off-label

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

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

PharmaCertify Team , , , , , , , , ,

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.

 

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

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

PharmaCertify Team , , , , , , ,

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

PharmaCertify Team , , , , , ,

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!

PharmaCertify Team , , , , , , , ,

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

A Preview of the 2019 Pharmaceutical Compliance Congress

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The 16th Annual Pharmaceutical Compliance Congress is scheduled for April 16-18, 2019 in Washington DC.

The 16th Annual Pharmaceutical Compliance Congress begins April 16-18 in Washington DC and as is often the case, the agenda promises a compelling mix of presentations covering topics important to new and experienced compliance professionals alike.

Tuesday, April 16th is dedicated to the Congress “prelude” and one of the sessions looks particularly interesting based on its subject matter. Nurse educators are a trending topic in life sciences compliance with the potential for patients misinterpreting the line between medical advice and a commercial sales pitch. The description for the Compliant Nurse Educator prelude includes the timely suggestion that attendees will “gain foundational and operational needed to structure and maintain compliant programs.”

On Day One, Wednesday, April 17th at 11:15 AM, the Highly-Acclaimed U.S. Healthcare Fraud and Enforcement Panel begins with current prosecutors reviewing “Top Enforcement Trends and Focal Points for 2019 and Beyond.” During the Former Prosecutors Panel that follows, three former Assistant US Attorneys will focus on “New Developments on High-Profile and Settlements Uncovering Healthcare Fraud.” The perspective from the regulator side of the table is not readily accessible outside of this type of conference and attendees will be listening carefully for suggestions and tips from those responsible for regulation.

Following the networking lunch (important tip: the networking sessions offer great opportunities to learn from your peers), Day One continues with a series of “content streams” divided by general topic matter.

Patient assistance programs (PAPs) and Patient support programs (PSPs) are certainly under scrutiny (see our recent blog post on the programs here), so we have to recommend Content Stream A: PAPs and PSPs. A team of panelists, including Jennifer McGee from Otsuka, Chetan Shankar from GSK, Francisco Ribeiro Filho of Tesaro and Ann-Marie Tejcek of Eli Lilly will speak in two sessions: Navigate the Complex Legal Landscape of PAPs and Examine PSP Enforcement Trends as Scrutiny Heats Up. Content Stream C: Transparency and Aggregate Spend is also of interest considering the pending expansion of the Sunshine Act to include Advance Practice Nurses and Physician Assistants. It’s time to update that Sunshine Act and Open Payments training!

A series of interactive workshops follow the content streams and I’m looking forward to the Beyond Due Diligence – Auditing and Monitoring Third-Parties session, in particular. Third-party vendor compliance continues to be an area of focus in the industry and Lori Queisser of Teva should bring an important global perspective to the challenges of bringing vendors into compliance as they conduct business of the company’s behalf around the world.

Speaking of hot topics – Interactive Workshop 4: Risks Associated with the Hub and Field Reimbursement Teams so I expect the impressive list of panelists, including Sarah Whipple from Akebia, Joe Philipose from Alexion, and Richard Konzelmann from Sanofi to be speaking to a crowded room of attendees anxious to hear how they are managing the compliance risks that are inextricably linked to the use of Hubs for specialty products.

After a networking and refreshment break at 4:25 PM (don’t forget to stop by the PharmaCertify Booth to see demos of our newest compliance training products), the conference transitions to a series of “think tank sessions.” Frankly, I am not sure of the difference between a workshop and a think tank, but I suppose the changing up the name does make for a more organized agenda.

Anyway, on the think tank front, the Speaker Programs – Best Practice Benchmarking is right at the top of my list. Our recently completed Managing Speaker Program Risk Compliance Foundations™ module is already popular among our client base and for good reason. The programs are fraught with risk at every stage, including planning and execution, and this session, featuring Jennifer McGee from Otsuka again, as well as Maggie Feltz of Purdue Pharma, and Rebecca Spitler of Johnson & Johnson, should prove to be a valuable primmer on how to navigate those risks.

Add Social Media – Practical and Pragmatic Guidance to our target list among the think tanks because, well, it’s social media. We’ll also be in the PAP and PSP Benchmarking – How is the Industry Adapting? think tank to hear how Casey Horton and Stefanie Doebler from Navigant are working with their clients to help minimize program risk.

Day 1 closes with an end-of-day cocktail reception and I do recommend taking the time to attend this important networking event before you run out to dinner. It’s a great opportunity to interact with your peers and learn how they are dealing with some of the same challenges you face every day.

Following the Chairman’s Review of Day One, Day Two, Thursday, April 18th opens with an interesting session titled, From the Trenches: An Inside Look at the Forces and Pressures that Drive People to Violate the Law. The idea of approaching compliance from a higher “ethics” level has been a topic for discussion in recent years and companies are clearly seeking ways to integrate the concepts into their policies and procedures. I’ll be interested to hear how the speaker, who is the CEO of Business Ethics Advisors, LLC, how is working with clients to do just that.

After a session dedicated to recent trends in enforcement, featuring Eric Rubenstein from the OIG and Heather Johnson from the FTC, the agenda takes a turn to the future with Rethinking the Compliance Profession – Where Should We Go from Here? Including such forward thinking presentations is appreciated and this look at the future of the industry should dovetail nicely from the opening session on ethics.

Next, attendees choose from what are described as “five in-depth summits.” The Small to Mid-Sized Company Resource Center holds interest for me based on the uniqueness of its title, and simply because I find the small to mid-sized company focused sessions so informative from a standpoint of learning what those with limited resources are doing to address the same challenges their peers at larger companies face.

With HCP interactions still representing so much of the compliance risk companies face, the Compliant Patient Interactions summit should be worthwhile, with an impressive array of industry professionals ideally sharing tips and suggestions for ensuring those interactions are conducted in a compliant manner. Hopefully, training is included on the list of talking points.

Following the final networking luncheon, the conference closes with the reveal of an inaugural benchmarking survey. The agenda does not list what organization conducted the survey, but I’m sure attendees will be listening closely to learn what their peers from “brand/generic, large/small and private/public” companies consider to be their top priorities on the established and emerging compliance risk areas.

Summary

The panel presentations, workshops, think tanks, and summits I touch on in this preview represent just a few of the sessions CBI has planned for this year’s conference. The Pharmaceutical Compliance Congress never fails to deliver the content and networking opportunities industry professionals need to stay abreast of current risk areas, policies, and best practices. I highly recommend the conference for the new and established life sciences compliance professional.

If you are considering the conference but have yet to register, we are still offering discounts on the regular conference registration rate. Contact me at smurphy@nxlevelsolutions.com if you’d like to take advantage of that discount. If you are attending, don’t forget to stop by the PharmaCertify booth to say hi and let me know what you think of our blog. As always, your feedback is appreciated.

Thanks for reading and I will see you in Washington!

Sean Murphy
Editor
Compliance Training Intelligence Blog

Fair Balance: Training on a Tricky Concept

PharmaCertify Team , , , , , ,
Mona Kay Gorman
This week, we welcome Mona Kay Gorman to the Compliance Training Intelligence Blog. Mona Kay is the Director of Training & Leadership Development at Valeritas. She has extensive experience in the management of compliance training and communication programs, as well as the design and delivery of virtual and live compliance training courses.

Has anyone ever asked you how to apply fair balance to a promotional discussion? In my experience, it’s one of the most challenging FDA standards of promotion to explain, train, and apply. Most industry professionals understand how to keep a conversation on-label, but the definition of fair balance is a bit vague, and appropriate use can be a hard concept to grasp. Through a few simple steps during training, and by making the effort to partner with the businesses, we demystify the concept and help promotional people effectively balance their messages.

Good Training Enables Better Practice

If you’ve ever attended a sales training workshop, you know that sales representatives are extensively trained on promotional messages to make their discussions sound confident and natural. Role-playing, or some type of repetitive practice, is understandably an important part of the training content. Fair balance can be practiced in the same way if the audience understands and can apply the concept. Some amount of hand-holding is helpful, so training design is important.

For instance, if the content includes only broad, high-level examples of fair balance, trainees may struggle to apply the examples to their day-to-day discussions. As a result, fair balance messages are tacked onto the end of a promotional call, like a canned disclaimer. When training is customized using role-specific customer types and messages, the examples are more relevant, and trainees understand what a balanced message sounds like for their specific discussions. Armed with this understanding, they can practice balancing the promotional messages they typically use in their day-to-day customer conversations.

Collaborate for Shared Success 

Since collaboration drives shared ownership and desire for success, partnering with business stakeholders is critical. When designing your training, meet with leadership members of your intended audience to share your vision and ask them about typical customer types and discussions. Seek feedback on the draft content. Are the examples and scenarios relevant and easy to apply? Do business leaders feel confident providing feedback during coaching sessions? Make sure the sales training department is part of the conversation as well. Collaboration helps stimulate pull-through.

Finally, make yourself available for questions, and keep your commercial partners informed of questions you receive during and after the training and the answers you provide to those questions. Doing so will drive communication and advocacy and establish you as a valued resource and partner.

Effort Well Spent

Effective fair balance training leads to confidence in execution. When training is optimized as described, sales representatives know how to balance their promotional discussions, the sales training department has more confidence pulling the concept through, and the stakeholders across the company support and even advocate one of the trickier promotional standards. When all of that occurs, organizational risk is reduced, and the compliance department is seen as a partner instead of just the “scary enforcer.” The extra time and resources spent developing relevant, customized fair balance training, and partnering with the business, is not only worthwhile, but necessary, to improve learning and ensure representatives are balancing their messaging appropriately.

Thanks for reading.

Mona Kay Gorman

To download a printable version of this article, please visit the Insights page on the PharmaCertify website.

 

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

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

Lesson 2: The More Things Change…

Tessa Hoyer of PharmaCertify greets attendees at the 19th Annual Pharmaceutical and Medical Device Compliance Congress.

The French journalist and novelist, Jean-Baptiste Alphonse Karr, is credited with coining the phrase, “the more things change, the more they stay the same.” For anyone who has attended multiple compliance conferences in the last five years, his words certainly ring true. Terms like “partnering with the business,” “tone from the top,” and “third-party risks” are still staples during conference presentations and this year’s Pharmaceutical and Medical Device Compliance Congress was no exception. For good reason.

As an example, the Compliance 3.0 presentation on Day 2 of the conference began with one panelist expressing his concern that “we still have to fight for a seat at the table.” In other words, while the concept has been bandied about for years now, the reality is that raising compliance to the organizational level of respect it requires to affect true behavior change is still a struggle. He and his co-presenters emphasized the need to not only find that seat alongside the businesses but truly understand their business policies as well as what they do and who they are. As another presenter put it, “bring value to the business as a compliance representative, educate them every step of the way, and help them educate their people.” She added, “when they get to the point where they are doing it themselves, that’s nirvana.”

Not surprisingly, the need to train and manage third-party vendors continues to be stressed. In the session covering the Foreign Corrupt Practices Act, one government representative even delved into the need to extend the corporation’s culture to the vendors. She added “you really need to know your third-party vendors and they need to understand you. You need to know who it is that is making payments on your behalf.” The presenters in the Third-Party Lifecycle Management session agreed, citing the need to “have vendors take the same training that is rolled out for your employees. Treat them as partners and make sure they understand the risks involved.  They are more likely to care about being compliant if they feel like a partner and if they will be held responsible.”

As with the conversation and debate over an “ethics-based approach to compliance,” concepts like “tone from the top,” “partnering with the business,” and “third-party risks” warrant our focus and consideration simply because they are that relevant and critical. Industry conferences offer the valuable opportunity to hear our peers share their latest insights and success stories around the themes that seem to drive the conversation. While the world of life sciences compliance is evolving, in some cases, the more things change, the more they stay the same…at least at the compliance conferences.

Thanks for reading!

Sean Murphy
Editor
Compliance Training Intelligence Blog