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 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

A Preview of the 2019 Pharmaceutical Compliance Congress

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Summary

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

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

Thanks for reading and I will see you in Washington!

Sean Murphy
Editor
Compliance Training Intelligence Blog

Lessons Learned at the 2018 Pharmaceutical and Medical Device Congress

Lesson 3: Learning to Listen

“There is only one rule for being a good talker – learn to listen.”
Christopher Morley

The importance of effective communication and more specifically, listening, wasn’t lost on the speakers at the 19th Annual Pharmaceutical and Medical Device Compliance Congress. The consequences of poor listening were summarized by one panelist on the Qui Tam Roundtable when she said, “the vast majority of whistleblowers who contact me have tried to report their concerns to the company, but the company didn’t want to hear it.” In an era when the nuances of an effective compliance program are discussed and debated in detail, the simple yet often lost art of effective listening needs to be a priority.

The value of listening extends across all departments and business units and it starts with field-based employees. A presenter in the Compliance Considerations for Small to Mid-Size Companies session echoed that sentiment, saying, “the stream of questions from the field is not going to stop, but those questions tell a story and you need to monitor them carefully and build your plan from there.” The data from those responsible for interacting with healthcare professionals is critical as you evolve your program and look for gaps and redundancies that need to be addressed in personal interactions and in your continuous training curriculum. And listening for that data begins with open, non-judgmental relationships across the company. Or, as another presenter in the Compliance Considerations for Small to Mid-Size Companies session stated it, “when employees interact with the compliance department, they should not feel like they are being judged.”

The need for open lines of communication doesn’t stop with the field. The industry trend toward “building a culture of ethics and compliance,” and frankly, the regulatory focus on the culpability of those in the C-Suite and boards of directors, more than ever, dictates the need for open and regular communication with company leadership. The proverbial “seat at the table” for Compliance extends upward in the organization. As was stated during the AUSA Roundtable, “Compliance should have a good relationship with the Chief Executive Officer, and the officers of the company. The two departments need to communicate openly and honestly.” He continued, “when issues do arise, the Department of Justice needs to see that you are being proactive and responding to those issues.” In other words, listening to one and another.

During the Chief Compliance Officer Roundtable, the risks associated with the use of third-party vendors was discussed in detail and the need for open lines of communication beyond the walls of the company was stressed. “Work with the stakeholders in the third party and make them feel like you are partnering with them,” one participant said, “be transparent, if you hear that people aren’t disclosing information, that’s a warning sign. If there is any confusion, ask questions.” And listen carefully to the answers.

The key takeaway: to build a truly effective and modern compliance program that proactively addresses the risks across the organization, a policy of open communication must be established from the top down. The concept of an ethics-based approach to compliance may seem nebulous and difficult to quantify, but it begins with fostering a level of respect across the company. And respect begins with real listening. When employee questions, feedback, concern, and complaints are welcomed, appreciated and nurtured in a respectful manner by Compliance and the C-Suite, all aspects of the compliance program, including the training, are enhanced.

Thanks for reading! I welcome your feedback.

Sean D. Murphy
PharmaCertify by NXLevel Solutions

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

Lesson 1: Rules and principles can coexist.

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

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

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

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

Thanks for reading!

Sean D. Murphy
Editor
Compliance Training Intelligence Blog