quick and easy task, and you may need input from others to ensure its completeness and accuracy, but it’s a critical first step toward designing (or redesigning) a better compliance training curriculum to help you reduce risk across your company. And that will be the topic of our next blog post as we move on to the D in the ADDIE model, Design.
In the meantime, if you’d like a complimentary template of the spreadsheet described in this post, which we call the Compliance Curriculum Analysis Tool (CCAT), email us at info@pharmacertify.com. We’ll be happy to show you the tool and ideas on how to use it.
Inthis week’s post, Dave Correale, a Senior Instructional Designer at NXLevel Solutions, introduces a new blog series on using the ADDIE model to help build a better compliance training curriculum.
Now that the relatives have gone home, the ill-advised presents have been returned, and the eggnog in the back of the fridge has spoiled, it’s time to consider a New Year’s resolution to refresh and revive your compliance training strategy.
But getting your arms around your compliance training needs and developing a plan to address them can seem overwhelming. One tool that can help is the ADDIE model. In the training industry, we use ADDIE as a model for developing individual training solutions, but it can also be an effective tool for organizing your approach to a broader training strategy. Over the next several blog posts, we’ll use the ADDIE model as a framework for helping you build a compliance training plan worth celebrating.
Analysis – In this post, we’ll provide practical tips on how you can identify and prioritize your training needs. There are a lot of factors to consider, and we’ll discuss concepts and tools you can use to bring order out of the chaos.
Design – This post will be a two-parter. In Part 1, we’ll look at instructional design and how to design solutions to meet the training needs identified in the analysis stage. How do you choose whether to create eLearning modules, live workshops, microlearning, performance support tools, etc.?
In Part 2, we’ll discuss visual design and the role it plays in creating effective learning experiences. Do your training solutions look generic, or do they reflect your organization’s culture? Do your visual choices support or distract from your learning objectives?
Development – After design, it’s time to develop. But what do you develop first? And do you build it in-house or use a vendor? Is there an off-the-shelf solution you could use? Do you have existing assets that just need a refresh? We’ll explore the thought process that goes into deciding how to best use the resources you have available.
Implementation – How you implement your training plan is as important as the plan itself. Planning, timing, communication, support from the business, and getting the most out of your available learning platforms are just some of the elements we’ll examine in this post.
Evaluation – Finally, how effective is your compliance training? How can you tell? This post explores ways to determine whether your training is having an impact.
So, clean out the fridge, put the decorations away, and stay tuned for more tips on how to reduce risk through better compliance training.
Welcome to my third post on the 23rd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress. Through these posts, I have been reviewing some of the key topics covered during the conference and providing my reactions, as well as related tips and suggestions for creating better a compliance training curriculum.
This week, I touch on key points raised concerning the special relationship between field medical and commercial teams, and the training needs created by that relationship. Spoiler alert: the more things change, the more your sales representatives need to understand the role of your medical team.
Ghosts of Conferences Past
In past years, presenters at compliance congresses would be quick to emphasize the need to draw a hard line between the actions of medical and commercial personnel. Medical was siloed into the communication of science, and product promotion was left to the commercial team — and never the twain shall meet … well, except for the joint interactions during which their separate permissible actions were clearly delineated.
The safest path was to ensure the actions of the medical team were laser-focused on science and external interactions only occurred at the request of healthcare professionals. And the easiest (and most straight-forward) path to compliance by both teams was through role-based training that made clear the appropriate actions for each –‘Sales reps, you can do this, and MSLs, you can do that’ (and vice versa).
Ghosts of Conferences Present
Well, in recent years, “the times, they are a changing.” As presenters in the Medical Affairs Today: Managing Evolving Risks session and the Recent Federal and State Enforcement Actions session noted, a shift is underway in the industry. Now some medical personnel are quicker to proactively provide information to HCPs, rather than just in response to a medical information request. Or, as it was said in the Recent Federal and State Enforcement Actions session, “Companies are shifting to a patient-centric focus, and that’s creating a sense of one company … that’s causing us to see a lot of creative ideas by medical, which poses some challenges.”
In terms of enforcement, one could understand why the industry would be lulled into a false sense of security. After all, recent corporate integrity agreements have hardly focused on the relationship between commercial and medical. But, as was highlighted in the Recent Federal and State Enforcement Actions session, some recent CIAs do include provisions relating to that relationship and the sharing of information. In addition, enforcement actions are typically lagging in nature, and settlements follow a few years after the actual conduct.
Promotion is Promotion, No Matter the Source
Presenters in both sessions made clear that the government doesn’t care what your role is. While collaboration across the two groups can have the noblest of intentions, sales reps and medical personnel must consider the potential risks of their actions. Guardrails are needed from the outset and the mistaken belief that the medical team’s actions and words cannot be interpreted as promotional just because of their job titles must be exposed for the dangerous fallacy that it is. To borrow a phrase from the Medical Affairs Today session, the medical team “cannot be driving towards promotional claims and they cannot be salesy.” Both teams need to be reminded of this on a regular basis through a multitude of touchpoints throughout their schedules – in other words, through continuous reinforcement and performance support.
Take the Role-Based Fork in the Road Carefully
By now, you may be asking how you should adjust your medical personnel’s compliance training in response to this industry shift, but that should not be your only concern. The training plan for your commercial team may need to be evaluated and modified as well. More than ever, sales representatives must understand the role of medical personnel, and what medical personnel are and are not permitted to do during joint interactions with HCPs.
An effective and modern commercial training plan includes a broad understanding and overview of the field medical role. Do your reps understand the role of field medical personnel? Are they continuously reminded of the need to keep the medical and commercial roles distinct? To appropriately prepare sales reps for their interactions with HCPs, their training should cover the need for the field medical role, its purpose, examples of typical field medical activities, and the principles behind them.
Joint Interactions Need Joint Training
Presenters in the Medical Affairs Today session touched on the need for collaboration between medical and commercial and the number of situations where their paths can cross, including HCP introductions, payor communications, speaker programs, and medical congresses. These interactions are filled with risk, so the divide between the two roles, and how each team can navigate that divide needs to be emphasized continuously in training.
Foundational training on joint interactions doesn’t need to be divided into multiple modules to effectively cover the requirements of each team. A successful collaboration demands the sharing of knowledge that can only be achieved through a collaborative training initiative.
On the reinforcement front, opportunities to remind those involved in joint interactions abound. For example, shortly before the start of a conference, you could deploy a microlearning that covers the rules for commercial vs. medical/scientific booths. Or a virtual live JEOPARDY game, for example, can be populated with questions related to HCP/MSL introductions, senior-level interactions, and interactions with payors. (By the way, we offer the only officially licensed JEOPARDY™ game on the market. It’s cool, it’s a great learning tool, and it’s easily customized with your content. Visit our website for a demo.)
Finally, it’s not all about interactions with HCPs. Both teams should be regularly reminded of the guardrails around internal interactions, too (eg, medical is not permitted to share an HCP’s response to an off-label question with commercial).
Summary
While the perception of the field medical role may be changing, the need to educate both your medical and commercial teams about each other’s purpose and functions has not.
The end of the year is a good time to re-evaluate your training plan to ensure your commercial and field medical curricula feature the foundational training, reinforcement solutions, and performance support tools necessary to establish and maintain a sense of compliance across both teams. If you’d like to see demos of the custom and off-the-shelf training courses we have helped your peers deploy in the life sciences industry, please contact us at info@pharmacertify.com.
Thanks for reading! Happy holidays and best wishes for an even more compliant 2023!
Welcome to the second post reflecting on the 23rd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress. In each post, I review some of the key topics covered during the conference and provide my reactions, as well as related tips and suggestions for maximizing the effectiveness of your compliance training curriculum.
This time around I delve into the ever popular (and somewhat confusing) topic of social media and, in particular, the session titled, MINI SUMMIT 5: Social Media — Auditing and Monitoring to Promote Compliance in this Rapidly Evolving Landscape.
If you attended the conference and missed this session, it’s worth the time to watch it online. And don’t be fooled by the title, the discussion wasn’t limited to auditing and monitoring. Training was mentioned early and often. Here are some of the key ideas shared during the session:
Follow the FDA (and the FTC)
The tone of the presentation, as well as the industry’s attitude towards social media, was best summarized with this quote from one speaker, “In some respects social media is heavily regulated, and … it’s the wild, wild west.” The rules and regulations are evolving and still somewhat undefined, but the risks continue to grow.
The presenters emphasized that the FDA’s regulations related to product promotion also apply to social media (staying on-label, not making unsubstantiated claims, avoiding promotional claims without risk information, etc.). The FTC has also issued a series of guidance documents on social media. Subsequently, the social media ground rules and principles established by both agencies need to be incorporated into your curriculum. Employing a continuous learning approach, with reinforcement solutions and performance tools blended into your plan, is the most effective way to ensure your team remembers and applies those rules and principles.
For example, you could deploy a foundational training module that covers your social media policy and then later follow up with a scenario-based microlearning module that specifically focuses on the proper way to respond when encountering product misinformation online. In terms of performance support, intranet banners and strategically placed posters are also a great way to consistently reinforce important tips and reminders.
Influencing the Influencers
The FTC’s guidance documents also cover the increasing use of social media influencers. According to the presenters, the FTC is particularly focused on “establishing a connection between the advertising and the influencer.” The agency has even established a preferred list of hashtags to help influencers identify themselves as paid spokespersons (#sponsored, #ad, #paid).
What does it mean for your social media training? You need to consider external as well as internal audiences, including any potential influencers involved in the promotion of your products on platforms such as Twitter and Instagram. Who is training your influencers? How often do they receive training? What form of training do they receive? How is it being tracked? You’ll sleep better if you have deployed on-going training that emphasizes compliant behavior to those in a position to influence the promotion of your products.
The Same Rules Apply to MSLs, Executives, and Outside Agencies, Too
The presenters often cited the distinction between promotional social media posts and those related to corporate communications. Each type follows a different set of rules. This difference does not depend on one’s job role, but rather the nature of the post itself. Whether an individual is part of the medical team, the C-suite, or even with an outside agency, that does not give them carte blanche to post content without regard to the rules.
Once again, it is important to evaluate your training audiences inside and outside your organization. What are the risks? Do the same risks apply across the board? Should all topics be covered at the same frequency? Are you making any risky assumptions based on job titles? Such audience/risk analysis is the starting point for effective social media training and a compliance training curriculum in general.
The More Examples, the Better
One of the more interesting comments in the session centered on the potential risks of training itself. One presenter said, “We did so much training, it actually scared the staff.” She continued by saying the training they deployed was generic in nature and lacked the specificity and examples necessary to make it stick. In her company’s case, they made the training more effective by adding examples of what employees can and can’t like or share. That’s an excellent idea that could be further enhanced by examining the training deployment calendar.
For instance, you could create a “training series” in which the foundational training establishes the “what” and “why” of your social media policy, and follow-up with microlearning, games, mini assessments and other learning nuggets that focus on specific social media examples. When training is spaced across a learner’s timeline, learning has been scientifically proven to increase and the retention of those examples will grow.
In addition, workshops and training games offer more opportunities to reinforce the good and bad of social media activity. When deployed live or virtually, the sessions foster a dialogue in which examples can be discussed and participants can cite their own examples of what they have seen online.
Summary
At the start of this mini summit, presenters referred to a quote by the former director of the Office of Prescription Drug Promotion, Tom Abrams, “It’s the message and not the medium, so we expect the same regulations to apply to social media…” Platforms will change and evolve, but the messages your learners post, like, or share need to adhere to the good foundational compliance practices the government, HCPs, and patients expect.
Thanks for reading! If you’d like to see examples of foundational or reinforcement training solutions to address the risks of tricky subjects such as social media, contact us at info@pharmacertify.com to speak to one of our compliance training specialists.
Sean Murphy Product and Marketing Manager PharmaCertify
Part 1: Off-the-Shelf Training: The Good, the Bad, and How to Spot the Difference
The PharmaCertify team stands ready to greet friends and clients in the Exhibit Hall at PCF’s Compliance Congress!
Welcome to the first of several posts reflecting on the 23rd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress. In each post, I will review some of the key topics covered during the conference and provide my reactions, as well as related tips and suggestions for maximizing the effectiveness of your training curriculum. After all, helping you roll out better life sciences compliance training is the aim of this blog, and it’s our mission at PharmaCertify.
I often find sessions focused on emerging, or early-stage, companies to be compelling because smaller companies face the same risks as their larger counterparts, but with smaller budgets and fewer resources. That’s why two sessions from this year’s conference caught my attention – Mini Summit 9: Compliance & Ethics in Emerging Companies, and Mini Summit 14: General Corporate Compliance in an Early-Stage Company and Shared Learnings for Larger Companies.
Neither session disappointed, as presenters detailed their experiences in overcoming the challenges smaller companies face (e.g., the techniques necessary to gain buy-in and resources from leadership, and the need for “ruthless prioritization” to determine which tasks to tackle first).
While I was pleasantly surprised to hear much of the conversation during Mini Summit 14 to be focused on training, I was dismayed to hear about most of the presenters’ poor experiences with off-the-shelf training solutions. As a result, many were quick to dismiss off-the-shelf eLearning as “too generic to be effective,” or, “not current enough to be relevant.”
The sad truth is there is a fair share of bad off-the-shelf training available to the life sciences industry. And there is no better way to torpedo the effectiveness of training than to roll out outdated training with generic content that is not targeted to your learners. But dismissing off-the-shelf training as ineffective or a waste of money overlooks the advantages of high-quality (and customizable) off-the-shelf training for emerging and early-stage companies.
Let’s review some of the comments from the session:
“We were used to seeing off-the-shelf training that looked like it was created in 1992.”
If a training vendor’s demos look like they were created 30 years ago, run (don’t walk) away immediately. Content and design age quickly, and learners evolve. Training, whether custom-built or off-the-shelf, needs to evolve with them to capture their attention and enhance learning results.
Visual design matters and plays a critical role in making learning memorable. Quality training uses a modern and fresh visual design. Beware of the tell-tale signs of poor design, such as the overuse of trite stock photos to portray sales representatives and healthcare professionals. (I call that the “shiny, happy doctor look.”)
“Totally generic training just doesn’t resonate.”
Look for training that is targeted to the life sciences industry and customizable to your company’s culture and its risks. Just do an Internet search for “pharmaceutical (or medical device) compliance training,” and you’ll find plenty of options. Considering today’s eLearning development tools, customization doesn’t need to be cumbersome or expensive. Ask vendors about the process for modifying their modules. Can they be easily branded with your logo? Can you add role-specific scenarios? Is it easy to add your policies and contact information? Look for training that is instructionally designed for seamless and easy customization. “Generic” should never be necessary, no matter how the term is defined.
“You can use off-the-shelf at large companies, but it doesn’t work at smaller companies.”
This caught my attention because it’s not what I have heard over the last 15 years. As mentioned above, emerging companies face the same risks as their larger counterparts – but with smaller budgets and fewer resources.
Off-the-shelf training, when priced on a per-learner basis, offers an affordable alternative to custom solutions when a company has a smaller number of learners. Even in situations with larger numbers of learners, off-the-shelf training may be more affordable – and it’s far less time-intensive for compliance officers to implement. And quality does not have to be sacrificed. So, if your field force is still small, and you need to train them on the risks associated with HCP interactions, a targeted off-the-shelf training module may be the right fit.
Summary
The Interactions with Healthcare Professionals customizable off-the-shelf eLearning Module
Don’t give up. There is effective compliance training out there for life sciences companies. And effective off-the-shelf training works just as well for emerging companies as it does for more established companies. Most importantly, effective off-the-shelf training has the power to help you reduce risk across your company, especially when it is blended with reinforcement microlearning, live workshops, targeted communications, and other components in a continuous flow of learning for your employees.
If you’d like to see demos of effective life sciences compliance training, including our Compliance Foundations off-the-shelf library, contact us at info@pharmacertify.com to speak to our team.
Thanks for reading!
Sean Murphy Product and Marketing Manager PharmaCertify
At PharmaCertify, our mission is to help you reduce risk through better compliance training. The mission of this blog is to provide you with a continuous flow of information to assist you in doing just that. To that end, I have reviewed the agenda for the upcoming Pharmaceutical and Medical Device Ethics and Compliance Congress (October 24-25 in Washington DC) with an eye toward the sessions I believe (and hope) are most likely to offer tips and suggestions to make your training curriculum more effective.
First, a disclaimer: while I know, or at least know of, many of the conference presenters, I am not familiar with the details of their presentations, or to what level they plan to address training. That said, here are the sessions I would put at the top of the list for helping you create better compliance training.
Day 1: Monday, October 24, 2022
9:00 am, MINI SUMMIT 3: New Product Launch Compliance Playbook For anyone prepping for a product launch, this looks like a can’t miss presentation. (Coincidentally, we recently posted a “Dear Connie the Compliance Training Director” article on this blog with ideas for how to cover the topics necessary to prepare a field team for a launch.) Terra Buckley, who heads up the Compliance Advisory Services team at MedPro, will be joined by Ann Beasley, Chief Compliance Officer at Zai Laboratory. Their combined industry experience and depth of knowledge is sure to make for a session chock full of the content you need to quell the product-launch training jitters.
9:00 am, MINI SUMMIT 4: You Finished Your Risk Assessment…Now What? Practical Approaches to Making Your Results Meaningful They had me at risk assessment. As followers of this blog can attest, we at PharmaCertify are advocates for designing a training curriculum based on risk. We utilize a process we call the compliance curriculum analysis process (CCAP) to help design a targeted training plan. So, you can see why I am intrigued by the title of this session, since it aligns with our approach. Here’s hoping Christie Camelio of EQRx, Olga Zinavenka from Endo International, and BJ D’Avella, of Paul Hastings delve into the training considerations following a risk assessment.
10:00 am, MINI SUMMIT 5: Social Media — Auditing and Monitoring to Promote Compliance in this Rapidly Evolving Landscape Here’s an anecdotal side note related to social media that highlights why I think this session should be a priority for anyone looking to optimize a compliance training curriculum: I was asked to review client changes to the storyboard for our Compliant Product Promotion eLearning module. The client added a comment on the social media screen of the document noting that her company’s policy does not allow for any product-related posts, even if they are on-label and truthful. Therein lies the problem.
The rules, policies, guidance, and best practices for the use of social media in this industry are constantly changing. You need to keep abreast of those changes and regularly consider how they should be integrated into your own policies, and subsequently, your training curriculum. Stephanie Kurteff of Medicines360, Nikki Reeves from King & Spalding, and Ed Sleeper, who is with HUTCHMED, will present.
11:00 am, MINI SUMMIT 8: New and Emerging Risks for Medical Device Medical device is in the house! Settlements are on the rise for the medical device industry, and compliance professionals facing the unique risks that accompany the promotion of devices would be wise to join Beth Weinman of Ropes & Gray, Sujata Dayal from Medline Industries, and Katherine Norris of Epsilon Life Sciences for their take on the new risks. If medical devices are your focus, and you want to know what you might be missing in your curriculum, you need to attend this one.
11:00 am, MINI SUMMIT 9: Compliance & Ethics in Emerging Companies I generally find the sessions focused on the risks facing emerging companies to be among the most valuable from a training standpoint. Compliance professionals from smaller companies face the same challenges as their colleagues from larger companies, with smaller budgets and fewer resources at their disposal. If the “emerging company” shoe figuratively fits your foot, I’m confident you will find the discussion with Kevin Ma from PharmaEssentia, Kristen Oberg from Mycovia Pharmaceuticals, and David Ryan of Epizyme to be helpful, especially (fingers crossed) if they include their suggestions for building effective training with what some might consider a shoestring budget.
1:30 pm, Keynote: US HHS Office of Inspector General Update If you’ve attended this conference over the years, you won’t be surprised that I’ve added this annual session by Mary Riordan of the OIG to my list. In fact, if I was writing this post by order of priority instead of chronologically, the session would be at the top of the list. Hearing the agency’s workplan for the upcoming year is a great starting point for anyone interested in knowing what topics should be targeted for training. Make it a priority.
Stop by the PharmaCertify booth in the Exhibit Hall to see examples of how we can help you be a compliance training hero!
5:45 pm, ADJOURNMENT AND NETWORKING RECEPTION: EXHIBIT HALL It’s been years since we’ve seen you in the Exhibit Hall! Don’t worry, I blame COVID, not you. But seriously, the reception is one of the best opportunities to mingle with your peers and share success stories for building and maintaining a successful compliance program. It’s also a great time to visit the wonderful vendors and learn the ways they can help you do just that.
The PharmaCertify team will be there (we’ve even got some surprise guests this year), with demos of the foundational, reinforcement, and performance support tools to help you launch better training. Even if it’s just to say hi, stop by the booth! We’re a friendly bunch.
Day 2: Tuesday, October 25, 2022
8:00 am, MINI SUMMIT 13: General Corporate Compliance in an Early-Stage Company and Shared Learnings for Larger Companies We may have a winner for the best session name for the conference, or at least the most audience-inclusive name. I have to say I am intrigued by the idea of carrying concepts from early-stage companies over to larger companies. While some challenges and risks are shared, some faced in early stages of product development are part in parcel to the limited resources to which they have access. The panel for this session is large and wide-ranging in terms of company size. It includes Rachel Batykefer from Mallinckrodt Pharmaceuticals, David Falcone from Merz Aesthetics, Andrea Kocharyan from Flagship Pioneering, Kirt Kraeuter from Moderna, Rachel Lei of Aldevron, and Kirsten Liston from Rethink Compliance.
9:00 am, MINI SUMMIT 17: The Evolving Transparency Reporting Landscape: Changes in 2022 and Preparing for 2023 I’m thrilled to see transparency reporting on the agenda. For context, we just revised the Compliance Foundations module, Raising Awareness of Global Transparency, and I can understand why the advent of new laws around the world make this a challenging topic for training. Determining who needs to know what, about which law, can be a challenging starting point. Our module covers the general concepts from a high-level, and includes a select list of laws, both established and new. We also include PDF documents related to the other laws in a “resources” section.
Okay, back to the session. Expect Kelly Tope of Takeda and Chelsea Ott from MedPro Systems to cover the relevant regulations in detail and jumpstart your thinking toward an effective approach to transparency training.
11:00 am, MINI SUMMIT 27: Practical Guidance for Building Better Compliance Training DO NOT MISS THIS ONE! You may think I am biased because the head of PharmaCertify, Dan O’Connor, is leading the panel, but I’ve seen the presentation slides and I am quite familiar with the training samples. Trust me when I say you want to be there. Dan will be joined by Madelyn Archibald of Bioventus, Ryan Bonistalli of Ultragenyx, and Jackie Parris from Incyte, who will share their experiences in designing, developing, and deploying better compliance training.
1:30 pm, CLOSING PLENARY SESSION: US Department of Justice Keynote, FDA Keynote, and AUSA Roundtable The presentations by current and former government representatives are usually worthwhile because the presenters offer a drastically different perspective than industry professionals. The experience and insights from this group are sure to be of value as they share their expectations for an effective program, and subsequently, a training curriculum.
The Department of Justice keynote, with Fraud Section Chief Glenn Leon, the FDA keynote with Acting Director Catherine Gray, and the AUSA Roundtable with Kelly Begg Lawrence from the District of Massachusetts, Jamie Yavelberg from the Civil Division of the DOJ, and Michael Loucks, of Skadden, Arps, Slate, Meagher & Flom, (and formerly with the District of Massachusetts) should all be considered for that important viewpoint.
Day 3: Wednesday, October 26, 2022
9:15 am, Cardiac Arrest — A CEO Lessons Learned from Surviving a Five-Year Criminal Prosecution If you’re staying for Day 3, don’t be late! I’m not sure if I can make the connection to an effective training curriculum with this one, but based on this description in the agenda, it could be interesting: Howard Root, former CEO from Vascular Solutions, will share his own experience as he faced down prosecution from the Department of Justice in a whistleblower case and won.
11:25 am, Debrief, Q&A and Best Practice Sharing Jill Dailey from Incyte, Joshua Marks from Takeda, and Daniel Spicehandler of Stryker will spend the final 35 minutes of the conference summarizing the key points and best practices shared during the first two days. Plan on attending to catch up on what you may have missed from the sessions you may have missed.
Discount Registration
Although it is billed as a “hybrid” event, the 23rd Pharmaceutical and Medical Device Ethics and Compliance Congress represents the first opportunity since the pandemic began for the industry to gather in person to share experiences, best practices, tips, and suggestions for building and maintaining an effective compliance program. While PCF has made every effort to replicate the experience of a live event with recent virtual congresses, the personal interaction and information sharing that occurs during live conferences outweighs an online experience.
If you are interested in attending the conference, we can help with a “friend of faculty” discount for first-time attendees. Please contact us at info@pharmacertify.com if you’d like to take advantage of this opportunity (in-person or online) to hear industry leaders, government representatives, and leading vendors at the discounted rate!
Thanks for reading and don’t forget to visit us at the PharmaCertify booth!
Great news! Connie the Compliance Training Director has emerged from her self-imposed quarantine and returned to the North American Headquarters of PharmaCertify. For her first post-pandemic post, Connie answers a question about the appropriate compliance training mix for product launch…
Dear Connie,
Connie the Compliance Training Director
I’ve read the recent post on this blog about the formula for a better compliance training curriculum, and I completely agree with the rationale for a combination of foundational training, reinforcement, and performance support. I am a compliance officer for a pharmaceutical company in the Northeast and my company is rapidly approaching our PDUFA date (fingers crossed) for a new product.
We’ll soon be hiring a new field team that is highly experienced in the industry. Do you have suggestions for the tools to use along each step of the continuous training rollout? I want to make sure I get this right, so that we have a successful launch while being sure our team stays compliant.
Sincerely,
Skittish in Schenectady
Dear Skittish,
I understand your concern! Product launch is a time fraught with compliance risk. Whether this is your company’s first product, or one of many, the risk of not fully preparing a new sales team can keep you up at night. But as opposed to being skittish about this, I dare say you should view a product launch as a terrific opportunity to ramp up the compliance knowledge in the company and build your reputation as a compliance training hero! Here’s how:
Build a Solid Foundation
From a foundational standpoint, I suggest you start with training on interactions with health care professionals to refresh the reps on topics such as the rules around gifts, meals, and consulting arrangements. If you’re doing speaker programs, you’ll also want to cover guidance around those on a comprehensive level. Enforcement around the programs continues to be a focus, with the most recent settlement costing the company $900 million in settlements…yikes! And don’t forget to include your policy on virtual meetings now that they’ve become more commonplace. (By the way, my friends at PharmaCertify have added Managing Speaker Program Risk to their list of customizable off-the-shelf eLearning modules. It’s worth a look, so email them at info@pharmacertify.com to see a demo.)
Launch Screen from the Compliance Foundations Module, Interactions with Healthcare Professionals
Make sure regulations, such as the Anti-Kickback Statute and False Claims Act, are covered in general terms and in context of what they mean for the reps as they interact with HCPs. You could even shape some of the foundational training around the tenets of the PhRMA Code – it’s always a reliable starting point.
You might also think about converting your code of conduct from a static document you hope they read now and then, to a learning tool that reminds them of the core tenets of how they are expected to conduct themselves. And rote repetition of the code in electronic form does not rise to the level of effective training. A well-designed and fresh course will help familiarize the new reps with specifics of your code. (FYI – the PharmaCertify team has lots of fun ideas for how to bring your Code to life!)
One final note on foundational training: the rest of your staff (i.e., your non-commercial employees) need a basic understanding of the health care compliance principles that govern how you do business, so they will need training, too. In this time of increasing enforcement, you need to be able to demonstrate that everyone in your company has received essential compliance training.
Reinforce and Refresh
The possibilities for on-going refresher training don’t stop at the code of conduct though. Consider integrating microlearning modules (PharmaCertify calls them QuickTakes) covering topics pulled from your larger training programs into a curriculum campaign. For example, since gifts and meals present a high level of risk, a five-minute module focused on items of minimal value, cash and cash equivalents, as well as in-office meals, out-of-office meals, and meals at third-party events, is a great way to keep the rules top of mind.
Also, too many people fall into the trap of thinking microlearning just means “short.” My buddies at PharmaCertify take a different view. They define microlearning as any training component designed to reinforce foundational training as part of a continuous learning plan. The formats could include live-action or animated video, workshops, and game-based training, and even strategically delivered quizzes and assessments. The idea is to keep the training nuggets flowing for higher risk areas, which increases retention and enhances learning.
On the live training front, think about games to ramp up learning. If you’ve ever been in front of a group of reps playing any game, you know how they like to compete! As Gordon Gecko said in the movie, Wall Street, “Competition is good.” I know, he really said “Greed is good,” but I got your attention with that one, didn’t I?
This is JEOPARDY! In fact, it’s the only officially licensed JEOPARDY game on the market.
Look for games that have a familiarity to them. A Jeopardy game is great and if you’re interested, I can get you a demo for the only officially licensed compliance Jeopardy game on the market. It’s also easy to customize, so you can add the categories and topics you need to reinforce.
You can take the event to another level by pitting regional teams against each other and adding music, sound effects, and prizes to the mix. If done right, the games will have the participants saying, “that was the best compliance training event I ever attended!” Trust me, I’ve heard it.
There is a trend toward more creative live and virtual compliance workshops, and in my opinion, it is long overdue. Simply having a representative from the compliance department speak to a PowerPoint deck might not cut it in the view of regulatory bodies, and it certainly is not going to accomplish any worthwhile learning objectives.
An image from the virtual Compliance Escape Room Workshop
I even saw a virtual escape room utilized during one recent workshop. In this case, participants solved clues about three scenarios as they competed in teams to “escape” the rooms. It was a big hit at the national sales meeting and won a gold award for Best Advance in Compliance Training from the prestigious Brandon Hall organization.
Support Their Performance
If there’s one element of the formula for effective compliance training that is most neglected, it’s performance support. Throughout my career in compliance training, I have too often seen training viewed through a myopic lens that is only focused on foundational training and occasional reinforcement. Performance support tools broaden the scope of your training campaign and provide just-in-time guidance.
Support materials can be as varied as interactive PDFs launched on the learning management system, animated video played through the corporate intranet, or an interactive microsite for sharing policy and code information. In addition, tip sheets and reminders about best practices and policies can also be sent directly to reps’ phones or iPads to support them with the information they need in the field.
Summary
I wish you well with your efforts and good luck with that PDUFA date! Product launch may, at first glance, be nerve-racking from a compliance standpoint, but when you take the time to analyze your current training against your risk, then develop a continuous curriculum to be delivered across your reps’ timelines, you’ll be surprised at how seamless it can be. Just keep that formula for an effective curriculum (foundational + reinforcement + performance support) at the forefront of your planning and I guarantee you’ll sleep much better at night.
Compliance Training Intelligence 