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

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

Key Messages from the 2021 Virtual Pharmaceutical Compliance Congress (And How the Messages Affect Your Compliance Curriculum)

In what was hopefully the last of the “virtual” compliance conferences (fingers and toes crossed), the 2021 Pharmaceutical Compliance Congress (PCC) offered time-tested and established standards (insert “tone from the top” and “ethics-based approach” here), thankfully blended with new best practices, trends, and suggestions from an impressive list of industry executives and government representatives. Some of the key messages from the three-day conference are listed below, along with my thoughts on how those concepts affect your training curriculum in 2021 and beyond.  

1. OIG’s Special Fraud Alert on Speaker Programs still ripples across the industry.

The comments surrounding the OIG’s Fraud Alert released last November certainly were not revelatory, but the fact that industry insiders and regulators are still stressing its importance is meaningful. The Alert was referenced right out of the gate in the presentation by Jim Stansel of PhRMA, and one presenter in the Enforcement Trends presentation summarized its impact by saying, “OIG has thrown down the gauntlet on speaker programs with the Fraud Alert.” As the industry moves away from virtual engagements toward more in-person programs, expect intensified scrutiny.

Speaker programs remain a hot topic for enforcement, and as the industry emerges from the pandemic, your learners need refresher training on the foundational rules of compliant speaker programs and the key concepts associated with those programs. We can help, with our recently updated PharmaCertify Foundations eLearning module, Managing Speaker Program Risk.

2. Data is your friend. (Or should that be “Data are your friend? That one always confuses me.)

The need to scrutinize data has been a recurring topic of conversation, and this year’s PCC was no exception. Having access to data in the right form and unitizing that data to identify trends and outliers is key to an effective compliance program. “Be proactive to dig deep into the data,” one presenter at the Chief Compliance Officer Showcase on Day 1 suggested, “and identify field personnel who are consistently right at the meal limits.”

In life sciences compliance, the devil is in the data, and an informed evaluation of data is critical when updating and optimizing your compliance training curriculum. What is the data telling you? If you’re seeing concerning trends, you’ve got a training challenge. And if you’re not seeing any trends, you’re probably not looking hard enough, or you’re not gathering the right data. As my colleague, Dan O’Connor, pointed out in the Creative Compliance Training Solutions presentation, “when you send out post-training surveys, don’t ask the learners if they liked the training, focus on what they learned and ask them what they can apply in their jobs.” The data is out there, you just have to find it.

3. An ounce of compliance prevention is worth a pound of effectiveness.

In the Former Prosecutor Panel, one presenter emphasized the need to proactively address issues, whether a company is establishing its compliance program or reinforcing important policies as the business evolves. “Getting legal advice on the front of the program is important,” he says, “and when you move back to live interactions, refresh employees on the perils of speaker programs.”

No matter the topic, an adaptive approach to learning is the most effective way to ensure your audience is mastering the concepts and policies. Retention is enhanced when training is rolled out on a continuous basis, in the form of microlearning nuggets, where learners are asked to repeatedly demonstrate their knowledge and understanding. You will sleep better knowing you’ve taken steps to reduce risk.

4. Join in the innovation.

During the Chief Compliance Officer Luminary Panel, one presenter pointed out that the pandemic has forced companies to be innovative in how they navigate business activities, and she reminded the audience that the compliance department “should play a big role in that innovation.” The day of compliance and business operating in siloed fashion are long over. “A seat at the table” is no longer a hopeful cliché randomly mentioned at compliance conferences. To facilitate a true partnership under which compliance polices and best practices are integrated into the daily activities of the workforce, everyone involved needs to understand that risk tolerance in the industry has changed, and the only way to reduce that risk is through a unified spirit of collaboration and innovation.

That notion of cooperation and collaboration extends to training. When compliance training and concepts are integrated regularly into each employee’s full curriculum and daily work, learning is enhanced and stronger ethical cultures are forged. And as was referenced on Day 1 of the conference, statistics from the Ethisphere Institute, an organization focused on defining and measuring corporate ethical standards, show that companies with strong ethical cultures perform better.

5. Evaluate your vendors’ compliance programs as part of your due diligence.

The idea of conducting due diligence before hiring third-party vendors has long been espoused at compliance conferences. But I was intrigued to hear a presenter in the Fireside Chat with CCOs suggest an even deeper dive into a vendor’s compliance program to evaluate whether its practices and principles align with those of your company.

On the training front, that includes a thorough evaluation of the vendor’s compliance training program. Do they cover the high-risk topics pertinent to your company and its products? Do they conduct compliance training in general? How often do they train their employees? How accurate and focused is that training in terms of content? These are the type of questions that need to be incorporated into your third-party vendor risk questionnaire and considered before the contracts are signed.

6. The Sunshine Act rises again.

Too often, life sciences professionals regard Sunshine Act/Open Payments training as a “one and done” event. But as presenters in the Analysis of OIG Special Fraud Alert on Speaker Programs and Assessment of Future Activities session pointed out, Medtronic’s recent settlement with the OIG included a payment to resolve allegations that it failed to accurately report payments to CMS. This topic is too big and too risky to not being training more aggressively.

In addition to refreshing the content in our Compliance Foundations module, The Sunshine Act and Open Payments, we recently added The Sunshine Act Payment Categories QuickTake module to our library of customizable off-the-shelf products. The five-minute module is the perfect complement and reinforcement course to the foundational training, which covers the topic at a higher level.

7. The pandemic is not an excuse.

The notion that the pandemic does not give companies an excuse to lose sight of compliance was repeated daily throughout the conference. Industry leaders and government representatives reminded the audience that the shift to virtual interactions and programs will not be viewed as justification for breaking the law or acting in bad faith. Even though the way in which business is conducted has changed, the core principles and rules governing compliance have not.

The same holds true for your training curriculum. Don’t use the pandemic as an excuse to “put off” searching for ways to enhance training and increase engagement. In fact, you should be doing just the opposite as the industry shifts back to more live interactions. We can help with our Compliance Curriculum Analysis Process (CCAP), which is a comprehensive process to identify training gaps and reinforcement opportunities in your training components.

8. Expect continuing focus on foundations and copay assistance.

Enforcement trends around patient support programs and foundations are growing. It’s a topic on the minds of regulators and routinely on compliance conference agendas. As one of the presenters in the Keynote Enforcement Panel on Emerging Trends Enforcement put it, “we are seeing a ton of copay assistance cases in our district.”

Emphasis needs to be placed on patient program training. And to borrow a phrase, we’ve got a module for that. The Compliance Foundations module, Patient Programs and Their Risks, is a great starting point. Module topics include protecting patient privacy, discussing programs with HCPs, working with vendors, and a topic that is top of mind in life sciences – donations to foundations.  

Conclusion

The organizers of the virtual PCC have made the main stage and on-demand sessions available until May 29 for attendees. If you were there, I highly recommend you visit the conference site for content you may have missed or to revisit the sessions most relevant to you and your company. It’s one of the perks of attending a virtual event.   

While Informa made every effort to replicate the look, agenda, and networking opportunities associated with a live event, it cannot match the on-site conference experience. Fortunately, I am told Informa is planning a live conference for the fall, which will be welcomed news if the dates don’t conflict with those of the Pharmaceutical Compliance Forum’s conference. Bring on the real thing!

Thanks for reading; I look forward to seeing you “live and in person” at a conference before too long!

Sean Murphy
PharmaCertify by NXLevel Solutions

Jen Anderson of Vertex, Jackie Parris of Incyte, and Dan O’Connor of PharmaCertify present during the Creative Compliance Training Solutions session at the virtual 2021 Pharmaceutical Compliance Congress.

A Preview of the 2021 Pharmaceutical Compliance Congress…As Seen Through My Compliance Training Glasses

pcc2021In what could be Informa’s final “virtual” compliance congress (fingers crossed), the spring kickoff Pharmaceutical Compliance Congress offers a plethora (sweet…I got to use “plethora!”) of industry leaders and government representatives covering oft discussed, yet still relevant topics, mixed with new and timely entries to the agenda (e.g., transparency tips for 2021, advancing virtual interactions, applying behavioral science to drive an ethical culture).

From a compliance training standpoint, the general sessions and breakout workshops at PCC offer attendees the rare opportunity to evaluate their own programs and curricula against the industry standards espoused by the well-known panelists and presenters. The bottom line: if you want to keep up with your peers, you really should try to be there. We can help make that happen with a sponsor discount on the regular registration rate. Just email me for the details, get yourself registered, and get ready to soak up three days of the information you need to keep your training meaningful.

I’ve perused the conference agenda with an eye toward what each session could mean for you in general and for your 2021 training plan and here are a few of the sessions that jump off the screen:

Day 1: Tuesday, April 27

Refill your coffee cup before 10:15 am, and make sure the rest of your morning/early afternoon calendar is clear because after the chairperson’s welcome, Informa comes out of the gate swinging with three general sessions sure to have you glued to your computer screen.

The fun begins at 10:50 with James Stansel, Executive Vice President, General Counsel and Corporate Secretary at PhRMA presenting the Current Snapshot of Affairs Coming Off an Unprecedented and Politically Charged Year. Could there be a more aptly titled presentation to kick off a life sciences compliance conference after what we went though over the last 12 months?

The content you really don’t want to miss starts flowing with the Fireside Chat with CCOs – Top 10 Items on Their Radar and Why They Should Be on Yours presentation from 11:00 – 12:00. Who doesn’t love a good top ten list? (except of course David Letterman since we are just “borrowing” the concept from him.) Other than maybe “best one hit wonder music acts,” I can’t think of a topic sure to have the audience around the virtual office water cooler buzzing for weeks to follow. And, let’s face it, once someone mentions Come on Eileen by Dexys Midnight Runners, the one hit wonder list just runs out of staying power, while that OIG Speaker Programs Fraud Alert is going to be on the industry’s mind for months to follow. Toora loora toora loo rye ay!

We break for lunch at 12:00 – but as importantly, you have plenty of time to visit the virtual Exhibit Hall and learn about the various products and services available from the vendors. We’ll be at the PharmaCertify booth with demos of our newest eLearning modules and other training tools to help you manage your company’s risk and build a stronger culture of ethics and compliance. We’re creating some cool (and effective) stuff that you really need to see. I implore you…come see us lonely vendors!

File the third general session, the Keynote Enforcement Panel, in the “oft discussed but still quite relevant” category. The panelists here represent the metaphorical heart of the PCC batting order, with an acting U.S. Attorney and a First Assistant U.S. Attorney being joined by a representative of the DOJ and another from a private law firm to hold court (okay, am I pushing the euphemisms too far?) over the audience with the latest list of topics expected to be at the forefront of enforcement this year.

At 3:00 pm on Day 1, the agenda is divided into four simultaneous working groups. All of them look compelling for different reasons, but if transparency training is on your 2021 radar, I suggest Trends from 2020 Transparency Reporting and Tips for 2021 with Terra Buckley and Chelsea Ott, both of Medpro Advisory Services. Terra is one of the best industry presenters I have heard on the life sciences compliance circuit and her recent move to head up the advisory services for Medpro is quite a coup for the company and quite a bonus for its clients. Terra knows the ins and outs of transparency (and all things compliance, for that matter) and she is sure to leave you with actionable suggestions for optimizing your program.  

At the same time, I can make an equally compelling case for the Advancing Digital and Virtual Interactions session, or the Optimizing Compliant Patient Interactions session based on recent headlines and settlements as well as the compliance star-studded panel scheduled for each one. Since the sessions are simultaneous, teaming up with colleagues and taking copious notes to share later is your best option to ensure appropriate coverage. That’s my plan, and if you’re looking for a “study buddy,” I’m happy to join forces. Don’t be shy, call me!

Day 2: Wednesday, April 28

After the annual year in review video presentation, the OIG fraud alert makes its first scheduled appearance at 10:30 on Day 2 with the Analysis of OIG Special Fraud Alert on Speaker Programs and Assessment of Future Activities. Considering the buzz it has stirred up in the industry since its release, don’t expect this to be the first, or final, reference to the document during the conference. The FDA Office of Prescription Drug Promotion (OPDP) and Center for Medicare and Medicaid (CMS) will follow at 11:05 and 11:35 respectively, in two sessions that typically prove to be helpful peaks into each agency’s workplan and focal points for the upcoming year.

Then at 12:00, it’s back to the Exhibit Hall. We’ll be waiting in case you didn’t get the chance to stop by on Day 1. After all, look at this top-notch lineup of sponsors and exhibitors ready to hear about your challenges and help you meet you goals!

During the afternoon, the 1:40 session, titled, Former Prosecutor Panel – Answers and Insights from Industry’s Trusted Advisors should offer insight, tips, and suggestions from a panel with unique insight into both sides of the regulatory table. And the CCO & GC Luminary Panel – Leading Strategies to Advance the Business and Accelerate Innovation, scheduled for 3:00, features a list of well-known and respected professionals, including Beth Holly from Regeneron.

At 4:00, attendees again break into one of four simultaneous “roundtable exchanges” to end the day. Depending on your priorities and business profile, you may not want to miss Table Talk A, Speaker Programs or Table Talk B, Insights for Emerging and Newly Commercial Companies, but I would be remiss to not recommend Table Talk D, Creative Compliance Training Solutions. My colleague, Dan O’Connor, will be joined by Jackie Parris of Incyte and Jen Anderson of Vertex to delve into how each company is using innovative training solutions to reduce risk across their companies. You don’t want to miss the demos in this one, so remember to “divide and conquer” across all the sessions if necessary.

Day 3: Thursday, April 29

The final day of the conference features a global tilt, beginning with the IFPMA Spotlight – Deep Dive into Evolving International Best Practices at 9:30, followed by Global Payments and FMV at 10:05, and the EU e-Privacy Directive and the Impact on Monitoring Digital Communications and Social Channels (that one is a mouthful, isn’t it?) at 10:40. Whether your company has a global footprint or not, the life sciences world is a small one and we’ve come a long way since the days of the FCPA being the primary driver of worldwide regulation, best practices, and ultimately, your training curriculum.  

The day ends with a one-hour Diversity and Inclusion Summit at 12:00. It’s a timely and important (if not long overdue) way to close the conference and I will be listening for ideas on how the panelists integrate diversity concepts and messaging into their compliance training.

Summary

Hopefully, the next time I write a compliance congress preview (Informa or PCF), it will be in anticipation of an upcoming live conference. As much as I appreciate the efforts of conference organizers to replicate the live experience virtually, frankly it can’t match the value of gathering in-person. For vendors and industry attendees alike, nothing replaces the insight available through face-to-face interactions.

That being said, Informa has created a compelling agenda for this year’s virtual version of the Pharmaceutical Compliance Congress with sessions applicable to both the new and seasoned life sciences compliance professional. Opportunities, such as this, to hear from esteemed leaders in the field and regulators are rare, and anyone interested in hearing up-to-date data, tips, and suggestions for modernizing and maintaining an effective compliance program should make every effort to attend. Again, we can help with that.

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

Sean Murphy
PharmaCertify by NXLevel Solutions

Key Training Takeaways from the KENX Biopharma and Biotech Corporate Compliance Summit

There is a new player in the life sciences commercial compliance conference space. After focusing on the GxP compliance field for years, the Knowledge Exchange Network (KENX) has joined the lineup of organizations targeting the commercial side of the industry. With Informa Connect (CBI) and PCF setting such a high bar for compliance conferences for years, I was looking forward to the possibility of hearing even more ideas for building an effective compliance program during KENX’s recent Biopharma and Biotech Corporate Compliance Summit webinar.

And that is exactly what happened, as an impressive array of industry leaders and established vendors presented new tips and suggestions for reducing risk and building an effective compliance program for established and emerging companies alike. Here are five key takeaways from the day-long webinar that may help you optimize your compliance training curriculum (that is, after all, our mission and passion at PharmaCertify):

1. “Establish a relationship with senior sales personnel so compliance is top of mind for new hires from the start.”

While the “partner with the business” refrain has been espoused frequently over recent years, the idea of turning to the sales leaders to make sure sales representatives hit the proverbial ground running is a compelling twist – particularly for compliance professionals from emerging companies, where resources are limited. Just as compliance needs to have a seat in the business, the business (and sales) needs to be part of the compliance committee to help establish a baseline of compliance expectations and avoid miscues from the start.

2. “The best practices and the rules are evolving quickly, especially during the pandemic. Keep in touch with your peers to discuss how they are managing the evolution to virtual interactions and changing policies.”

I have written about how the larger compliance conferences offer a rare opportunity for compliance professionals to interact with their peers one-on-one and soak in best practices for compliance. But isn’t it a shame that those opportunities are so rare? They don’t have to be. Organizations like KENX, Informa Connect, and PCF offer smaller one-day sessions focused on a plethora of topics, and even when conducted virtually, these programs offer a chance to connect with those who are dealing with the same challenges as you. Even if it’s through a compliance training group like the one we created on LinkedIn, sharing common experiences, successes, and bumps in the road is a critical tool for navigating the morass of changing policy and priorities during the pandemic.

3. “Study the 2020 OIG Fraud Alert to identify the areas that are top of mind for government regulators moving forward.”

A cursory review of the special fraud alert released by the OIG last November reveals nothing revelatory or surprising in terms of the fraud and abuse risks related to speaker programs. Rather, as was noted during the webinar, the importance of the alert lies more in the mere fact that the agency released it. On page 3 of the document, the agency states “Our investigations have revealed that, often, HCPs receive generous compensation to speak at programs offered under circumstances that are not conducive to learning or to speak to audience members who have no legitimate reason to attend.” Anyone who has been paying attention to recent settlements is not shocked by such a statement but the language points to two of the areas the OIG considers to be of primary concern for compliance violations. Consider this special alert as a shot across the bow of the industry. The focus on the speaker programs isn’t going away anytime soon, and now is the time to make sure your policy and training targeting reps, presenters, and vendors is up to date and covers all the risk areas.   

4. “Trade show vendors have probably not thought through the potential compliance concerns of holding the meetings virtually. You need to be engaged with them about those details beforehand.”

Compliance training cannot end with employees, especially during a pandemic when the rules are constantly changing. When a vendor is organizing a trade show or conducting any business on behalf of the company, the risk grows exponentially. Are your trade show vendors aware of the rules and your policies regarding product promotion and scientific exchange? Have you fully considered the ramifications of building and delivering online training for vendors? Don’t assume that your vendors are going to take the same diligent approach to compliance as you do and don’t just hope they stay abreast of the latest best practices around virtual communication. If you launched vendor training prior to the pandemic, consider adding microlearning refresher training to highlight changes in policy.

5. “Utilize a campaign approach to training to support branding efforts and make the concepts more memorable.”

The session titled, “Training – Best Practices for Promotional Compliance challenges in a Virtual World, Creative Solutions to Keep Sales Reps from Going Off the Guardrails” offered a range of tips for changing behavior through core training, performance support, and reinforcement training (I know, I’m biased because the co-presenter was my colleague, Dan O’Connor, but you really should see this slide deck). No matter your budget, rolling out branded components across a learner’s timeline, rather than launching one large bolus of content, has been proven to enhance learning and increase the retention of that content. The “Forgetting Curve” is real, and if you want to make your training more memorable, you need to make it continuous.

All the presentations during the Biopharma and Biotech Corporate Compliance Summit offered enough nuanced twists on familiar topics to make a one-day commitment of time worthwhile. The last year has seen an upheaval in how the industry conducts business, which has resulted in a sudden need for changes to compliance practices and policies. Even with established organizations like PCF and Informa Connect continuing to keep their own events timely and relevant, there is always room for another player. Welcome to the party, KNEX.

Thanks for reading!

Sean Murphy
PharmaCertify

Ten Training Takeaways from the 21st Pharmaceutical and Medical Device Ethics and Compliance Congress

The Pharmaceutical Compliance Forum (PCF) went to great lengths to replicate the experience of a live conference in this year’s virtual Pharmaceutical and Medical Device Ethics and Compliance Congress. The virtual conference platform featured presentation rooms and realistic exhibit halls that made navigating the user interface simple and logical.

Organizers took advantage of the virtual nature of the conference to maximize the amount of content available through live presentations, along with a plethora of recorded presentations available for viewing any time. In fact, if you attended the conference, the sessions will remain available to you for up to six months – so don’t be shy about logging back in and catching up on what you missed.

I’ve done just that over the last few weeks and in the spirit of the PharmaCertify mission to help you reduce risk and strengthen the compliance culture in your company, here are ten key conference takeaways to help you build a more effective training curriculum.

  1. Meals, meals, meals.
    How to handle meals during the pandemic (in speaker programs and otherwise) continues to be a common refrain during conferences. Speakers from the pharmaceutical and medical device industries touched on the topic, with the conversation mostly focused on the importance of sending meals only to HCPs’ offices and hospitals, and not to their homes. PhRMA’s guidance released earlier this year is a good starting point for updating policies and building new training: https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA-Code-Section-2.pdf. Clearly if you have not addressed the way in which meals should be provided in your policies and subsequently in your training, you should.
  2. Remember the changes to the Sunshine Act.
    Speaking of updates, attendees were reminded that the changes to the Sunshine Act go into effect in January. If your core Sunshine Act training hasn’t been updated, you need to make your learners aware of the changes in the list of covered recipients and the nature of payment categories…quickly!
  3. Be aggressive.
    Throughout the conference, government regulators agreed that they tend to view companies that have a robust compliance program more favorably during investigations. Or, as one panelist in the AUSA Roundtable put it, “if you’ve properly dealt with the problem, we’re probably going to go away.” That extends to your compliance curriculum. So not only is a “check the box” approach to training a bad idea in terms of learning, it also isn’t going to impress regulators when they come calling. A modern and effective curriculum needs to be evaluated against your company’s risk, and it needs to be supplemented with regular nuggets of training spread across the learner’s timeline.
  4. Keep the communication flowing.
    An effective curriculum doesn’t end with the deployment of training. The importance of on-going communication during the pandemic was reiterated in multiple sessions throughout the conference. Presenters focused on how the sudden shift in the way business is conducted has forced them to think about how they stay in touch with leadership and the field. The need to think differently has clearly given birth to ideas and best practices that will continue post-pandemic. Whether designating “compliance liaisons” from the businesses to bring ideas and questions back from the field, or rotating people from the businesses through the compliance department, presenters are finding creative methods to ensure compliance stays top of mind for the long term.
  5. Patient support and speaker programs are still in focus.
    Gregory Demske and Mary Riordan reminded attendees that the OIG’s focus is still squarely on patient support programs and speaker programs. And interestingly, Demske encouraged viewers to ask themselves if they really need to go back to in-person speaker programs after the pandemic and warned that the agency is going to continue to look carefully at “payments to prescribers that are under the guise of speaker programs.” Recent CIAs focused on speaker programs and patient support programs are a good starting point as you evaluate your training plan.
  6. Pay attention to social media.
    According to presenters in the social media mini summit, 70-80% of patients get information from online resources. While that’s not a surprising number in our digital age, it’s concerning in light of the dearth of guidance from federal agencies. Presenters emphasized the need to stay abreast of the emerging social media platforms and evaluate training plans in context of the limited social media guidance that is available. And the risks of social media aren’t limited to the pharmaceutical industry. In the Medical Device Roundtable session, one presenter warned that cutting-edge technology often can lead to representatives being overly enthusiastic on social media. It’s a scary, changing world online, and as a compliance professional, you need to be continually addressing it in targeted training.
  7. Customize training for company-specific risk.
    I may be biased, but the discussion about the risk-frequency framework by Dan O’Connor in the State-of-the-Art Compliance Training mini summit is “can’t miss” conference viewing. If you did miss it, let me know, and I will be happy to coordinate a brief review of the concept with Dan. The framework is a great starting point for evaluating the appropriate mix of training based on the riskiness of the activity and the frequency at which that activity occurs. Ours is not a one-style-of-training fits all world and the framework is a good way to look at your curriculum and make adjustments in the tools and techniques to address risk accordingly.
  8. Emphasize a culture of integrity, not just compliance.
    Those of us who have been working in life sciences compliance for a long time know the industry has been touting the need to shift away from a rules-based approach to compliance to one based on values and ethics. That shift is in process and was best summarized by a presenter in the Integrating Ethics and Compliance session when she said she finds the word “compliance” to be limiting and she prefers the word “integrity” to emphasize that how one does something is as important as what someone does. Or, as another presenter in the same session said, “now is the time to create a culture where people are comfortable speaking up.” That’s the language of a values-based approach and it certainly seems like it’s here to stay. Does your training incorporate these themes?
  9. The core rules still apply.
    While COVID-19 has changed the way in which business is conducted and how interactions occur, the core principles of compliance still apply. In fact, as multiple regulators and industry professionals were quick to note, “COVID is not an excuse for non-compliance.” Some of the details may have changed, but speaker programs need to be monitored, speakers need to be trained, reps need to stay on-label, federal regulations still apply,  and state disclosure laws need to be followed.
  10. More risk is okay if you have a strong foundation to manage that risk.
    Many years ago, when I started working in compliance training, I could not have imagined someone being bold enough to publicly say more risk is okay. But there I was in the CCO Fireside Chat, when I heard a presenter confidently say, “striking a balance between the legal environment and business goals is key.” To my surprise, he followed up by saying, “and to help the business be more risk tolerant you need training that is sticky and impactful.” The assessment is an honest and refreshing one, and hearing the word “sticky” used in reference to compliance training brings music to the ears of someone who has been part of a team encouraging the industry to do that for 15 years. The future may be filled with more engaging and dynamic training after all.
  11. Thanks for reading!

    Sean Murphy
    PharmaCertify By NXLevel Solutions

Compliance Training Lessons from the 2020 Virtual Pharmaceutical Compliance Congress

Part 2: A Continued Focus on Speaker Programs and Patient Support Programs

This is the second in a series delving into compliance training lessons learned at the 2020 Virtual Pharmaceutical Compliance Congress. Before the sudden changes brought on by COVID-19, speaker programs and patient support programs were two of the hottest topics in the industry and the pandemic has only heightened the concern. Through live presentations and on-demand sessions available throughout the conference, regulatory officials and industry representatives offered suggestions for managing the programs.

Speaker Programs

During the Enforcement Deep Dive and the DOJ and SEC Insights sessions, panelists reviewed the recent settlements and CIAs related to speaker programs. The cases mostly focused on what one presenter referred to as the “hallmark red flags” he and his colleagues look for in an investigation: repeat speakers and attendees, speakers who were high-prescribing HCPs, alcohol being served, and less than adequate attendance. Alleged violations in the settlements were based on everything from the inappropriate fees paid to speakers and improper promotional activities at the programs, to some companies paying speakers for programs that never occurred.

While regulators provided the groundwork related to traditional topics like speaker criteria and compensation, and attendee management, industry professionals shared tips for effectively managing the programs during a pandemic. In the session titled, Operational Considerations for Speaker Programs During a Pandemic, presenters offered a list of considerations such as updating training on tracking and reporting attendance; adding up to an hour of prep time so all participants have the opportunity to get comfortable with using the technology; and reviewing existing HCP contracts and adjusting provisions for travel since travel to the programs is not currently required.

Not surprisingly, the practicality of providing meals during the pandemic was raised throughout the conference. During the DOJ Enforcement Trends Related to Speaker Programs on-demand session, the challenges with documenting and tracking consumption were raised as a unique risk associated with virtual programs. For example, “ensuring attendees stay for the educational component of a program,” and “providing meals in a way that accounts for COVID-19 related health and safety issues” are suddenly necessary considerations.

Virtual speaker programs raise challenges the industry has not had to consider before the pandemic. Presenters offered an important reminder as to why diligence to how these programs are executed is more critical than ever, by reminding the audience that “government agencies have made it clear they will scrutinize conduct…companies should still comply with codes of conduct and government regulations. There is no COVID-19 defense.”

Patient Support Programs

On the patient support program front, the emphasis in investigations is on what one presenter called “good evidence of bad motivation.” As with speaker programs, the fundamental rules continue to apply. For example, the programs cannot be used to influence a provider’s or patient’s medical decisions and patient privacy must always be protected. Grants and donations to foundations cannot be driven by sales and marketing, or as one presenter put it, “the commercial side should never determine how much goes to foundations.”

With patient foundations being a focus in recent CIAs, presenters during the Enforcement Snapshot and Best Practices Related to PAPs, Coupons and Foundations session covered the important requirements established in those settlements, including the need for a governance committee that is solely responsible for activities related to copay foundations; the importance of establishing an annual budget for donations to foundations; the requirement that donations must be selected using a risk-based approach and random sampling; and the need to be aware of state limitations on copay assistance, such as Massachusetts and California not permitting assistance when a generic is available.

Presenters also pointed out that settlements involving patient support programs have changed for one significant reason: the foundations have also been targeted and have entered into agreements with the government. As one presenter put it, “that means the foundations have skin in the game. Gone are the days when manufacturers called all the shots around contributions to foundations, program design, and compliance controls.”

The requirements detailed in recent settlements point to the need for updated policies and practices, and subsequently, updated training around patient support programs. Not only does core training need to be modified, a new approach is needed to ensure pull through on the significant changes.

A New Approach to Training

Clearly, the fundamental rules related to speaker programs and patient support programs have not changed and still need to be addressed in training, as they were before the onset of the pandemic. speaker programs and patient support programs continue to be high-risk activities. When they are not managed properly, companies face the potential for off-label promotion, false claims, and Anti-Kickback Statute violations, to name just a few. But the nuances of how these programs are executed are now in flux and require serious consideration in terms of content updates and delivery modalities.

Foundational training remains an important starting point. Dedicated training on speaker programs should still include core topics such as program logistics, audience requirements, speaker compensation and training, and answering off-label questions. And patient support program courses must continue to focus on areas such as protecting patient privacy, working with vendors, and working with patient assistance foundations.

Clearly, COVID-19 requires changes to how both types of programs are planned and executed. To ensure targeted employees stay in compliance a supplemental approach towards reinforcement may be appropriate. For example, mini modules covering the provision of meals should be considered to stress the details of updated policies. In addition, microlearning components in the form of mini-assessments, videos, and podcasts are a valuable way to increase the retention of new and updated policies as well as the foundational topics. And custom scenario-based training is an ideal format for highlighting aspects of policies that are particularly relevant to conducting these programs during the pandemic.

Increasing the retention of compliance training is more challenging than ever given the changes in which your field staff and other employees conduct business. The information shared during the Pharmaceutical Compliance Conference serves as a reminder that speaker programs and patient support programs continue to be high areas for risk and a focus of investigations. The onset of COVID-19 has complicated that risk by forcing the industry to rethink how the programs are managed and how employees are trained on the details. Creating a continuous training curriculum, with new microlearning components integrated across learners’ timelines, is critically important to ensuring those details are not lost while understanding that the potential for violations are increased.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

Up Next: Enhancing Training Engagement in a Changing Industry and World

Compliance Training Lessons from the 2020 Virtual Pharmaceutical Compliance Congress

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

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

Dear Connie, the Compliance Training Specialist, Tackles Return-To-Work Policy Training

Welcome to “Dear Connie, the Compliance Training Specialist,” where we answer questions about compliance training topics and present solutions for strengthening your compliance culture and reducing risk.

This week: Don’t forsake the fundamentals when building return-to-work policy training.

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Dear Connie,

As my company considers reopening our offices under the threat of COVID-19, I’ve been asked to create training based on our new back to work policy. The policy covers precautionary measures (wearing a mask, hygiene, social distancing, etc.) as well as the potential risk factors (international travel, living with someone who has tested positive, sore throat, shortness of breath, etc.).

What type of training do you recommend based on this unique content? Obviously, face-to-face training is not plausible right now, but is one eLearning module enough for a topic this important?

Signed,

Cautious in California

Dear Cautious,

Great question! As the life sciences industry, and the country in general, plans a careful return to work, now is the time to finalize a training and communication plan to help maximize the safety and well-being of employees. A topic this important deserves not to be rushed and framing the challenge within the context of the ADDIE model is important.

Analysis

You don’t want to miss any instructional challenges on a topic like this one. For example, what are the different roles of the learners? Do you have to consider different training tools for office staff versus lab employees? How about field employees? What pre-existing knowledge does each group bring to the training? Only after you’ve established the learner groups and identified the challenges of reaching each of those groups, can you start to design the proper training.

Design

Now you need to establish the learning objectives and think about how the content will be structured and what tools will be utilized. I would certainly consider a campaign approach, perhaps starting with an eLearning module, followed by other learning nuggets, to make it more memorable and engaging. You may want to also consider on-site posters to reinforce key messages, like the need for employees to follow the rules on washing hands and not touching their faces.

Development

In a case like this, development extends well beyond just creating a storyboard for an introductory eLearning module. The content needs to be organized in a manner that maximizes the engagement for each group, as determined in the design phase. The tools and media utilized to emphasize key messages are important. Animated video, for example, is a popular trend, but you need to be careful the animation doesn’t present such serious content in an inappropriate or humorous manner.

Implementation

Don’t fall into the trap of thinking that since this is critical to their safety and well-being, the learners are going to welcome the training with open arms and dive in enthusiastically. Implementing the training in a manner that optimizes retention is critical, perhaps more than ever. Consider the way in which lessons are “chunked” and delivered across each learner’s timeline.

Evaluation

Training intended to help employees learn the rules of returning to work during the COVID-19 crisis should be evaluated and adjusted accordingly. Gather feedback from the learners through surveys and personal outreach. You need to know it’s working, and you need to answer the learners’ questions. Consider sending out short updates as the Centers for Disease Control (CDC) issues new guidance. Don’t let the training get stale!

Summary

The COVID-19 pandemic has changed the life sciences industry, but the fundamentals of memorable and effective training stay the same. Now is not the time to abandon those principles and practices to expedite the development and launch of new policy training. In fact, when faced with the challenges of ensuring the health and safety of employees, just the opposite is true.

My friends at NXLevel Solutions have over 15 years of experience developing policy training that improves retention of content and changes learner behavior. Contact Dan O’Connor at doconnor@nxlevelsolutions.com to ask how they can help ensure your “Return to Work” training helps maximize the safety of your company’s employees during these uncertain and crazy times.

Thanks for the question and stay safe!

Connie

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

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.