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: Myth vs. Reality

Myth #1: Off-the-Shelf Training Doesn’t Align with My Content Requirements

Welcome to the first installment of our series on the myths and realities associated with off-the-shelf compliance training. In each post, we will dive into one commonly heard myth concerning the pros and cons of using off-the-shelf eLearning to reduce compliance risk in the life sciences industry. We begin this week with the frequent lament, “off-the-shelf training doesn’t align with my content requirements.”

The Myth 

Multiple presenters at the 2019 Pharmaceutical Compliance Congress emphasized the importance of targeting training to the audience. As one speaker said, “scientists are not going find value in training that features scenarios with sales representatives.” He ended his comments by saying that is why he only uses custom-developed training.

In addition, in its recently updated guidance on the evaluation of corporate compliance programs, the Department of Justice emphasizes the need for “appropriately tailored training and communications.” When describing what prosecutors should take into consideration when evaluating a company’s program, the DOJ asks, “has the company provided tailored training for high-risk and control employees, including training that addresses risk in the area where the misconduct occurred?”

Clearly, government regulators and industry leaders recognize the importance of targeting training to the roles and risks associated with individual learner groups. And the belief that only fully-custom training can meet those requirements is predictable and understandable.

But is it reality?

The Case for Off-the-Shelf

Knowledge Check from the Compliance Foundations eLearning module: Healthcare Compliance Overview

While I agree wholeheartedly about the need to target the audience and use role-appropriate content, well-designed off-the-shelf training allows for extensive customization, in a streamlined, cost-efficient manner.

Consider Healthcare Compliance Overview, a module from our library of Compliance Foundations eLearning courses. The module covers a broad range of commercial compliance topics, including the False Claims Act, off-label promotion, HIPAA, good product promotion, and the Anti-Kickback Statute so our clients typically launch it to their full staffs. Most of our clients customize the content to reflect the needs of specific learner groups, e.g. sales, medical, clinical, and corporate. Since the modules are built in a “templated” format, the process is simplified and the cost is less than custom-developed training.

Healthcare Compliance Overview features knowledge checks instructionally designed to reinforce key objectives throughout the module. The knowledge checks are often written in the form of scenarios that reflect “real-life” experiences some learner groups are likely to face in their daily activities. Since the modules are so easy to customize, our clients roll out multiple “versions” of the module, each one tailored to the appropriate audience. The result: highly professional and engaging customized compliance training at less cost than custom training.

The Bottom Line

Custom development certainly offers the opportunity to tailor compliance training to various learner groups within a life sciences company, but it comes with a steep price and lengthy development timeline. Delivering appropriately targeted off-the-shelf compliance training throughout the company is not only possible, but it is often the optimal solution based on budget and time frame. Just be sure the off-the-shelf training offers the right level of flexibility.

Launching off-the-shelf compliance training, customized for your learners, is a simple four-step process with PharmaCertify:

  1. Review your risks and goals with our team.
  2. Select from our Compliance Foundations curriculum.
  3. Make our content your content through the customization process.
  4. Launch your training!

Contact me at smurphy@nxlevelsolutions.com to learn more about our customization process.

Thanks for reading!

Connie the Compliance Training Manager Tackles New Hire Training!

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

Fair Balance: Training on a Tricky Concept

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

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

Good Training Enables Better Practice

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

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

Collaborate for Shared Success 

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

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

Effort Well Spent

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

Thanks for reading.

Mona Kay Gorman

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

 

Lessons Learned at the 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