Connie the Compliance Training Manager Tackles New Hire Training!

Welcome to a new edition of “Dear Connie, the Compliance Training Specialist,” where Connie answers questions about life science compliance training concepts and discusses new ideas for making that training more effective.

This week: Connie hears from a compliance training manager looking for a more exciting way to train new sales representatives.

Dear Connie,

I know I should change my new hire compliance training session for the sales representatives because my PowerPoint deck might be getting a little stale, but I only get an hour in front of them, so I don’t really have time for a more creative approach. Any suggestions?

Concerned Compliance Manager in Cambridge


Dear Concerned,

You may be surprised to hear that an hour is more than enough time to conduct a more engaging and more memorable live training session. Now is the time to ditch that overused and dull PowerPoint deck!

Make it More Competitive

Research shows that learners are motivated by competition. So how about creating a Jeopardy-style game format with questions designed around your company’s policies and risks? In my experience, five categories, with five questions per category, fills an hour of time. Make sure you take a few minutes after each question to explain why the answer is right or wrong and ask the participants for examples of similar situations they have faced.

Depending on the size of your audience, I suggest you pick 3-5 participants per team to “represent” groups in the audience and have representatives buzz in once they think they know the answer. It’s a great way to take the learning to another level and create an interactive experience where ideas are exchanged with the audience. One warning: have someone there with a timer to make sure they don’t buzz in and then take forever to figure out the answer.

Make it More Engaging

You could also create an interactive workshop where the participants are divided into groups and asked to “solve” compliance scenarios together. Break the workshop into two activities to keep it moving and make sure each team has a tablet or laptop on a table. I like the idea of a Compliance Sprint as the first activity. Have the teams solve a series of exercises (a card sort works well) based on situations they are likely to encounter in the field.

You could also mix in a Compliance Mystery. The same teams play compliance “detective” and solve more complex scenarios with the help of a series of clues. The clues can be emails, phone call transcripts, business cards from a meeting, or whatever clues help provide hints about the scenario. Be creative and make it fun, but make sure you make it realistic in terms of their work activities. Of course, both activities should be scored and tracked on a leader board to raise the engagement level even more.

If you have the time and resources, you can certainly create the game or the workshop in-house, but my friends at PharmaCertify (that’s the compliance training division of NXLevel Solutions) have workshops just like the ones I described that are easily customized with your content. I’ve been there when their clients have used their workshops, and wow it is fun to watch the learning! They’d be happy to demo the workshops for you. Just email Tessa Hoyer at thoyer@nxlevelsolutions.com.

Thanks for the question and remember to make it fun and make it memorable!

Your compatriot in compliance training,

Connie

A Preview of the 2019 Pharmaceutical Compliance Congress

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

PAPs and PSPs: Training Beyond the In‑Program Staff

Patient Assistance Programs (PAPs) and Patient Support Programs (PSPs) are in the news. The programs are under increased scrutiny for violations of the Anti-Kickback Statute, HIPAA, and False Claims Act. Recent settlements and Corporate Integrity Agreements highlight the need for vigilant and more effective training for these programs.

Nicole Serena Waldron & Associates

With that in mind, we recently sat down with Nicole Serena, Senior Consultant for Waldron & Associates and 25-year industry professional, to discuss her suggestions for how to approach PAP and PSP training to better reduce the risks and the red flags associated with the programs.

A Focus on Customer-Facing Staff

Serena began by highlighting the need to extend training beyond those working directly in the programs to other employees who require a fundamental awareness of how they work, why they are important, and the associated risks. Everyone involved, particularly the sales representatives, MSLs, and nurse educators who interact with healthcare professionals need to be aware of the programs and understand that value.

Serena points out that when a company is launching a specialty or biological product, healthcare professionals will often ask if the company has an assistance program for the product. “Depending on the company and what kind of roles are involved when launching a product,” she says, “sales representatives, MSLs, and nurse educators are all part of the team introducing the program to a clinic and discussing how it supports the patients. They all need to be trained on what they can say, and they need to know they can’t give any incentive for patients to be enrolled.”

According to Serena, when representatives don’t have the proper training and they don’t understand their company’s assistance and support programs, their interactions with HCPs hold the potential for increased risk. “Since they are the first people to hear about problems customers have with a PAP or PSP, representatives need to be careful how they react to that information,” she says, “and since they are responsible for managing the relationship with the HCP, they need to be careful about not over promising.”

In addition, the training shouldn’t assume that employees understand the programs just because they have worked in the pharmaceutical industry. “An employee’s previous position may have been with a division of the company that dealt with a general medicine product, like a high blood pressure pill or antibiotic, which would not involve a PAP or PSP,” says Serena, “so when he or she gets moved into a specialty product role, that background training is critical.”

Extend Training Beyond the Field Force

Vendors are sometimes overlooked for training, particularly when they claim to have their own PAP and PSP training in place. Even if that is the case, rolling out the company training to the vendor’s staff helps ensures consistency in messaging and accountability of trainee rosters. In other words, the vendors need to be trained using the same training the inside employees receive.

According to Serena, “vendor work forces have quite a large turnover in the staff working on the programs, so it can be difficult for them to have enough resources to track training.” The pharmaceutical company needs to take responsibility for that, roll out the company’s own training to the vendors, and track it on company systems.

Since marketing departments are often responsible for funding the programs and developing program materials, marketing staff should be included on the training roster. “All marketing staff need a base level of training,” says Serena, “and those tasked with working in partnership with the in-program team need a deeper level of training.”

In addition, since Medical Information is tasked with answering HCP questions that come in by phone, an awareness on how the programs work is critical for them as well. Add the Finance Department employees to the training list as well. They need to understand the reason for the program, its value to the company, and the justification for why it shouldn’t be eliminated when budgets need to be cut. Finally, don’t overlook the need for PAP and PSP training for the Compliance Department. Compliance is often staffed with professionals from other disciplines across the company and their awareness and familiarity with the programs may be limited.

Although this post delves into the broad scope of employee groups who should be trained on PAPs and PSPs, the list should not be considered complete by any means. Every company’s approach to the programs is different and the structure, frequency, and roster lists for program training will vary.

The stakes are high though and careful planning is needed to help ensure a higher level of compliance across the company. As Serena so succinctly puts it, “everyone in the industry talks about the importance of being patient centric. These programs speak to the value of that focus and the company’s reputation and that must be taken into consideration when planning the training.”

Thanks for reading!

Sean Murphy
PharmaCertify by NXLevel Solutions

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

Lesson 2: The More Things Change…

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

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

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

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

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

Thanks for reading!

Sean Murphy
Editor
Compliance Training Intelligence Blog

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

Key Takeaways from the 2018 Compliance Congress West

Early morning over San Francisco, the site of the 2018 Compliance Congress West.

To say the audience at the 19th Life Sciences Compliance Congress West was energized and engaged is an understatement. The size and scope of the two-day conference led to unusually interactive discussions, with the audience eagerly sharing their experiences along with the presenters and panelists.  For someone relatively new to the field of life sciences compliance training, I found the exchange of ideas and advice quite educational and enlightening.

PharmaCertify was there as a conference sponsor and we found an agenda filled with information designed to help attendees strengthen their compliance cultures and reduce risk, which of course is a mission close to our hearts from a compliance training standpoint.  Here are my takeaways, with a focus on training of course (it’s what we do):

1. Build an ethical culture, not just a compliant one.

This was a recurring theme, and it’s a compelling one. On the surface, the line between ethics and compliance may appear inconsequential and not significant enough to be worthy of consideration. But more companies are evolving away from a rules-based approach to compliance to one that stresses ethical decision making as the foundation for their principle-based policies. It begins with a question: are people doing the right thing when no one is looking?

For us, the answer begins with a new approach to training. Modern life sciences companies need to teach the value of ethical decision making, and not just recite the rules and regulations. Training needs to instill in learners the understanding that the company trusts and expects them to do just that.

2. Hubs are in, so get that training out!

Patient support hubs are trending, and since they serve as the “connection point” for so many stakeholders (patients, providers, and physicians), they come with a high level of risk. With the influence of commercialized companies, and the lack of guidance from the Office of Inspector General and Department of Justice, patient support hubs are a hot bed of kickback and false claims risks.

Job aids, clear business rules and program guidance, and a robust training curriculum are necessary to mitigate that risk. All parties involved, including vendors, must be continuously trained on how to interact with patients and understand what they can or cannot say and do.

3. If you think PSPs and PAPs are in the regulatory spotlight, you’re right.

The scrutiny on Patient Support Programs (PSPs) and Patient Assistance Programs (PAPs) is intensifying, with a growing number of settlements (Jazz Pharmaceuticals, United Therapeutics) raising questions over the idea of companies donating to independent charities. In addition to causing potential false claims and HIPAA violations, the donations raise concerns that they may be intended to induce patients to purchase certain products and implicate the Anti-Kickback Statute.

As was highlighted during the conference, PSPs and PAPs can be beneficial to patients, but commercial organizations cannot have any influence on the support being provided. Training needs to emphasize that sales representatives are not permitted to discuss specific PAPs or disease state funds with patients or healthcare professionals. And as prescription costs climb, the scrutiny and risks will continue to grow.

4. Nurse Educators: Are they here to stay?

The jury is still out. As defined during the presentation on nurse educators, “white coat marketing” refers to the use of healthcare professionals in marketing or sales activity, and therein lies the risk with the use of nurse educators. According to the Office of Inspector General (OIG), the practice is scrutinized under the Anti-Kickback Statute because patients rely on the advice of physicians, they may “have difficulty distinguishing between medical advice and a commercial sales pitch.”

Recently unsealed qui tam cases highlight the risks and cause for concern, with one company deploying “nurse ambassadors” directly to patients’ homes and another implementing nurse-led adherence programs designed to increase product refills. Patients tend to trust the opinion and advice of their physician, and by extension, their nurse educator. However, it can be confusing for a patient to decipher advice from marketing, and exposure points emerge when nurse educators are trained similarly to sales representatives and conducting calls with those representatives. Asking yourself key questions about the training:

  • What materials do the nurse educators use (disease state, promotional, fair, balanced, etc.)?
  • Does the training focus on adherence and education instead of sales and marketing?
  • Does the training resemble sales training (e.g., overcoming objections, cold calling)?

5. Speaker Programs: How is this still happening?

The idea that speaker programs bring high levels of risk is not a secret, so much so that one audience member even asked, “how is this (insert expletive) still happening?” Good question. Selling in the life sciences industry is a relationship-based activity, and back in the “good old days,” there was little monitoring around meals, vacations, golf outings, etc. Now, the risks are rampant and include speaker selection (make sure they are credible), payments, receipts, the amount of money spent, spouses or guests in attendance, and analytics. The panelists also used Insys as a case study for the importance of communication, particularly email. Multiple documented emails within the company revealed how they were trying to utilize speakers. Training needs to emphasize the need for open, honest and communication, with no hidden agendas because as was quoted about the Insys case, “it takes a very long time to turn your ship around.”

6. Calibrate Your Compliance Training for Greater Impact

There’s plenty of guidance available from the DOJ and OIG to assist ethics and compliance professionals with determining their training priorities. The OIG guidance alone offers 49 distinct metrics for communication, education, and training. It can be a bit overwhelming, so what’s a compliance officer to do?

A presentation by Dan O’Connor of NXLevel and Jeremy Lutsky of Theravance offered attendees a practical framework for designing, developing, and implementing compliance training, beginning with the questions, “Is there a training need?” In other words, is there actually a knowledge and/or skill deficit or is there a problem with incentives, motivation, unclear expectations, etc.?

Assuming there is a training need, ethics and compliance officers can use the long-established ADDIE (Analysis-Design-Development-Implementation-Evaluation) process to efficiently attack the problem, beginning with analyzing risk by role in the organization. Several pragmatic approaches were shared by Dan and Jeremy, including use of the “3F” Curriculum Framework, Bloom’s Taxonomy, and a structured process for evaluating existing training.

7. The food choices in San Francisco are, well, pretty good.

The restaurant choices are clearly bountiful in the City by the Bay and we leave you today with a brief note on two that we enjoyed during our stay:

We couldn’t resist the chowder at the Hog Island Oyster Co. and we weren’t disappointed!

The Hog Island Oyster Company is nestled in the Ferry Building Marketplace, where you can watch the ferries come and go as you enjoy freshly-shucked oysters on the half shell. Choose oysters from various locations or order a dozen or two to try them all! They all come with a fresh vinaigrette or cocktail sauce if you so desire. While their main stake is oysters, the rest of the menu is not neglected. The chowder comes stacked with clams in a nice cream base with veggies, potatoes, bacon and cheese! And the fish sliders are perfectly crispy paired with a tangy coleslaw that compliments the fish nicely. From the bar, the Chardonnay from Napa was crisp and light, and the Wolfback Ridge IPA was a perfect pairing for the fish sliders.

The Douglas Room is a quaint restaurant located adjacent to the Tilden Hotel that offers a boutique gastropub vibe to transport diners to another time (think speakeasy era). The talented mixologists curate creative spins on classic martinis behind the bar to help authenticate the experience. For dinner or late-night snacks, the innovative menu features locally sourced and seasonal ingredients. We enjoyed the shishito peppers, duck confit wings, wedge salad, and Tilden burger. The portions were perfect for sharing, and the presentation was stunning. We’ll be back when the conference returns to San Francisco!

Tessa Hoyer, PharmaCertify by NXLevel Solutions

A Look Ahead: The 2018 Pharmaceutical and Medical Device Compliance Congress!

Look for the “elephant in the Exhibit Hall” at the Pharmaceutical and Medical Device Compliance Congress to see demos of our compliance training solutions!

If you haven’t yet registered for the 19th Annual Pharmaceutical and Medical Device Compliance Congress, there is still time to save $600 on the registration fee with our sponsor discount offer. Contact me at smurphy@nxlevelsolutions.com to ask about the details.

The conference kicks off Wednesday, November 7th at the Mandarin Oriental Hotel in Washington DC, and NXLevel’s PharmaCertify team will be there to catch up with friends and clients and showcase our newest compliance training products. If you’re attending, stop by Booth 108 in the Exhibit Hall (you can’t miss us, we’re right next to the food table and by the bar) to say hello and register for a chance to win an Echo Smart Speaker with Alexa!

You will also see us listening attentively throughout the panel sessions and presentations for the latest compliance best practices and suggestions from what is always an impressive list of industry professionals and government representatives. In addition to the keynotes and plenary sessions, PCF has packed the agenda with 27 different mini summits attendees can choose to attend. With that in my mind, we’ve once again scoured the agenda and highlighted a few of the presentations we’re looking forward to in particular.

Day 1: Wednesday, November 7, 2018

Preconference 1: Patient Support Programs: Risk and Risk Management Best Practices

Right out of the gate, PCF is offering attendees the choice of four compelling preconference sessions from 8:00 AM to 12:00 Noon. This Patient Support Programs session is offered as a “deep dive workshop” with timely talking points that include the most common manifestations or structures of Patient Support Programs (PAPs) and the best practices and approvals of the activities. A quick scan of recent corporate integrity agreements highlights the enforcement focus on PAPs, and kudos to PCF for wasting no time addressing it, with a panel that includes Nereyda Garcia from Alnylam Pharmaceuticals, and Nicole Serena from Bayer.

Keynote: OIG Update

Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General for Office of Inspector General, returns for this highly-anticipated review of recent settlement actions and the OIG’s workplan for the upcoming year. From year to year, the presentation is considered one of the cornerstones of the conference as Ms. Riordan discusses the areas currently on the enforcement radar for her office.

Chief Compliance Officer Roundtable

The conference agenda doesn’t provide any details in terms of what topics the CCOs will cover but based on the level of panelist expertise and the fact that it’s scheduled for one hour and fifteen minutes, the roundtable is sure to provide a bevy of useable, first-hand lessons and advice. Panelists include Jill Fallows-Macaluso from Novo Nordisk, Indrani Lall Franchini from Alexion, Jonathan Kellerman of Allergan, Puja Leekha of Lundbeck, and Lori Queisser of Teva.

Networking Reception

The networking reception is a rare, can’t miss opportunity to meet with your peers face-to-face and exchange tips and ideas for strengthening and growing your compliance program. And don’t forget to visit the vendors while you’re in there. They bring a range of innovation and expertise to the industry… and you don’t want to miss those cool giveaways!

Day 2: Thursday, November 8, 2018

During the first half of Day 2, we hear from the government regulators, investigators, and prosecutors with three different sessions: the Assistant US Attorney Roundtable, FCPA Enforcement Update, and the Qui Tam Roundtable.

FCPA Enforcement Update

In light of the recent FCPA case settlement by Stryker, this session should provide interesting insight into the enforcement trend surrounding the Act. Will more cases surface? Is there a renewed focus on the life sciences industry? With panelists from the FBO, the DOJ, and formerly with the SEC, the conversation should prove to be enlightening and educational.

Mini Summit 1: Fostering a Culture of Ethics and Compliance Beyond Just the Laws and Regulations

The first of seven 11:00 AM mini summits, this session captured my attention for its interesting title. The debate over a rules-based approach to compliance versus a values-based approach is not new to the life sciences industry. I will be curious to hear, particularly from a training perspective, how this panel fosters a culture that emphasizes empowerment to always “make the right decision” while still communicating the need to follow the rules and the laws.

Mini Summit IV: Annual Medical Device Compliance Roundtable

This dedicated medical device session features Jonathan Glazier from Philips North America, Marc Levine of Insightec, Laura O’Donnell from GE Healthcare, and David Ryan of Epizyme discussing the topics unique to the industry. The medical device industry faces some of the same compliance issues as their pharmaceutical brethren, but the nature of the products and business process (e.g., reimbursement) present unique challenges. I am anxious to hear how these presenters address risk and strengthen their compliance cultures while facing those challenges.

Mini Summit VII: Compliance 3.0: Managing Promotional Programs, Relationships with Patient Advocacy Groups and New Entrants into the Marketplace.

That title to this session is a mouthful, but it invokes a promise of a forward-thinking approach to the content. Expect this impressive panel, which includes Terra Buckley of Celgene, Michael Clark of Indivior, and Sujata Dayal of Johnson & Johnson to offer bold suggestions beyond the current thinking for the pressing topics listed in the title.

Mini Summit X: Is Your Board of Directors Bored of Your Compliance Dashboards?

Okay, I admit it, the sessions with the creative names tend to catch and pique my interest. Thinking beyond the clever title though, this afternoon mini summit tackles the tricky subject of the board’s involvement and support of the company’s compliance program. It’s a topic that’s been of focus for regulators

Mini Summit XII: The Fine Line of Promotion with Medical Professionals: Avoiding White Coat Marketing   

Since employees who interact with healthcare professionals face a high level of compliance risk, I will be interested to hear how the panelists, including Pamela Lonzer from Alexion, Margaret Sparks from Sanofi, and Ravi Taylor of Ferring, balance the business need for representatives and others to engage with those HCPs, while instituting safeguards to ensure compliance with company policies and regulations.

Mini Summit XXVII: The Compliance Training Revolution

PharmaCertify had the opportunity to sponsor the 3rd Annual Life Science Compliance Training Conference back in June (you can read our key takeaways here), and I came away from that conference pleased that the industry is clearly developing more innovative training with the intent to optimize the learning and create lasting results. It’s been our focus since we started developing compliance training 12 years ago, and I look forward to hearing more about the techniques the panelists utilize to accomplish that same goal.

Summary

Again, these are just a few of the many sessions PCF is offering at the 19th Annual Pharmaceutical and Medical Device Compliance Congress. We look forward to seeing you there and as always, I welcome your feedback on this preview and our blog in general. If you’re attending the conference, don’t forget to stop by the PharmaCertify booth (#108 in the Exhibit Hall) to say hello.

Thanks for reading and we’ll see you in Washington!