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

PharmaCertify Team , , , , , , , , ,

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

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

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

  1. Meals, meals, meals.
    How to handle meals during the pandemic (in speaker programs and otherwise) continues to be a common refrain during conferences. Speakers from the pharmaceutical and medical device industries touched on the topic, with the conversation mostly focused on the importance of sending meals only to HCPs’ offices and hospitals, and not to their homes. PhRMA’s guidance released earlier this year is a good starting point for updating policies and building new training: https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA-Code-Section-2.pdf. Clearly if you have not addressed the way in which meals should be provided in your policies and subsequently in your training, you should.

  2. Remember the changes to the Sunshine Act.
    Speaking of updates, attendees were reminded that the changes to the Sunshine Act go into effect in January. If your core Sunshine Act training hasn’t been updated, you need to make your learners aware of the changes in the list of covered recipients and the nature of payment categories…quickly!

  3. Be aggressive.
    Throughout the conference, government regulators agreed that they tend to view companies that have a robust compliance program more favorably during investigations. Or, as one panelist in the AUSA Roundtable put it, “if you’ve properly dealt with the problem, we’re probably going to go away.” That extends to your compliance curriculum. So not only is a “check the box” approach to training a bad idea in terms of learning, it also isn’t going to impress regulators when they come calling. A modern and effective curriculum needs to be evaluated against your company’s risk, and it needs to be supplemented with regular nuggets of training spread across the learner’s timeline.

  4. Keep the communication flowing.
    An effective curriculum doesn’t end with the deployment of training. The importance of on-going communication during the pandemic was reiterated in multiple sessions throughout the conference. Presenters focused on how the sudden shift in the way business is conducted has forced them to think about how they stay in touch with leadership and the field. The need to think differently has clearly given birth to ideas and best practices that will continue post-pandemic. Whether designating “compliance liaisons” from the businesses to bring ideas and questions back from the field, or rotating people from the businesses through the compliance department, presenters are finding creative methods to ensure compliance stays top of mind for the long term.

  5. Patient support and speaker programs are still in focus.
    Gregory Demske and Mary Riordan reminded attendees that the OIG’s focus is still squarely on patient support programs and speaker programs. And interestingly, Demske encouraged viewers to ask themselves if they really need to go back to in-person speaker programs after the pandemic and warned that the agency is going to continue to look carefully at “payments to prescribers that are under the guise of speaker programs.” Recent CIAs focused on speaker programs and patient support programs are a good starting point as you evaluate your training plan.

  6. Pay attention to social media.
    According to presenters in the social media mini summit, 70-80% of patients get information from online resources. While that’s not a surprising number in our digital age, it’s concerning in light of the dearth of guidance from federal agencies. Presenters emphasized the need to stay abreast of the emerging social media platforms and evaluate training plans in context of the limited social media guidance that is available. And the risks of social media aren’t limited to the pharmaceutical industry. In the Medical Device Roundtable session, one presenter warned that cutting-edge technology often can lead to representatives being overly enthusiastic on social media. It’s a scary, changing world online, and as a compliance professional, you need to be continually addressing it in targeted training.

  7. Customize training for company-specific risk.
    I may be biased, but the discussion about the risk-frequency framework by Dan O’Connor in the State-of-the-Art Compliance Training mini summit is “can’t miss” conference viewing. If you did miss it, let me know, and I will be happy to coordinate a brief review of the concept with Dan. The framework is a great starting point for evaluating the appropriate mix of training based on the riskiness of the activity and the frequency at which that activity occurs. Ours is not a one-style-of-training fits all world and the framework is a good way to look at your curriculum and make adjustments in the tools and techniques to address risk accordingly.

  8. Emphasize a culture of integrity, not just compliance.
    Those of us who have been working in life sciences compliance for a long time know the industry has been touting the need to shift away from a rules-based approach to compliance to one based on values and ethics. That shift is in process and was best summarized by a presenter in the Integrating Ethics and Compliance session when she said she finds the word “compliance” to be limiting and she prefers the word “integrity” to emphasize that how one does something is as important as what someone does. Or, as another presenter in the same session said, “now is the time to create a culture where people are comfortable speaking up.” That’s the language of a values-based approach and it certainly seems like it’s here to stay. Does your training incorporate these themes?

  9. The core rules still apply.
    While COVID-19 has changed the way in which business is conducted and how interactions occur, the core principles of compliance still apply. In fact, as multiple regulators and industry professionals were quick to note, “COVID is not an excuse for non-compliance.” Some of the details may have changed, but speaker programs need to be monitored, speakers need to be trained, reps need to stay on-label, federal regulations still apply,  and state disclosure laws need to be followed.

  10. More risk is okay if you have a strong foundation to manage that risk.
    Many years ago, when I started working in compliance training, I could not have imagined someone being bold enough to publicly say more risk is okay. But there I was in the CCO Fireside Chat, when I heard a presenter confidently say, “striking a balance between the legal environment and business goals is key.” To my surprise, he followed up by saying, “and to help the business be more risk tolerant you need training that is sticky and impactful.” The assessment is an honest and refreshing one, and hearing the word “sticky” used in reference to compliance training brings music to the ears of someone who has been part of a team encouraging the industry to do that for 15 years. The future may be filled with more engaging and dynamic training after all.

    11. Thanks for reading!

    Sean Murphy
    PharmaCertify By NXLevel Solutions

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

PharmaCertify Team , , , , , , , , , , , , , , ,

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

My First Glance at the Agenda for the 17th Annual Pharmaceutical Compliance Congress

PharmaCertify Team , , , , , , , , , , ,
The 17th Annual Pharmaceutical Compliance Congress is scheduled for April 29 – May 1, 2020 in Washington D.C.

When scanning an agenda for an upcoming compliance conference, I begin by identifying the presentations that feature new topics, or ones that offer a compelling twist on a long-standing topic. This isn’t to suggest you should ever focus exclusively on the “new and shiny” sessions over those that have a more familiar ring. For those of us steeped in many years of conference attendance, sessions like DOJ and SEC Insights and Third-Party Risk Assessment and Oversight are always worthwhile for the updates offered by industry leaders and government regulators.

My initial review of the agenda for CBI’s 17th Annual Pharmaceutical Compliance Congress, scheduled for April 29 – May 1 in Washington D.C., reveals an intriguing mix of new and bold content, along with tried, true, and recognizable presentations. The conference is consistently one of the “can’t-miss” opportunities for life sciences compliance professionals to interact with their peers and hear best practices and suggestions for reducing risk across their companies. From a training development perspective, the presentations help keep us aware of important content trends, as we strive to provide training products you need to continually evolve your curriculum and address compliance risk.

With that in my mind, here are my thoughts on some of the sessions planned for this year’s conference.

Day One – Wednesday, April 29, 2020

CBI has scheduled three concurrent “summits” to open the conference. Summit 1, Bio/Pharma Compliance Boot Camp appears to be an ideal opportunity for those attendees new to compliance to gain a foothold on the topics that form the foundation of the industry. Perri Pomper of Clinical Genomics and Ed Sleeper of Esperion will be joined by Mahnu Davar and Daniel Kracov of Arnold & Porter to cover the essentials. If you are new to the industry, you don’t want to miss this one.

After a networking and refreshment break in the Exhibit Hall (shameless plug – don’t forget to stop by the PharmaCertify booth), three more concurrent summits are planned for the afternoon. Summit IV, Primer Course on Compliant Patient Interactions, from Clinical to Commercial, offers an update on an obviously hot topic, from Rahul Khara of Acceleron Pharma and Seth Lundy of King & Spalding. In Summit V, Compliance and Legal Watch-Outs for Partnering and Deal-Making, Erik Eglite of Aurina Pharmaceuticals will address the compliance challenges inherent in product partnerships. Summit VI, Empowerment, Diversity and Inclusion, stands out as something new and compelling for this conference. Kudos to CBI, as well as presenters, Sujata Dayal of Johnson & Johnson, Jim Massey of AstraZeneca, and Maggie Feltz, of Purdue Pharma, for taking on such an important and timely topic.

Day One closes with the PCC Kick-Off Party and Welcome Cocktail Reception. This is one of the best opportunities you’ll have to interact with your peers while visiting the vendors who provide an array of the services you need to build a stronger culture of compliance. While there, visit the PharmaCertify booth to see demos of our newest compliance training products, all designed to help you enhance the retention of key policies and regulations in the field and across the company.

Day Two – Thursday, April 30, 2020

Following a networking breakfast, and the chairperson’s opening remarks, Day Two begins with a Regulatory and Enforcement Showcase, featuring presentations from representatives of PhRMA and  government entities, including the OIG, various U.S. Attorney offices, the DOJ, and the SEC. The Enforcement Docket Deep-Dive is the annual review of recent corporate integrity agreements and settlements. The panel features an impressive array of representatives from U.S. attorney offices around the country. Consistently, from year to year, these enforcement updates offer critical insight into the latest government oversight trends.

The session titled, Chasing Miracles – When Drug Research is Personal jumped off the screen for me. As a company dedicated to the development of compliance training that reduces risk on a sustained basis, we strive to make that training relevant, personal, and meaningful. I look forward to hearing John Crowley and Patrik Florencio, both of Amicus Therapeutics, discuss how they introduce and communicate the “criticality of compliance in advancing lifesaving therapies,” as it is described in the agenda.

Following the networking lunch, attendees choose from six concurrent workshops. While that may seem like a daunting decision, I recommend partnering with colleagues and associates to divide and conquer. Sharing notes over dinner or coffee is a powerful way to get the most out of the conference and bring more actionable knowledge back to your job.

While all the workshops look to be worthwhile on the surface, three stood out for applicability and relevancy to risk areas. First, Calling All Emerging Biotechs – Pre-Commercial Considerations and Checklist appears to be an ideal opportunity for anyone working with a smaller company, with one product commercialized or soon to be commercialized. I am anxious to hear if Eric Baim of Dovetail Consulting, Tiago Garrido of Verastem, and Rupa Cornell of Stealth BioTherapeutics touch on training as they cover the unique risk and resourcing challenges faced by companies in this tier.

On the hot topic front, the Enforcement Snapshot and Best Practices Related to PAPs, Coupons, Copays and Foundations addresses the risk that seems to be on everyone’s mind, including the collective ones at the OIG. Stephanie Doebler of Covington and Burling LLP, and Katherine Chaurette from Blueprint Medicines Corporation will present.

On the persistently relevant front, Third-Party Risk Assessment and Oversight, with Dennis Barnes of Mayne Pharma, Tali Guy, of Teva Pharmaceuticals, and Michael Clarke of ConvaTec, will surely be relevant for anyone whose company conducts business globally through third-party vendors. That’s a wide swath.

The concurrent workshops continue throughout the afternoon, with six from 2:55 pm to 3:55 pm and six more from 4:25 pm to 5:30 pm. Workshop G has a compelling title in line with the earlier one focused on emerging biotechs, “Product Approved, Now What? Building Out the Compliance Infrastructure with Limited Resources.”  It’s a topic near and dear to the hearts and budgets of many of our clients and I will be listening closely for how Jeffrey Levitt of Stemline Therapeutics, John Knighton, of TherapeuticsMD, and Jim Flaherty of Rhythm Therapeutics handle development and deployment of training on those limited resources.

Back on the hot topic front, Workshop K, Hub and Specialty Pharmacy Oversight and Risk Assessment, features Sarah Whipple of Akebia Therapeutics, and Meenakshi Datta of Sidley Austin; and I am interested in hearing their expert analysis on assessing the risks associated with hubs, and of course, how that risk is addressed in training.

Finally, you do not want to miss Workshop P, State-of-the-Art Compliance Training, with Erica Powers of SAGE Therapeutics, and my colleague from PharmaCertify, Dan O’Connor. In this case, “state-of-the-art training” may not mean what you assume it means in terms of design and budget. Erica and Dan will present different methods for addressing risk and deploying more effective training, no matter your learning objectives and business goals.

Day Three – Friday, May 1, 2020

If the multitudes of workshop choices on Day Two aren’t enough to satiate your hunger for compelling compliance content, CBI has scheduled five full sessions followed by your choice of five tailored content tracks, with two presentations per track:

  • Track 1: Speaker Programs – Current Enforcement Trends, Best Practices Benchmarks, and Future Fate
  • Track 2: Commercial and Government Pricing Transparency and Reporting
  • Track 3: Taking Monitoring, Auditing, and Investigations to the Next Level
  • Track 4: Zero-in on Compliant Patient Interactions
  • Track 5: Clinical Trial Legal and Contracting Considerations and Risk Management Strategies

Among the presentations that precede the track sessions, Lessons Learned from the Field. Anti-Kickback Accusations and the Aftermath – An Inside Look at Sales and Marketing Practices Under Fire should be interesting to say the least. If the title alone wasn’t intriguing enough, the presenter is Jonathan Roper, former district sales manager for Insys Therapeutics. Roper was charged with violating the Anti-Kickback Statute in connection with his participation in the company’s scheme to encourage HCPs to prescribe its fentanyl-based sublingual spray. I am encouraged to see that along with sharing his story from the Insys trenches, Roper is expected to cover the importance of an effective compliance training program in his comments. Buckle your seat belts, it’s going to be an interesting 30-minute session.

An Opportunity to Attend

The sessions I cover above represent only a fraction of the veritable plethora of important content covered in the three-day conference. Whether you work as an n of 1, or by contrast, you have access to a wealth of resources and personnel, the conference offers countless opportunities to bring back the information you need to build, maintain, and grow a better program and culture of compliance.

As a conference sponsor, we are offering a significant discount on the registration fee. Contact me at smurphy@nxlevelsolutions.com if you are interested in this opportunity, and we will see you in Washington!

Be a compliance training hero, with a little help from PharmaCertify…and a discount on the conference registration!

Sean Murphy
Marketing Manager
PharmaCertify by NXLevel Solutions

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

PharmaCertify Team , , , , , , , ,
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!

 

Off-the-Shelf Compliance Training Myths

PharmaCertify Team , , , , , , ,

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!

Lessons Learned at the 19th Annual Pharmaceutical and Medical Device Compliance Congress

PharmaCertify Team , , , , , , , , , , , , ,

Lesson 1: Rules and principles can coexist.

Welcome to the first in a multi-part series based on lessons learned from the recent Pharmaceutical and Medical Device Compliance Congress in Washington D.C. Our goal in this series is to share best practices and tips for strengthening your compliance culture and reducing risk based on the themes and best practices heard during the three-day conference and provide suggestions on implementing those concepts from a training perspective. We begin this week with a twist on a topic that has been on the agenda for a few years now…rules vs. principles.

During the Compliance Considerations for Small to Mid-Size Pharma and Device Companies panel presentation, a team of industry compliance officers and consultants discussed the challenges and opportunities brought on by limited resources and personnel. The suggestions were varied and intriguing, but one stood apart for me, especially from a training perspective. When he was offering the details of how he approached his transition to a small company compliance department, one chief compliance officer said, “it’s important to start with foundation training, and then have a conversation about culture.” In the milieu of conversation about the importance of principles, and the need for “an ethical approach to decision making,” it was refreshing to hear acknowledgement that rules-based and principles-focused approaches can co-exist and work in conjunction.

Foundational training lays the groundwork for the rules and policies that are critical for all life sciences employees to understand and incorporate into their daily activities. Although the “check the box” approach to training has been much maligned in recent years, being able to document that your staff, especially those who interact with healthcare professionals on a regular basis, have successfully completed training in topics such as HIPAA, on-label promotion, the False Claims Act, and the Anti-Kickback Statute, is a critical first step. Once that foundation is established, on-going opportunities and touchpoints can be utilized to establish the “why” behind the decisions as you strive to strengthen the culture across the organization.  As was emphasized during the presentation, you need to “have a plan that builds across all work streams” to do that throughout the year. As one example, workshops with interactive activities that immerse employees in ethical scenarios are an effective method for reinforcing the principles. In addition, assessments, microlearning, and games deployed across an employee’s timeline remind learners that compliance isn’t just about rules and regulations, it’s about “doing the right thing, for the right reason.”

During the Chief Compliance Officer Roundtable at the conference, one participant made the point that “a principle-based philosophy helps ensure compliance throughout the company and not just at the surface level.” That’s certainly true, but from our perspective, a principle philosophy is more effective when its built on a solid foundation of policy and rules-based training.

Thanks for reading!

Sean D. Murphy
Editor
Compliance Training Intelligence Blog

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

PharmaCertify Team , , , , , , , , , ,

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

Connie the Compliance Training Specialist Returns!

PharmaCertify Team , , , , , , ,

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

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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

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

PharmaCertify Team , , , , , , , , ,

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Thanks for reading!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

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

PharmaCertify Team , , , , , , , , ,

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

This week: Clearing the Confusion of Medical Device Codes

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Dear Connie,

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

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

Can you help me sleep better, Connie?

Quizzical in Quincy

Dear Quizzical,

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

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

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

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

Good luck and good training!

Connie