A Preview of the 2020 Virtual Pharmaceutical Compliance Congress

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

On-Demand Presentations

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

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

Day 1: Monday August 10

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

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

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

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

Day 2: Tuesday August 11

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

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

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

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

Day 3, Wednesday August 12

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

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

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

Day 4, Thursday August 13

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

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

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

Day 4, Thursday August 13

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

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

See You at the Conference

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

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

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

Sean Murphy
Product & Marketing Manager
PharmaCertify by NXLevel Solutions

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

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

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

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Dear Connie,

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

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

Signed,

Cautious in California

Dear Cautious,

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

Analysis

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

Design

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

Development

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

Implementation

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

Evaluation

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

Summary

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

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

Thanks for the question and stay safe!

Connie

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

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

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

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

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

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

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

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

 

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

Sean Murphy
Product and Marketing Manager

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

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

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

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

Risk-Based Training

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

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

Curriculum Analysis

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

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

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

Test and Test Again

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

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

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

Effective Implementation, Review, and Revision

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

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

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

 

What I Heard at the 20th Annual Pharmaceutical and Medical Device Life Sciences Compliance Congress…and What It Means for Your Compliance Training!

Dan O’Connor of PharmaCertify and a panel of industry leaders share their experiences during the training workshop at this year’s Pharmaceutical and Medical Device Compliance Congress.

Presenters at this year’s Life Sciences Compliance Congress from the Pharmaceutical Compliance Forum (PCF) covered some of the same ground as previous conferences (tone at the top, sharing resources, mine the data, etc.) while mixing in a significant amount of new content and thought-provoking ideas for the attendees to consider. PCF even added an impressive amount of “mini-summits” to the agenda to ensure the content appealed to compliance professionals dealing with a variety of risks. It was a challenging, yet worthwhile, amount of information to absorb.

Following are some of the more interesting ideas shared at the conference, along with thoughts on what they mean for the compliance industry and for anyone interested in building and maintaining a successful compliance program.

  1. “Don’t worry about developing a culture of compliance, develop a culture of integrity instead.”
    The idea of making compliance concepts more relatable or understandable is nothing new and it was discussed extensively during this year’s Chief Compliance Officer Roundtable. According to the presenters, employees understand “integrity” more than they understand building a “culture of compliance.” The panelists offered examples of how they strive to integrate the concept of integrity throughout the company – from annual integrity awards, to asking every employee to write how they model integrity and ethical behavior in their daily business activities. As they put it, “don’t make it a compliance policy issue, make it an integrity issue.”
  2. “Don’t underestimate the ability of people to rationalize.”
    The life sciences industry holds the potential to “alleviate pain, restore health, and extend life.” While that is a noble responsibility, it holds the potential for dangerous rationalization. It’s too easy to think, “since we are saving lives, I need to get this product out faster…so I need to make this sale as quickly as possible,” or “I know my product is better than the competition, so I need to do whatever is needed to make the sale.” Continuous training is needed to instill a sense of responsibility in learners and help guard against the dangers of rationalization.
  3. “If you don’t get access to the Board as a member of the compliance team, that company is not a place you want to be.”
    Surprisingly, this one came from the AUSA Roundtable. I did not expect to hear career advice offered by a group of Assistant U.S. Attorneys, but it reinforces the notion that the compliance department must be integrated into the entire company, top to bottom, to be effective. It was a theme carried throughout the conference and led to compelling debates around topics like whether the compliance department should report to the legal department (hint: most regulators prefer to see it having the clout that comes with being a standalone department).
  4. “The shift to a patient-centered business model comes with risk.”
    During the session on “charitable contributions compliance considerations,” panelists focused on the need to avoid any suggestion that support programs and assistance programs are being used to increase sales. The separation between more sales and making products available to more patients is a fine line. As was also mentioned (and most industry insiders know), the list of Corporate Integrity Agreements (CIAs) focused on donations is growing. Panelists stressed the need to be careful about “where the charitable money is coming from.” If it comes from the commercial budget, it will be considered a commercial payment.
  5. “Communication style and protocol is key when dealing with co-pay foundations.”
    During the Helping Patient Access to Products session, presenters raised surprising points about the nuances of communication. As an example, “smiley face icons” in emails may seem innocuous, but they need to be avoided not only for general inappropriateness purposes, and because they hold the potential to be misleading during an investigation. Does that “wink” imply a favor or quid pro quo? The key throughout all communication is to avoid any suggestion that a support program is being used to overcome a co-pay barrier.
  6. “International cooperation across policing agencies continues to increase.”
    According to the presenters in the US DOJ and US SEC Update on FCPA Enforcement session, they are seeing a growing number of referrals from overseas regulatory bodies – significantly more than they saw ten years ago. Risk is rising, as are the number of whistleblower cases, and the panelists encouraged audience members to carefully review the DOJ’s April 2019 Evaluation of Corporate Compliance Programs document for what the agency considers to be the best practices for building and maintaining an effective program and reducing risk.
  7. “The lack of understanding between pharmaceutical sampling and medical device sampling is like day and night, and that makes it complicated.”
    Much of the Annual Medical Device Roundtable was understandably dedicated to the challenges associated with “asset management.” Consider that every missing, or unaccounted for, device could be considered a kickback during an investigation.  As one panelist emphasized, “the government has zero tolerance for asset management problems.” Another raised the interesting point that companies must ensure they are loaning devices to HCPs for the right reasons, and not because those HCPs want “to replace a machine that is currently not functioning” or “to use it for one test.”
  8. “Sharing resources can become political. Your initiatives may get pushed back when budgets are tightened.”
    The sessions dedicated to compliance for small to mid-sized businesses always provide unique insight to those attendees faced with limited resources and budget and this conference was no exception. The idea of reaching out to other areas of the company for support is a common refrain, and the added twist of what happens when budgets tighten was thought provoking. As the presenters explained, when compliance is a priority with corporate and with the Board, fighting that pushback gets easier. Tone at the top may be a bit cliché, but it’s a powerful weapon in the battle for time and money.
  9. “A corporate integrity agreement can be an opportunity to improve your overall compliance program.”
    Dreading the thought of a CIA is understandable, but the five years spent abiding by the terms of the settlement provides the momentum to build up a budget and showcase the importance of the program. Buy-in from corporate on resources is automatic during the CIA and it serves as the blueprint for what can be accomplished moving forward. Exiting the CIA is the time to evaluate lessons learned and evaluate methods for making the compliance program even stronger. From a training standpoint, the end of a CIA is also the time to evaluate what mandated programs were successful and explore opportunities to deploy more targeted, role-based training.
  10. “Your risk assessment needs to guide your monitoring and make it more meaningful.” This is actually a hybrid of statements made by Mary Riordan of the Office of Inspector General (OIG) during her much-anticipated annual speech and multiple presenters throughout the two days of presentations. The bottom line: a successful compliance program cannot be a cookie cutter effort, replicated from one company to another. Risks assessments need to be conducted at least on an annual basis and every aspect of the compliance program, including training, should be evaluated and modified accordingly. Continuous improvement is needed to make it meaningful and relevant.

What Else Does It Means for Your Compliance Training?

Whether you work in the pharmaceutical or medical device industry, the world of compliance is evolving, and the design and delivery of training must evolve as well. Based on the information shared in the OIG, DOJ, and AUSA sessions, the guidelines for who receives what training, at what frequency, needs to be enhanced.

As an example, during the session on reducing risk using a portfolio approach to compliance training, panelists discussed the need to integrate contextual reminders like vis aids, static prompts like intranet banners and poster, and active prompts like emails and desk drops to more effectively change behavior and facilitate a shift to that “culture of integrity.” The need to “make compliance training stick” is growing and now is the time to reevaluate your training curriculum and delivery methods.

Thanks for reading, I hope to see you at the “21” Annual Pharmaceutical and Medical Device Compliance Congress in 2020!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

Off-the-Shelf Compliance Training Myths

Myth #3: It won’t run properly on my learning management system.

In this third installment of our series on the myths associated with off-the-shelf compliance training, I discuss the concern that only training sold in conjunction with an LMS, or other type of online content delivery system, will run properly and accurately record data with that LMS. This theory is based on the idea that training modules from other vendors are not developed with the specifications of that system and therefore hold the potential for technical difficulties and “clunky” performance.

So, if you’ve already committed to an online compliance training content management system, the only way to ensure eLearning modules function correctly is to utilize the training that is packaged with the system, right? In a word…no.

The Myth 

Companies selling whole compliance training systems are understandably interested in fostering the notion that customers have no need to search elsewhere for training after they have made the commitment to purchase an enterprise-wide system to manage and deliver compliance training. The modules are a natural extension of the core product and offer myriad opportunities to garner additional revenue throughout the life of the system contract.

Adding fuel to the “it won’t run properly” fire is the idea that since there are so many varieties and brands of systems available to life sciences companies, including the large, well-known names; small systems targeted to compliance; industry upstarts; and systems intended more for GMP training where 21 CFR Part 11 compliance is a requirement, consistent performance across all platforms must inherently be a difficult, if not impossible, challenge. It’s a logical conclusion, even when SCORM compliance is factored into the compatibility equation as indicated by the fact that LMS compatibility continues to be one of the first questions our clients ask when we map out a strategy for deploying our Compliance Foundations™ off-the-shelf eLearning modules.

The Reality

If an LMS is built to modern specifications by a technical team that understands the need for it to house a range of training types, and the training is built with an eye toward flexibility and SCORM compliance, compatibility and performance of the individual components should never pose a problem. An effective compliance training curriculum requires a thoughtful and well-planned mix of training modalities delivered continuously across a learner’s timeline. That formula sometimes consists of elements from a variety of development vendors and the ultimate success of that curriculum must never be threatened by the limitations or lack of flexibility on which the training is housed.

So not only is the suggestion that off-the-shelf training won’t run properly on a wide range of systems a misleading and counterproductive myth, it is anathema to the very notion of what is at the foundation of successful compliance training.

The Bottom Line

In 15 years of delivering online life sciences compliance training, the technical team behind PharmaCertify has never faced an LMS communication and compatibility issue we could not overcome quickly and efficiently. The training we build for our pharmaceutical and medical clients is launched on systems large, small, and everything in between. Communication with the LMS team on the client side is key and early in the project, we learn the specifications of the system and provide a test module to that team to ensure seamless integration into the LMS.

Since we work with companies in various stages of training preparedness, including some that do not have an LMS in place, we also offer our Access LMS as a cost-efficient solution for deploying training to employees and third-party vendors alike. But, no matter the LMS, our first goal is to ensure your training reaches your learners according to your planned schedule and without technical concerns, and the critical completion and reporting data you need to verify learner compliance with your training curriculum is accurate, accessible, and reliable.

To see a demo of the PharmaCertify compliance training solutions, including the Access LMS, contact Dan O’Connor at doconnor@nxlevelsolutions.com.

Thanks for reading!

Off-the-Shelf Compliance Training Myths

Myth #2: It’s Not Really Targeted to the Life Sciences Industry

In this installment of our series on the myths and realities associated with off-the-shelf compliance training, I cover the common concern that off-the-shelf compliance and ethics training is not effective because it is so rarely focused on the life sciences and the only way to get targeted training is to build from the ground up.

The Myth 

All too often, life sciences companies purchase off-the-compliance training designed with generic content that is somehow intended to be applicable to any industry. This especially holds true when training is sold under the banner of ethics training. After all, ethics is ethics, no matter the industry…at least that is the sales pitch from companies who sell generic compliance training.

Unfortunately, the aggressive marketing and sales efforts of those companies perpetuate the myth among many life science companies that custom-development is the only training option that will meet their needs. Unknowing compliance professionals think they have only two bad options: 1) purchase generic training, or 2) hire a generalist training developer to build expensive modules from scratch, with the added burden of having to provide subject matter expertise to the training developer (As if they don’t have enough to do already!). There is a better approach, one that can be both efficient and cost-effective.

The Reality

Those pedaling generic compliance training may insist otherwise, but effective life sciences compliance training absolutely requires content targeted to the pharmaceutical or medical device industries. The intricacies and details of the risks in our industry are far too unique to expect learners to find real value in generic training. But that doesn’t mean the only path to quality training is through custom development. Off-the-shelf training, with content developed by industry experts and vetted by your peers in the industry, is readily available for customization and launch.

Interactions with Healthcare Professionals Compliance Foundations eLearning Module

Our Compliance Foundations™ eLearning modules cover the topics those working in the life sciences industry need to effectively reduce the risk inherent to their job responsibilities. Off-the-shelf courses include Good Promotional Practices; Interactions with Healthcare Professionals; Healthcare Compliance Overview; On-label Promotion; and Managing Speaker Program Risk to name a few. The modules are designed for easy customization, so your language, policies, and practices are easily woven into the content. And our modules can be launched on any SCORM-compliance learning management system…either the one you have in place or our cost-effective LMS.

The Bottom Line

There is a better way. You don’t deserve to have to settle for generic compliance training. You can have off-the-shelf content that is specifically targeted to the risks in our industry and the ability to further customize the training specifically to your company. You also don’t need to always build from scratch to ensure the content is relevant and optimized for the risks your learners face every day as they interact with healthcare professionals and conduct their work-related activities.

But don’t just take my word for it when you can see for yourself. Follow the four steps below to access demos of the Compliance Foundations™, and see first-hand, the level of industry focus we bring to our modules.

  1. Visit http://www.pharmacertify.com/demo/interactions_hcps/start_course.htm
  2. Follow the navigation prompts to review the demo.
  3. Visit http://pharmacertify.com/foundations-compliance-training.html to see short descriptions of all of our Compliance Foundations modules.
  4. Contact Tessa Hoyer at thoyer@nxlevelsolutions.com for course outlines and to learn more.

Thanks for reading!

A Preview of the 4th Annual Life Science Ethics & Compliance Training Conference

PharmaCertify is a proud sponsor of the 4th Annual Life Science Ethics & Compliance Training Conference scheduled for June 5th and 6th in Chicago. As someone who has spent the last 12 years in the field of life sciences compliance training, I find the focus of this annual conference especially compelling as industry leaders and consultants share ideas, tips, and experiences for reducing risk through innovative training. It’s an exciting and energized group of presenters every year. Below are some of the presentations I find to be of note this year. You can learn more about the conference and download a full agenda at https://www.q1productions.com/compliancetraining/. Contact us about our sponsor discount if you are interested in registering.

Day 1: Wednesday, June 5

Day 1 will be chaired by PharmaCertify’s own Dan O’Connor, and after the opening ice-breaker, the conference begins in earnest with a keynote panel titled, Assessing Risk Tolerance & Company Culture as a Driver for Ethics and Compliance Education. Kudos to the conference organizers for scheduling a great kickoff session. Building an effective compliance training curriculum begins with a thorough risk assessment and I am looking forward to hearing the details of each presenter’s process for “shaping training based on tolerance, and conveying liabilities to ultimately create a culture of compliant and ethical behavior…”

Following the keynote panel, a multi-part session from 10:00 AM to Noon begins with the Legal Interpretation of Enforcement Trends & Areas of Inspection presentation. The talking points on the agenda include the first official reference to the new and trending topic of patient assistance programs. That theme continues later in the day with a case study from Catherine Starks of Sidley Austin, Risk Evaluation & Training Approaches for Compliant Patient Assistance Programs.  With PAPs and PSPs programs being the focus of recent corporate integrity agreements, any discussion of the associated risks and the best practices for conducting compliant programs is worthwhile.

The first session after the lunch break, Developing a Compliance Training Cadence Based on Risk & Needs of Business caught my if for only one word: cadence. The rhythm and pace at which compliance training is launched across a life sciences company is critical to the success of that training. Microlearning is all the rage lately and effective microlearning is more about the frequency and schedule at which training is delivered than it is about the length of the individual learning components. In this session, the presenter will discuss the factors affecting that cadence, including establishing a “cadence to coincide with business agendas and timetables to inform stakeholders at optimal moments.”

Two case studies on the topic of “measuring training effectiveness and risk reduction” are scheduled for the afternoon and I am excited to hear the speakers from Exsurco and Gilead detail their strategies for tracking retention and engagement, and as described in the agenda, “translating the data into actionable strategy.”

Day 2: Thursday, June 6

Day 2 kicks off with one of the more intriguingly-titled sessions from this or any conference: Masterclass: Effectively Maintaining Training Priorities Upon Exiting a Corporate Integrity Agreement. The end of a CIA presents a great opportunity for companies to incorporate the lessons learned during the term of the CIA, when training schedules and the modules were under the demands of the agreement and create a curriculum even more dynamic in terms of scope and levels of engagement. I look forward to hearing Maureen Mason of AstraZeneca discuss her philosophy and suggestions for maintaining the diligence of a strict curriculum while expanding and enhancing the company’s compliance curriculum.

“Cadence” isn’t the only word that jumped off the screen when I initially reviewed the conference agenda. The sessions scheduled after the 10:00 AM coffee and networking break (don’t forget to visit us at the PharmaCertify booth to see demos of our newest training products), Multi-Part Case Study: Contextual Compliance Risk Evaluation in Prioritizing Training caught my eye for the use of one word: contextual. In our 15th year developing compliance training for life sciences, the team at PharmaCertify has worked with compliance departments ranging from an “n of 1”, to those that have a full team of internal resources. And while context does matter, ultimately results are what count no matter the number of resources. In this case, the large corporation perspective will be provided by Abbvie, the mid-sized by a speaker from Convatec, and the “limited resources” perspective by Otsuka.

After the lunch break, two breakout groups are divided by industry, in sessions titled, Compliance Considerations Specific to Pharmaceutical & Medical Device Organizations. I am glad to see the focus on the medical device industry, which too often is not as well represented at conferences. Two speakers from Teleflex will provide the me device experience and their talking points include updates to the AdvaMed Code of Conduct; compliant interactions & “no touch;” and the EU General Data Protection Regulation.

The afternoon of Day 2 includes a session on third-party vendors: Managing Distributor Partner Compliance Training. The intricacies of doing business through third-party vendors hold the potential for increased risks compliance violations. It’s a critical topic and any opportunity to hear tips and suggestions related to training, tracking and managing global vendors is worthwhile and valuable.

Discounted Conference Registration

The 4th Annual Life Science Ethics & Compliance Training Conference is scheduled for June 5-6, in Chicago, Illinois and if you’re interested in hearing industry leaders share their experiences and best practices, there is still time to register. Contact me at smurphy@nxlevelsolutions.com to take advantage of our discount registration rate. I can’t recommend this conference more highly!

Thanks for reading!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

Off-the-Shelf Compliance Training: Myth vs. Reality

Myth #1: Off-the-Shelf Training Doesn’t Align with My Content Requirements

Welcome to the first installment of our series on the myths and realities associated with off-the-shelf compliance training. In each post, we will dive into one commonly heard myth concerning the pros and cons of using off-the-shelf eLearning to reduce compliance risk in the life sciences industry. We begin this week with the frequent lament, “off-the-shelf training doesn’t align with my content requirements.”

The Myth 

Multiple presenters at the 2019 Pharmaceutical Compliance Congress emphasized the importance of targeting training to the audience. As one speaker said, “scientists are not going find value in training that features scenarios with sales representatives.” He ended his comments by saying that is why he only uses custom-developed training.

In addition, in its recently updated guidance on the evaluation of corporate compliance programs, the Department of Justice emphasizes the need for “appropriately tailored training and communications.” When describing what prosecutors should take into consideration when evaluating a company’s program, the DOJ asks, “has the company provided tailored training for high-risk and control employees, including training that addresses risk in the area where the misconduct occurred?”

Clearly, government regulators and industry leaders recognize the importance of targeting training to the roles and risks associated with individual learner groups. And the belief that only fully-custom training can meet those requirements is predictable and understandable.

But is it reality?

The Case for Off-the-Shelf

Knowledge Check from the Compliance Foundations eLearning module: Healthcare Compliance Overview

While I agree wholeheartedly about the need to target the audience and use role-appropriate content, well-designed off-the-shelf training allows for extensive customization, in a streamlined, cost-efficient manner.

Consider Healthcare Compliance Overview, a module from our library of Compliance Foundations eLearning courses. The module covers a broad range of commercial compliance topics, including the False Claims Act, off-label promotion, HIPAA, good product promotion, and the Anti-Kickback Statute so our clients typically launch it to their full staffs. Most of our clients customize the content to reflect the needs of specific learner groups, e.g. sales, medical, clinical, and corporate. Since the modules are built in a “templated” format, the process is simplified and the cost is less than custom-developed training.

Healthcare Compliance Overview features knowledge checks instructionally designed to reinforce key objectives throughout the module. The knowledge checks are often written in the form of scenarios that reflect “real-life” experiences some learner groups are likely to face in their daily activities. Since the modules are so easy to customize, our clients roll out multiple “versions” of the module, each one tailored to the appropriate audience. The result: highly professional and engaging customized compliance training at less cost than custom training.

The Bottom Line

Custom development certainly offers the opportunity to tailor compliance training to various learner groups within a life sciences company, but it comes with a steep price and lengthy development timeline. Delivering appropriately targeted off-the-shelf compliance training throughout the company is not only possible, but it is often the optimal solution based on budget and time frame. Just be sure the off-the-shelf training offers the right level of flexibility.

Launching off-the-shelf compliance training, customized for your learners, is a simple four-step process with PharmaCertify:

  1. Review your risks and goals with our team.
  2. Select from our Compliance Foundations curriculum.
  3. Make our content your content through the customization process.
  4. Launch your training!

Contact me at smurphy@nxlevelsolutions.com to learn more about our customization process.

Thanks for reading!

Connie the Compliance Training Manager Tackles New Hire Training!

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

This week: Connie hears from a compliance training manager looking for a more exciting way to train new sales representatives.

Dear Connie,

I know I should change my new hire compliance training session for the sales representatives because my PowerPoint deck might be getting a little stale, but I only get an hour in front of them, so I don’t really have time for a more creative approach. Any suggestions?

Concerned Compliance Manager in Cambridge


Dear Concerned,

You may be surprised to hear that an hour is more than enough time to conduct a more engaging and more memorable live training session. Now is the time to ditch that overused and dull PowerPoint deck!

Make it More Competitive

Research shows that learners are motivated by competition. So how about creating a Jeopardy-style game format with questions designed around your company’s policies and risks? In my experience, five categories, with five questions per category, fills an hour of time. Make sure you take a few minutes after each question to explain why the answer is right or wrong and ask the participants for examples of similar situations they have faced.

Depending on the size of your audience, I suggest you pick 3-5 participants per team to “represent” groups in the audience and have representatives buzz in once they think they know the answer. It’s a great way to take the learning to another level and create an interactive experience where ideas are exchanged with the audience. One warning: have someone there with a timer to make sure they don’t buzz in and then take forever to figure out the answer.

Make it More Engaging

You could also create an interactive workshop where the participants are divided into groups and asked to “solve” compliance scenarios together. Break the workshop into two activities to keep it moving and make sure each team has a tablet or laptop on a table. I like the idea of a Compliance Sprint as the first activity. Have the teams solve a series of exercises (a card sort works well) based on situations they are likely to encounter in the field.

You could also mix in a Compliance Mystery. The same teams play compliance “detective” and solve more complex scenarios with the help of a series of clues. The clues can be emails, phone call transcripts, business cards from a meeting, or whatever clues help provide hints about the scenario. Be creative and make it fun, but make sure you make it realistic in terms of their work activities. Of course, both activities should be scored and tracked on a leader board to raise the engagement level even more.

If you have the time and resources, you can certainly create the game or the workshop in-house, but my friends at PharmaCertify (that’s the compliance training division of NXLevel Solutions) have workshops just like the ones I described that are easily customized with your content. I’ve been there when their clients have used their workshops, and wow it is fun to watch the learning! They’d be happy to demo the workshops for you. Just email Tessa Hoyer at thoyer@nxlevelsolutions.com.

Thanks for the question and remember to make it fun and make it memorable!

Your compatriot in compliance training,

Connie