A Preview of the 10th Annual Life Sciences West Coast Compliance Congress

CBI’s West Coast Compliance Congress is scheduled for Tuesday, October 22nd through Thursday, October 24th in San Francisco, and a review of the pre-conference agenda reveals a compelling mix of panel presentations and master classes focused on the most pressing challenges facing life sciences compliance professionals. Here are the sessions we have noted as most intriguing.

Tuesday, October 22, 2019: Pre-Conference

Attendees face an interesting choice right from the start of the conference with two Pre-Conference Summits scheduled simultaneously for 1:30 – 5:00 on Tuesday. Both are focused on topics critically important considering recent industry settlements.

During Summit A, Patient Assistance and Support Programs – Ensuring Patient Centricity Through Compliant Frameworks, summit leaders, Terra Buckley of Celgene, Daryl Kreml of Sage Therapeutics, and Kari Loeser of Relypsa will delve into the risks associated with assistance programs, hub services, nurse educator programs, and reimbursement services. It’s a comprehensive look at the topic by an impressive group of panelists. Don’t miss it.

In fact, the only valid reason to miss Summit A may be to take in Summit B: Third-Party Risks and Oversight – Innovative Models Driving Compliance. The increasing trend toward outsourcing services in the life sciences industry has led to the need for even greater diligence around the selection and management of third-party vendors. According to the agenda, representatives from Advanced Bionics, Merck, and Varian Medical Systems will “share best practices, uncover red flags and set a tactical plan for enhancing oversight.”

Wednesday, October 23, 2019: Day 1

After opening remarks by Erik Atkinsson of Cytokinetics, Day 1 begins with a session intriguingly titled, Trailblazer Talk. Averi Price of Radius Health, Sharon Delshad of Nalpropion Pharmaceuticals, and Daryl Kreml of Sage Therapeutics will focus on “adapting and evolving compliance programs in support of innovation.” I expect it to be an enlightening program from three highly-regarded industry veterans.

When attending any compliance conference, I make a note not to miss the sessions featuring government prosecutors and regulators. The Current and Former Prosecutor Panel is no exception as former prosecutors Tiffany Mosely of Loeb & Loeb, LLP and Joes Verla Jr. of Bass, Berry & Sims will join Adam Reeves from the United States Attorney’s Office in the Northern District of California to discuss trends for next year and beyond. Hearing from the government side always offers important lessons and insights.

Later, on Day 1, the “New Guidance” session subtitled, Walk Through the Evaluation of Corporate Compliance Programs – Foundational Understanding and Future Impact, is compelling based solely on the use of “evaluation” in the title. If this is indeed a step-by-step review of what makes a successful compliance program, the time invested should be more than worthwhile. I wouldn’t miss it.

The afternoon of Day 1 includes two sets of simultaneous “master classes,” beginning at 1:30 with the Transparency and Aggregate Spend session and Data Privacy and Cybersecurity session.  At 2:15, it’s a choice between Promotional Compliance in one session and Non-Promotional Activities in the other. I understand the need to schedule simultaneous sessions to pack as much content as possible into the conference, but it makes for difficult choices. If you are attending with coworkers, I suggest a divide and note-sharing approach to maximize the opportunity.

Day 1 ends with a networking wine and cheese reception, which may be your best opportunity to network with peers and industry leaders. This makes for a great exchange of tips, suggestions, best practices, and business cards.

Thursday, October 24, 2019: Day 2

Day 2 opens with two concurrent master classes at 8:30 and two more at 9:30. The HCP Engagement and Contracting – Mitigate Compliance Risk and Improve Operational Efficiency session stands out as one I would not miss considering the current regulatory focus in that area.

Speaking of HCP contracts and current regulatory focus, the in-conference workshop at 10:45, Strengthen Speaker Program Compliance Through Innovative Initiatives and Best Practices is certainly worthy of an asterisk in your agenda. And if speaker programs are high on your list of risk areas, we now offer a Compliance Foundations™ eLearning module titled, Managing Speaker Program Risk. The 30-minute module covers topics like program planning, speaker compensation, attendee management, and speaker responsibilities, to list just a few. And it’s easily customized with your specific policies and contact information. Let me know if you’d like to a content outline.

Before the conference closes with an Exclusive Benchmarking Think-Tank, Greg Moss of Kadmon Holdings, Sunita Ramamurthy from Loxo Oncology, and L. Kathleen Durousseau of Rigel Pharmaceuticals will cover Governance Best Practices and Working with the Board. We often hear about the importance of “tone from the top” at compliance conferences and any discussion centered on ideas for working with the board to establish the proper tone is worthwhile. It’s a strong topic for the end of the conference.

Thanks for reading this preview of the 10th Annual Life Sciences West Coast Compliance Congress. As always, I welcome your comments, feedback, and stories from the conference. If you are attending the conference, please say hello to my colleague from PharmaCertify, Dan O’Connor, who will be there as well.

Sean Murphy
Marketing and Product Manager
PharmaCertify by NXLevel Solutions

A Preview of the 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 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

9th Annual Life Sciences West Coast Compliance Congress: A Preview

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.

Summary

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 smurphy@nxlevelsolutions.com if you are considering attending. If you’re already registered, we look forward to seeing you in San Francisco!

Thanks for reading!

Sean Murphy
Marketing Manager and Compliance Training Insights Blog Editor
PharmaCertify by NXLevel Solutions

4th Annual Life Sciences Compliance Congress for Specialty Products: A Preview

CBI’s Compliance Congress for Specialty Products kicks off next Thursday, September 13th in Boston, and Dan O’Connor, Senior Vice President for PharmaCertify, will be there to catch up with our clients and colleagues and hear industry leaders and government regulators share strategies for proactively addressing current risks for specialty pharmaceutical manufacturers.

We’ve reviewed the conference agenda and here are the sessions and presentations we are looking forward to in particular:

Day One, Thursday, September 13

Prosecutors’ Perspectives Panel

Following the opening keynote address, the conference begins with this prosecutor panel focused on biotech and specialty pharma companies. Charles Grabow, Assistant US Attorney from New Jersey, and Gregg Shapiro, Chief of the Affirmative Civil Enforcement Unit for the DOJ in Boston, will be joined by Jane Yoon from Paul Hastings, LLP, to discuss the high-risk areas for this unique industry group. Government panels typically offer some of the most compelling and important information during conferences and since this conference is focused on such a defined segment of the industry, the conversation should be revealing and educational.

Coping Strategies for the Lonely Compliance Officer

In addition to having the most creative name of any of the presentations, this session features three professionals facing the challenges that come with being a compliance professional for an emerging pharmaceutical company. We will be curious to hear how Heather Godling from Sobi, Francisco Ribeiro of Tesaro, and Sarah Whipple at Akebia Therapeutics, creatively utilize the limited personnel and resources available to them to build and maintain a strong culture of compliance.

Expert Panel: Evaluate the Risks Associated with Disease State Awareness and Other Pre-Launch Activities

The “Pre-Launch Activities” part of this title caught my eye. No matter their growth stage, all companies need to be aware of the compliance risks and concerns they face now and as they progress toward launch. That extends to compliance policies regarding interactions with healthcare practitioners. Ideally, compliance training for a new sales team should be built and planned before the product is commercialized.

Ensure Transparency in Contributions to Independent Patient Assistance Foundations
And
Reboot Your Approach to Patient Assistance Programs (PAPs) and Reimbursement HUB Support  

Patient support programs are an emerging enforcement trend in the pharmaceutical industry as more and more companies enter into settlements at least partly related to the programs (e.g., Aegerion, United Therapeutics, Jazz Pharmaceuticals). Add the high cost of specialty pharmaceutical products to the mix, and it’s no surprise that CBI has scheduled back-to-back sessions on this important topic.

Day Two, Friday, September 14

Daybreak Discussion: Specialty Café – Forecasting Priorities from Now to 2020

In a novel presentation structure spread across two consecutive time slots (8:15 – 8:40 and 8:45 – 9:10), attendees will have the opportunity to sit in small groups, share ideas and listen to their peers discuss three timely topics: Risk-based Approaches for Advanced Therapies; PBM Contracting Considerations; and Compliant Medical Affairs and Commercial Interactions. The format offers a welcome twist  from the typical large group presentation and should lead to a compelling exchange of peer-to-peer ideas. It’s a great idea.

Explore the Trends in Drug Pricing Legislation and Other State Initiatives

John Oroho, from Porzio Life Sciences, LLC, is a respected and established thought leader in the life sciences compliance industry and his presentation is a can’t miss opportunity to hear the latest news and regulatory updates on these two ever-evolving topics.

Scale Up Your Compliance Program for Global Operations

Going global can be fraught with risk and compliance traps. In terms of anti-bribery alone, pharmaceutical companies need to now consider Loi Bertrand, the EFPIA Code, the Medicines Australia Code of Conduct, and a cadre of emerging codes and regulations around the world.  These on-going changes in the global landscape make the presentation by Masha Chestukhin of Sanofi, and Darryl Williams of MediSpend, an important pre-lunch session.

GDPR is Here – Now What Do We Do?

Are you confused about the General Protection Privacy Regulation (aka, GDPR) and its impact on you as a pharmaceutical compliance professional? You’re not alone. The questions concerning details like data inventory and documentation abound, and what exactly does it mean when data subjects have the “right to be forgotten?” What about training? Who needs to be trained? How does it impact the field employees interacting with HCPs? We look forward to hearing answers, ideas and opinions from David Ryan, Vice President, Associate General Counsel, Chief Compliance Officer at Epizyme and Trish Shorey, Privacy Officer, Global Compliance and Risk Management at Shire.

If you’re attending the conference, we want to hear from you. Let us know what you think of the sessions and presenters, and conference content. And of course, if you see Dan, he’d be happy to share demos of our newest compliance training solutions and discuss how we help clients build a stronger culture of compliance and reduce risk.  

Thanks for reading!

10 Tips for Creating Transparency Training That Sticks

With government investigators rigorously examining Open Payments, and on the hunt for red flags, the need for effective tracking and reporting training is more important than ever. Here are ten tips to help you build and deploy transparency training that reduces risk across your organization. 

  1. Go global.
    Make sure your employees understand that transparency covers multiple countries, not just the U.S. Global companies need to think beyond the Sunshine Act and include the relevant codes and laws from around the world. Don’t forget to incorporate requirements from codes like the EFPIA Disclosure Code and the Medicines Australia Code of Conduct, and regulations like Loi Bertrand (French Sunshine Act).
  2. Keep the reports formal.
    Stress the importance of using legal names of healthcare professionals for reporting purposes. Even if an HCP is commonly known as Bob, his license probably reads as Robert. Only legal names should be used. Warn the learners about facility names as well. For example, Saint Joseph’s Hospital for Children might be commonly known as Saint Joe’s, but the full name needs to be used in the reports.
  3. Add in reference resources.
    When developing training, include resources for learners to use on an on-going basis. Infographics or quick reference materials are good options for learners to self-check information they may have forgotten after they completed the training.
  4. Emphasize that ALL HCP spend needs to be tracked.
    Spend reporting requirements vary from jurisdiction to jurisdiction. A cup of coffee may or may not be reportable, depending on the circumstances. Learners should understand that accuracy is important for HCP spend, regardless of amount or spend type.
  5. Don’t forget the T&E process.
    The details of the travel and expense system are critical. Make sure learners know how to properly record HCP spend in your company’s system. For example, some systems (e.g., Concur) differentiate between a “business guest” and an “HCP guest.” Attributing the spending to the correct category in the system is a time-saving step that helps ensure accurate data.
  6. Include examples of data entry errors.
    Some data entry errors are common, and so are the instructions for correcting them. Identify the common errors in your system and highlight them in the training so learners recognize them during the actual data entry process.
  7. Include a section on HCP interactions.
    Healthcare professionals are aware of the buzz around transparency and privacy. They’re bound to have questions. Instruct sales representatives on how to answer their questions and address their concerns.
  8. Review the rules on speaker programs.
    HCP consultants who serve as speakers on behalf of the company need to make the audience aware that they are being paid by the company. Also, sign-in sheets are necessary to accurately record attendance and account for every physician in attendance.
  9. Make it easy to report errors.
    Include information about the process learners should use, including contact information, when they find errors (misspellings, incorrect state license number, incorrect address, etc.) in the training. Make that information available as a resource they can use later.
  10. It’s all about accuracy.
    No matter the format (live, eLearning, WebEx, etc.), make sure the need for accurate reporting is a recurring theme throughout the training. Take the time to identify and fully understand where errors typically occur in the process and build that information into the follow up training in the form of scenarios and stories. Long live accuracy…king of the content.

The Compliance Foundations™ customizable eLearning module, Global Transparency: Reporting HCP and HCO Transfers of Value, helps learners understand the requirements of worldwide transparency laws and codes, and how those rules help foster open relationships with a company’s HCP customers. Contact me at smurphy@nxlevelsolutions.com if you’d like to see a content outline or course demo.

Thanks for reading!

Sean Murphy
Editor
Compliance Training Insights Blog