11 Key Takeaways from the 3rd Annual Life Science Compliance Training Conference

Last week, we sponsored Q1 Production’s 3rd Annual Life Science Compliance Training Conference, where a highly-energized group of compliance training leaders from the pharmaceutical and medical device industries shared their ideas and techniques for making compliance training more engaging, creative and effective.

Here are my key takeaways from two great days of presentations and spirited conversation:

1. Less is more.
The idea of shorter, higher-impact training was reiterated throughout the conference and was a common theme across the presentations. One presenter said her company now limits all compliance training to 15 minutes and another said her company “hasn’t rolled out training longer than 15 minutes in two years.”

2. Remember the tone from the middle.
While “tone from the top” has been a point of emphasis in the industry for a long time, “tone from the middle” was cited as a key in multiple sessions in Chicago. “The immediate manager has to understand the message,” one presenter said, “that is who the people in the field are going to hear the message from.”

3. Communication is training too.
As one presenter put it, “anytime we can connect with an employee with something they can takeaway, it’s training.” Companies are using a variety of methods to make that connection, ranging from quick reminders via email, to video clips, resource websites, and graphic comic novels. Think outside the box and look for continuous touch points.

4. Tell a good story.
Research shows that well written stories improve learning and increase retention of critical compliance content and policies. The quality of the writing is the key. Once you find a good writer, have him or her create a story arc and develop a narrative. To save on budget in the production, use illustration instead of video. It’s less complex. The quality of the writing is as important, if not more important, than the nature of the medium.

5. Measure the metrics.
Data is important and even the “soft” metrics like feedback from the learners and the managers, testing results, changes in audit data, and increases in hotline reports, are important when identifying what curriculum adjustments are necessary. Data is important, so much so that one presenter noted that she recently hired a “data analytics person” to see what else they can learn.

6. The principles-based approach to compliance is here to stay.
The principles-based approach to compliance was introduced years ago and it has clearly become a trend in the life science industry. Multiple presenters discussed the need to empower personnel with the ability to make decisions, rather than just training on the rules. As one presenter put it, “let them make their decisions about what is the right thing to do, and let them know where to get the answers if they are uncomfortable making the decisions.”

7. GXP compliance training requires a different approach.
This one was a surprise and was raised in response to questions from the audience. Several presenters noted that they are also responsible for GXP compliance training and the nature of the content and the expectations of the learners require a much more traditional approach to training. Essentially, a rules-based approach is much more necessary when dealing with manufacturing compliance.

8. Create a brand.
To quote one presenter, “companies spend millions of dollars branding products, so why not brand compliance training?” Branding gives you more opportunities to creatively communicate the key concepts and messaging. Brand the policies and the principles to create a coordinated and clear message.

9. One size does not fit all.
When developing compliance training, keep the learner’s application of the content in mind. In other words, make it relevant to the learners. Use scenarios that reflect risks they are likely to encounter. As one presenter stated, “training needs to be risk-based, and you need to train on the topics that are core to your business.”

10. Relationships count.
Getting stakeholder buy in on the training at every stage (development/delivery/completion) is critical. Don’t just focus on the proverbial seat at the table with upper management, develop relationships across the company, and seek feedback from the business groups, sales managers, and sales training.

11. And finally, beware of the speaker programs!
When evaluating risks, make those speaker programs a priority.

Kudos to Q1 productions, the presenters, and everyone involved in the 3rd Annual Life Science Compliance Training Conference. From the opening audience ice-breaker, to the closing session, it was one of the most informative, focused, and engaging conferences I have attended in ten years of working in life science compliance.

I look forward to next year’s conference and I highly recommend it to anyone interested in sharing ideas and hearing what others in the industry are doing to make their curricula more engaging and more effective.

Thanks for reading!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

The 3rd Annual Life Science Compliance Training Conference: A Preview

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The 3rd Annual Life Science Compliance Training Conference opens Wednesday, June 6, 2018  at the Hilton Garden Inn in Chicago. The PharmaCertify team will be there to catch up with clients and colleagues, and share demos of our newest compliance training solutions. I also always welcome the opportunity to hear from those who are directly responsible for building and maintaining a modern and effective compliance curriculum. It’s always an enlightening experience. Here are a few presentations I am looking forward to in particular:

Day One

Structure and Delivery of Compliance Content for Executive Level

After opening remarks from PharmaCertify’s own Dan O’Connor, who is chairing Day One, the conference begins with this compelling panel presentation. Recent enforcement headlines, and an increasing number of presentations by regulators at large compliance congresses, highlight the importance of training C-Suite executives in compliance. But what topics are most critical and what tools are most effective? I am anxious to hear what delivery and engagement tools the presenter’s company uses to help support and encourage a strong “tone from the top” as part of the effort to build a stronger compliance culture throughout the organization.

Adapting Compliance Training Methods and Materials Based on Evaluated Risk
Gary Mendelsohn, Astellas

Data is trending for good reason. The data gained through extensive auditing and monitoring is an important tool for evaluating whether compliance training methods and content need to be modified to better address organizational risks. This is a timely topic as life sciences companies continue to look to the data for answers on how to better target their training.

Alignment of Compliance Training with Current Areas of Inspection
Kelly Tope, Zimmer Biomet

A medical device perspective on compliance training is always welcome in compliance conferences. While dealing with some of the same challenges of their pharmaceutical counterparts, medical device professionals face unique challenges due to the nature of their HCP interactions and reimbursement arrangements. This session should provide helpful information for both sides of the life sciences fence, as common and industry-specific settlements are reviewed for training topic relevance.

Case Study: Providing Employees Access to Performance and Development Resources
Jackie Bauer and Stacey Leonard, Abbvie

When evaluating a compliance conference agenda, my eyes are always drawn to the words, “case study.” Attendees are there to hear what techniques, programs, and tools work for their peers and case studies offer the best framework for doing so. With the phrase “continuous learning” in this session description, my interest is piqued even more by the potential for learning what tools and materials the presenter deploys on a regular basis to enhance learning and increase retention of key content.

Day Two

Panel: Building Employee Accountability to Support Compliance Training
Kim Ingham, Merck, Sharon Delgado, Orexigen Therapeutics Inc., Susan Novak, Celgene

Industry professionals have been espousing the importance of a “culture of compliance” for about as long as compliance has been a focus for the life sciences. By contrast, a “culture of accountability” is a term I have not seen applied to the compliance space, and at first glance opens the door for exciting possibilities. This session promises “varied perspectives on how to build and engage staff in heightened levels of accountability,” and I am excited to hear what strategies the presenters utilize to encourage accountability across each of their three companies.

Advanced Adult-Learning Practices for Heightened Engagement in Compliance Training
Abby Talanca, Johnson & Johnson

As compliance training tools have advanced, on-going research into adult learning practices has led to the utilization of more effective development methods and delivery mechanisms to enhance learning. Based on the agenda description for this presentation, I will be curious to hear exactly how the Johnson & Johnson compliance team integrates modern methods like continuous learning into their curriculum to increase retention and maximize on-the-job application of the knowledge gained through the training.

Train the Trainer Workshop: Increasing Connection & Retention in Compliance Training
Mona Kay Gorman, Valeritas

Compliance training curriculums are often developed with an understandable focus on internal stakeholders and with a lack of attention paid to the internal trainers – those responsible for delivering the training. Mona Kay Gorman brings extensive experience delivering engaging live compliance training, and hearing her suggestions for how to improve the skills of trainers so workshops and courses are more engaging and effective should prove valuable and worthwhile.

Proactive Approach to Analyzing Compliance Data for Preventative Training
Kevin Ryan, Novo Nordisk

Extending the topic data analysis to the second day, the description for this session promises a review of the data sources available to compliance teams, and how to use that data once its collected to conduct gap analysis studies, and identify trends and potential compliance risks. Data collection and analysis offers forward-thinking compliance training professionals a critical tool for identifying trends and potential risks, then using that information to target training and segmenting trainee groups more accurately. It’s an important and timely presentation.

Next Stop: Chicago

The agenda for the 3rd Annual Compliance Training Conference offers a great lineup of industry professionals sharing the latest in training best practices, suggestions, and tips. If you’re attending, stop by the PharmaCertify booth in between sessions to see demos of our newest compliance training solutions. If you can’t attend this year, watch for my blog post with conference highlights right here on the Compliance Training Insights Blog shortly after we return.

Thanks for reading!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

News and Notes from the 15th Annual Pharmaceutical Compliance Congress

CBI’s annual Pharmaceutical Compliance Congress, which took place April 23rd to the 25th in Washington DC, featured industry leaders and government representatives espousing the usual best practices for building and maintaining an effective compliance program, but this year’s agenda offered a few surprises and changes in the regulatory wind. The notes below highlight some of the sessions we found to be particularly interesting and newsworthy.

Day 1

CCO Exchange – Adapting and Evolving Compliance Programs in Support of Innovation

Following the opening remarks and a session covering politics and the pharmaceutical industry, the conference kicked into gear as Maggie Feltz of Purdue Pharma, Jennifer McGee of Otsuka, Jill Fallows Macaluso of Novo Nordisk, and Sujata Dayal of Johnson & Johnson discussed their process for “partnering with business” in the company to maximize the strength of their compliance programs. The panelists stressed the importance of establishing a relationship with business that is built on open dialogue and trust.  Documentation is also key to that relationship and as one panelist pointed out, “the government cares about how you document that you are preventing issues.” It’s important to “shape the way you are perceived in the relationship by using business language,” she emphasized, and to measure your own effectiveness by simply determining whether business is inviting you back to the table. Your compliance program is only effective if you have a seat at that table.

Once the partnership is established, you need to “get the business to think and talk about risk and conduct a benefit-risk analysis,” according to one panelist. Another reminded the audience that Corporate Integrity Agreements (CIAs) hold important clues about topics of focus for the government. This is particularly enlightening considering the recent Aegerion and United Therapeutics CIAs that dealt with third-party patient assistance programs, a topic discussed throughout the conference.

The panelists also covered working with third-party vendors and the need for monitoring and testing of those vendors to ensure they are complying. As one panelist put it, “you need to be sure those companies are applying your standards.”

Stakeholder Spotlight – Strategies for Collaborating with Business Partners to Enhance Compliance Enterprise-Wide   

Gail Cawkwell, Medical Affairs at Intercept Pharmaceuticals, Cecilia Matthews, Human Resources at MedImmune, Gregory Moss, Deputy General Counselor at Kadmon, and Gary Cupit, CEO of PortA Pharmaceuticals provided the business perspective on the compliance/business partnership. The panelists reiterated key points from the CCO session, with one emphasizing the need for the two departments to tackle the issues together as business partners and another seeing compliance not as a goal, but “a base objective that underlies everything.”

One panelist emphasized the need to be aggressive in the approach, pointing out that she is the person “bothering the compliance department, digging into SOPs, asking why they do things that way, and asking how each policy helps the company.”  She prides herself on partnering with compliance to “find a better way to do it.”

Highly-Acclaimed U.S. Healthcare Fraud and Enforcement Panel – Past and Present Prosecutor Parley

A large group of current and past government enforcement representatives covered the current compliance risks facing the life sciences industry. The session started with a discussion about the nation’s opioid crisis and how each office is addressing the epidemic. One current assistant U.S. attorney summarized the threat to the industry succinctly, “If your company is involved in opioids at all, you are under intense scrutiny.”

In one of the more interesting moments of the conference, the panelists pointed out that the focus on off-label enforcement has shifted away from large pharmaceutical companies to smaller ones. According to one speaker, small companies and startups are under greater pressure to sell and to save money, especially if they are funded by venture capital companies. That leads to a higher risk of off-label promotion.

Continuing a theme, prescription assistance programs and patient charities were addressed in relation to kickback risk. As stated, “any coordination between the charity and the company that shows the company is just trying to pay for its product being prescribed is a concern.” At least two current regulators supported the idea of self-disclosure and being honest about potential violations. “Being candid about where the compliance program has fallen short and the steps the company is going to take to correct the problem is important,” one of them said.

The group of former regulators, who mostly now serve as industry counsel, touched on exclusion as a risk. While it may be considered a rarely-sought tool, prosecutors have the threat of exclusion available to them as leverage. They also delved into the importance of data and reminded the audience that prosecutors are indeed scouring Sunshine Act data.

Patient Assistance Programs and Reimbursement Hub Services Compliance – A New Wave of Enforcement Actions

Attendees were provided five options for the first breakout sessions. The PAP and Hub Services panel was moderated by Jane Yoon of Paul Hastings LLP, and featured Peter Agnoletto of Sanofi, Sarah Whipple of Akebia Therapeutics, and Evan Bartell of KPMG LLP.

The discussion began with a polling question asking attendees where the management of donations sits in their organization. Corporate Social Responsibility and the Grants Committee were the top answers. The question led to a discussion over best practices, with one speaker warning, “you at least need to take commercial out of any involvement with donations.” Another admitted that not having a say in how the money is spent is hard concept for the business to grasp but the separation is important.

In the next polling question, attendees were asked if they monitor relationships and interactions with the foundations. 57% replied yes, and 28% said no. The panel reminded the audience that recent CIAs included the stipulation that those relationships are monitored.

Another question was focused on sales representatives and their involvement with donations. 48% of the audience said their reps are provided with talking points. Panelists suggested that if the sales reps are involved, compliance needs to understand how the information is being used. Clear guidelines need to be established and the reps need to be trained on those guidelines.

Off-label Communications – Deep Dive into the New Regulatory Updates and Actions

Angela Rodin of KPMG LLP and Laura Terrell of DLA Piper LLP presented the update on the status of off-label promotion trends and enforcement in the industry. Starting in 2012, enforcement shifted, as companies argued that off-label marketing is protected under the First Amendment and therefore cannot be prosecuted under misbranding provisions of the Food, Drug, and Cosmetic Act (FDCA). One presenter pointed out that while the government is no long pursuing off-label promotion as a stand-alone FDCA case, it continues to enforce False Claims Act (FCA) and Anti-Kickback Statute (AKS) cases related to off-label promotion.

The bottom line is that even with strong support of free speech as a defense of off-label promotion, life sciences companies still need to be cautious. Clear and effective training is still needed.

Social Media – New Challenges and Updates

Elizabeth Kim of Loeb & Loeb LLP began the social media presentation with the underlying premise that while the digital landscape has changed dramatically over recent years, the legal landscape remains the same. Even on social media, promotional statements cannot be false or misleading and communications must be consistent with labeling and fair-balanced.

Social media is challenging, the presenter stressed, because it promotes a dialogue, which means the company has a lack of control over the conversation. But there are some steps companies can take that at least help with the control. The ability for readers to comment on posts can be turned off on Facebook. No such control exists with Twitter. In addition, key words can be flagged on Facebook to help monitor comments. Unfortunately, as the presenter noted, most companies lack the resources and personnel to properly monitor social media outlets.

She also mentioned that while companies have no obligation to correct third-party, independent comments, public, unsolicited requests for off-label information must be met with a limited response to contact Medical Affairs only. “If you do reply,” she said, “responses should be narrowly tailored. Watch out for getting into arguments.”

The FDA’s Office of Prescription Drug Promotion (OPDP) has issued 233 warning letters over the last ten years for omitting information, minimizing risk information, and overstating efficacy claims on social media. As existing platforms evolve, and new ones appear, the need for updated training to ensure your field-based employees are abiding by laws like the FCA and FDCA, as well as OIG guidance and the PhRMA Code, is critical.

Medical Affairs and MSL Oversight

The Medical Affairs panel included Tina Beamon, Alicia Temoche, and Stephanie Macholtz from Alexion Pharmaceuticals, and Christine O’Connor-Fiore from Boehringer Ingelheim. The session began with the panelists establishing the general rules for how Medical Affairs may interact with healthcare professionals. Attendees were reminded that Medical Affairs can “do things R&D and Commercial cannot do” and “they are not limited to the label.” MSLs provide training to consultants for speaker programs but in the words of one panelist, “they are not Commercial and their integrity must be protected.”

The panelists admitted that the model for Medical Affairs and Commercial interactions has changed in reaction to marketplace changes. Medical Affairs should share insights as long as those insights are not off-label. “The walls between Commercial and Medical Affairs are coming down,” she said, “and a framework needs to be in place to protect the integrity of the MSL.”

Behavioral Compliance – Using Psychology to Make Programs More Effective

In one of the more unique sessions I’ve witnessed in years of attending compliance congresses, this session focused on behavioral compliance as a tool for generating more compliant outcomes. Yogesh Bahl, of AlixPartners, Kevin Ryan of Novo Nordisk, and Charlene Davis of Sun Pharmaceuticals provided conceptual concepts around the philosophy and practical application of behavioral compliance, using ideas known as “ethical nudges.”

The session began with the audience being asked to provide feedback on which of two compliance posters they thought were more effective. Essentially, one reflected a “rules-based” approach, and the other a “values-based” one. The values-based poster was the more popular choice and the content of the session supported that approach. The underlying premise behind the ethical nudges is that “people become ethical by doing ethical things.” Ethical nudges were essentially defined as “interactions based on the understanding of internal decision-making to promote desirable choices.” They included “read and affirm” documents presented right before a critical HCP interaction, visual cues like signage and posters, and micro-training launched strategically in conjunction with the need for ethical decision making.

Critical CIA and Enforcement Learnings – Zero-In on Emerging Trends to Elevate Compliance Safeguards      

The key points of this session were no surprise considering the oft-repeated focus of recent CIAs. BJ D’Avella of Deloitte and Touche LLP and Seth Lundy of King & Spalding LLP reminded attendees that “the focus of CIAs had shifted to interactions with patients, and more than ever, companies need to have a Risk Assessment and Mitigation Plan (RAMP) in place.” That RAMP needs to include activity-based risks in addition to the usual product-based risks.

One of the presenters pointed out that the OIG is focusing on a “smaller number of CIAs that send messages to the industry.” He reminded the audience that CIAs are not laws, but they are a strong indicator of where to focus risk mitigation efforts.

Day 2

CCO Scenario Symposium – What Would You Do?

After a review of the sessions and events of Day 1 by Michael Shaw of GlaxoSmithKline, Day 2 began with this session, during which panelists were asked to participate in a mock case study of “Bad Pharma Co” and expand on lessons learned from this fictional company. Beth Levine of Regeneron Pharmaceuticals, Ashley Watson of Merck, Jerald Korn of Tesaro, and Keith McGahan of Spectrum Pharmaceuticals were asked to discuss the optimal organizational structure companies like the mock one presented in the case study. One presenter felt that having compliance as part of the legal department was a benefit because it gave her greater access to the CEO and others in the board of directors. Others felt that if compliance has that type of access, “it doesn’t matter where they sit.”

Other scenarios brought up in the case study led presenters to offer tips on dealing with compliance situations and those who raise the concerns. For example, one speaker emphasized that “no matter the source, the company’s obligation is to search for the facts of the case.” Speculation about the whistleblower and his or her credibility should not come into play. Also, “if someone sends information about a violation anonymously, it needs to be kept that way.”

Meeting of the Enforcement Minds

Heather Johnson from the Federal Trade Commission, Sally Molloy from the Department of Justice, and Eric Rubenstein from the OIG presented their suggestions for companies to keep their compliance programs attuned to current regulatory challenges. On the topic of bribery for example, one presenter suggested that “internal controls need to be robust and designed so that they are not siloed. It’s all bribery.” Another emphasized that recent trends point to Medicare and Medicaid fraud as a primary source for qui tam cases.

Beyond the Seven Elements of and Effective Compliance Program – What Else Are You Doing?

As a compliance training company, this session, featuring Jerald Korn of Tesaro, Chad Morin of bluebird bio, and Gregory Moss of Kadmon Holdings, held particularly interest for us. As one presenter stated, “creating a brand for the compliance department is a fun way to convey important information.” That holds true for the training as well, and we work with companies to create a continuous, engaging, and “fun” curriculum.

Another speaker noted the importance of being creative in the policies to help ensure compliant behavior, as well as the need to establish a collaborative culture. As stated, “you’re not trying to check the boxes on all seven elements, you’re trying to build a robust program that is effective.”

Existing and Emerging State Laws Governing Transparency Reporting

The state laws presentation, with Maggie Feltz and Michael Grandison of Purdue Pharma, and Brian Bohnenkamp of King & Spalding, LLP, began with tips for managing aggregate spend:

  • Train company-wide, not just the sales force
  • Train, retrain, then train some more
  • Monitor throughout the year

The panel pointed out that state laws fall into three categories; drug pricing transparency, aggregate spend laws, and sales representative licensing and reporting laws. The landscape across all three changes quickly and they expect 2018 to be as busy as 2017.

In recent state-related news, Maryland’s law was found to be unconstitutional and according to one panelist, that “has quieted some of what other states have been considering.” Oregon was brought up as the most challenging law since it “requires documentation to support your documents.” In New Jersey, where the law was passed on the last day of the outgoing administration, one speaker mentioned that Governor Murphy’s team is considering major changes. On the drug pricing front, the panel expects two or three more laws to be implemented.

Obviously, the state law landscape is confusing and changes are happening at a dizzying rate. As one speaker emphasized, diligence, and continuous training is necessary to “ensure every decision-maker is aware of new requirements.”

Maximization of Compliance Resources

I close with what may have been the best session of the entire conference! (okay, I may be a bit biased since this panel included my colleague, and head of PharmaCertify, Dan O’Connor.) Dan was joined by Chad Morin of bluebird bio and Laurie Kathleen Durousseau of Rigel Pharmaceuticals. The session focused on how compliance professionals can best focus their time and energy toward those activities that are most critical during the various growth stages of a life science company from pre-clinical to established.

Starting with a quick poll of the audience, the panel first determined the average size and stage of companies represented. Most of the audience members were an “n of 1” compliance department in a company with 200 or fewer employees that is in the “Clinical” or “First Product” stage. The panel then shared their suggestions for which compliance-related activities to prioritize during each growth stage. In the “first product” stage for example, aggregate spend transparency reporting; government price reporting; specialized training by function; and patient support program design were discussed, among other topics.

The panelists also covered the need for small departments to partner with the business, as well as other departments, to spread the resource load and accomplish the objectives of each stage. For any compliance department challenged with limited resources and personnel, it was a worthwhile thirty minutes of learning. If you missed the conference, Dan would be happy to provide his perspective on the topic. Feel free to contact him at doconnor@nxlevelsolutions.com.

Summary

The world of life sciences compliance is changing, and so is CBI’s Pharmaceutical Compliance Congress. This year’s conference presented a compelling balance of traditional content that newcomers to the field should find valuable as a base of knowledge, with enough updates on key areas of regulatory focus (off-label, patient assistance programs, state laws, etc.) to keep the seasoned compliance professionals in the audience satisfied with agenda. It also offers industry professionals a rare opportunity to meet face-to-face with their peers and hear best practices for strengthening their compliance cultures and reducing risk. I highly recommend the conference next year for chief compliance officers, specialists, managers, and anyone working in the life sciences compliance training industry. Kudos to CBI and all the presenters!

Thanks for reading.

Sean Murphy
Editor, PharmaCertify Compliance Training Insights Blog

“Dear Connie the Compliance Training Specialist” is back!

Welcome to this edition of “Dear Connie the Compliance Training Specialist,” where we answer questions about timely compliance topics and delve into the best training for reducing risk.

This week: raising knowledge retention at the next POA.

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Dear Connie,

During the compliance portion of our last Plan of Action meeting, I introduced several scenarios for group discussion with the hope of making the session more engaging. For the most part, I think it was more successful than just reviewing a slide deck (our usual approach), but not everyone was engaged and I’m not sure they’re going to remember the key points. Any suggestions for our next workshop?

Signed,

Bewildered in Bridgewater

Dear Bewildered,

Kudos to you for making the effort to move beyond the “PowerPoint Overload” approach to live compliance training. To engage the entire audience, I suggest you “gamify” the discussion and have everyone team up to solve scenario-based challenges. Research has shown that creating a competitive environment raises the retention of key lessons and makes the content stick with the learners.

Here are a few suggestions that can add a level of interactivity, even if the time allotted to compliance is limited:

Form Teams

Competition is more fun and learning is enhanced when groups of participants work together to solve the scenario. Instead of asking individuals in the audience to give their opinion, create teams of participants based on regions, products, or any number of qualifiers. To save time at the session, create the teams ahead of time, in the planning stage.

Add Activities

Don’t just ask the teams to present their best suggestions for a scenario. Add activities that stimulate cooperation within the team. For instance, you can employ a card-sort exercise with scenario “flashcards” the teams sort into two piles, e.g., “permissible” and “not permissible.”

Teams can also compete against one another to solve a scenario-based “mystery” using their understanding of compliance best practices and company policies. Provide clues (emails, call transcripts, receipts, and text messages) during the workshop or ahead of time via email.

The activities can be developed in analog (paper-based) form or electronically through an online gaming platform or outside vendor.

Keep Score

Enhance the competitive spirit even more with a leaderboard that you update manually or electronically. Display the board continuously during workshop, or only after each activity is completed. If you send out questions in the weeks before the workshop, tell the learners they get points for how quickly they respond and for accuracy. Add those scores to the leaderboard as well.

Remember the Debrief

Don’t forget to leave time to debrief the audience once the activities are completed. You need to make sure the nuances and “gray areas” are understood, and the participants understand which company policies to reference for on-going guidance around the topics that were covered.

These are just a few tactics for raising the retention rate and “making live compliance learning stick.” My friends here at the compliance training division of NXLevel Solutions have experience creating compliance workshops for a range of life sciences clients. Feel free to contact them at 609-483-6875 to hear more ideas.

Thanks for the great question!

Connie the Compliance Training Specialist

Celebrating Data Privacy Day with a Training Checklist!

Did you celebrate Data Privacy Day this week? Data Privacy Day (January 28), led by the National Cyber Security Alliance, commemorates the 1981 signing of the first legally binding international treaty to address privacy and data protection. Rather than just break out the cake, balloons, and noisemakers this year, we decided to celebrate with a data privacy topic training checklist. In the life sciences industry, massive amounts of public and private data are collected, stored, and shared around the world. Proper training on the management of that data is critical to ensure privacy is maintained in an appropriate and secure manner.

Here’s a brief list of key training suggestions:

  • Divide the training into three categories: patient data, customer data, and company data.
  • Understanding the difference between public and private data is key. Public data is available to the public. Private data needs to be protected.
  • Emphasize why data needs to be protected. Legal penalties, loss of public trust, remediation costs, and prison time are all possible consequences.
  • Provide examples of patient data, and train learners to know to limit their access to Personal Health Information (PHI) and get written consent from the patient if they do need to access it.
  • Remind learners that customer data also needs to be protected and cite cases in which customer data can be shared.
  • Spend a significant amount of time covering company data and information. Don’t forget the perils of social media.
  • Give them tactics for protecting electronic, print, and verbal data. For example, sign-on codes, usernames, and passwords need to be kept secret, and paper documents that contain sensitive information must be locked in file drawers when not in use.
  • Data privacy is a global concern. Employees need to be sensitive to governing laws when they are dealing with anyone outside of the United States.
  • The General Data Privacy Regulation (GDPR) is a comprehensive and timely law. Learners need to be aware of its requirements.
  • When covering record retention and disposition, teach learners how to respond to a data breach. Stress the importance of notifying management and the legal department when a breach occurs.

Your customers, business partners, and patients all expect you to keep private information secure and confidential and there are severe consequences when that does not occur. The checklist above is a good starting point, but effective data privacy training needs to be carefully planned and vetted with the appropriate stakeholders to ensure it addresses the critical topics.

Thanks for reading!

Sean Murphy
PharmaCertify by NXLevel Solutions

“Dear Connie the Compliance Training Specialist” Debuts on the PharmaCertify Blog!

Welcome to the inaugural edition of “Dear Connie the Compliance Training Specialist,” where we answers questions about timely compliance topics and delve into the best training methods to reduce the risks.  

This week: managing the potential perils of speaker programs

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Dear Connie,

I am a compliance manager for a small pharmaceutical company in the Northeast. I am concerned that our new sales representatives may assume that they don’t need to worry about the details on speaker programs since an outside vendor manages them for us. We touch on speaker programs in the initial training all representatives take, but I am not sure we emphasized their responsibilities enough. Am I crazy to be concerned?

Signed,

Concerned in Connecticut

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Dear Concerned,

First, you are not crazy and I understand your concern. Speaker programs are a hotbed for potential compliance risks. It has been my experience that if you roll out additional training, like microlearning, assessments, and contests continuously to the reps, you’ll significantly reduce the risk around speaker programs.

Here are just a few topics to keep top-of-mind for the reps, and cover in the continuous training, even when an outside vendor is managing the program for you.

Attending to Attendees Concerns

On-going training needs to emphasize the finer details involving attendance. Representatives need to know that transparency laws require attendance to be documented, and it also helps the company evaluate the program. Whether a meal is offered or not, all attendees must sign-in. Reps need to remember no-shows and those who refuse a meal must be documented.

Speaker programs typically have a minimum required number of attendees. If the RSVPs fall short of that number, the program should be cancelled. Verbal commitments do not count.

Off-label Questions

Off-label questions asked during the presentation are another area of concern. If your company allows speakers to answer off-label questions (not all companies do), the speaker needs to make attendees aware that the question is in reference to an off-label use, and answer only the question that is asked. If that doesn’t happen, the sales representative must interrupt the speaker. Otherwise, the company can be accused of promoting the product for the off-label use. This is a great topic for role-playing during live training.

In addition, physician speakers represent the company. The programs are promotional in nature, so representatives must follow FDA regulations and speakers must follow the approved program. They may not proactively share their experience involving unapproved uses of products.

Speaker Requirements and Issues

I remember one case when a speaker unavoidably arrived late due to traffic and he suggested that he skip several slides to catch up on the time. Make sure the representative knows to stand firm on this. All slides must be delivered.

Another time, the representative realized, after the presentation started, that the speaker added his own slides to the deck. Representatives need to be trained to not panic and cause a disruption, but make note of the incident and notify a manager and the compliance department about the incident. Representatives should remind speakers that in the future, only the approved slides may be used.

Speakers sometimes ask if they can bring additional material about the topic being discussed, to hand out to the attendees. Representatives need to be trained to always let the speaker know that all materials must be approved by their company in advance of the program – whether the request occurs prior to the program or when the speaker arrives. Unapproved handouts are not permitted.

Thank you for a great question!

Connie the Compliance Training Specialist

Compliance Trends 2018: Our Point of View

The festivities have ended and a shiny new year is upon us, so we are switching hats – from party to prognostication – to delve into what we see as the hot compliance topics and trends for 2018. Based on our reading of the enforcement tea leaves, several 2017 topics should remain at the forefront, but our prediction on the level of activity emanating from the OPDP has changed from last year. So if you’ve resolved to stay up-to-date on all the compliance news fit to blog this year, what better way to start than with this look ahead.

We expect funding for patient assistance organizations, which are charities that provide financial assistance to patients to help cover the cost of medications, to be a trending topic in 2018. In 2016, federal agencies started to focus on the topic and issued subpoenas related to support provided to these charities. In 2017, two companies entered into settlements with the government over that funding. The government considers the practice to be a violation of the Anti-Kickback Statute because the funding offsets the co-pay of patients who participate in government healthcare programs.

Donations to charities that assist with medication costs are permitted, but assistance cannot be directed to patients who are prescribed the donating company’s medications. We would not be surprised to see the government take more of an interest in the financial relationship between the industry and charitable patient organizations this year. Training must emphasize the need to maintain appropriate independence between the company and the patient organizations it chooses to support.

In 2017, a small group of states passed laws related to price reporting, sales representative registration, and physician payment caps. That trend should continue in 2018 and the laws will most likely be focused on pricing transparency, as opposed to spend transparency, which was more common a few years ago. Expect more states to follow New Jersey’s lead and implement broader restrictions and caps on payments to healthcare professionals. The law is intended to combat the growing opioid addiction crisis.

2017 was a surprising year for the Office of Prescription Drug Promotion (OPDP). After a flurry of letters at the end of 2016, we expected the agency to continue that trend into 2017, but only four letters were issued the entire year. That is a record low. Don’t expect a dramatic increase this year.

The letters that were issued last year were focused on false and misleading statements related to risk and omission of risk. Two industry settlements in 2017 included charges of failure to disclose risk in violation of the Risk Evaluation and Mitigation Strategy, so emphasizing the importance of fair balance and truthful, accurate promotional statements when training sales representatives is critical.

On the global front, we would not be surprised to see an uptick in Foreign Corrupt Practices Act enforcement following the implementation of new processes that reward companies for self-disclosing potential violations and cooperating with investigations.

With that, we end this “preview” edition of the Compliance News in Review. To be automatically notified when we post new editions of the News in Review, conference highlights, or compliance training tips, just click the “follow” button on the right side of this page.

Have a safe and compliant 2018!