A Look Ahead: The 2018 Pharmaceutical and Medical Device Compliance Congress!

Look for the “elephant in the Exhibit Hall” at the Pharmaceutical and Medical Device Compliance Congress to see demos of our compliance training solutions!

If you haven’t yet registered for the 19th Annual Pharmaceutical and Medical Device Compliance Congress, there is still time to save $600 on the registration fee with our sponsor discount offer. Contact me at smurphy@nxlevelsolutions.com to ask about the details.

The conference kicks off Wednesday, November 7th at the Mandarin Oriental Hotel in Washington DC, and NXLevel’s PharmaCertify team will be there to catch up with friends and clients and showcase our newest compliance training products. If you’re attending, stop by Booth 108 in the Exhibit Hall (you can’t miss us, we’re right next to the food table and by the bar) to say hello and register for a chance to win an Echo Smart Speaker with Alexa!

You will also see us listening attentively throughout the panel sessions and presentations for the latest compliance best practices and suggestions from what is always an impressive list of industry professionals and government representatives. In addition to the keynotes and plenary sessions, PCF has packed the agenda with 27 different mini summits attendees can choose to attend. With that in my mind, we’ve once again scoured the agenda and highlighted a few of the presentations we’re looking forward to in particular.

Day 1: Wednesday, November 7, 2018

Preconference 1: Patient Support Programs: Risk and Risk Management Best Practices

Right out of the gate, PCF is offering attendees the choice of four compelling preconference sessions from 8:00 AM to 12:00 Noon. This Patient Support Programs session is offered as a “deep dive workshop” with timely talking points that include the most common manifestations or structures of Patient Support Programs (PAPs) and the best practices and approvals of the activities. A quick scan of recent corporate integrity agreements highlights the enforcement focus on PAPs, and kudos to PCF for wasting no time addressing it, with a panel that includes Nereyda Garcia from Alnylam Pharmaceuticals, and Nicole Serena from Bayer.

Keynote: OIG Update

Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General for Office of Inspector General, returns for this highly-anticipated review of recent settlement actions and the OIG’s workplan for the upcoming year. From year to year, the presentation is considered one of the cornerstones of the conference as Ms. Riordan discusses the areas currently on the enforcement radar for her office.

Chief Compliance Officer Roundtable

The conference agenda doesn’t provide any details in terms of what topics the CCOs will cover but based on the level of panelist expertise and the fact that it’s scheduled for one hour and fifteen minutes, the roundtable is sure to provide a bevy of useable, first-hand lessons and advice. Panelists include Jill Fallows-Macaluso from Novo Nordisk, Indrani Lall Franchini from Alexion, Jonathan Kellerman of Allergan, Puja Leekha of Lundbeck, and Lori Queisser of Teva.

Networking Reception

The networking reception is a rare, can’t miss opportunity to meet with your peers face-to-face and exchange tips and ideas for strengthening and growing your compliance program. And don’t forget to visit the vendors while you’re in there. They bring a range of innovation and expertise to the industry… and you don’t want to miss those cool giveaways!

Day 2: Thursday, November 8, 2018

During the first half of Day 2, we hear from the government regulators, investigators, and prosecutors with three different sessions: the Assistant US Attorney Roundtable, FCPA Enforcement Update, and the Qui Tam Roundtable.

FCPA Enforcement Update

In light of the recent FCPA case settlement by Stryker, this session should provide interesting insight into the enforcement trend surrounding the Act. Will more cases surface? Is there a renewed focus on the life sciences industry? With panelists from the FBO, the DOJ, and formerly with the SEC, the conversation should prove to be enlightening and educational.

Mini Summit 1: Fostering a Culture of Ethics and Compliance Beyond Just the Laws and Regulations

The first of seven 11:00 AM mini summits, this session captured my attention for its interesting title. The debate over a rules-based approach to compliance versus a values-based approach is not new to the life sciences industry. I will be curious to hear, particularly from a training perspective, how this panel fosters a culture that emphasizes empowerment to always “make the right decision” while still communicating the need to follow the rules and the laws.

Mini Summit IV: Annual Medical Device Compliance Roundtable

This dedicated medical device session features Jonathan Glazier from Philips North America, Marc Levine of Insightec, Laura O’Donnell from GE Healthcare, and David Ryan of Epizyme discussing the topics unique to the industry. The medical device industry faces some of the same compliance issues as their pharmaceutical brethren, but the nature of the products and business process (e.g., reimbursement) present unique challenges. I am anxious to hear how these presenters address risk and strengthen their compliance cultures while facing those challenges.

Mini Summit VII: Compliance 3.0: Managing Promotional Programs, Relationships with Patient Advocacy Groups and New Entrants into the Marketplace.

That title to this session is a mouthful, but it invokes a promise of a forward-thinking approach to the content. Expect this impressive panel, which includes Terra Buckley of Celgene, Michael Clark of Indivior, and Sujata Dayal of Johnson & Johnson to offer bold suggestions beyond the current thinking for the pressing topics listed in the title.

Mini Summit X: Is Your Board of Directors Bored of Your Compliance Dashboards?

Okay, I admit it, the sessions with the creative names tend to catch and pique my interest. Thinking beyond the clever title though, this afternoon mini summit tackles the tricky subject of the board’s involvement and support of the company’s compliance program. It’s a topic that’s been of focus for regulators

Mini Summit XII: The Fine Line of Promotion with Medical Professionals: Avoiding White Coat Marketing   

Since employees who interact with healthcare professionals face a high level of compliance risk, I will be interested to hear how the panelists, including Pamela Lonzer from Alexion, Margaret Sparks from Sanofi, and Ravi Taylor of Ferring, balance the business need for representatives and others to engage with those HCPs, while instituting safeguards to ensure compliance with company policies and regulations.

Mini Summit XXVII: The Compliance Training Revolution

PharmaCertify had the opportunity to sponsor the 3rd Annual Life Science Compliance Training Conference back in June (you can read our key takeaways here), and I came away from that conference pleased that the industry is clearly developing more innovative training with the intent to optimize the learning and create lasting results. It’s been our focus since we started developing compliance training 12 years ago, and I look forward to hearing more about the techniques the panelists utilize to accomplish that same goal.

Summary

Again, these are just a few of the many sessions PCF is offering at the 19th Annual Pharmaceutical and Medical Device Compliance Congress. We look forward to seeing you there and as always, I welcome your feedback on this preview and our blog in general. If you’re attending the conference, don’t forget to stop by the PharmaCertify booth (#108 in the Exhibit Hall) to say hello.

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

9th Annual Life Sciences West Coast Compliance Congress: A Preview

CBI’s 9th Annual Life Sciences West Coast Compliance Congress is less than three weeks away and we’re looking forward to yet another opportunity to catch up with colleagues and clients and showcase our newest life science compliance training products. The conference gives those of us located on the other side of the country an opportunity to hear tips and best practices from industry professionals who don’t normally participate in the East Coast conferences. A quick scan of the agenda reveals company names as diverse as. Here’s a brief preview of the sessions and panel presentations scheduled for the two-day conference.

Day 1: Wednesday, October 17th 

Chief Compliance Officer Keynote Panel

After two pre-conference summits, one covering aggregate spend and the other patient support programs, the conference sets the stage with a panel of former and current chief compliance officers, moderated by John Kelly of Bass Berry & Sims, and formerly of the Department of Justice. As someone who attends a significant amount of conferences, I support this idea of diving right into the topics at hand, rather than leading off with a speaker who may bring some name recognition or star power but doesn’t necessarily speak to the primary concerns of the audience.

Enforcement Panel: Fraud and Enforcement Trends – Current and Former Perspectives

The enforcement panel scheduled for 2:15 is an interesting blend of those currently in an enforcement role (Chinhayi Coleman Cadet from the Northern District of California and Rachael Honig from New Jersey) with those who formerly served in an enforcement role and now work in the private sector (the aforementioned John Kelly of Bass Berry & Sims and Robert Marasco from Dinsmore & Shohl LLP and former AUSA from New Jersey and the Southern District of California).  The duel perspectives should provide compelling insight into the current prosecutorial trends in the life sciences industry.

Roundtable Discussion: Lessons Learned and Continuing Implementation of General Data Protection Regulation (GDPR)

After a networking and refreshment break, the conversation turns to the timely topic of GDPR. Clearly, there are questions and confusion around the regulation, and we’re especially hoping to hear how these panelists build and deploy training on the hot topic of GDPR. Who are they training in the organization? What topics under the GDPR umbrella are they covering? How often are they updating that training?

Immediately following the GDPR session, Day One closes with a networking, wine, and cheese reception. As you chat with your colleagues and network with new associates, we invite you to stop by the PharmaCertify Booth to learn more about our training solutions. While there, don’t forget to enter the drawing to win an Amazon Echo Smart Speaker with Alexa!

Day 2: Thursday, October 18th

Interactive Exchange: Strengthen Speaker Programs through Innovative Compliance Initiatives and Lessons Learned

Following two sessions on monitoring and auditing, the focus turns, not surprisingly, to yet another hot topic currently under the regulatory microscope, speaker programs. This session should prove to be even more enlightening and revelatory since it is billed as an “interactive exchange” with panelists listed as “conversation contributors.” Those contributors, Ishita Arora of Horizon Pharmaceuticals, Danielle Davis of Insys Therapeutics, Eric Jen of Horizon Therapeutics, and Jenny Shire of Daiichi Sankyo, are sure to have the full attention of an audience hungry for suggestions on how to manage risk in planning and executing the programs.

Choose Between Two Master Classes (A-B)

Before a networking lunch break, attendees have the option to choose between two “master classes” focused on topics that continue to be a source of risk.

Master Class A: Take Action in Light of New Regulatory Updates Surrounding Promotional Compliance and Off-Label Communication

During CBI’s Compliance Congress earlier this year, we learned that the regulatory focus on off-label promotion has shifted somewhat from larger companies to emerging companies and start-ups. Off-label concerns continue to be at the top of qui tam cases, and we’ll be curious to hear the steps Sharon Delshad of Nalpropion Pharmaceuticals and Gary Messplay from King & Spalding recommend for reducing off-label risk

Master Class B: Navigate Third-Party Relationships and Outsourcing Arrangements

For companies that utilize third-party entities for global transactions, Richard J. Ciamacca of Amring Pharmaceuticals, which positions itself as a company that “sells uniquely positioned and harder-to-manufacture generics that bring value to customers and patients,” will offer his insights on navigating the potential risks of those relationships.

Calibrate to Your Organization’s Size – Compliance Program Benchmarking Based on Company Resources

Anytime I see “benchmarking” in the title for a session, I am intrigued. It’s one of the reasons attendees are so interested in attending conferences like these, they want to benchmark their activities and programs against others in the industry. This hour-long session is divided into three presentations: How Companies Can Collect Leads and Advertise Digitally Without Violating Patient Privacy with Sharon Delshad of Nalpropion; Managed Markets Compliance – Mitigate Risks in Relationships with Payers; and Collaborate with Medical Affairs and Elevate MSL Oversight with Tim Ayers from Life Science Compliance Consulting LLC and Gregory S. Moss from Kadmon.

Summary

CBI has a well-earned reputation for organizing compliance conferences that bring together an impressive array of professionals and government representatives to share tips, best practices, and lessons learned. The 9th Annual Life Sciences West Coast Compliance Congress is no exception.

As a proud sponsor of the 9th Annual Life Sciences West Coast Compliance Congress, we can offer you a $500 discount on the regular registration price. It’s not too late to register at this special rate, but the discount certificates are limited. Contact me at smurphy@nxlevelsolutions.com if you are considering attending. If you’re already registered, we look forward to seeing you in San Francisco!

Thanks for reading!

Sean Murphy
Marketing Manager and Compliance Training Insights Blog Editor
PharmaCertify by NXLevel Solutions

4th Annual Life Sciences Compliance Congress for Specialty Products: A Preview

CBI’s Compliance Congress for Specialty Products kicks off next Thursday, September 13th in Boston, and Dan O’Connor, Senior Vice President for PharmaCertify, will be there to catch up with our clients and colleagues and hear industry leaders and government regulators share strategies for proactively addressing current risks for specialty pharmaceutical manufacturers.

We’ve reviewed the conference agenda and here are the sessions and presentations we are looking forward to in particular:

Day One, Thursday, September 13

Prosecutors’ Perspectives Panel

Following the opening keynote address, the conference begins with this prosecutor panel focused on biotech and specialty pharma companies. Charles Grabow, Assistant US Attorney from New Jersey, and Gregg Shapiro, Chief of the Affirmative Civil Enforcement Unit for the DOJ in Boston, will be joined by Jane Yoon from Paul Hastings, LLP, to discuss the high-risk areas for this unique industry group. Government panels typically offer some of the most compelling and important information during conferences and since this conference is focused on such a defined segment of the industry, the conversation should be revealing and educational.

Coping Strategies for the Lonely Compliance Officer

In addition to having the most creative name of any of the presentations, this session features three professionals facing the challenges that come with being a compliance professional for an emerging pharmaceutical company. We will be curious to hear how Heather Godling from Sobi, Francisco Ribeiro of Tesaro, and Sarah Whipple at Akebia Therapeutics, creatively utilize the limited personnel and resources available to them to build and maintain a strong culture of compliance.

Expert Panel: Evaluate the Risks Associated with Disease State Awareness and Other Pre-Launch Activities

The “Pre-Launch Activities” part of this title caught my eye. No matter their growth stage, all companies need to be aware of the compliance risks and concerns they face now and as they progress toward launch. That extends to compliance policies regarding interactions with healthcare practitioners. Ideally, compliance training for a new sales team should be built and planned before the product is commercialized.

Ensure Transparency in Contributions to Independent Patient Assistance Foundations
And
Reboot Your Approach to Patient Assistance Programs (PAPs) and Reimbursement HUB Support  

Patient support programs are an emerging enforcement trend in the pharmaceutical industry as more and more companies enter into settlements at least partly related to the programs (e.g., Aegerion, United Therapeutics, Jazz Pharmaceuticals). Add the high cost of specialty pharmaceutical products to the mix, and it’s no surprise that CBI has scheduled back-to-back sessions on this important topic.

Day Two, Friday, September 14

Daybreak Discussion: Specialty Café – Forecasting Priorities from Now to 2020

In a novel presentation structure spread across two consecutive time slots (8:15 – 8:40 and 8:45 – 9:10), attendees will have the opportunity to sit in small groups, share ideas and listen to their peers discuss three timely topics: Risk-based Approaches for Advanced Therapies; PBM Contracting Considerations; and Compliant Medical Affairs and Commercial Interactions. The format offers a welcome twist  from the typical large group presentation and should lead to a compelling exchange of peer-to-peer ideas. It’s a great idea.

Explore the Trends in Drug Pricing Legislation and Other State Initiatives

John Oroho, from Porzio Life Sciences, LLC, is a respected and established thought leader in the life sciences compliance industry and his presentation is a can’t miss opportunity to hear the latest news and regulatory updates on these two ever-evolving topics.

Scale Up Your Compliance Program for Global Operations

Going global can be fraught with risk and compliance traps. In terms of anti-bribery alone, pharmaceutical companies need to now consider Loi Bertrand, the EFPIA Code, the Medicines Australia Code of Conduct, and a cadre of emerging codes and regulations around the world.  These on-going changes in the global landscape make the presentation by Masha Chestukhin of Sanofi, and Darryl Williams of MediSpend, an important pre-lunch session.

GDPR is Here – Now What Do We Do?

Are you confused about the General Protection Privacy Regulation (aka, GDPR) and its impact on you as a pharmaceutical compliance professional? You’re not alone. The questions concerning details like data inventory and documentation abound, and what exactly does it mean when data subjects have the “right to be forgotten?” What about training? Who needs to be trained? How does it impact the field employees interacting with HCPs? We look forward to hearing answers, ideas and opinions from David Ryan, Vice President, Associate General Counsel, Chief Compliance Officer at Epizyme and Trish Shorey, Privacy Officer, Global Compliance and Risk Management at Shire.

If you’re attending the conference, we want to hear from you. Let us know what you think of the sessions and presenters, and conference content. And of course, if you see Dan, he’d be happy to share demos of our newest compliance training solutions and discuss how we help clients build a stronger culture of compliance and reduce risk.  

Thanks for reading!

10 Tips for Creating Transparency Training That Sticks

With government investigators rigorously examining Open Payments, and on the hunt for red flags, the need for effective tracking and reporting training is more important than ever. Here are ten tips to help you build and deploy transparency training that reduces risk across your organization. 

  1. Go global.
    Make sure your employees understand that transparency covers multiple countries, not just the U.S. Global companies need to think beyond the Sunshine Act and include the relevant codes and laws from around the world. Don’t forget to incorporate requirements from codes like the EFPIA Disclosure Code and the Medicines Australia Code of Conduct, and regulations like Loi Bertrand (French Sunshine Act).
  2. Keep the reports formal.
    Stress the importance of using legal names of healthcare professionals for reporting purposes. Even if an HCP is commonly known as Bob, his license probably reads as Robert. Only legal names should be used. Warn the learners about facility names as well. For example, Saint Joseph’s Hospital for Children might be commonly known as Saint Joe’s, but the full name needs to be used in the reports.
  3. Add in reference resources.
    When developing training, include resources for learners to use on an on-going basis. Infographics or quick reference materials are good options for learners to self-check information they may have forgotten after they completed the training.
  4. Emphasize that ALL HCP spend needs to be tracked.
    Spend reporting requirements vary from jurisdiction to jurisdiction. A cup of coffee may or may not be reportable, depending on the circumstances. Learners should understand that accuracy is important for HCP spend, regardless of amount or spend type.
  5. Don’t forget the T&E process.
    The details of the travel and expense system are critical. Make sure learners know how to properly record HCP spend in your company’s system. For example, some systems (e.g., Concur) differentiate between a “business guest” and an “HCP guest.” Attributing the spending to the correct category in the system is a time-saving step that helps ensure accurate data.
  6. Include examples of data entry errors.
    Some data entry errors are common, and so are the instructions for correcting them. Identify the common errors in your system and highlight them in the training so learners recognize them during the actual data entry process.
  7. Include a section on HCP interactions.
    Healthcare professionals are aware of the buzz around transparency and privacy. They’re bound to have questions. Instruct sales representatives on how to answer their questions and address their concerns.
  8. Review the rules on speaker programs.
    HCP consultants who serve as speakers on behalf of the company need to make the audience aware that they are being paid by the company. Also, sign-in sheets are necessary to accurately record attendance and account for every physician in attendance.
  9. Make it easy to report errors.
    Include information about the process learners should use, including contact information, when they find errors (misspellings, incorrect state license number, incorrect address, etc.) in the training. Make that information available as a resource they can use later.
  10. It’s all about accuracy.
    No matter the format (live, eLearning, WebEx, etc.), make sure the need for accurate reporting is a recurring theme throughout the training. Take the time to identify and fully understand where errors typically occur in the process and build that information into the follow up training in the form of scenarios and stories. Long live accuracy…king of the content.

The Compliance Foundations™ customizable eLearning module, Global Transparency: Reporting HCP and HCO Transfers of Value, helps learners understand the requirements of worldwide transparency laws and codes, and how those rules help foster open relationships with a company’s HCP customers. Contact me at smurphy@nxlevelsolutions.com if you’d like to see a content outline or course demo.

Thanks for reading!

Sean Murphy
Editor
Compliance Training Insights Blog

Key Tips for Optimizing Your Speaker Programs Training

Life sciences compliance leaders and regulators seem to agree that speaker programs are fraught with the potential for risk and compliance violations. Industry conferences feature sessions dedicated to the off-label, kickback and false claims risks of speaker programs and the trend toward transparency puts the marketing dollars data out there for anyone to review. With the public and regulatory spotlight shining brightly on speaker programs, the need for updated and effective training has grown exponentially. With that in mind, we present the following list of suggestions to keep in mind when building and deploying your speaker program training.

One training does not fit all.

From speaker evaluation and selection, through program organization and execution, different employees, with varying responsibilities, are involved with speaker programs. Those different roles and responsibilities demand different training requirements. For example, Medical Affairs personnel serve a different role at the speaker programs than their colleagues in the commercial group and in marketing. The core training should be customized with content relevant to each of the groups to make it relevant and maximize the effectiveness.

Integrate real-life situations.

Speaking of relevancy, your speaker programs training needs to extend beyond the reciting of rote concepts and policy. To make the training stick, include the situations the employees are likely to face during the programs. For the commercial team, don’t just tell them the FDA’s rules on product promotion apply to speaker programs, include knowledge checks that feature speakers veering off the approved slide deck to discuss anecdotal, unsubstantiated product claims. The same rules that govern their interactions with healthcare professionals also apply to the speaker’s conduct and in their role as program host, sales representatives need to know how to react when it happens.

The devil is in the details…expected and otherwise.

Don’t stop at the obvious when outlining the topics to be covered in your training. The exceptions can be just as problematic as the rule and should be covered in the training as well. On the attendee front for example, commercial representatives need to understand the rules for government employees from agencies like the Department of Defense and Veterans Administration, and what is acceptable for their participation.

Don’t forget the vendors.

With third-party vendors facilitating so many aspects of speaker programs, the risks extend well beyond your own employees. Vendors need to understand the regulatory environment at a high level, and be familiar with your company’s speaker program policy. Along with topics like venue selection, meal limits, and attendee requirements, make sure the training emphasizes their role in meeting transparency requirements and the importance of delivering relevant program data to the company in a timely fashion.

Make the program training continuous.

Speaker program training should not be a one and done event. Studies show that learners forget up to 80% of what they have learned quickly after the completion of the eLearning module or live training event. To raise retention levels and increase the transfer of the knowledge before and during the programs, follow the introductory learning with continuous nuggets of training. These can take the form of brief assessments, contests, and sprints focused on specific details, delivered across the learners’ timelines.

Speaker programs offer companies the opportunity to provide healthcare professionals with education and training on the safe and on-label use of their products, delivered by one of their peers. Engaging, effective and on-going training on the coordination and execution of those programs lowers the potential for risk and strengthens a company’s compliance culture.

If you are interested in learning more about the online and workshop-based speaker program training solutions available from PharmaCertify, please contact Dan O’Connor at doconnor@nxlevelsolutions.com.

The 2018 Compliance Training Survey Results Are In!

We recently concluded our 2018 Life Sciences Compliance Training Survey, and the results reveal some expected trends and a few surprises about what your peers are doing and planning to maximize the effectiveness of their compliance training. So, without further ado, and in the words of any good compliance training manager, let’s dive into the data.

Industry and Company Size

We began by asking what industry the respondents represent and the size of their companies. 82% work in the “Pharmaceutical/Biopharmaceutical” industry and 18% in “Medical Device/Diagnostic Equipment.” Company sizes vary, with 36% indicating more than 5,000 employees, 22% under 100 employees, and 18% at 251 – 500 employees as the three lead categories.

Training Objectives

Complying with laws and regulations is still a priority for the industry. In fact, 86% chose it as one of their three answers when asked what training objectives are most important to them. 82% added “build or strengthen our culture of compliance” and 55% selected “reduce field compliance risk.” We’re particularly excited to see those last two answers score so high since our stated mission has long been to “help life sciences companies strengthen their compliance cultures and reduce risk” through innovative training.

Budget

If you don’t have a dedicated compliance training budget, you’re not alone. 41% of the respondents told us just that, while 27% have under $50,000 to spend and 23% do not have access to that information. A small percentage of respondents fell into the $50,001 – $100,000 range for their budgets. Effective compliance training isn’t necessarily budget dependent, and solutions that stick don’t always dictate astronomical budgets. The key to increasing retention and reducing risk is looking for opportunities to spread learning creatively across an employee’s timeline, no matter the budget.

12-Month Compliance Priorities

Over 95% of the survey respondents selected “enhancing our training” when asked which compliance activities they plan to undertake in the next twelve months. Clearly, your peers are aware of the need for up-to-date and modern training. That’s exciting! Over the last ten years, we’ve watched compliance training evolve, from its beginning in PowerPoint presentations delivered by legal departments, to today’s environment, where trainers realize that a blended, continuous approach using a mix of components is most effective. As we heard at this year’s Life Science Compliance Training Conference in Chicago, tools like microlearning, workshops, storytelling, and gamification are needed to make the training stick. Other choices that finished high in the 12-month activities category include “enhancing the overall effective of our compliance program” at 68%, “rewriting policies and/or Code of Conduct” at 64%, “increasing senior leadership and board involvement” at 36% and “conducting a risk assessment” at 32%.

Targeting Compliance Training

Basically, the question about how respondents targeted their compliance training came down to three answers: based on job role at 59%; we don’t, everyone in the organization is trained on all compliance policies at 45%; and based on risk at 41%. Generally, we recommend a mix of all three. Certainly, everyone should be trained on core concepts, and principles associated with compliance and on topics relevant across the board, like adverse events. Based on roles, and the risk associated with those roles, you need to consider more focused and continuing training related to specific functions. We’ve written a whitepaper on the topic titled, Improving Outcomes: Analyzing a Compliance Training Curriculum to Reduce Risk, which was published in Life Science Compliance Update. Visit the Insights page on our website to download a reprint of the article.

Training Methods

If there is one topic where the answers can be considered “across the board,” this is it. Respondents were asked to select all methods they use in their training curriculum. “Classroom training during onboarding” finished highest at 73% and other answers finished in a healthy mix. “Presentations at POA meetings” was at 64%, “custom eLearning” at 55%, and “individual guidance by compliance professionals” at 50%. In a nod to the power of continuous learning, “email-based messaging” finished at 32%, and “games and/or contests” at 27%. Finally, “coaching and guidance provided by trained field managers” finished at 32%. Tone from the middle counts!

Training Frequency

On the question of how frequently employees complete compliance training, 57% chose “annually” as one of their selections. Based on historical context, I am surprised that number isn’t higher. 38% chose “ad hoc, in response to specific needs,” and “quarterly” and “monthly” each finished with 19%. The industry seems to be adopting the idea that effective compliance training needs to be rolled out more than once a year.

Measuring Effectiveness

Assessments built into eLearning modules or workshops (59%) is still the most preferred method for measuring training effectiveness according to the survey results. Field observations (e.g., ride-alongs) finished a close second at 50%. While I was excited to see 9% of the respondents select “analysis of helpline/hotline data” (the details are in the data), the fact that 23% indicate that they do not measure the effectiveness of the training is concerning to say the least. On-going measurement is a critical component in any successful compliance training plan. As was emphasized at the training conference, you need to be examining the audit data, looking for increases in the hotline reports, meeting with the businesses, and deploying scientifically-sound assessments to measure the results.

Summary

Our first Life Sciences Compliance Training Survey provided a compelling peak into the tools and processes some professionals are using to increase the effectiveness of their training. Strengthening compliance cultures and reducing risk is a lofty goal, and while it’s only a sample, the survey results show that companies are taking important steps to think beyond a “check-the-box” mentality about compliance training. That’s an idea that will ultimately benefit the industry, its healthcare professional customers, and most importantly, the patients it serves.

Thanks for reading!

Sean Murphy
Editor, Compliance Training Insights Blog

Connie the Compliance Training Specialist Returns!

Welcome to a new edition of “Dear Connie the Compliance Training Specialist,” where we answer questions about life science compliance training concepts and discuss new ideas for making that training more effective.

This week: create a campaign to make it stick!

Dear Connie,

I am a compliance training manager for a mid-sized life sciences company in Pennsylvania and I am worried about our training on interactions with HCPs. We rolled out a new policy last year, and in January I launched comprehensive training on that policy. But based on our monitoring and data from our hotline, employees are still forgetting the key concepts and principles from their training. Connie, where do I go from here?

Signed,

Perplexed in Perkiomen

———————————————————————

Dear Perplexed,

Your challenge is a common one, but there are steps you can take to make the training more memorable. Just this month, at the 3rd Annual Life Science Compliance Training Conference, a number of your peers talked about how they use a campaign approach to make training more effective and make it stick with their learners.

Create a Brand

Develop a brand for the training campaign. Branding works for your company’s products, and it will work for your compliance training. Every time employees interact with your compliance training “brand” they form associations. The images you select reinforce those associations. Make sure your brand communicates the importance of integrity, clearly and consistently. Carry that branding throughout the training and on all communication.

Less is More

I suggest smaller training delivered throughout the year, rather than a longer more cumbersome course once or twice a year. When you take a “less is more” philosophy and keep seat times to no more than 15 minutes per module, you’re likely to see an uptick in retention. Don’t forget to keep the training flowing continuously, and build in follow up assessments, microlearning and contests to reset the forgetting curve that inevitably occurs after they complete the initial module or workshop.

Build the Messaging

The communication plan is critical too. Clear and concise messaging about the importance of the training, needs to be delivered in all three stages: pre-launch, launch, and post-launch. You should seek help from the stakeholders to deliver the messaging (one presenter at the conference said her company refers to these people as “compliance connectors”). The district managers are important in the process. They are the ones talking to the sales representatives on a regular basis, so you need to get them on board and funnel the messaging through them. Remember, communication is an ongoing process, you should constantly refine, adjust, and expand communications as you monitor the results of the training.

I could talk for hours about the need for a campaign approach to life sciences compliance training. I haven’t even touched on the need to solicit and evaluate learner feedback. Fortunately, my friends at PharmaCertify (that’s the life sciences compliance training division of NXLevel Solutions) have years of experience building training plans, and they’d be happy to share more ideas with you. Email my buddy Dan O’Connor at doconnor@nxlevelsolutions.com to see what they’ve done for other life sciences compliance clients.

Thanks for the great question and good luck!

Signed,

Connie the Compliance Training Specialist