A Plan for Maximizing Your Time at PCF’s 2020 Compliance Congress

For this year’s Virtual 21st Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, the Pharmaceutical Compliance Forum (PCF) has planned an impressive agenda, chock full of keynote presentations, mini summits, plenary sessions, fireside chats, and updates from an impressive array of industry leaders and government representatives with the OIG, FDA, DOJ, and US Attorney offices. So, what’s a busy compliance professional like you to do when looking at that agenda and deciding which sessions are most worthwhile? The solution: approach the conference as if you were building a training plan.

As someone who has spent many years with a company that designs and develops compliance training solutions that reduce risk and strengthen ethical cultures, I understand that most critical step in any successful training project is having a plan. Getting the most out of this virtual compliance congress is no different. That begins with determining just what you hope to learn over the three days.

Decide on Your Learning Objectives

As you peruse the agenda, determine which topics and presentation titles align with the information you hope to gain from the conference. The conference covers a plethora of topics, from GDPR, to the FCPA, recent CIAs, state pricing transparency, and the Sunshine Act, just to scratch the surface. In addition, some sessions, like Mini Summit VIII on Day 1: Compliance Considerations for Rare and Ultra and Ultra Rare Drugs, will be on your list simply based on your product profile or company description. At the same time, if you work for a medical device company, you’ll obviously want to make Mini Summit XI: Annual Medical Device Roundtable on Day 2 a priority.

Implement Your Plan

A “virtual” conference does hold some advantages. For example, with the morning mini summits available on demand throughout the conference, you won’t be locked into one summit during each concurrent time slot. Kudos to the conference organizers for structuring the mornings this way! So if training and speaker programs are both high on your needs list, you can watch Mini Summit I: State of the Art Compliance Training (In Dynamic Times) at 10:00 AM on Monday, then come back later during the conference for the Mini Summit III: Key Considerations and Best Practices in Operationalizing Speaker Programs.

While the afternoon sessions are scheduled one after another each day, the demands of your job and life outside the conference may make attending each one unrealistic. The broader topics presented in the afternoon will therefore require planning as to which ones move to the top of your needs list. Of course, if you are attending with colleagues, I suggest dividing the sessions between yourself and those colleagues and sharing notes later to maximize the learning.

Based on my experience, there are certain sessions I suggest you prioritize no matter your objectives. For example, the OIG Update on Day 1 always offers a valuable review of the agency’s legal actions from the previous year and a peak into its priority list for the year to come.  In addition, expect the Annual AUSA Roundtable on Day 3 to be filled with insights into the topics regulators are moving to the forefront of enforcement as the industry continues to navigate the challenges of doing business during a pandemic.   

As with in-person conferences, PCF has integrated time to visit the Exhibit Hall into the agenda every day. I know I am biased here, but those visits absolutely need to be in your plan. The list of sponsors includes renowned law firms, consultants, software companies, and training developers like us who often offer the critical advice, service, or product you need to help develop and maintain a successful compliance program.

In fact, if you’re attending the Virtual 21st Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, I invite you to stop by the PharmaCertify booth to learn more about our training solutions and see a demo of the newest addition to our Compliance Foundations™ library of off-the-shelf modules, Patient Programs and Their Risks.

Evaluate the Results

The benefits of building a plan to maximize conference learning and networking opportunities are not unique to virtual events. When the industry (and the world) blessedly puts this pandemic in its rearview mirror, and we have the opportunity to travel to conferences again, the challenges of conquering the amount of content made available at large conferences, such as this one, will remain.

Just as effective compliance training plans need to constantly be evaluated and updated, you need to analyze the way in which you approached this impressive agenda. Did the sessions you attended meet your needs? Do you feel they were worth your time commitment? What would you do differently? Are more attendees needed from your organization? And perhaps most importantly, do you now have a notebook full of actionable best practices, suggestions, and tips applicable to your compliance program, your company, and its products?

Thanks for reading, I look forward to seeing you at the conference!

Sean Murphy
PharmaCertify By NXLevel Solutions

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

Compliance Training Lessons from the 2020 Virtual Pharmaceutical Compliance Congress

Part I: A Conference Overview and What It All Means for Your Training

State of the Art Compliance Training, with Dan O’Connor of PharmaCertify, was just one of the 14 on-demand sessions at PCC2020.

Welcome to the first in this multi-part series based on CBI’s recent Pharmaceutical Compliance Congress! For obvious reasons, the conference went virtual this year, yet it offered an impressive lineup of industry professionals, vendors, and government officials offering compelling tips and guidelines for building and maintaining an effective compliance program in the life sciences industry. In addition to the live presentations, organizers offered 14 “on-demand” presentations covering an impressive array of topics, so from a content perspective, the virtual format created even more opportunities for learning.

Over the next month, I will touch on some of the thoughts shared by presenters related to topics like speaker programs, patient programs, risk assessments, third-parties, patient advocacy groups, transparency, and strategies for field team compliance, to name a few. And since the mission of this blog, and the PharmaCertify team, is to help you reduce risk and strengthen your compliance culture through training, I will include suggestions for growing and modifying your compliance training practices and curriculum in response to the information shared during the conference.

Kudos to the team at CBI/Informa for their diligent efforts to replicate the learning and networking experience of the live conference. PCC 2020 was a busy conference, with an impressive volume of content scheduled throughout the week and in the on-demand sessions. If you attended and did not have the opportunity to review the on-demand sessions, I have been told these will remain available until September 14th. You will especially want to review the State-of-the-Art Compliance Training session, where my colleague Dan O’Connor and compliance professionals from Sage Therapeutics, Regeneron, and Akebia Therapeutics share creative approaches for increasing training engagement and adoption. You don’t want to miss that one!

While some of the topics were familiar to anyone who has attended the conference in recent years, the “elephant in the room” was not ignored, as a multitude of presenters addressed the overwhelming challenges of keeping an entire organization focused on conducting business in a compliant manner during these unprecedented times. The result was an interesting blend of traditional and familiar compliance conference topics and guidance on navigating the risk associated with conducting business in a highly regulated industry during a pandemic, or at least as much guidance as can be expected at this time.

From a high-level training standpoint, the presentations at the conference affirm the need for a more dynamic and blended curriculum, with microlearning and other components delivered across your learners’ timelines. The method by which life sciences employees conduct their daily activities has suddenly changed, and the level of risk and potential for violations has grown exponentially with that shift.

One of the more compelling presentations was the “Criticality of Compliance” session with John Crowley of Amicus Therapeutics. John shared his family’s moving story and his incredible journey as he pushed for the development of a product to help his two children (did you know his story was the basis for the feature film, Extraordinary Measures?). As he spoke, John reflected on what the commitment means to the patients battling the rare diseases his company’s products treat, “as life sciences professionals, we are an extension of the oath that doctors and nurses have taken, and it is a solemn oath,” he said, “if there is a compliance violation, everything we hoped for in the next several years is threatened.” It is a laudable approach to building a culture of compliance at Amicus and one worthy of emulation.

I look forward to sharing more ideas from the conference, as well as subsequent training suggestions you can utilize to strive toward similar ideals and goals in your organization.

Thanks for reading!

Sean Murphy
PharmaCertify By NXLevel Solutions

Coming Up: Speaker Programs and Patient Support Programs

A Preview of the 2020 Virtual Pharmaceutical Compliance Congress

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

On-Demand Presentations

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

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

Day 1: Monday August 10

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

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

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

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

Day 2: Tuesday August 11

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

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

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

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

Day 3, Wednesday August 12

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

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

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

Day 4, Thursday August 13

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

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

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

Day 4, Thursday August 13

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

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

See You at the Conference

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

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

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

Sean Murphy
Product & Marketing Manager
PharmaCertify by NXLevel Solutions

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

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

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

—————————————————————————————————

Dear Connie,

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

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

Signed,

Cautious in California

Dear Cautious,

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

Analysis

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

Design

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

Development

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

Implementation

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

Evaluation

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

Summary

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

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

Thanks for the question and stay safe!

Connie

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

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

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

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

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

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

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

What Else Does It Means for Your Compliance Training?

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

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

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

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

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 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!