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

A Medical Device Issue of Dear Connie, the Compliance Training Specialist!

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

This week: Clearing the Confusion of Medical Device Codes

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Dear Connie,

I am a new compliance training manager for a growth-oriented medical device company near Boston, Massachusetts. I always look forward to your tips on training for the life sciences compliance industry in general, but in this case, my question is specific to the medical device space.

My company is growing rapidly overseas and I don’t have a good handle on the details of all the codes that govern our industry. I have created my own spreadsheet with what I think I need to know for each, but I sure would welcome a more official resource for comparison. As I start the process of analyzing my curriculum, how do I know I am targeting the right employees and third-party vendors with the right code training?

Can you help me sleep better, Connie?

Quizzical in Quincy

Dear Quizzical,

I feel your pain and your sleeplessness. The proliferation of medical device codes around the world can be confusing for those of us trying to manage risk. In addition to the AdvaMed Code, you need to be aware of the AdvaMed Code of Ethics on Interactions with Health Care Professionals in China, the MedTech Europe Code of Ethical Business Practice, and the APCMed Code of Ethical Conduct for Interactions with Health Care Professionals…whew that’s a mouthful and a training plateful.

Fortunately, AdvaMed has published a chart comparing the purpose and scope of each one, as well as topics like healthcare professional training requirements, provisions on payments of royalties, sales and promotional meetings, entertainment and recreation, support of third-party educational conferences, and more. I suggest you download the chart from the Resource Center page on the AdvaMed website and read it carefully – there is a plethora of helpful information there.

By the way, since you mentioned that you’ve started an analysis of your curriculum, I also recommend the article published by my friends at PharmaCertify for the industry publication, Life Science Compliance Update. It’s called Improving Outcomes: Analyzing a Compliance Training Curriculum to Reduce Risk and the reprint is available for download on their website.

Thanks for the great question. I always enjoy hearing from my friends in the medical device world.

Good luck and good training!

Connie

A Preview of the 15th Annual Pharmaceutical Compliance Congress!

The 15th Annual Pharmaceutical Compliance Congress is only a week away and the conference agenda offers a new twist on the standard array of presentations by industry leaders and government regulators. Here are some of the presentations and panel sessions the PharmaCertify™ team is looking forward to:

Day 1: Tuesday, April 24

CCO Exchange
Adapting and Evolving Compliance Programs in Support of Innovation

Following the chairman’s opening remarks, and the “luminary address” that kicks off the conference, this panel session features leading industry representatives, including Maggie Feltz of Purdue Pharma and Sujata Dayal of Johnson & Johnson. The title is intriguing and I look forward to hearing the panelists discuss how they have adapted their programs, and their training curriculum, to take advantage of advances in technology and new concepts like microlearning and continuous learning.

Stakeholder Spotlight
Evaluation of Compliance Programs from the Internal Customer Perspective

The focus on “internal customer perspective” in this session caught my eye. It’s a stakeholder group that is not often discussed at conferences, and I’m curious to hear how the presenters define internal customers and the parameters and tools used tools for evaluation.

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

The description of this unique session promises a “point/counterpoint” approach to the subject matter, with current and former prosecutors and defense attorneys presenting their views on recent settlements and on-going investigations. Typically, the two sides present in separate sessions, so this joint “parlay” approach should prove to be engaging and revealing.

Patient Assistant Programs (PAPs) and Reimbursement Hub Services Compliance
A New Wave of Enforcement Actions

The latter part of the title makes this session so compelling and the “wave of enforcement actions” has led to several of our clients asking about training on PAPs and Reimbursement Services compliance (look for that addition to our curriculum of customizable off-the-shelf compliance modules in the near future). I am curious to hear how the industry representatives on the panel are dealing with the need for training considering the growing regulatory focus.

Master Class Series 3
Behavioral Compliance – Using Behavioral Psychology to Make Compliance Programs More Effective

This one is on the top of my list! After spending over ten years in the life sciences compliance training space, I recognize the key to flattening the proverbial “forgetting curve” is the utilization of modern and continuous learning tools and techniques built on advances in behavioral psychology and the science of learning. Look for me in the front row!

Day 2: Wednesday, April 25

Patient Support Programs Track
All Three Sessions

Continuing the focus on Patient Assistant Programs and Reimbursement Hubs covered in one session on Day 1, this track features three sessions that should shed light on a burgeoning area of enforcement: Evolving Role and Landscape of Patient Advocacy in Life Sciences; Mitigate Risk Within Hub Operations; and Legal Nuances and Limitations of Drug Copayment Offset Programs.

Small to Mid-Sized Bio/Pharma Working Group Track
Beyond the Seven Elements of An Effective Compliance Program – What Else Are You Doing?  

The definition of an effective compliance program has evolved well past the point of simply covering the seven elements first established by the OIG years ago. From a training standpoint, modern continuous learning techniques and tools have the potential to increase the retention of key compliance concepts and further reduce risk. I am curious to know what strategies the four industry professionals featured in this session have integrated into their programs to make it even stronger.

Small to Mid-Sized Bio/Pharma Working Group Track
Maximization of Compliance Resources

I may be a little biased on this one since my colleague, Dan O’Connor, will be joined by Chad Morin of bluebird bio and Laurie Kathleen Durousseau of Rigel Pharmaceuticals to discuss strategies for building and maintaining a strong compliance program when resources are at a minimum due to staffing and budgetary constraints.

Transparency and Open Payments Track
CMS Transparency and Open Payments Update
Existing and Emerging State Laws Governing Transparency Reporting
      

With transparency being such a regulatory focus and risk area, I anticipate a large and rapt audience for the presentation by Robin Usi, Director for the Division of Data and Informatics at CMS. In addition, the ever-changing list of states updating their existing transparency laws, as well as those launching new regulations (we see you New Jersey), moves the second session high on our attendance sheet.

Compliance Café and Community Exchange

Kudos to CBI and the panelists involved for this novel and clever way of closing out the conference! This collaborative session offers a great opportunity for attendees to collaborate with their peers and exchange ideas and suggestions from what they heard throughout the conference, and most-importantly, “align learnings and develop next-level strategies to take back to the office.” Well done.

The 15th Annual Pharmaceutical Compliance Congress promises a plethora of opportunities to catch up on the latest in regulatory and enforcement news, as well as best practices for building and strengthening an effective compliance program. We hope you’ll take a few minutes in between sessions to visit the PharmaCertify Booth in the Exhibit Hall to say hello and see demos of our newest compliance training solutions. Our mission is to help you build a stronger compliance culture and reduce risk, and we welcome the opportunity to show you how we’ve done just that for our clients.

Thanks for reading and we’ll see you in Washington!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

“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

“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!