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.
“There is only one rule for being a good talker – learn to listen.”
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.
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!
Compliance Training Intelligence Blog
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
Compliance Training Intelligence Blog
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:
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!
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.
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.
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!
CBI’s 9th Annual Life Sciences West Coast Compliance Congress is less than three weeks away and we’re looking forward to yet another opportunity to catch up with colleagues and clients and showcase our newest life science compliance training products. The conference gives those of us located on the other side of the country an opportunity to hear tips and best practices from industry professionals who don’t normally participate in the East Coast conferences. A quick scan of the agenda reveals company names as diverse as. Here’s a brief preview of the sessions and panel presentations scheduled for the two-day conference.
Day 1: Wednesday, October 17th
Chief Compliance Officer Keynote Panel
After two pre-conference summits, one covering aggregate spend and the other patient support programs, the conference sets the stage with a panel of former and current chief compliance officers, moderated by John Kelly of Bass Berry & Sims, and formerly of the Department of Justice. As someone who attends a significant amount of conferences, I support this idea of diving right into the topics at hand, rather than leading off with a speaker who may bring some name recognition or star power but doesn’t necessarily speak to the primary concerns of the audience.
Enforcement Panel: Fraud and Enforcement Trends – Current and Former Perspectives
The enforcement panel scheduled for 2:15 is an interesting blend of those currently in an enforcement role (Chinhayi Coleman Cadet from the Northern District of California and Rachael Honig from New Jersey) with those who formerly served in an enforcement role and now work in the private sector (the aforementioned John Kelly of Bass Berry & Sims and Robert Marasco from Dinsmore & Shohl LLP and former AUSA from New Jersey and the Southern District of California). The duel perspectives should provide compelling insight into the current prosecutorial trends in the life sciences industry.
Roundtable Discussion: Lessons Learned and Continuing Implementation of General Data Protection Regulation (GDPR)
After a networking and refreshment break, the conversation turns to the timely topic of GDPR. Clearly, there are questions and confusion around the regulation, and we’re especially hoping to hear how these panelists build and deploy training on the hot topic of GDPR. Who are they training in the organization? What topics under the GDPR umbrella are they covering? How often are they updating that training?
Immediately following the GDPR session, Day One closes with a networking, wine, and cheese reception. As you chat with your colleagues and network with new associates, we invite you to stop by the PharmaCertify Booth to learn more about our training solutions. While there, don’t forget to enter the drawing to win an Amazon Echo Smart Speaker with Alexa!
Day 2: Thursday, October 18th
Interactive Exchange: Strengthen Speaker Programs through Innovative Compliance Initiatives and Lessons Learned
Following two sessions on monitoring and auditing, the focus turns, not surprisingly, to yet another hot topic currently under the regulatory microscope, speaker programs. This session should prove to be even more enlightening and revelatory since it is billed as an “interactive exchange” with panelists listed as “conversation contributors.” Those contributors, Ishita Arora of Horizon Pharmaceuticals, Danielle Davis of Insys Therapeutics, Eric Jen of Horizon Therapeutics, and Jenny Shire of Daiichi Sankyo, are sure to have the full attention of an audience hungry for suggestions on how to manage risk in planning and executing the programs.
Choose Between Two Master Classes (A-B)
Before a networking lunch break, attendees have the option to choose between two “master classes” focused on topics that continue to be a source of risk.
Master Class A: Take Action in Light of New Regulatory Updates Surrounding Promotional Compliance and Off-Label Communication
During CBI’s Compliance Congress earlier this year, we learned that the regulatory focus on off-label promotion has shifted somewhat from larger companies to emerging companies and start-ups. Off-label concerns continue to be at the top of qui tam cases, and we’ll be curious to hear the steps Sharon Delshad of Nalpropion Pharmaceuticals and Gary Messplay from King & Spalding recommend for reducing off-label risk
Master Class B: Navigate Third-Party Relationships and Outsourcing Arrangements
For companies that utilize third-party entities for global transactions, Richard J. Ciamacca of Amring Pharmaceuticals, which positions itself as a company that “sells uniquely positioned and harder-to-manufacture generics that bring value to customers and patients,” will offer his insights on navigating the potential risks of those relationships.
Calibrate to Your Organization’s Size – Compliance Program Benchmarking Based on Company Resources
Anytime I see “benchmarking” in the title for a session, I am intrigued. It’s one of the reasons attendees are so interested in attending conferences like these, they want to benchmark their activities and programs against others in the industry. This hour-long session is divided into three presentations: How Companies Can Collect Leads and Advertise Digitally Without Violating Patient Privacy with Sharon Delshad of Nalpropion; Managed Markets Compliance – Mitigate Risks in Relationships with Payers; and Collaborate with Medical Affairs and Elevate MSL Oversight with Tim Ayers from Life Science Compliance Consulting LLC and Gregory S. Moss from Kadmon.
CBI has a well-earned reputation for organizing compliance conferences that bring together an impressive array of professionals and government representatives to share tips, best practices, and lessons learned. The 9th Annual Life Sciences West Coast Compliance Congress is no exception.
As a proud sponsor of the 9th Annual Life Sciences West Coast Compliance Congress, we can offer you a $500 discount on the regular registration price. It’s not too late to register at this special rate, but the discount certificates are limited. Contact me at firstname.lastname@example.org if you are considering attending. If you’re already registered, we look forward to seeing you in San Francisco!
Thanks for reading!
Marketing Manager and Compliance Training Insights Blog Editor
PharmaCertify by NXLevel Solutions