Compliance Training Lessons from the 2020 Virtual Pharmaceutical Compliance Congress

Part 3: Compliance Training in An Uncertain Time

This is the third and final post in a series covering the compliance training lessons learned at the 2020 Virtual Pharmaceutical Compliance Congress. Throughout the conference, regulators and industry professionals stressed the need for constant evaluation and modification of all aspects of a compliance program, including the training program. The successful mitigation of risk in a program requires continual careful documentation and evaluation of training topics, audiences, and deployment frequency, as well as the effectiveness of the tools utilized to deploy the training.   

We’ll see you back in Washington D.C. for PCC2021!

To say 2020 has been an eventful and tumultuous year for the life sciences industry is an understatement. The COVID-19 pandemic has forced sudden change in the way in which business is conducted and created a milieu of unforeseen compliance concerns. Those issues were certainly not lost on the presenters at the 2020 Virtual Pharmaceutical Compliance Congress as timely suggestions for managing the “new normal” were blended with more traditional content related to building and managing an effective compliance program. One presenter summarized it interestingly when she said, “the plan you prepared in January does not make sense with what you need to focus on now.”

The need for on-going risk assessment was repeated throughout the conference, beginning in the Enforcement Docket Deep Dive session with one U.S. Attorney commenting, “programs must be updated over time to align with changes in the business and changes in settlements.” That risk assessment includes the on-going analysis and evaluation of a training curriculum, particularly as the way in which the industry interacts with each other and with HCPs continues to evolve.

A Rush to Roll Out New Training

The rush to cover new topics based on updated policies for virtual interactions can lead to a convoluted curriculum and do more harm than good. Regularly scheduled, comprehensive curriculum analysis helps ensure ongoing training covers existing and new topics with the right audiences, at the right level of detail, with the proper frequency based on the level of risk – and that analysis should not be pushed aside solely for the sake of expediency.

A “risk level” analysis has always been a foundational step in identifying content gaps and the need for updates in the topics covered. 2020 is no exception as the pandemic has forced a change in the way field teams interact with HCPs and conduct support programs. During the session, Look at How In-House Legal and Compliance Departments are Evolving in 2020 to Help Address Business Challenges, one compliance officer succinctly put it, “The way in which we do business has changed, so policies need to be more precise and training must be more engaging.”

Curriculum analysis begins with documenting a detailed list of topics covered in current training materials versus those required by the shift to virtual engagements. (Incidentally, PhRMA’s Statement on Application of PhRMA Code Section 2 During Emergency Periods is a good starting point for those changes). Your documentation should specifically include the target audience for each topic and indicate the level of risk each topic represents for each audience, as well as the frequency and level of detail at which each topic is presented.

Following the documentation phase, an analysis is necessary to determine whether the level of training versus the risk for the audience is sufficient. As a final step, solutions to address gaps and redundancies can be planned as new topics are added to the curriculum.

Increasing Retention and Enhancing Learning

An effective training curriculum also requires ongoing “engagement evaluation” to ensure learning is maximized. Let’s face it, the sudden onslaught of new and updated policies on virtual interactions is causing confusion. During the Candid Conversations on Key Themes and Industry Insights session of the conference, more than one panelist cited the movement to virtual programs as the topic keeping them up at night. The variables abound, and just updating foundational training programs with new policies is risky and flawed. More novel methods of training (quizzes, gamification, microlearning, etc.) offer opportunities to integrate nuggets of information into the curriculum and cut through the clutter of change to help raise engagement levels.

One industry speaker highlighted this best when he said, “You need to give them the tools to deal with awkward situations in this new way of conducting business, like how to respond to off-label questions.” That tool list begins with updated training components deployed repeatedly and strategically across the learner’s timeline. The changes wrought by COVID-19 only heighten the need to evaluate your curriculum for its power to change individual behavior – especially with updates to policies and changes in SOPs happening at such an unforeseen rate.

Unsolicited Change

The unknown can be daunting. The writer and poet Raheel Farooq once wrote, “The greatest fear in life is not of death, but unsolicited change.” We, as an industry, a country, and a world, have certainly seen our share of unsolicited change this year and it wasn’t lost on the presenters at this year’s conference. Panelists were quick to admit they didn’t have all the answers in terms of how training, and compliance in general, should be managed in these tumultuous times, but that’s okay. I’m confident most attendees would agree that the opportunity to share concerns, questions, and ideas was worthwhile, valuable, and reassuring. Kudos to all the presenters and conference organizers for making the 2020 Pharmaceutical Compliance Congress such a success under such difficult circumstances. I look forward to attending the 2021 conference “live and in-person,” as I am sure do you.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

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

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

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

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Dear Connie,

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

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

Signed,

Cautious in California

Dear Cautious,

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

Analysis

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

Design

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

Development

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

Implementation

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

Evaluation

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

Summary

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

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

Thanks for the question and stay safe!

Connie

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

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

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

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

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

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

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

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

 

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

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

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!

 

Previewing the 20th Pharmaceutical and Medical Device Compliance Congress

Visit Tessa Hoyer and the rest of the PharmaCertify team in the Exhibit Hall to see demos of our newest compliance training solutions!

The Pharmaceutical Compliance Forum (PCF) is celebrating a milestone this year with the 20th anniversary of its annual Pharmaceutical and Medical Device Compliance Congress. I have attended the past 12 of these conferences (yikes) and I am consistently impressed with PCF’s ability to create a fresh and relevant agenda while still covering the fundamentals.

The conference is just around the corner (November 6-8 at the Mandarin Oriental Hotel in Washington D.C.) so let’s get the celebration started with a preview of this year’s sessions.

Day 1: Wednesday, November 6, 2019

Pre-Conference Symposia, 8:00 a.m.

Although the conference “officially” opens at 1:00 p.m., four pre-conference symposia are scheduled from 8:00 to 12:00 Noon as follows:

  1. Risk Assessment Recommendations Based on DOJ Updated Guidance
  2. Third-party Interactions, Including Distributors and Non-Distributor Third Party Vendor Compliance
  3. Investigations: Interconnectivity of Auditing, Monitoring, Investigations, Including Privilege
  4. Emerging Role of Analytics, Bog Data & AI Opportunities for Life Sciences: Implications for Ethics and Compliance

All the sessions offer valuable and worthwhile content as described in the agenda, and that makes the decision as to which one to attend even more challenging. Pre-conference Sessions 1 and 2 are consecutive so you can attend both, but you still need to decide between Sessions 3 and 4. Session 3, which is focused on investigations, is described as covering “issues for a big company vs. a small company,” so it certainly has broad appeal. My suggestion is to take a “divide, conquer, and share notes” approach if you happen to be attending with co-workers, or can tag-team with friendly colleagues from other companies.

Opening Plenary Session, 1:00 p.m.

The conference officially begins with a welcome and introduction from the five PCF co-chairs (Sujata Dayal of Johnson & Johnson, Jeffrey Kawalek of Jazz Pharmaceuticals, Jennifer McGee of Otsuka America Pharmaceutical, Donna White of Chiesi, and Joe Zimmerman of Ferring Pharmaceuticals), at 1:00 p.m. I would normally skip over the opening 15 minutes when previewing a conference, but since industry luminaries are involved, I would suggest you stay on high alert for any unexpected and bonus pearls of wisdom.

20th Anniversary Dialogue: Lessons Learned from 20 Years of Pharma and Medical Device Investigations, Prosecutions, Ethics and Compliance, 1:15 p.m.

The celebration kicks into high gear for this 1:15 p.m. session that features no less than seven presenters, including industry leaders Douglas Lankler from Pfizer, and Lori Queisser from Teva Pharmaceuticals, as well as government regulators Daniel Levinson, former Inspector General for the U.S. Department of Health and Human Services, and James Sheehan of the Charities Bureau of the New York State Department of Law. It’s an impressive array of experience from both sides of the issues.

Keynotes: OIG Update/ US DOJ Update/FDA Update, 2:15 p.m.

At this point, the government’s perspective will be presented in three consecutive keynotes by Mary Riordan of the Office of Inspector General, Brian Benczkowski of the DOJ, and Thomas Abrams of the FDA. The annual discussions of where the industry has been and what will be next year’s likely focus and workplans, always offer clues as to where compliance professionals should be focusing their efforts and future plans.

Annual Chief Compliance Officer Roundtable, 5:00 p.m.

After a presentation on pricing cost containment, the Annual Chief Compliance Office Roundtable closes Day 1. Although the agenda does not detail the topics to be covered, expect the seven industry professionals listed, including Charlene Davis of Aerie Pharmaceuticals, Sunitha Ramamurthy of Loxo Oncology, and Adam Dubow of Bristol-Myers Squibb, to cover a wide swath of relevant and important topics. Keith Korenchuk of Danaher Diagnostics and Thomas Schumacher of Medtronic will bring a welcomed medical device angle to the discussion.

Adjournment and Networking Reception and 20th Anniversary Party, 6:00 p.m.

I typically highlight the conference networking reception as a can’t-miss opportunity to share information and experiences with other compliance professionals, and to form valuable relationships with industry peers. This year’s compliance congress brings the bonus of an anniversary party so let the noisemakers ring and the champagne flow!

Day 2: Thursday, November 7, 2019

Morning Plenary Session, 8:45 a.m.

Following a series of concurrent breakfast roundtables from 7:15 to 8:15 a.m., and the Co-chair’s Welcome and Introductions, Day 2 kicks off with an interview of the Countess of Frederiksborg, Alexandra Christina. In addition to being a Countess, she is the Chairperson of the Ethics and Compliance Board Committee for Ferring Pharmaceutics and co-author of The Sincerity Edge: How Ethical Leaders Build Dynamic Businesses.

U.S. DOJ and U.S. SEC Update on FCPA Enforcement, 9:15 a.m.

The FCPA is back! Or, at least the topic is back on conference agendas after what seems like an extended absence (or at least from the conferences I attended). Presenters include Robert Dodge of the SEC, David Last of the DOJ’s FCPA Unit, and Gary Giampetruzzi, partner at Paul Hastings and former Head of Government Investigations at Pfizer.

AUSA Roundtable, 10:00 a.m.

John Bentivoglio, Partner at Skadden, keeps the enforcement topics going as he moderates the discussion from the AUSA angle with Rachel Honig of the District of New Jersey, Amanda Massenlam Strachan of the District of Massachusetts, and John Claud, from the Consumer Protection Branch of the DOJ.

Mini Summits Block A, 11:15 a.m.

This is where the agenda gets challenging but potentially rewarding. PCF has scheduled four “blocks” of mini summits (A, B, C, and D) right up to the closing plenary session at 4:45 p.m. As with the pre-conference symposia, a “divide and conquer” approach with your colleagues is recommended. Even if those colleagues aren’t from the same company, make friends, then share notes over dinner or via email the following week. For the sake of brevity, I will highlight one mini summit per block, but please review all options in the agenda to determine your best fit based on your interests, compliance challenges, and company risks.

Mini Summit II: Reduce Compliance Risk Using a Portfolio Approach to Training! (Microlearning Alone is Not the Answer)

I may be a bit biased since I have spent the last 12 years building compliance training and my colleague, Dan O’Connor, is moderating this session. But, with microlearning being all the rage, this promises to be a compelling look at what that term really means, and as importantly, why it is not the one and only panacea for making training stick.

If you work in medical device, please consider Mini Summit VII: Annual Medical Device Roundtable. Kudos to PCF for integrating medical device sessions into the agenda.

Mini Summits Block B, 12:45 p.m.

Mini Summit VIII: Lessons Learned from Enforcement Actions

This session stands out as an opportunity to hear an impressive array of industry leaders, including Tom Glavin from Olympus, William Hrubes of ACell, Puja Leekha of Lundbeck, and Kathleen Boozang, Dean of the Seton Hall University School of Law. Legal actions and settlements have long been the guideposts for where and how regulators focus their efforts and they should be an integral component in the planning of a yearly compliance plan and training curriculum.

Note: attendees dealing with the risk that combination (med device/pharma) products bring should alternatively consider, Mini Summit XIV: Issues with Medical Device/Combination Products.

Mini Summits Block C, 2:00 p.m.

Mini Summit XIX: Compliance – Board Communications: Effective Measurement and Reporting Strategies

Expect a deep dive into a topic that has risen to the forefront of industry concern with this look at the most effective methods for integrating the Board of Directors into the compliance program. Expect Katherine Norris of Berkeley Research Group to lead an informative panel that pleasantly includes a current member of the U.S. Board of Directors for Sanofi, Thomas Costa.

Mini Summits Block D, 3:30 p.m.

Mini Summit XXIII: Social Media Engagement by Manufacturers

Social media seems to be such a moving target for the life sciences industry. Hopefully, this team of industry professionals, including Joanne Kwan of Exelixis and Jessica Sergi of EMD Serono, can offer insight and guidance to an audience sure to be hungry for answers to vexing and evolving questions.

Again, the mini summits listed above are only a few of the sessions offered during this year’s conference. Visit the agenda section of the conference website to review the full list and decide which presentations best meet your needs.

After completion of the mini summits, the Day 2 adjourns with an important and sure to be sobering plenary session on “what pharmaceutical/medical device industries can learn from the opioid cases,” followed by a discussion on the “changing face of the qui tam.”

Day 3: Friday, November 8, 2019

Day 3 features an “industry only best practices think tank,” with Sujata Dayal from Johnson & Johnson and Jacob Elberg, Associate Professor of Law at Seton Hall, followed by a benchmarking survey and table discussion breakouts before the conference closes at 12:00 Noon.

It’s Not to Late to Attend!

The Pharmaceutical and Medical Device Compliance Congress offers compliance professionals the rare opportunity, along with CBI’s conference in the Spring, to interact face-to-face with their peers and learn from leaders in the industry and regulators. From a compliance training standpoint, our organization considers it an invaluable opportunity to hear about the challenges facing pharmaceutical and medical device companies directly from those who matter the most, our clients, colleagues, and friends.

If you’re interested in attending, contact me at smurphy@nxlevelsolutions.com to take advantage of our conference sponsor registration discount.

See you in Washington!

Sean Murphy
PharmaCertify by NXLevel Solutions

A Preview of the 10th Annual Life Sciences West Coast Compliance Congress

CBI’s West Coast Compliance Congress is scheduled for Tuesday, October 22nd through Thursday, October 24th in San Francisco, and a review of the pre-conference agenda reveals a compelling mix of panel presentations and master classes focused on the most pressing challenges facing life sciences compliance professionals. Here are the sessions we have noted as most intriguing.

Tuesday, October 22, 2019: Pre-Conference

Attendees face an interesting choice right from the start of the conference with two Pre-Conference Summits scheduled simultaneously for 1:30 – 5:00 on Tuesday. Both are focused on topics critically important considering recent industry settlements.

During Summit A, Patient Assistance and Support Programs – Ensuring Patient Centricity Through Compliant Frameworks, summit leaders, Terra Buckley of Celgene, Daryl Kreml of Sage Therapeutics, and Kari Loeser of Relypsa will delve into the risks associated with assistance programs, hub services, nurse educator programs, and reimbursement services. It’s a comprehensive look at the topic by an impressive group of panelists. Don’t miss it.

In fact, the only valid reason to miss Summit A may be to take in Summit B: Third-Party Risks and Oversight – Innovative Models Driving Compliance. The increasing trend toward outsourcing services in the life sciences industry has led to the need for even greater diligence around the selection and management of third-party vendors. According to the agenda, representatives from Advanced Bionics, Merck, and Varian Medical Systems will “share best practices, uncover red flags and set a tactical plan for enhancing oversight.”

Wednesday, October 23, 2019: Day 1

After opening remarks by Erik Atkinsson of Cytokinetics, Day 1 begins with a session intriguingly titled, Trailblazer Talk. Averi Price of Radius Health, Sharon Delshad of Nalpropion Pharmaceuticals, and Daryl Kreml of Sage Therapeutics will focus on “adapting and evolving compliance programs in support of innovation.” I expect it to be an enlightening program from three highly-regarded industry veterans.

When attending any compliance conference, I make a note not to miss the sessions featuring government prosecutors and regulators. The Current and Former Prosecutor Panel is no exception as former prosecutors Tiffany Mosely of Loeb & Loeb, LLP and Joes Verla Jr. of Bass, Berry & Sims will join Adam Reeves from the United States Attorney’s Office in the Northern District of California to discuss trends for next year and beyond. Hearing from the government side always offers important lessons and insights.

Later, on Day 1, the “New Guidance” session subtitled, Walk Through the Evaluation of Corporate Compliance Programs – Foundational Understanding and Future Impact, is compelling based solely on the use of “evaluation” in the title. If this is indeed a step-by-step review of what makes a successful compliance program, the time invested should be more than worthwhile. I wouldn’t miss it.

The afternoon of Day 1 includes two sets of simultaneous “master classes,” beginning at 1:30 with the Transparency and Aggregate Spend session and Data Privacy and Cybersecurity session.  At 2:15, it’s a choice between Promotional Compliance in one session and Non-Promotional Activities in the other. I understand the need to schedule simultaneous sessions to pack as much content as possible into the conference, but it makes for difficult choices. If you are attending with coworkers, I suggest a divide and note-sharing approach to maximize the opportunity.

Day 1 ends with a networking wine and cheese reception, which may be your best opportunity to network with peers and industry leaders. This makes for a great exchange of tips, suggestions, best practices, and business cards.

Thursday, October 24, 2019: Day 2

Day 2 opens with two concurrent master classes at 8:30 and two more at 9:30. The HCP Engagement and Contracting – Mitigate Compliance Risk and Improve Operational Efficiency session stands out as one I would not miss considering the current regulatory focus in that area.

Speaking of HCP contracts and current regulatory focus, the in-conference workshop at 10:45, Strengthen Speaker Program Compliance Through Innovative Initiatives and Best Practices is certainly worthy of an asterisk in your agenda. And if speaker programs are high on your list of risk areas, we now offer a Compliance Foundations™ eLearning module titled, Managing Speaker Program Risk. The 30-minute module covers topics like program planning, speaker compensation, attendee management, and speaker responsibilities, to list just a few. And it’s easily customized with your specific policies and contact information. Let me know if you’d like to a content outline.

Before the conference closes with an Exclusive Benchmarking Think-Tank, Greg Moss of Kadmon Holdings, Sunita Ramamurthy from Loxo Oncology, and L. Kathleen Durousseau of Rigel Pharmaceuticals will cover Governance Best Practices and Working with the Board. We often hear about the importance of “tone from the top” at compliance conferences and any discussion centered on ideas for working with the board to establish the proper tone is worthwhile. It’s a strong topic for the end of the conference.

Thanks for reading this preview of the 10th Annual Life Sciences West Coast Compliance Congress. As always, I welcome your comments, feedback, and stories from the conference. If you are attending the conference, please say hello to my colleague from PharmaCertify, Dan O’Connor, who will be there as well.

Sean Murphy
Marketing and Product Manager
PharmaCertify by NXLevel Solutions

A Preview of the 5th Annual Life Sciences Compliance Congress for Specialty Products

 

 

Cambridge, Massachusetts, the site of the 5th Annual Compliance Congress for Specialty Products.

The 2019 compliance conference season is just around the corner and the PharmaCertify™ team is gearing up for a slate of sessions beginning with a two-day stop at CBI’s 5th Annual Life Sciences Compliance Congress for Specialty Products.

This conference holds particular interest since the compliance challenges faced by specialty companies, including a number of our clients, are somewhat unique to the industry. With that in mind, I have perused the agenda for the sessions that look compelling for the specialty audience.

Day 1: Thursday, September 12, 2019

8:30 a.m. Keynote Panel: Focal Points and Top Enforcement Trends for Specialty

Set your iPhone alarm and don’t be late for the opening session! The enforcement panels are often a source of valuable information at compliance conferences in general and in light of the focus on specialty biotech companies in this conference, this is an intriguing choice to kick off the conference. Assistant U.S. attorneys from Massachusetts, New York, and New Jersey will join the panel to hopefully discuss the trends specifically relevant to this audience.

11:30 a.m. Creative Training Techniques for Out-of-the-Box Engagement

Okay, I confess, I am a little biased since this session will be moderated by my colleague Dan O’Connor. But being on the “inside” has afforded me the opportunity to hear and see the plans for the presentation and trust me, you don’t want to use this time to refill your coffee. Dan and the panelists from Avanir Pharmaceuticals, Sanofi Genzyme, and Sarepta Therapeutics will share real-world and tested techniques for creating and deploying training that sticks.

1:15 p.m. Where is the Line? Tackling the Overlap in Medical and Commercial Activities

Understanding the divide between MSLs and sales representatives remains a key topic for training consideration in the pharmaceutical industry in general. And that line does change over time. In fact, presenters at the 16th Annual Pharmaceutical Compliance Congress in April stressed that the recent trend toward a principles-based culture requires even more collaboration between Medical Affairs and Field Sales. Expect the panelists from Radius Health, Sunovion, TESARO, and Akebia to address that change.

2:15 p.m. How Far is Too Far? Navigate the Risks While Maintaining the Merits of Patient Support Activities

Patient support programs are in the news. I know…tell you something you don’t know, right? I find the title of this session interesting though in that it highlights the need for risk awareness while pointing out that the programs hold benefits for the patients that pharmaceutical companies are committed to serving. Keeping those programs compliant is a worthwhile and noble effort and we look forward to the panelists from Sage Therapeutics, Sanofi Genzyme, and Acceleron Pharma sharing their suggestions for accomplishing that task.

5:00 p.m. Networking Wine and Cheese Reception

While this may seem like an obvious choice for a favorite session (somewhat akin to saying “lunch” was my favorite subject in high school), I make note of it for reasons beyond the libations. The networking sessions at compliance conferences offer a great opportunity to learn from your peers in face-to-face conversations. You’ll even get to chat with the vendors who made the time and financial commitment to share their products and services with you. Don’t forget to stop by the PharmaCertify booth to say hi – the wine is on us! Oh wait…it’s already on CBI.

Day 2: Friday, September 3, 2019

8:30 a.m. The Impact of Recent FDA Guidance on Product Communications – Dramatic Change in Operations or Business as Usual?

After a review of Day 1 by the conference chair, Day 2 begins with this cleverly titled session. I admit, I was pulled in by the title and I’m intrigued to hear the answer. My best guess, based on recent presentations by the FDA’s Office of Prescription Drug Promotion, is that the truth lies somewhere between “dramatic change in operations” and “business as usual.”

11:30 a.m. Cell and Gene Therapies Learning Lab – Compliance Considerations for Highly Complex, Potentially Curative Treatments

While the two “comprehensive breakouts” scheduled for 11:30 a.m. both look intriguing and educational, I lean to this one simply because of the title. After all, what’s better than a specialty pharmaceutical product conference that features discussions about well…specialty pharmaceutical compliance considerations? This is a great example of how such smaller, more focused conferences can present learning opportunities that are rare in the larger compliance congress settings. We look forward to hearing the presenters from EMD Serono and IQVIA discuss how those considerations differ from the broader risks and concerns.

2:00 p.m. Fireside Chat What You Need to Know and What You Wish You Had Known – Compliance for the Beginner and the Expert

Great title!  Described as an interview session with participants from Sage Therapeutics and Acceleron Pharma, this is certainly a unique and bold way to end the conference. Hopefully, it fills attendees’ minds and notebooks with memorable tips, suggestions and reminders to help them build a stronger culture of compliance and reduce risk. Well played, CBI, well played.

Discounted Registration Fee!

As a conference sponsor, the PharmaCertify team is offering a discount registration voucher for the 5th Annual Life Sciences Compliance Congress for Specialty Products. Contact me at smurphy@nxlevelsolutions.com if you’d like to take advantage of this opportunity to network with your peers and hear industry leaders share best practices and tips for building, maintaining, and training on a strong compliance program. While at the conference, stop by the PharmaCertify booth to see demos of our newest Compliance Foundations™ eLearning modules, custom training courses and the newly updated Access LMS.

Thanks for reading!

Sean Murphy
Marketing Manager, PharmaCertify by NXLevel Solutions

Off-the-Shelf Compliance Training Myths

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

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

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

The Myth 

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

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

The Reality

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

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

The Bottom Line

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

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

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

Thanks for reading!

Off-the-Shelf Compliance Training Myths

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

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

The Myth 

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

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

The Reality

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

Interactions with Healthcare Professionals Compliance Foundations eLearning Module

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

The Bottom Line

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

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

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

Thanks for reading!