medical device compliance

A New Year, a New and Improved Compliance Training Curriculum

PharmaCertify Team , , , , , ,

Welcome to 2022 and a brave, new (and hopefully more effective) world in life sciences compliance training! Over the last two years, the industry has had to navigate the convergence of new and important regulatory documents (DOJ’s Evaluation of Corporate Compliance Programs, OIG’s Serious Fraud Alert on Speaker Programs), as well as updates to leading industry guidance (PhRMA Code, AdvaMed Code). Mix in a series of corporate integrity agreements and settlements focused on key topics, along with a global pandemic, and you have a perfect recipe for a shift in how risk is evaluated and remediated.

So, what’s the appropriate method for recalibrating your compliance training curriculum in response to these events and forces? The solution is as easy as A, B, C, and D:  

Assess Your Company’s Compliance Training Curriculum

Regular risk assessment is a long-time best practice for building and maintaining effective compliance programs. It’s nothing new, and as usual, the major conferences from Informa and PCF in 2021 included multiple sessions where risk assessment was a major topic of discussion. But this time, the regulatory guidance and industry code updates added a sense of urgency to the importance of this best practice.

The Compliance Curriculum Analysis Tool

But what good is a risk assessment if you don’t then assess your training curriculum against that risk? When we work with clients, we 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. It is often a revealing process, identifying gaps and redundancies in topics, and when and how the information is covered.

Good news! It doesn’t have to be a complicated process. Using tools like our Compliance Curriculum Analysis Tool (CCAT) can help.  And it can also be as straightforward as evaluating compliance risk for the product you are about to launch and establishing a baseline of online foundational curriculum around topics like HIPAA and Interactions with HCPs. No matter where you are in the product development cycle, know your risk levels as they relate to topics and audiences. Then look for opportunities to effectively address those risks in your curriculum with a continuous stream of foundational and reinforcement training.

Blend the Formats

The 2022 PhRMA Code Changes QuickTake eLearning Module

The days of using one large PowerPoint deck to train on all things compliance during onboarding sessions are long gone. Good riddance. Effective, well-designed training covering critical topics like bribery, kickbacks, HCP interactions, and speaker programs is readily available.

But the curriculum all stakeholders now expect doesn’t stop at eLearning modules covering foundational topics. You should also plan reinforcement training to help ensure that proper behaviors are integrated into your learners’ daily practices.

If your risk assessments show speaker programs to be a big risk area, don’t count on that one eLearning module or live training session to quell that risk. Why not launch a mini module specifically covering the selection and training of speakers? We call them QuickTakes. In fact, today’s development tools allow for smaller, more focused sections to efficiently and cost effectively be pulled from the larger modules.

Virtual workshops and games can be utilized to train on topics best discussed in live environments, where follow-up discussions and dialogue strengthen the core lessons. For example, if your assessments identify off-label promotion as high risk due to the nature of your company’s products, design a “compliance mystery” workshop, with scenarios replicating real-life environments sales representative can expect to experience in the field.

Compliance JEOPARDY!

Or, ramp up the competition and raise the level of learning with an online or virtual game like our Compliance JEOPARDY!, which is currently the only officially-licensed Jeopardy game on the market.

Finally, does your curriculum include performance support and just-in-time tools to help guide the learners before and after training events? Print and digital support materials can be designed in conjunction with the training and delivered to learners where they need it most – at their fingertips in the field.

A blended curriculum is not only the best approach for “making the learning stick,” it’s what the government, the industry, and perhaps most importantly, your audiences, now expect.

Communicate Across the Company

I admit that every time I heard the phrase “tone from the top” over the last ten years, I found myself wondering why the same topic was covered ad nauseum and seemingly at every conference. Then, a variation on that mantra started to seep into the presentations: “tone from the middle.” The reality is that key messages and lessons in compliance are delivered from the middle, more specifically, managers. And bringing those managers into the communication process helps ensure those in the field are reminded of the importance of compliance every day. It’s why presenters at conferences constantly stress the need to “partner with the business” and why compliance needs to be integrated throughout the company.

Speaking of communication, what does your plan look like? If you don’t have one, you should. Digital banners, animated video, and posters help reinforce the themes related to training and carry the messages across the company. For example, a QuickTake module covering kickbacks can easily be exported into a video for hosting on the company’s intranet. Or consider the approach we’ve taken with a number of clients to portray the compliance department in a more approachable light and produce lighthearted videos showcasing the risks involved in engaging with your company’s HCP partners.

Deliver It Continuously

One of my previous blog articles asked what a 170-year-old German psychologist had to do with compliance training and learning. The answer then, and even more so now considering the forces at work in the industry, is “everything.” Hermann Ebbinghaus is credited with theorizing fundamentals of human learning, including the learning curve, the spacing effect, and the forgetting curve. The forgetting curve essentially states that what humans remember after a learning event drops steeply after the completion of that event.

Continuous delivery helps reset the forgetting curve.

What Ebbinghaus theorized is interwoven into the government documents and settlements we’ve witnessed in recent years: “one and done” just doesn’t cut it. Unless you are taking a continuous approach to the delivery of your company’s compliance training components, you’re probably not taking every step possible to maximize the learning.

Are you deploying training nuggets across the learners’ timelines? Does your training plan include ongoing assessments and quizzes to help flatten that forgetting curve and increase knowledge retention? Are you asking for feedback from the learners on the quality of the training materials and adjusting accordingly? Have you explored available platforms for repurposing and sharing your training content?

In the DOJ’s guidance, the agency noted that some “companies have invested in shorter, more targeted training sessions to enable employees to identify and raise issues to appropriate compliance, internal audit, or other risk management functions.” The possibilities for doing that extend well beyond the creation of shorter eLearning modules. The availability of video, animation, podcasts, quizzes, and games, as well the delivery platforms necessary to continuously deliver those components, all create the opportunity to envelop learners in a framework of minimized risk.

Summary

The advent of new regulatory guidance documents and revised industry codes, as well as the implementation of recent industry settlements, affect the way risk is evaluated and judged in the life sciences industry.

We may be facing an onslaught of requirements and regulatory expectations during a time when the norms of business have been disrupted and disorganized, but using the instructional techniques and concepts outlined above, you have the opportunity to not only navigate your way through those changing expectations, but to elevate your compliance training curriculum to one that helps you rest easier on those waves of change.  

Thank you for reading! As always, my colleagues and I at PharmaCertify welcome the chance to discuss the compliance training challenges you may be facing.

Sean Murphy
PharmaCertify by NXLevel Solutions
smurphy@nxlevelsolutions.com

Training Takeaways from the 2021 Pharmaceutical and Medical Device Ethics & Compliance Congress, and What It All Means for Your 2022 Curriculum!

PharmaCertify Team , , , , , ,
The virtual PharmaCertify booth at the Compliance Congress featured compliance training modules and games for workshops and online use!

The Pharmaceutical Compliance Forum (PCF) understandably went virtual again for the Virtual 22nd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress. Though the lack of booth traffic that inevitably accompanies virtual conferences left the PharmaCertify team longing for the return to in-person events, this year’s presentations featured a bevy of new and compelling content from industry professionals and government regulators alike.

Here are ten takeaways to keep top of mind as you continue to plan, revise, and refine your training curriculum for the first quarter of 2022 and beyond.

The focus on speaker programs isn’t going away.

If the 2020 release of the OIG’s Special Fraud Alert related to speaker programs was a figurative shot across the bow of the life sciences industry, the updated PhRMA Code, scheduled to take effect January 2022, offers steadying guidance on the details of how to conduct more compliant programs. In the OIG Update session and across multiple mini summits involving industry leaders, the mandate was clear: speaker programs are rife with the potential for fraudulent activity and assessing program practices and the level at which you train on those practices is crucial.

Hold the third parties you use for managing speaker programs to the same standards as your internal organization.

The revised Compliance Foundations eLearning module, Managing Speaker Program Risk, is now available!

Third parties have long been a staple of emphasis at industry compliance conferences, but the increased emphasis on speaker programs highlighted in recent CIAs, the OIG’s Special Fraud Alert, and the revised PhRMA Code speaks to the need for increased scrutiny. And presenters at the conference picked up on that theme. As one presenter noted, “You need to be clear up front, when you are negotiating with third parties you expect full transparency.” And training needs to be part of that consideration from the start of the conversations. Have the vendors you’re considering instituted their own training on speaker programs? Do they need to be added to your list of learners? If yes, do they have access to your enterprise LMS or will they need to access the courses through a separate portal?  

Look to the new PhRMA Code for guidance.

During the mini summit focused on the OIG Alert, PhRMA Code, and AdvaMed Code, Julie Wagner, from PhRMA, detailed the process the organization went through to plan and revamp its Code. It was clearly a thoughtful and well-planned series of steps. Other presenters throughout the conference (on the industry side as well as government representatives) emphasized the need for companies to look to the Code as a framework for how to conduct HCP interactions. The updates to the Code reflect the key takeaways from recent corporate integrity agreements as well as the challenges of conducting business in a post-pandemic world. Whether your company is a signatory or not, training on the new PhRMA Code is more critical than ever. That’s why we have rebuilt our Compliance Foundations eLearning module, The PhRMA Code, with a more intuitive interface and design, and an instructionally redesigned approach to the content. Contact us at info@pharmacertify.com to see a content outline.       

Assess risk across your organization, and don’t forget your training curriculum.

I may be a bit biased since the moderator is my colleague, Dan O’Connor, but the mini summit titled, Optimize Your Compliance Training: A Practical Approach to the DOJ’s Guidance, was one of the most important of the entire conference. Dan discussed the need to assess risk according to audience, topic, format, and cadence with his panelists, Katrina Church of Bioventus, Matthew Hill of Novo Nordisk, and Karen Snyder of Ironwood Pharmaceuticals. If you’re not mapping your activities frequency against the risk associated with each of those activities, the learning will suffer, and risk will rise. All risk is not created equal, and as one presenter in the DOJ/SEC panel said, “It’s difficult to implement an effective program if you don’t know where your risks are.”  

You really do want employees to speak up. So, tell them.

Self-remediation was a theme during the DOJ Keynote as panelists emphasized the importance of companies bringing issues found during their own due diligence to the attention of the agency. Doing so appears to go a long way in how the agency treats cases, especially when the companies demonstrate they are taking the necessary measures to identify the root causes of the issue and remediate them. Does your training encourage employees to speak up when they witness potential violations? Is that message pushed out in periodic scenarios as part of your on-going microlearning efforts? The compliance department can’t be everywhere at all times, so reports of violations are more likely to come from the field. Make sure your learners are well-versed in your reporting and non-retaliation policies.

Be ready for surprises when the industry shifts back to field-based interactions.  

During the Chief Compliance Officer Fireside Chat, one CCO touched on the need to expect surprises as the industry returns to more field-based interactions by saying, “When we get back out into the field, I’m sure there will be things we weren’t expecting.” Is your curriculum built to respond to those surprises? Have you integrated the type of learning nuggets that can be quickly modified and re-deployed as the bumps in the compliance road appear? Including such easy-to-modify components such as mini-modules, alerts, and read and signs into your curriculum creates the agility to respond rapidly before those surprises cause even more uproar.

Patient programs and third-party vendors: a risky combination.

Since the OIG requires manufacturers to take steps to exclude federally insured patients from patient assistance programs, presenters in the mini summit dedicated to patient assistance programs spent a considerable amount of time discussing the need for thorough assessments of the vendors who manage the programs. As one presenter commented, “part of that is looking at the capabilities of the vendor, what processes they have, do they have rules that align with your company’s policies and expectations, and do they have qualified and trained personnel to run these programs.” And as was highlighted, multiple vendors may be involved in different aspects of the programs. The internal and external training matrix can be complex for patient programs but identifying the appropriate level of training across all vendor personnel is the first step to ensuring continuing compliance.

Measure your company’s culture and look for opportunities to strengthen it.

One of the medical device summits featured a lively discussion of company culture as a driver for employee engagement. The conversation focused on the idea that culture is the driving force behind an organization’s approach to its business and everyone in that organization is responsible for maintaining that culture. As one presenter noted, “Culture eats strategy for lunch.” It was a refreshing twist on the rules-based vs. values-based debate and at PharmaCertify, we absolutely agree that life sciences companies need to seek out opportunities to strengthen their ethical cultures – including through training. After all its in our mission statement: helping life sciences companies strengthen their compliance cultures and reduce risk through training.

When it comes to compliance, patients are the new HCPs.

Comments from panelists in the mini summit focused on patient advocacy organizations, their growing reach, and the attention they therefore require from a compliance standpoint. Even the smaller, niche organizations have a big voice with governmental agencies, so they shouldn’t be ignored. Is your compliance program, including your training curriculum, addressing patient advocacy to the appropriate level? The risk is real and as one presenter stressed, “they are the new HCPs.”

Social influencers need to be considered.

The AUSA Roundtable session concluded with a notable discussion on the influx of social influencers and the expectation for more enforcement related to these celebrities who sometimes hold sway over the purchasing habits of the American public. A recent situation involving celebrity, Kourtney Kardashian, was cited as an example of one influencer making public comments, which led to a warning letter being issued to the company by the FDA. Kardashian made a public appearance on a popular television show, as a recognized and paid spokesperson for the product, and made false or misleading efficacy and risk claims. As trivial as the topic of social influencers may seem, they need to be properly trained and prepared to appropriately speak about products.    

Summary

I have only scratched the surface of the plethora of content presented during the during the Virtual 22nd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress. As with past conferences, the depth and expansiveness of topics covered was impressive and well-suited for newcomers to the life sciences compliance industry as well as experienced veterans. There was something for everyone.

PCF, the organizers, and all the presenters deserve a hearty congratulations and kudos for such a wide-ranging and informative conference. There remains no better resource for up-to-date best practices and advice than conferences like this one. Hopefully, the pandemic will be in our proverbial rear-view mirror this time next year and we’ll meet in person for the 23rd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress and never have to deal with that “virtual” word in the title again.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

A Preview of the 22nd Annual Pharmaceutical and Medical Device Ethics and Compliance Congress

PharmaCertify Team , , , , , , ,
Visit the PharmaCertify booth at the Pharmaceutical and Medical Device Compliance Congress to see demos of our newest modules, reinforcement programs, and games!

Here we are, over a year after Covid completely upended our lives, personally and professionally, and we are still attending compliance conferences virtually. The Pharmaceutical Compliance Forum (PCF) opted for a virtual forum for the Pharmaceutical and Medical Device Ethics and Compliance Congress again this year and a quick review of the agenda highlights the notion that no matter the format, this conference consistently presents the information any compliance professional needs to help reduce risk. Here are my pre-conference thoughts on the sessions of interest, particularly those that affect compliance training curricula.

Day 1: Tuesday, November 2, 2021

In an interesting twist on the standard agenda format, PCF opens the congress this year with a series of concurrent mini summits covering a range of topics. My standard advice applies; divide and conquer. If you’re attending with colleagues, plan to attend different presentations, then share notes. Even if you attend on your own, find a friend in one of the early networking sessions and don’t be shy about asking if they are interested in taking the same note sharing tact. It’s a veritable plethora of content to wade through…and that is definitely a good thing.

Mini Summit 1: Enforcement Action Updates

I tend to include most of the enforcement panels in these preview blog posts simply because they’re rare opportunities to hear the experiences and advice of those on the forefront of actions and settlements, including topics that trainers should be concerned about. This conference is no exception. Panelists include Assistant US Attorneys from the Eastern District of Pennsylvania and the District of Massachusetts, as well as the Assistant Director of Civil Division/Fraud Section of the Department of Justice.

Mini Summit 3: Evolutions of Investigations

The title for this one caught my eye and moved to the top of my priority list. Investigations have formed the foundation for the industry’s focus throughout the growth of the compliance industry and they certainly influence the training that has evolved from the early days of PowerPoint presentations to the multi-layered foundational and reinforcement training that is now considered the vanguard of effective eLearning.

Transition Breaks and Lunch

I include the breaks in this “must attend” list of sessions because they offer the best opportunity to interact directly with peers, vendors, and consultants. These are the people who not only provide crucial funding for the conference but also offer the products and services you need to help reduce risk and build a stronger culture of ethics and compliance. We’re here and we’re anxious to meet you. So, I invite you to check in with these critical vendors in the exhibit hall.

Mini Summit 5: DOJ/SEC FCPA Panel

Please see my thoughts on Mini Summit 1. The same apply to this session focused on the Foreign Corrupt Practices Act.

Mini Summit 7: Annual Medical Device Update

Hooray for Medical Device! It’s in the conference name and it is rightfully in the agenda. While many of the topics listed throughout the agenda apply to medical device companies, concerns and challenges unique to the industry abound. The panel includes chief compliance officers from Medtronic, ZOLL Medical, and Olympus, as well as a representative from AdvaMed and I’m looking forward to hearing how they address the issues associated with the rising number of recent medical device settlements.

Open Forum with PhRMA and AdvaMed

The Senior Assistant General Counsel for PhRMA and Vice President, Global Compliance and Governance for AdvaMed will be available in an open forum, hopefully ready and willing to take your questions. Enough said.

The Pivotal Role of CCO’s in Fostering a Strong Culture of Inclusion, Trust, and Psychological Safety

After a break, the conference switches from concurrent summits to this important and timely general session. I’m especially intrigued by the phrase “psychological safety” in the title, and I look forward to hearing whether inclusion and diversity are included in the discussion.

“Evolving our Operating Model” Discussion Breakouts

For the final session of the day, attendees choose one of three titles: 1. Managing Remote Teams, 2. Scope and Structure of the Compliance Function, and 3. Ethics and Compliance – The Road Ahead. To borrow a cliché, Covid has clearly changed the world and our industry for the long term. While the same core principles apply no matter how business is conducted and even how training is launched, compliance challenges shift and grow with the advent of virtual interactions. That’s why numbers 1 and 3 are of particular interest to me.

Day 2: Wednesday, November 3, 2021

Day 2 kicks off with more mini summits and interactive workshops followed by the opening plenary session at 1:00 pm.

INTERACTIVE WORKSHOP III: Hot Topics in Medical Device

Medical device is back with its own workshop and that is definitely a good thing! I look forward to hearing what topics Sujata Dayal from Medline Industries and Dana McMahon of Stryker include in their presentation and comparing the list to what we cover in our off-the-shelf and custom training solutions we provide for our medical device clients.

MINI SUMMIT 15: Optimize Your Compliance Training: A Practical Approach to the DOJ’s Guidance

I confess, since my colleague, Dan O’Connor, is the moderator on this one, I may be a bit biased. But I’ve seen the initial outline for the presentation and trust me, you don’t want to miss it. Dan, and his panel of compliance professionals will delve into the landmark guidance from the DOJ and present a practical framework for building and managing a continuous curriculum of training that will help your organization align with its principles.

MINI SUMMIT 16: Patient Assistance Programs

Speaking of hot topics! Regulators are paying attention to your patient programs, and you should be doing the same. So, you don’t want to miss this opportunity to hear Noor Haq from Amgen and Kevin Ryan from ACADIA share their experiences and tips for managing and minimizing the compliance concerns associated with PAPs. By the way, here at PharmaCertify, we’ve developed a new customizable eLearning module covering patient programs. Visit our website to see a description.

INTERACTIVE WORKSHOP 4: How to Establish Risk Tolerance in an Emerging Organization

If your company faces the challenges unique to those that fall into the emerging category, this holds the potential to be one of the most valuable sessions on the docket. Terra Buckley, who is now the Vice President of Compliance Advisory Services, is a seasoned industry professional, and frankly, one of the most dynamic presenters I have seen on all topics related to life sciences. Terra will be joined by David Ryan, Chief Compliance Officer at Epizyme.

Opening Plenary Session

Several presentations are listed as part of the plenary session that runs from 1:00 pm to the close of the day’s agenda at 5:30 pm.  

Keynote: OIG Update

Following the fireside chat with Giovanni Caforio, MD, Chairman and Chief Executive Officer at Bristol Myers Squibb, Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General at OIG will deliver her annual update on the agency’s enforcement actions and workplan. It’s always a highly anticipated presentation and for good reason. Her slides and notes form a solid foundation for where companies should be focusing their efforts and their resources in the coming year. 

Response to OIG Special Fraud Alert and PhRMA and AdvaMed Code Update

The conference organizers have combined these three weighty topics into one presentation, and I am anxious to hear the panel of industry professionals and representatives from PhRMA and AdvaMed delve into the important details of each one. The Fraud Alert and the updates to the two codes led to significant changes in the content for our off-the-shelf and custom training courses at PharmaCertify, and we’re developing reinforcement components like a brief explanatory video describing the PhRMA Code to roll out in conjunction with the updated foundational module.

Annual Chief Compliance Officer Fireside Chat

Day 2 ends with an impressive lineup of chief compliance officers from pharma and med device, representing companies of different sizes and therapeutic focus. Ann Beasley, from Zai Lab, Shefari Kothari from Novartis, Angela Main of Zimmer Biomet, Kristin Rand from Moderna, and Latarsha Stewart from Servier Pharmaceuticals are sure to add a compelling exclamation point to a day chock full of critical compliance experiences and advice.

Day 3: Thursday, November 4, 2021

Following the form of the first two days, Day 3 begins with a series of MINI SUMMIT 21: Interactions with Health Care Professionals

Interactions with healthcare professionals are the foundation upon which solid compliance practices, principles, and training must be established. Whether those interactions are in person or virtual, they are fraught with risk, yet when they are conducted in a compliant manner, they continue to form the core of what makes the life sciences industry what it strives to be; a noble group whose primary focus is helping its customers improve the lives of patients. That’s why I’m looking forward to hearing the best practices for those interactions espoused by a panel that includes representatives from both the pharmaceutical and medical device industries.

INTERACTIVE WORKSHOP V: Evolution of Ethics & Compliance

We have been hearing about the industry shifting away from “a culture of compliance” to an “ethics-based” approach to compliance for a few years now. While the notion is a laudable one, the practicality of that migration is more challenging in such a risk-based environment. I am eager to hear the presenters’ tips for executing that evolution, including how they carry it through to their compliance training.

MINI SUMMIT 25: Trends in FDA Advertising/Promotion Enforcement: Know the Risk Areas

Any session with “Know the Risk Areas” as part of its title gets my attention and when the focus is on advertising and promotion it’s no exception.

Closing Plenary Session

The afternoon on Day 3 includes a plenary session with a series of interviews and sessions. After a keynote interview with Tim Wright, the Chief Executive Officer from MiMedx and a fireside chat with Rady Johnson from Pfizer, Catherine Gray from the FDA presents the annual FDA Keynote. Like the OIG Update from Mary Riordan, the review of the FDA’s workplan is worthwhile and important. And the AUSA Roundtable offers another valuable view of current trends and hot topics from those on the regulatory side of the table.

Day 4: Friday, November 5, 2021

Industry Only Best Practices Think Tank  

I’d like to wax poetic about this, the final session of the conference, but I remain relegated to the figurative “kids’ table” of vendors and exhibitors who can only wonder what juicy nuggets of compelling and important information those insiders are discussing behind their locked virtual walls. In the meantime, I continue to stare at my email inbox, awaiting my golden ticket. Here’s a suggestion for the PCF team: perhaps an outline of the ideas and suggestions discussed during the session could be shared with all attendees after the conference concludes.

Summary and Complimentary Conference Registration

That’s quite a bit of content for any conference, so kudos to PCF and the organizers for creating such a hefty agenda and gathering so many impressive presenters. And I’ve only scratched the surface of the list of mini summits and plenary sessions. If you’re attending the conference, I invite you to stop by the PharmaCertify booth to see demos of our newest compliance training programs, workshops, and games. You don’t want to miss our new Compliance JEOPARDY!® game, the only officially licensed one on the market!

If you haven’t yet registered, we can help! As a conference sponsor, we are offering a limited number of complimentary registrations. Just contact my colleague, Dan O’Connor, at doconnor@nxlevelsolutions.com to take advantage of the opportunity to learn from your peers and fellow compliance professionals. You don’t want to miss it.

Thanks for reading and I will see you online for the conference!

Sean Murphy
PharmaCertify by NXLevel Solutions

Five Ideas for Your Compliance Session at the Next National Sales Meeting or POA

PharmaCertify Team , , , , , , ,

Your next national sales meeting or POA is just around the corner! If you haven’t thought of a fun and engaging way to make the content stick during your time in front of the reps, especially with the move to virtual events, all is not lost. There is still time to craft a compelling session to help ensure key compliance concepts are communicated effectively and learning is optimized.

Here are five ideas that might just have your participants saying, “that was the best compliance session I’ve ever attended!” Trust me, it does happen. I’ve seen and heard it myself.

Play Compliance JEOPARDY!

Jeopardy-style games have long been a staple of compliance training and the familiar format continues to be a great way to get your learners’ competitive juices flowing. It’s a popular format that your audience will recognize instantly.

PharmaCertify offers the only officially licensed JEOPARDY! game on the market and wow is it cool! You can populate the game with categories and clues written by our subject matter experts or draw questions from your own policies. Either way, our instructional designers will work with you to create a series of clues that challenge the participants’ knowledge at just the right level to enhance the learning.

Compliance JEOPARDY! is flexible. We offer a baseline off-the-shelf version to get you started, and depending on the amount of time you have at the meeting and your learning objectives, you can include up to 51 clues in one game (including Double JEOPARDY! and Final JEOPARDY!)

Make It a Compliance Mystery

Who doesn’t love a good mystery?  A mystery-themed workshop is an ideal way to present new compliance concepts and reinforce existing knowledge in a live, or virtual, collaborative and information-sharing environment.

When created thoughtfully and using sound instructional principles, a mystery workshop can draw the learners in as they play “compliance detectives” to solve scenarios through their knowledge of compliance best practices and guidance. You can even make it a blended event by rolling out “clues” in the form of email messages, voicemail transcripts, and text messages, before the date of the workshop.

At PharmaCertify, we include a compliance mystery activity in our Compliance Reality Challenge. Participants begin the Compliance Mystery by reviewing the clues they were presented prior to the workshop. Once they complete that review, they are presented with a screen from which they choose red flags. They then answer a series of questions to test their understanding of the scenario and their decision-making skills.

Following the completion of the activity, facilitators briefly have the opportunity to review the scenarios and provide clarification on policies as necessary. After the workshop summary and a review of the key lessons learned, a leaderboard can be revealed to highlight the final scores.

Build a Virtual Compliance Escape Room

Escape rooms are all the rage, and a virtual escape room can be a great device for transferring that popularity into a memorable learning activity.

The escape room can build trust and collaboration as participants work in teams to solve challenges and use codes to escape. An escape room can be a blended event, with core training and other pre-work delivered prior to the activity, which will allow you to focus on specific concepts during your time with the participants.

Escape room activities begin with a scene for the group of learners to explore. Each participant clicks on each “hotspot” to review key information. Once all hotspots have been explored, a “Next” button appears, and participants are presented with a series of questions regarding the scene. As members of a team answer questions, the score for that team is averaged automatically to generate a final team score. The workshops are generally designed for a 45-minute duration, and include introductory remarks, debriefs between activities, and wrap-up remarks.

Build Your Own Compliance Scenarios

Scenario-based learning is a tried-and-true method for helping learners improve their decision-making skills. Scenarios give your reps the chance to apply knowledge from previous training in a safe environment.

Our Compliance Scenarios training game is an easy way to create role-play situations for your next meeting. With Compliance Scenarios, you can transport the audience into simulated interactions with healthcare professionals during the training session.

We’ll work with you to develop discussion points for a series of branching scenarios, and we’ll create the photo or illustrated images to go along with the content. When learners think critically to solve a simple or complex scenario, retention is increased, and learning is enhanced!

Pursue Trivia (see what I did there?)

Who doesn’t like trivia? In fact, did you know that new versions of TRIVIAL PURSUIT are still being released. There’s a new “Master Edition” available with over 3,000 questions? Looks like my holiday shopping list just got a little longer.

Whether they are played online, around the kitchen table, in a bar, or during your company’s training meeting, trivia games are a powerful way to pull participants into a fun learning experience.

Compliance Trivia by PharmaCertify is customizable and can turn your session into a competitive experience through an assortment of question types, including multiple choice, select all that apply, image match, and polling.

Even if you’ve already mapped out an activity for that next meeting, but you need one more reinforcement activity to fill the time available, Compliance Trivia will leave your audience brimming with confidence and compliance knowledge.

Summary

The time available to capture the audience’s attention at a sales meeting may seem fleeting but the lessons your participants learn will be incorporated in their daily work activities well beyond the session. Themed workshops and games are just a few of the options available to “make the learning stick,” but an engaging and meaningful session is a necessary and important step in the continuous process of reducing risk and creating a stronger culture of compliance and ethics in your company.

Thanks for reading. As always, I welcome any comments or feedback.

Sean Murphy
PharmaCertify by NXLevel Solutions

Reduce Compliance Risk: Play a Game

PharmaCertify Team , , , , ,

In this week’s post, Dave Correale, Senior Instructional Designer at NXLevel Solutions, discusses the benefits of using games to reinforce key compliance concepts and make training more engaging.

Imagine you’ve been given a 30-minute slot at an upcoming sales meeting. You’d really like to use the time to reinforce your company’s privacy principles, but you don’t want to just present a boring slide presentation. You know a game would be more fun, but would it be effective? How do you build a game around privacy principles, anyway? Besides, you’re not sure you even have the time or resources to build an effective game.

Let’s explore the first question: Would it be effective? While some of the more ambitious claims surrounding game-based learning are not yet substantiated by research, there is strong evidence that games can increase learner motivation and engagement, critical factors in the success of any learning program.

But how do you build an effective learning game around a topic like privacy? One mistake some people make when implementing a training game is they focus too much on the game and not enough on the objectives. Games are not a panacea. A game will likely not be effective for learning if it is not designed to meet specific instructional objectives. And just because a game is effective for one set of learners, in one specific circumstance, it not necessarily be effective for all learners in all circumstances. Just because you are using a game for learning, you cannot ignore valid instructional design principles and practices.

Fortunately, there are many types of games to meet many different types of learning objectives in a variety of circumstances. The level of participation itself can be diverse: games can involve teams or individuals playfully competing against each other in real time, or they can involve single players whose only competition is the game itself.

Let’s return to your 30-minute slot at a fictional sales meeting. Your goal is to reinforce learning on a topic your learners should already be familiar with. You could have employee teams play against each other in a “Jeopardy-style” contest. We’ve all seen the actual Jeopardy!® board – there’s room there to deliver a lot of content. But instead of bullet points, you’re leveraging familiar game show mechanics to raise curiosity among the learners and harness their competitive instincts. You can also build deeper connections between your employees and engage virtual employees in something more than just polling questions.

Single-player games also afford a number of possibilities. Perhaps your company is concerned with the number of recent settlements involving speaker programs. Players could work their way through an unfolding speaker program scenario where they need to engage with the speaker before the program and then respond to situations that arise during the speaker’s presentation. As they respond to each situation, the game moves forward, learners see the consequences of their decisions, and important lessons are learned or reinforced.

Finally, what about the time and resources required to design and develop an effective game? This is why PharmaCertify’s library of learning games is a good fit for ethics and compliance teams. Our collection of prebuilt games, which includes the only official Jeopardy!® game available, are easily customized to help you increase learner engagement and meet your learning objectives while requiring a fraction of the time and cost required to build a game from scratch. Contact Dan O’Connor at doconnor@nxlevelsolutions.com to see a demo and start planning your next compliance training success story.

And look for additional posts in the future that continue to discuss how game-based learning solutions can help you reduce compliance risk and strengthen your culture of ethics.

Thanks for reading!

David Correale, Senior Instructional Designer, NXLevel Solutions

Key Training Takeaways from the 2021 Virtual Compliance Congress for Specialty Products

PharmaCertify Team , , , , , , ,

Although Informa’s virtual 2021 Compliance Congress for Specialty Products was targeted to those companies that focus on rare and orphan diseases, many of the key messages shared by the panel of industry professionals and regulators were applicable to compliance professionals from companies of all shapes and sizes.

Here are some of the key takeaways from the three-day conference, with my thoughts on what those messages mean for your compliance training program:

To say the pandemic has changed the way life sciences conducts business may be cliché, but based on the presentations in this conference as well as the Pharmaceutical Compliance Congress in April, at least some of those changes are here to stay. Change begats an increased volume of risk, and in the opening session, Keeping Up with Industry Trends — Top Compliance Concerns Facing CCOs, presenters emphasized the need for risk assessments now more than ever.

1. The current pace of change highlights the importance of risk assessment.

You need to take the same approach with your training curriculum. What are the key risk areas based on your company’s products? How often are the topics relevant to your product covered in live and online training? Are key areas addressed with reinforcement and just-in-time training? We call this process the Compliance Curriculum Analysis Process (CCAP). In fact, I wrote about how the process can improve outcomes for the publication, Life Science Compliance Update, back in 2017. Thanks to the pandemic, and increased governmental scrutiny, it’s even more relevant today.  

2. Choose the right company when making a career move.

While most presentations in compliance conferences are focused on the best practices and concepts necessary to optimize a program, hearing one of the presenters stress the need to be aware of culture before joining a company was refreshing and enlightening. As the presenter pointed out, you cannot be shy about exploring whether the company makes compliance meaningful and if compliance is valued – before you accept a job offer.

Don’t forget to explore their approach to training as well. Are they regularly rolling out the kind of creative training and microlearning that helps flatten the “forgetting curve” my colleague Dan O’Connor, Erica Powers of Sage Therapeutics, and Karen Snyder of Ironwood Pharmaceuticals addressed in the Optimize Your Compliance Training: A Practical Approach to the DOJ’s Guidance session? (By the way, you really should see the slides from that presentation and the examples of fun an innovative training your peers are using to help reduce risk. Drop me an email at smurphy@nxlevelsolutions.com if you’re interested.)

3. Equip leaders with consistent and proper messaging.

In a twist on the familiar “tone-from-top” mantra, another presenter in the opening CCO session stressed the need for the compliance department to take the lead in providing leadership with the proper messaging needed to reinforce that tone. As he said, “consistency is key as you cascade communication across your program.” It applies to training as well. Not only does the C-Suite need to be trained in the same concepts and policies as employees, they, and the management team, need to be repeatedly reminded of the need for a seamless message. As we’ve been told in just about every conference over the last five years, you need to earn a “seat at the table” with leadership. Once you’re in that proverbial seat, helping them espouse the messaging necessary to keep your program consistent is the key to keeping it meaningful.

4. Don’t decline meetings during the pandemic.

During the Compliance During a Pandemic session, presenters spoke at length about the importance of open lines of communication and the need to make every attempt to meet with business colleagues whenever possible. The businesses and field employees need to know you are accessible when they have questions. As another presenter chimed in, “you need to constantly make sure they know who to go to.”  That concept extends to your training curriculum. Does your training include surveys and other feedback mechanisms? Do you encourage outreach in your eLearning? Creating and nurturing an open dialogue can only make your training more effective, during the pandemic and beyond.

5. If you’re going to have live speaker programs, you need to be wary of red flags.

That’s according to one presenter during the prosecutors’ presentation on high-priority risk areas. As he put it, the very fact that HHS even issued the Special Fraud Alert on Speaker Programs should be interpreted as a warning. While multiple presenters in other sessions suggested their companies will move to hybrid models with virtual and live programs, the opinions of the prosecutors were clear: expect the OIG’s focus to be on the live versions.

Managing Speaker Program Risk is one of the newly updated Compliance Foundations eLearning modules available from PharmaCertify. It covers the critical content your reps need to understand to remain in compliance, and like all our modules, it’s easily customized with your policies and content! Contact me to see a demo.

6. Not every patient advocacy organization is the size of the American Diabetes Association.

Day 2 kicked off with the Optimize and Mitigate Risk within Patient Interactions and Support Programs. Presenters noted the trickiness in dealing with advocacy groups in particular – not all the groups will be large and experienced enough to understand the potential pitfalls of compliance. You may need to educate them on the guidelines and principles, and that can be a challenge, especially on the delivery front since outside learners often don’t have access to your internal learning management system.

PharmaCertify can help with the Access LMS platform. Access LMS is a cloud-based, affordable alternative for reaching outside vendors and organizations with your compliance training. It’s simple, it’s easy-to-use, and it won’t break your budget. Contact my colleague, Dan O’Connor, at doconnor@nxlevelsolutions.com to see a demo. 

7. Dig deep into the weeds with MSL/commercial training.

The relationship between the medical and commercial divisions is nuanced and fraught with risk. During the Compliant Frameworks for Medical Affairs and Commercial Interactions session, a presenter whose company recently launched its first product reinforced the need for detail. While medical/commercial interactions have always been a pain point for her, she clarifies gray areas on topics such as “the rules for visiting HCPs together,” with what she calls “ways of working documents that clarify what each group can do and why.

At PharmaCertify, we take the same approach with our MSLs and Sales Reps: Understanding the Divide Compliance Foundations module. The content is designed to cover each role in a manner that helps reps and MSLs understand their own rules as well as those of the other group. I’d be happy to send you a content outline.

8. Follow the money. The prosecutors are.

It’s no secret that the government is scouring Open Payments data. And they are following the trail of money flowing to HCPs. During the enforcement panel, one prosecutor bluntly stated, “if you pay a provider hundreds of thousands of dollars, we are going to be looking at it.”

Reps need to consistently be reminded of HCP spend limits and incorporating microlearning components like on-going assessments and quizzes into your curriculum is key to ensuring those numbers are top of mind. We’d welcome the opportunity to show you how it works.    

Summary

Kudos to Informa and all presenters for putting forth a valuable and important learning experience despite the challenges that always accompany a virtual event. The pandemic has changed the way in which we share ideas, best practices, and personal experiences as much as it has changed the industry in general. As the world inches back to a more “normal” approach to information sharing, I anxiously await the day when we can again meet in person in a conference exhibit hall and exchange ideas for how you can reduce risk and build a stronger ethical culture through training.

Thanks for reading!

Sean Murphy
PharmaCertify by NXLevel Solutions

Compliance Training Lessons from the 2020 Virtual Pharmaceutical Compliance Congress

PharmaCertify Team , , , , , , ,

Part I: A Conference Overview and What It All Means for Your Training

State of the Art Compliance Training, with Dan O’Connor of PharmaCertify, was just one of the 14 on-demand sessions at PCC2020.

Welcome to the first in this multi-part series based on CBI’s recent Pharmaceutical Compliance Congress! For obvious reasons, the conference went virtual this year, yet it offered an impressive lineup of industry professionals, vendors, and government officials offering compelling tips and guidelines for building and maintaining an effective compliance program in the life sciences industry. In addition to the live presentations, organizers offered 14 “on-demand” presentations covering an impressive array of topics, so from a content perspective, the virtual format created even more opportunities for learning.

Over the next month, I will touch on some of the thoughts shared by presenters related to topics like speaker programs, patient programs, risk assessments, third-parties, patient advocacy groups, transparency, and strategies for field team compliance, to name a few. And since the mission of this blog, and the PharmaCertify team, is to help you reduce risk and strengthen your compliance culture through training, I will include suggestions for growing and modifying your compliance training practices and curriculum in response to the information shared during the conference.

Kudos to the team at CBI/Informa for their diligent efforts to replicate the learning and networking experience of the live conference. PCC 2020 was a busy conference, with an impressive volume of content scheduled throughout the week and in the on-demand sessions. If you attended and did not have the opportunity to review the on-demand sessions, I have been told these will remain available until September 14th. You will especially want to review the State-of-the-Art Compliance Training session, where my colleague Dan O’Connor and compliance professionals from Sage Therapeutics, Regeneron, and Akebia Therapeutics share creative approaches for increasing training engagement and adoption. You don’t want to miss that one!

While some of the topics were familiar to anyone who has attended the conference in recent years, the “elephant in the room” was not ignored, as a multitude of presenters addressed the overwhelming challenges of keeping an entire organization focused on conducting business in a compliant manner during these unprecedented times. The result was an interesting blend of traditional and familiar compliance conference topics and guidance on navigating the risk associated with conducting business in a highly regulated industry during a pandemic, or at least as much guidance as can be expected at this time.

From a high-level training standpoint, the presentations at the conference affirm the need for a more dynamic and blended curriculum, with microlearning and other components delivered across your learners’ timelines. The method by which life sciences employees conduct their daily activities has suddenly changed, and the level of risk and potential for violations has grown exponentially with that shift.

One of the more compelling presentations was the “Criticality of Compliance” session with John Crowley of Amicus Therapeutics. John shared his family’s moving story and his incredible journey as he pushed for the development of a product to help his two children (did you know his story was the basis for the feature film, Extraordinary Measures?). As he spoke, John reflected on what the commitment means to the patients battling the rare diseases his company’s products treat, “as life sciences professionals, we are an extension of the oath that doctors and nurses have taken, and it is a solemn oath,” he said, “if there is a compliance violation, everything we hoped for in the next several years is threatened.” It is a laudable approach to building a culture of compliance at Amicus and one worthy of emulation.

I look forward to sharing more ideas from the conference, as well as subsequent training suggestions you can utilize to strive toward similar ideals and goals in your organization.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

Coming Up: Speaker Programs and Patient Support Programs

A Preview of the 2020 Virtual Pharmaceutical Compliance Congress

PharmaCertify Team , , , , , , ,

As you may have expected, CBI’s Pharmaceutical Compliance Congress is going virtual in 2020. Whether presented live or online, the conference remains one of the few opportunities for those in life science compliance to interact with their peers and learn tips, suggestions, and best practices from industry leaders and government representatives. Live panels and on-demand presentations spread across the agenda represent a wide variety of the topics important to anyone striving to build and maintain a strong and effective compliance program and ethical culture. Here are a few of the presentations I am particularly looking forward to.

On-Demand Presentations

To provide an extensive range of content, organizers have made some sessions available on demand. Or, as they say it on the website, “on-demand content is available anytime, to accommodate your needs and schedule.”

On-demand titles range from Strategies for Field Team Compliance, to Best Practices Around the World for Global Compliance Management, and Hub and Specialty Pharmacy Contract Oversight and Risk Assessment, to name just a few. Make sure you watch the State-of-the-Art Compliance Training panel discussion being hosted by my colleague from PharmaCertify, Dan O’Connor. Dan will be joined by Alex Ganz of Akebia Therapeutics, Jeffrey Hagy of Regeneron, and Erica Powers of Sage Therapeutics for a deep dive into practical and innovative training approaches that you can apply immediately. I’ve seen the notes on this one, trust me, you don’t want to miss it. The full list of on-demand sessions is on the conference website homepage: https://informaconnect.com/pcc/.

Day 1: Monday August 10

After opening remarks and the video review of the year in compliance, James Stansel, Executive Vice President and General Counsel of PhRMA, will present the organization’s annual address, Healthcare Policy Update – Current State of Regulatory Reform Driving Innovation and Access. Then Gary Cantrell, Deputy Inspector General for Investigations at OIG, will deliver the annual OIG/HHS Update.

The panel presentation from the U.S. Attorneys’ offices typically offers a revealing look into the trends and topics currently in focus for the government. This year, Enforcement Docket Deep Dive – Analysis of Recent CIAs and Settlement Trends features representatives from offices around the country, including New Jersey, Southern New York, Nevada, and Massachusetts. Expect patient assistance programs to be at or near the top of the list this year – and, on this note, PharmaCertify will soon offer a new eLearning module covering patient programs. Send me a note if you’d like to preview the content outline.

From 3:00 pm to 3:45 pm, participants choose between two live Q&A sessions, Boot Camp Q&A, with Perri Pomper from Clinical Genomics, Ed Sleeper from Esperion, and Daniel Kracov and Mahnu Davar, both of Arnold & Porter; and Primer Q&A with Rahul Khara of Acceleron Pharma, and Seth Lundy from King & Spalding.

The Opening Night Networking Happy Hour follows the Q&A sessions, and when I preview the live conferences, this is where I typically suggest attendees not miss this great opportunity to interact with peers in one-to-one conversations. There is no reason to believe the virtual networking won’t be as valuable, as attendees and presenters clearly look forward to these rare chances to exchange experiences “face-to-face.” My colleagues and I will be there!

Day 2: Tuesday August 11

The opening session on Day 2 is compelling for its title, When Drug Research is Personal: Fireside Chat with Amicus Therapeutics’ CEO and CRO on the Criticality of Compliance in Advancing Lifesaving Therapies. For those of us who work in compliance training, making that training more meaningful to the individual learner is one of our persistent goals. If our clients can communicate the importance of the training to the careers of the learners, and the lives of the patients, learning is enhanced. I am looking forward to hearing John Crowley and Patrik Florencio describe how the “criticality of compliance in advancing lifesaving therapies” is put into practice at Amicus Therapeutics.

Scanning the agenda for the rest of Day 2, anytime the words “digital revolution” appear in a session title, I am intrigued. So, I will be curious to hear Chad Morin of bluebird bio. and Brian Berry of Vertex Pharmaceuticals describe that revolution in the Patient Centricity and Compliance in the Digital Revolution session.

From 3:00 pm to 3:45 pm, attendees choose from one of four hot topic roundtables. The roundtables are diverse and compelling, depending on your objectives. As always, I recommend dividing with colleagues, or even sharing notes with a new friend you meet in the networking session, to conquer and gather as much information as possible.

Two of the roundtables jump off the screen for me. The word “checklist” in any title always catches my eye. Calling All Emerging Biotechs – Pre-commercial Compliance Considerations and Checklist with Tiago Garrido of Verastem Oncology, Rupa Cornell of Takeda, and Trish Dring of MacroGenics looks to be an interesting primer for anyone in the unique position of preparing a product launch. And, since our training is so often targeted to field teams and the risks they encounter in interactions with HCPs, the Strategies for Field Team Compliance, with Erica Powers of Sage Therapeutics, Patrick Mooty of Sumitomo Dainippon Pharma America, and Julianne Brierley of Novartis will be on my list.

Day 3, Wednesday August 12

Wednesday’s agenda begins with the CCO Showcase: Cutting-Edge and Proactive Models Driving Compliance and Transcending Silos Across the Business. Kudos to conference organizers for scheduling such an impressive lineup of chief compliance officers: Daryl Kreml from Sage Therapeutics, Beth Levine from Regeneron, Jill Macaluso from Novo Nordisk, Bryant Aaron from Novartis, Tina Beamon from Karyopharm Therapeutics, and Joshua Marks from Boehringer Ingelheim. Dedicating time for follow up Q&A after the presentation is a great idea since the interaction with the audience usually offers some of the most interesting exchanges of ideas.

Following the DOJ and SEC Insights session from 2:00 pm – 2:45 pm (e.g., the U.S Attorneys session is always worthwhile) attendees are encouraged to participate in “peer-to-peer networking time.” Each attendee will have his or her own virtual meeting room for what is described as a “streamlined networking opportunity.” It’s another attempt by organizers to provide for personal interaction, and regardless of the outcome, they should be applauded for the effort. Think speed dating without the detail about long walks on the beach and pina coladas.

Day 3 closes with additional roundtable discussions intended to foster small group discussions. Rather than dedicate Wednesday’s roundtables to specific topics, I have been informed the focus will be on “thoughts from the day and conference so far.” I like it!

Day 4, Thursday August 13

Thursday’s agenda kicks off with what should be a worthwhile discussion about navigating the sea of life sciences compliance challenges in the crazy year that is 2020 with a session titled, A Look at How In-House Legal and Compliance Departments are Evolving in 2020 to Help Address Business Challenges. John Oroho from Porzio will moderate the panel joined by Tara D’Orsi of Kyowa Kirin, Michael Clarke of ConvaTec, and Michael Hercz of Sentynl Therapeutics.

Following a late morning session focused on emerging risk areas from industry advisors (hey, how come I wasn’t invited?!) and a lunch break, the day continues with a Small Group Interaction Hosted by Track Presenters, then into the series of live hot topic roundtables from 3:45 pm to 4:30 pm.

Two roundtables stand out for me based on the hot topics in compliance training: Speaker Programs – Current Enforcement Trends, Best Practice Benchmarks and Future Fate with Peter Agnoletto from Sanofi, John Knighton from TherapeuticsMD, Jennifer DeVincenzo of Sobi, and Charlene Davis of Aerie Pharmaceuticals; and Zero-In on Compliant Patient Interactions, with Terra Buckley of Mesoblast, Rahul Khara of Acceleron Pharma, Laurie Durousseau of Rigel Pharmaceuticla, and Christie Camelio from TG Therapeutics.

Day 4, Thursday August 13

The conference closes with two sessions sure to draw a large audience of attendees. First up is, Anti-Kickback Accusations and the Aftermath — An Inside Look at Sales and Marketing Practices Under Fire with Jonathan Roper, a former district sales manager for Insys Therapeutics. The Insys case obviously holds a deep cauldron of lessons learned in every aspect of compliance, and its impact continues to reverberate across the industry.

Finally, conference organizers could not have picked a better session to close with than Empowerment, Diversity and Inclusion. Sujata Dayal of Medline Industries, Jim Massey, formerly of AstraZeneca, Maggie Feltz of Purdue Pharma, and Veleka Peeples-Dyer from Baker & McKenzie LLP will delve into what is certainly a timely and important topic in today’s world.

See You at the Conference

The logistics involved in the transition to a virtual conference must be daunting. CBI, Informa Connect, and all the speakers, are to be congratulated on their efforts and dedication to bringing so much critical content to the agenda. It looks to be a fantastic five days of learning and I hope this information provides you with more context on some key topics that caught my interest.

If you’re attending the conference, I hope to see you in the virtual PharmaCertify booth, where you can learn more about our training products and services and share thoughts about the conference. If you have not yet registered, we still have $500 sponsor discount registration certificates available. Contact us at info@pharmacertify.com to take advantage of this opportunity to join us.

Thanks for reading. I will see you online at the conference!

Sean Murphy
Product & Marketing Manager
PharmaCertify by NXLevel Solutions

In a Virtual Detailing World, the Rules Regarding Good Product Promotion Still Apply

PharmaCertify Team , , , , , , , , ,

Life sciences detailing has changed, even if only temporarily, but the rules and best practices related to good product promotion have not. As field sales teams acclimate themselves to the reality of meeting with healthcare professionals through virtual means, they need to ensure those rules aren’t lost in the milieu of that change.

For example, no matter the means by which promotional speech is delivered, the FDA defines it as “any affirmative statement about a prescription drug or medical device.” Regardless of format, promotional statements made while meeting with healthcare professionals must always be truthful and accurate.

Representatives must never exaggerate or mislead the healthcare professional regarding the use, safety profile, or any other aspects of the product and any statements made about a product must include the benefits and the risks associated with the use of the product. They must never overstate the effectiveness of the product, make efficacy claims not supported by substantial research or misrepresent clinical study data. Fair balance cannot be ignored just because a rep is not meeting with the healthcare professional in person.

Products may only be promoted for uses approved by the FDA. In fact, if a healthcare professional asks a representative about an unapproved or off-label use, the rep needs to refer the question to the medical affairs department and, even during a virtual visit, a rep must never steer a conversation with the intent of prompting the healthcare professional to ask an off-label question.

Now is not the time to let the emphasis on good and compliant product promotion slip through the cracks. Updated training and microlearning covering topics like promotional speech, the Bad Ad Program, the use of social media, off-label marketing, and the dissemination of reprints and scientific publications is more important than ever to keep field sales teams compliant and effective.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

Note: the training content shared in this post is from our Good Product Promotion eLearning module, one of the 26 customizable modules available in our Compliance Foundations suite.

 

The 2019 DOJ Guidance Document: A Baseline for Life Sciences Compliance Training

PharmaCertify Team , , , , , , , ,
Sean Murphy
Product and Marketing Manager

One of the significant events of 2019 affecting life sciences compliance was the April release of a new guidance document, Evaluation of Corporate Compliance Programs, (https://www.justice.gov/criminal-fraud/page/file/937501/download) by the criminal division of the Department of Justice (DOJ).  The primary intent of the document is to guide prosecutors and courts as they evaluate corporate compliance programs, but it also serves as an important baseline for life sciences businesses evaluating all areas of their compliance programs, including the training curricula.

The guidance document highlights three questions for prosecutors to consider when evaluating a program:

  1. Is the corporation’s compliance program well designed?
  2. Is the program being applied in good faith?
  3. Does the corporation’s compliance program work in practice?

In this post, I examine the DOJ’s document in more detail, and discuss its implications for your compliance training curriculum.

Risk-Based Training

In reference to a “well-designed compliance program,” the DOJ stresses the need for prosecutors to focus on whether a company’s program is customized for the particular risk profile of that company. According to the guidance, prosecutors should “understand the company’s business from a commercial perspective, how the company has identified, assessed, and defined its risk profile, and the degree to which the program devotes appropriate scrutiny and resources to the spectrum of risk.” The company’s periodic training and certification should include all “directors, officers, relevant employees, and, where appropriate, agents and business partners.” In addition, training should be tailored to “audience size, sophistication, or subject matter expertise.”

In pursuit of these standards, foundational training is an effective method for providing a baseline, but additional risk-focused content continuously delivered to individual business units is one way to address that risk. As an example, scenario-based mini modules covering the topics highlighted in risk assessments and audits of the compliance hotline should follow the more comprehensive foundational training for each business unit to make it more relevant and engaging. In addition, microlearning nuggets in the form of quizzes, assessments, and contests have been proven to drive higher retention rates when delivered strategically across a learner’s calendar. Targeted, continuous learning covering the topics deemed critical to each business unit is the key to truly reducing risk.

Curriculum Analysis

On the topic of risk-based training, the DOJ recommends prosecutors ask, “What analysis has the company undertaken to determine who should be trained and on what subjects?” In line with that suggestion, a compliance curriculum analysis is a critical first step for any compliance professional interested in understanding the details of existing organizational training and it’s a necessary starting point for the reconfiguration of that curriculum to effectively address the risks. The categories covered in the analysis should include:

  • Training Type (eLearning, Live, Webinar)
  • Topic(s) Covered
  • Level of Training (Awareness, Detailed, General, etc.)
  • Length
  • Audience(s)
  • Risk Rating Per Audience (Low, Medium, High)

An instructional design analysis should also be included to determine if the proper learning objectives are established and followed, and the visuals, audio, navigation, and assessment are optimized for learning. The data should then be curated into a spreadsheet with sortable cells and columns to allow for an organized and multi-level review of all training programs and topics. At PharmaCertify, we use our Compliance Curriculum Analysis Tool, or CCAT, to assist our clients with this analysis. Once the CCAT is complete, we summarize to highlight the strengths, gaps, and redundancies in the overall curriculum.

Test and Test Again

The document also delves into the measurement of training effectiveness by encouraging prosecutors to ask if employees have been tested on what they learned and how the company has addressed employees who fail all or a portion of the testing. While the inclusion of standard assessments with each course is an assumed necessity, using assessments as learning tools has been shown to strengthen long-term memory.

A study by Jeffrey D. Karpicke and Henry Roediger III, of the Department of Psychology at Washington University revealed that learners are poor judges of what they remember, and when given the choice, they stop studying before they have mastered the subject. So even when they think they know it, they don’t, and assessments spaced repeatedly over time is the best method to increase the retention of critical compliance policies and best practices. When possible, alternative types of tests should also be deployed, including:

  • Pre- and post-training tests to measure gains scores
  • Priming assessments to encourage the formation of cognitive schema
  • Diagnostic assessments to help target remediation
  • Cumulative exams to encourage information retrieval and re-encoding

Effective Implementation, Review, and Revision

Finally, prosecutors are asked to consider whether a compliance program is a “paper program, or one implemented, reviewed, and revised, as appropriate in an effective manner.” This holds true not just for the program in general, but for the compliance training curriculum. Just as the corporation should “provide for a staff sufficient to audit, document, and analyze the results of the efforts,” the proper resources and time need to be dedicated to the evaluation of the current curriculum, with subsequent modifications conducted accordingly.

The DOJ’s Evaluation of Corporate Compliance Programs document refers to a compliance program’s capacity to evolve as a hallmark of its effectiveness. That evolution is necessary because “a company’s business changes over time, as do the environments in which it operates, the nature of its customers, the laws that govern its actions, and the applicable industry standards.” An effective life sciences compliance training curriculum must align the current business with the environment, customers, and laws, and now is the time to bring all of those components together.

I hope the insights above are helpful as you continue to improve your compliance training effectiveness throughout 2020. Thanks for reading!