My First Glance at the Agenda for the 17th Annual Pharmaceutical Compliance Congress

The 17th Annual Pharmaceutical Compliance Congress is scheduled for April 29 – May 1, 2020 in Washington D.C.

When scanning an agenda for an upcoming compliance conference, I begin by identifying the presentations that feature new topics, or ones that offer a compelling twist on a long-standing topic. This isn’t to suggest you should ever focus exclusively on the “new and shiny” sessions over those that have a more familiar ring. For those of us steeped in many years of conference attendance, sessions like DOJ and SEC Insights and Third-Party Risk Assessment and Oversight are always worthwhile for the updates offered by industry leaders and government regulators.

My initial review of the agenda for CBI’s 17th Annual Pharmaceutical Compliance Congress, scheduled for April 29 – May 1 in Washington D.C., reveals an intriguing mix of new and bold content, along with tried, true, and recognizable presentations. The conference is consistently one of the “can’t-miss” opportunities for life sciences compliance professionals to interact with their peers and hear best practices and suggestions for reducing risk across their companies. From a training development perspective, the presentations help keep us aware of important content trends, as we strive to provide training products you need to continually evolve your curriculum and address compliance risk.

With that in my mind, here are my thoughts on some of the sessions planned for this year’s conference.

Day One – Wednesday, April 29, 2020

CBI has scheduled three concurrent “summits” to open the conference. Summit 1, Bio/Pharma Compliance Boot Camp appears to be an ideal opportunity for those attendees new to compliance to gain a foothold on the topics that form the foundation of the industry. Perri Pomper of Clinical Genomics and Ed Sleeper of Esperion will be joined by Mahnu Davar and Daniel Kracov of Arnold & Porter to cover the essentials. If you are new to the industry, you don’t want to miss this one.

After a networking and refreshment break in the Exhibit Hall (shameless plug – don’t forget to stop by the PharmaCertify booth), three more concurrent summits are planned for the afternoon. Summit IV, Primer Course on Compliant Patient Interactions, from Clinical to Commercial, offers an update on an obviously hot topic, from Rahul Khara of Acceleron Pharma and Seth Lundy of King & Spalding. In Summit V, Compliance and Legal Watch-Outs for Partnering and Deal-Making, Erik Eglite of Aurina Pharmaceuticals will address the compliance challenges inherent in product partnerships. Summit VI, Empowerment, Diversity and Inclusion, stands out as something new and compelling for this conference. Kudos to CBI, as well as presenters, Sujata Dayal of Johnson & Johnson, Jim Massey of AstraZeneca, and Maggie Feltz, of Purdue Pharma, for taking on such an important and timely topic.

Day One closes with the PCC Kick-Off Party and Welcome Cocktail Reception. This is one of the best opportunities you’ll have to interact with your peers while visiting the vendors who provide an array of the services you need to build a stronger culture of compliance. While there, visit the PharmaCertify booth to see demos of our newest compliance training products, all designed to help you enhance the retention of key policies and regulations in the field and across the company.

Day Two – Thursday, April 30, 2020

Following a networking breakfast, and the chairperson’s opening remarks, Day Two begins with a Regulatory and Enforcement Showcase, featuring presentations from representatives of PhRMA and  government entities, including the OIG, various U.S. Attorney offices, the DOJ, and the SEC. The Enforcement Docket Deep-Dive is the annual review of recent corporate integrity agreements and settlements. The panel features an impressive array of representatives from U.S. attorney offices around the country. Consistently, from year to year, these enforcement updates offer critical insight into the latest government oversight trends.

The session titled, Chasing Miracles – When Drug Research is Personal jumped off the screen for me. As a company dedicated to the development of compliance training that reduces risk on a sustained basis, we strive to make that training relevant, personal, and meaningful. I look forward to hearing John Crowley and Patrik Florencio, both of Amicus Therapeutics, discuss how they introduce and communicate the “criticality of compliance in advancing lifesaving therapies,” as it is described in the agenda.

Following the networking lunch, attendees choose from six concurrent workshops. While that may seem like a daunting decision, I recommend partnering with colleagues and associates to divide and conquer. Sharing notes over dinner or coffee is a powerful way to get the most out of the conference and bring more actionable knowledge back to your job.

While all the workshops look to be worthwhile on the surface, three stood out for applicability and relevancy to risk areas. First, Calling All Emerging Biotechs – Pre-Commercial Considerations and Checklist appears to be an ideal opportunity for anyone working with a smaller company, with one product commercialized or soon to be commercialized. I am anxious to hear if Eric Baim of Dovetail Consulting, Tiago Garrido of Verastem, and Rupa Cornell of Stealth BioTherapeutics touch on training as they cover the unique risk and resourcing challenges faced by companies in this tier.

On the hot topic front, the Enforcement Snapshot and Best Practices Related to PAPs, Coupons, Copays and Foundations addresses the risk that seems to be on everyone’s mind, including the collective ones at the OIG. Stephanie Doebler of Covington and Burling LLP, and Katherine Chaurette from Blueprint Medicines Corporation will present.

On the persistently relevant front, Third-Party Risk Assessment and Oversight, with Dennis Barnes of Mayne Pharma, Tali Guy, of Teva Pharmaceuticals, and Michael Clarke of ConvaTec, will surely be relevant for anyone whose company conducts business globally through third-party vendors. That’s a wide swath.

The concurrent workshops continue throughout the afternoon, with six from 2:55 pm to 3:55 pm and six more from 4:25 pm to 5:30 pm. Workshop G has a compelling title in line with the earlier one focused on emerging biotechs, “Product Approved, Now What? Building Out the Compliance Infrastructure with Limited Resources.”  It’s a topic near and dear to the hearts and budgets of many of our clients and I will be listening closely for how Jeffrey Levitt of Stemline Therapeutics, John Knighton, of TherapeuticsMD, and Jim Flaherty of Rhythm Therapeutics handle development and deployment of training on those limited resources.

Back on the hot topic front, Workshop K, Hub and Specialty Pharmacy Oversight and Risk Assessment, features Sarah Whipple of Akebia Therapeutics, and Meenakshi Datta of Sidley Austin; and I am interested in hearing their expert analysis on assessing the risks associated with hubs, and of course, how that risk is addressed in training.

Finally, you do not want to miss Workshop P, State-of-the-Art Compliance Training, with Erica Powers of SAGE Therapeutics, and my colleague from PharmaCertify, Dan O’Connor. In this case, “state-of-the-art training” may not mean what you assume it means in terms of design and budget. Erica and Dan will present different methods for addressing risk and deploying more effective training, no matter your learning objectives and business goals.

Day Three – Friday, May 1, 2020

If the multitudes of workshop choices on Day Two aren’t enough to satiate your hunger for compelling compliance content, CBI has scheduled five full sessions followed by your choice of five tailored content tracks, with two presentations per track:

  • Track 1: Speaker Programs – Current Enforcement Trends, Best Practices Benchmarks, and Future Fate
  • Track 2: Commercial and Government Pricing Transparency and Reporting
  • Track 3: Taking Monitoring, Auditing, and Investigations to the Next Level
  • Track 4: Zero-in on Compliant Patient Interactions
  • Track 5: Clinical Trial Legal and Contracting Considerations and Risk Management Strategies

Among the presentations that precede the track sessions, Lessons Learned from the Field. Anti-Kickback Accusations and the Aftermath – An Inside Look at Sales and Marketing Practices Under Fire should be interesting to say the least. If the title alone wasn’t intriguing enough, the presenter is Jonathan Roper, former district sales manager for Insys Therapeutics. Roper was charged with violating the Anti-Kickback Statute in connection with his participation in the company’s scheme to encourage HCPs to prescribe its fentanyl-based sublingual spray. I am encouraged to see that along with sharing his story from the Insys trenches, Roper is expected to cover the importance of an effective compliance training program in his comments. Buckle your seat belts, it’s going to be an interesting 30-minute session.

An Opportunity to Attend

The sessions I cover above represent only a fraction of the veritable plethora of important content covered in the three-day conference. Whether you work as an n of 1, or by contrast, you have access to a wealth of resources and personnel, the conference offers countless opportunities to bring back the information you need to build, maintain, and grow a better program and culture of compliance.

As a conference sponsor, we are offering a significant discount on the registration fee. Contact me at smurphy@nxlevelsolutions.com if you are interested in this opportunity, and we will see you in Washington!

Be a compliance training hero, with a little help from PharmaCertify…and a discount on the conference registration!

Sean Murphy
Marketing Manager
PharmaCertify by NXLevel Solutions

The 2019 DOJ Guidance Document: A Baseline for Life Sciences Compliance Training

Sean Murphy
Product and Marketing Manager

One of the significant events of 2019 affecting life sciences compliance was the April release of a new guidance document, Evaluation of Corporate Compliance Programs, (https://www.justice.gov/criminal-fraud/page/file/937501/download) by the criminal division of the Department of Justice (DOJ).  The primary intent of the document is to guide prosecutors and courts as they evaluate corporate compliance programs, but it also serves as an important baseline for life sciences businesses evaluating all areas of their compliance programs, including the training curricula.

The guidance document highlights three questions for prosecutors to consider when evaluating a program:

  1. Is the corporation’s compliance program well designed?
  2. Is the program being applied in good faith?
  3. Does the corporation’s compliance program work in practice?

In this post, I examine the DOJ’s document in more detail, and discuss its implications for your compliance training curriculum.

Risk-Based Training

In reference to a “well-designed compliance program,” the DOJ stresses the need for prosecutors to focus on whether a company’s program is customized for the particular risk profile of that company. According to the guidance, prosecutors should “understand the company’s business from a commercial perspective, how the company has identified, assessed, and defined its risk profile, and the degree to which the program devotes appropriate scrutiny and resources to the spectrum of risk.” The company’s periodic training and certification should include all “directors, officers, relevant employees, and, where appropriate, agents and business partners.” In addition, training should be tailored to “audience size, sophistication, or subject matter expertise.”

In pursuit of these standards, foundational training is an effective method for providing a baseline, but additional risk-focused content continuously delivered to individual business units is one way to address that risk. As an example, scenario-based mini modules covering the topics highlighted in risk assessments and audits of the compliance hotline should follow the more comprehensive foundational training for each business unit to make it more relevant and engaging. In addition, microlearning nuggets in the form of quizzes, assessments, and contests have been proven to drive higher retention rates when delivered strategically across a learner’s calendar. Targeted, continuous learning covering the topics deemed critical to each business unit is the key to truly reducing risk.

Curriculum Analysis

On the topic of risk-based training, the DOJ recommends prosecutors ask, “What analysis has the company undertaken to determine who should be trained and on what subjects?” In line with that suggestion, a compliance curriculum analysis is a critical first step for any compliance professional interested in understanding the details of existing organizational training and it’s a necessary starting point for the reconfiguration of that curriculum to effectively address the risks. The categories covered in the analysis should include:

  • Training Type (eLearning, Live, Webinar)
  • Topic(s) Covered
  • Level of Training (Awareness, Detailed, General, etc.)
  • Length
  • Audience(s)
  • Risk Rating Per Audience (Low, Medium, High)

An instructional design analysis should also be included to determine if the proper learning objectives are established and followed, and the visuals, audio, navigation, and assessment are optimized for learning. The data should then be curated into a spreadsheet with sortable cells and columns to allow for an organized and multi-level review of all training programs and topics. At PharmaCertify, we use our Compliance Curriculum Analysis Tool, or CCAT, to assist our clients with this analysis. Once the CCAT is complete, we summarize to highlight the strengths, gaps, and redundancies in the overall curriculum.

Test and Test Again

The document also delves into the measurement of training effectiveness by encouraging prosecutors to ask if employees have been tested on what they learned and how the company has addressed employees who fail all or a portion of the testing. While the inclusion of standard assessments with each course is an assumed necessity, using assessments as learning tools has been shown to strengthen long-term memory.

A study by Jeffrey D. Karpicke and Henry Roediger III, of the Department of Psychology at Washington University revealed that learners are poor judges of what they remember, and when given the choice, they stop studying before they have mastered the subject. So even when they think they know it, they don’t, and assessments spaced repeatedly over time is the best method to increase the retention of critical compliance policies and best practices. When possible, alternative types of tests should also be deployed, including:

  • Pre- and post-training tests to measure gains scores
  • Priming assessments to encourage the formation of cognitive schema
  • Diagnostic assessments to help target remediation
  • Cumulative exams to encourage information retrieval and re-encoding

Effective Implementation, Review, and Revision

Finally, prosecutors are asked to consider whether a compliance program is a “paper program, or one implemented, reviewed, and revised, as appropriate in an effective manner.” This holds true not just for the program in general, but for the compliance training curriculum. Just as the corporation should “provide for a staff sufficient to audit, document, and analyze the results of the efforts,” the proper resources and time need to be dedicated to the evaluation of the current curriculum, with subsequent modifications conducted accordingly.

The DOJ’s Evaluation of Corporate Compliance Programs document refers to a compliance program’s capacity to evolve as a hallmark of its effectiveness. That evolution is necessary because “a company’s business changes over time, as do the environments in which it operates, the nature of its customers, the laws that govern its actions, and the applicable industry standards.” An effective life sciences compliance training curriculum must align the current business with the environment, customers, and laws, and now is the time to bring all of those components together.

I hope the insights above are helpful as you continue to improve your compliance training effectiveness throughout 2020. Thanks for reading!

 

What I Heard at the 20th Annual Pharmaceutical and Medical Device Life Sciences Compliance Congress…and What It Means for Your Compliance Training!

Dan O’Connor of PharmaCertify and a panel of industry leaders share their experiences during the training workshop at this year’s Pharmaceutical and Medical Device Compliance Congress.

Presenters at this year’s Life Sciences Compliance Congress from the Pharmaceutical Compliance Forum (PCF) covered some of the same ground as previous conferences (tone at the top, sharing resources, mine the data, etc.) while mixing in a significant amount of new content and thought-provoking ideas for the attendees to consider. PCF even added an impressive amount of “mini-summits” to the agenda to ensure the content appealed to compliance professionals dealing with a variety of risks. It was a challenging, yet worthwhile, amount of information to absorb.

Following are some of the more interesting ideas shared at the conference, along with thoughts on what they mean for the compliance industry and for anyone interested in building and maintaining a successful compliance program.

  1. “Don’t worry about developing a culture of compliance, develop a culture of integrity instead.”
    The idea of making compliance concepts more relatable or understandable is nothing new and it was discussed extensively during this year’s Chief Compliance Officer Roundtable. According to the presenters, employees understand “integrity” more than they understand building a “culture of compliance.” The panelists offered examples of how they strive to integrate the concept of integrity throughout the company – from annual integrity awards, to asking every employee to write how they model integrity and ethical behavior in their daily business activities. As they put it, “don’t make it a compliance policy issue, make it an integrity issue.”
  2. “Don’t underestimate the ability of people to rationalize.”
    The life sciences industry holds the potential to “alleviate pain, restore health, and extend life.” While that is a noble responsibility, it holds the potential for dangerous rationalization. It’s too easy to think, “since we are saving lives, I need to get this product out faster…so I need to make this sale as quickly as possible,” or “I know my product is better than the competition, so I need to do whatever is needed to make the sale.” Continuous training is needed to instill a sense of responsibility in learners and help guard against the dangers of rationalization.
  3. “If you don’t get access to the Board as a member of the compliance team, that company is not a place you want to be.”
    Surprisingly, this one came from the AUSA Roundtable. I did not expect to hear career advice offered by a group of Assistant U.S. Attorneys, but it reinforces the notion that the compliance department must be integrated into the entire company, top to bottom, to be effective. It was a theme carried throughout the conference and led to compelling debates around topics like whether the compliance department should report to the legal department (hint: most regulators prefer to see it having the clout that comes with being a standalone department).
  4. “The shift to a patient-centered business model comes with risk.”
    During the session on “charitable contributions compliance considerations,” panelists focused on the need to avoid any suggestion that support programs and assistance programs are being used to increase sales. The separation between more sales and making products available to more patients is a fine line. As was also mentioned (and most industry insiders know), the list of Corporate Integrity Agreements (CIAs) focused on donations is growing. Panelists stressed the need to be careful about “where the charitable money is coming from.” If it comes from the commercial budget, it will be considered a commercial payment.
  5. “Communication style and protocol is key when dealing with co-pay foundations.”
    During the Helping Patient Access to Products session, presenters raised surprising points about the nuances of communication. As an example, “smiley face icons” in emails may seem innocuous, but they need to be avoided not only for general inappropriateness purposes, and because they hold the potential to be misleading during an investigation. Does that “wink” imply a favor or quid pro quo? The key throughout all communication is to avoid any suggestion that a support program is being used to overcome a co-pay barrier.
  6. “International cooperation across policing agencies continues to increase.”
    According to the presenters in the US DOJ and US SEC Update on FCPA Enforcement session, they are seeing a growing number of referrals from overseas regulatory bodies – significantly more than they saw ten years ago. Risk is rising, as are the number of whistleblower cases, and the panelists encouraged audience members to carefully review the DOJ’s April 2019 Evaluation of Corporate Compliance Programs document for what the agency considers to be the best practices for building and maintaining an effective program and reducing risk.
  7. “The lack of understanding between pharmaceutical sampling and medical device sampling is like day and night, and that makes it complicated.”
    Much of the Annual Medical Device Roundtable was understandably dedicated to the challenges associated with “asset management.” Consider that every missing, or unaccounted for, device could be considered a kickback during an investigation.  As one panelist emphasized, “the government has zero tolerance for asset management problems.” Another raised the interesting point that companies must ensure they are loaning devices to HCPs for the right reasons, and not because those HCPs want “to replace a machine that is currently not functioning” or “to use it for one test.”
  8. “Sharing resources can become political. Your initiatives may get pushed back when budgets are tightened.”
    The sessions dedicated to compliance for small to mid-sized businesses always provide unique insight to those attendees faced with limited resources and budget and this conference was no exception. The idea of reaching out to other areas of the company for support is a common refrain, and the added twist of what happens when budgets tighten was thought provoking. As the presenters explained, when compliance is a priority with corporate and with the Board, fighting that pushback gets easier. Tone at the top may be a bit cliché, but it’s a powerful weapon in the battle for time and money.
  9. “A corporate integrity agreement can be an opportunity to improve your overall compliance program.”
    Dreading the thought of a CIA is understandable, but the five years spent abiding by the terms of the settlement provides the momentum to build up a budget and showcase the importance of the program. Buy-in from corporate on resources is automatic during the CIA and it serves as the blueprint for what can be accomplished moving forward. Exiting the CIA is the time to evaluate lessons learned and evaluate methods for making the compliance program even stronger. From a training standpoint, the end of a CIA is also the time to evaluate what mandated programs were successful and explore opportunities to deploy more targeted, role-based training.
  10. “Your risk assessment needs to guide your monitoring and make it more meaningful.” This is actually a hybrid of statements made by Mary Riordan of the Office of Inspector General (OIG) during her much-anticipated annual speech and multiple presenters throughout the two days of presentations. The bottom line: a successful compliance program cannot be a cookie cutter effort, replicated from one company to another. Risks assessments need to be conducted at least on an annual basis and every aspect of the compliance program, including training, should be evaluated and modified accordingly. Continuous improvement is needed to make it meaningful and relevant.

What Else Does It Means for Your Compliance Training?

Whether you work in the pharmaceutical or medical device industry, the world of compliance is evolving, and the design and delivery of training must evolve as well. Based on the information shared in the OIG, DOJ, and AUSA sessions, the guidelines for who receives what training, at what frequency, needs to be enhanced.

As an example, during the session on reducing risk using a portfolio approach to compliance training, panelists discussed the need to integrate contextual reminders like vis aids, static prompts like intranet banners and poster, and active prompts like emails and desk drops to more effectively change behavior and facilitate a shift to that “culture of integrity.” The need to “make compliance training stick” is growing and now is the time to reevaluate your training curriculum and delivery methods.

Thanks for reading, I hope to see you at the “21” Annual Pharmaceutical and Medical Device Compliance Congress in 2020!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

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

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

Tuesday, October 22, 2019: Pre-Conference

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

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

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

Wednesday, October 23, 2019: Day 1

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

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

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

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

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

Thursday, October 24, 2019: Day 2

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

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

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

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

Sean Murphy
Marketing and Product Manager
PharmaCertify by NXLevel Solutions

A Preview of the 5th Annual Life Sciences Compliance Congress for Specialty Products

 

 

Cambridge, Massachusetts, the site of the 5th Annual Compliance Congress for Specialty Products.

The 2019 compliance conference season is just around the corner and the PharmaCertify™ team is gearing up for a slate of sessions beginning with a two-day stop at CBI’s 5th Annual Life Sciences Compliance Congress for Specialty Products.

This conference holds particular interest since the compliance challenges faced by specialty companies, including a number of our clients, are somewhat unique to the industry. With that in mind, I have perused the agenda for the sessions that look compelling for the specialty audience.

Day 1: Thursday, September 12, 2019

8:30 a.m. Keynote Panel: Focal Points and Top Enforcement Trends for Specialty

Set your iPhone alarm and don’t be late for the opening session! The enforcement panels are often a source of valuable information at compliance conferences in general and in light of the focus on specialty biotech companies in this conference, this is an intriguing choice to kick off the conference. Assistant U.S. attorneys from Massachusetts, New York, and New Jersey will join the panel to hopefully discuss the trends specifically relevant to this audience.

11:30 a.m. Creative Training Techniques for Out-of-the-Box Engagement

Okay, I confess, I am a little biased since this session will be moderated by my colleague Dan O’Connor. But being on the “inside” has afforded me the opportunity to hear and see the plans for the presentation and trust me, you don’t want to use this time to refill your coffee. Dan and the panelists from Avanir Pharmaceuticals, Sanofi Genzyme, and Sarepta Therapeutics will share real-world and tested techniques for creating and deploying training that sticks.

1:15 p.m. Where is the Line? Tackling the Overlap in Medical and Commercial Activities

Understanding the divide between MSLs and sales representatives remains a key topic for training consideration in the pharmaceutical industry in general. And that line does change over time. In fact, presenters at the 16th Annual Pharmaceutical Compliance Congress in April stressed that the recent trend toward a principles-based culture requires even more collaboration between Medical Affairs and Field Sales. Expect the panelists from Radius Health, Sunovion, TESARO, and Akebia to address that change.

2:15 p.m. How Far is Too Far? Navigate the Risks While Maintaining the Merits of Patient Support Activities

Patient support programs are in the news. I know…tell you something you don’t know, right? I find the title of this session interesting though in that it highlights the need for risk awareness while pointing out that the programs hold benefits for the patients that pharmaceutical companies are committed to serving. Keeping those programs compliant is a worthwhile and noble effort and we look forward to the panelists from Sage Therapeutics, Sanofi Genzyme, and Acceleron Pharma sharing their suggestions for accomplishing that task.

5:00 p.m. Networking Wine and Cheese Reception

While this may seem like an obvious choice for a favorite session (somewhat akin to saying “lunch” was my favorite subject in high school), I make note of it for reasons beyond the libations. The networking sessions at compliance conferences offer a great opportunity to learn from your peers in face-to-face conversations. You’ll even get to chat with the vendors who made the time and financial commitment to share their products and services with you. Don’t forget to stop by the PharmaCertify booth to say hi – the wine is on us! Oh wait…it’s already on CBI.

Day 2: Friday, September 3, 2019

8:30 a.m. The Impact of Recent FDA Guidance on Product Communications – Dramatic Change in Operations or Business as Usual?

After a review of Day 1 by the conference chair, Day 2 begins with this cleverly titled session. I admit, I was pulled in by the title and I’m intrigued to hear the answer. My best guess, based on recent presentations by the FDA’s Office of Prescription Drug Promotion, is that the truth lies somewhere between “dramatic change in operations” and “business as usual.”

11:30 a.m. Cell and Gene Therapies Learning Lab – Compliance Considerations for Highly Complex, Potentially Curative Treatments

While the two “comprehensive breakouts” scheduled for 11:30 a.m. both look intriguing and educational, I lean to this one simply because of the title. After all, what’s better than a specialty pharmaceutical product conference that features discussions about well…specialty pharmaceutical compliance considerations? This is a great example of how such smaller, more focused conferences can present learning opportunities that are rare in the larger compliance congress settings. We look forward to hearing the presenters from EMD Serono and IQVIA discuss how those considerations differ from the broader risks and concerns.

2:00 p.m. Fireside Chat What You Need to Know and What You Wish You Had Known – Compliance for the Beginner and the Expert

Great title!  Described as an interview session with participants from Sage Therapeutics and Acceleron Pharma, this is certainly a unique and bold way to end the conference. Hopefully, it fills attendees’ minds and notebooks with memorable tips, suggestions and reminders to help them build a stronger culture of compliance and reduce risk. Well played, CBI, well played.

Discounted Registration Fee!

As a conference sponsor, the PharmaCertify team is offering a discount registration voucher for the 5th Annual Life Sciences Compliance Congress for Specialty Products. Contact me at smurphy@nxlevelsolutions.com if you’d like to take advantage of this opportunity to network with your peers and hear industry leaders share best practices and tips for building, maintaining, and training on a strong compliance program. While at the conference, stop by the PharmaCertify booth to see demos of our newest Compliance Foundations™ eLearning modules, custom training courses and the newly updated Access LMS.

Thanks for reading!

Sean Murphy
Marketing Manager, PharmaCertify by NXLevel Solutions

Off-the-Shelf Compliance Training Myths

Myth #3: It won’t run properly on my learning management system.

In this third installment of our series on the myths associated with off-the-shelf compliance training, I discuss the concern that only training sold in conjunction with an LMS, or other type of online content delivery system, will run properly and accurately record data with that LMS. This theory is based on the idea that training modules from other vendors are not developed with the specifications of that system and therefore hold the potential for technical difficulties and “clunky” performance.

So, if you’ve already committed to an online compliance training content management system, the only way to ensure eLearning modules function correctly is to utilize the training that is packaged with the system, right? In a word…no.

The Myth 

Companies selling whole compliance training systems are understandably interested in fostering the notion that customers have no need to search elsewhere for training after they have made the commitment to purchase an enterprise-wide system to manage and deliver compliance training. The modules are a natural extension of the core product and offer myriad opportunities to garner additional revenue throughout the life of the system contract.

Adding fuel to the “it won’t run properly” fire is the idea that since there are so many varieties and brands of systems available to life sciences companies, including the large, well-known names; small systems targeted to compliance; industry upstarts; and systems intended more for GMP training where 21 CFR Part 11 compliance is a requirement, consistent performance across all platforms must inherently be a difficult, if not impossible, challenge. It’s a logical conclusion, even when SCORM compliance is factored into the compatibility equation as indicated by the fact that LMS compatibility continues to be one of the first questions our clients ask when we map out a strategy for deploying our Compliance Foundations™ off-the-shelf eLearning modules.

The Reality

If an LMS is built to modern specifications by a technical team that understands the need for it to house a range of training types, and the training is built with an eye toward flexibility and SCORM compliance, compatibility and performance of the individual components should never pose a problem. An effective compliance training curriculum requires a thoughtful and well-planned mix of training modalities delivered continuously across a learner’s timeline. That formula sometimes consists of elements from a variety of development vendors and the ultimate success of that curriculum must never be threatened by the limitations or lack of flexibility on which the training is housed.

So not only is the suggestion that off-the-shelf training won’t run properly on a wide range of systems a misleading and counterproductive myth, it is anathema to the very notion of what is at the foundation of successful compliance training.

The Bottom Line

In 15 years of delivering online life sciences compliance training, the technical team behind PharmaCertify has never faced an LMS communication and compatibility issue we could not overcome quickly and efficiently. The training we build for our pharmaceutical and medical clients is launched on systems large, small, and everything in between. Communication with the LMS team on the client side is key and early in the project, we learn the specifications of the system and provide a test module to that team to ensure seamless integration into the LMS.

Since we work with companies in various stages of training preparedness, including some that do not have an LMS in place, we also offer our Access LMS as a cost-efficient solution for deploying training to employees and third-party vendors alike. But, no matter the LMS, our first goal is to ensure your training reaches your learners according to your planned schedule and without technical concerns, and the critical completion and reporting data you need to verify learner compliance with your training curriculum is accurate, accessible, and reliable.

To see a demo of the PharmaCertify compliance training solutions, including the Access LMS, contact Dan O’Connor at doconnor@nxlevelsolutions.com.

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Off-the-Shelf Compliance Training Myths

Myth #2: It’s Not Really Targeted to the Life Sciences Industry

In this installment of our series on the myths and realities associated with off-the-shelf compliance training, I cover the common concern that off-the-shelf compliance and ethics training is not effective because it is so rarely focused on the life sciences and the only way to get targeted training is to build from the ground up.

The Myth 

All too often, life sciences companies purchase off-the-compliance training designed with generic content that is somehow intended to be applicable to any industry. This especially holds true when training is sold under the banner of ethics training. After all, ethics is ethics, no matter the industry…at least that is the sales pitch from companies who sell generic compliance training.

Unfortunately, the aggressive marketing and sales efforts of those companies perpetuate the myth among many life science companies that custom-development is the only training option that will meet their needs. Unknowing compliance professionals think they have only two bad options: 1) purchase generic training, or 2) hire a generalist training developer to build expensive modules from scratch, with the added burden of having to provide subject matter expertise to the training developer (As if they don’t have enough to do already!). There is a better approach, one that can be both efficient and cost-effective.

The Reality

Those pedaling generic compliance training may insist otherwise, but effective life sciences compliance training absolutely requires content targeted to the pharmaceutical or medical device industries. The intricacies and details of the risks in our industry are far too unique to expect learners to find real value in generic training. But that doesn’t mean the only path to quality training is through custom development. Off-the-shelf training, with content developed by industry experts and vetted by your peers in the industry, is readily available for customization and launch.

Interactions with Healthcare Professionals Compliance Foundations eLearning Module

Our Compliance Foundations™ eLearning modules cover the topics those working in the life sciences industry need to effectively reduce the risk inherent to their job responsibilities. Off-the-shelf courses include Good Promotional Practices; Interactions with Healthcare Professionals; Healthcare Compliance Overview; On-label Promotion; and Managing Speaker Program Risk to name a few. The modules are designed for easy customization, so your language, policies, and practices are easily woven into the content. And our modules can be launched on any SCORM-compliance learning management system…either the one you have in place or our cost-effective LMS.

The Bottom Line

There is a better way. You don’t deserve to have to settle for generic compliance training. You can have off-the-shelf content that is specifically targeted to the risks in our industry and the ability to further customize the training specifically to your company. You also don’t need to always build from scratch to ensure the content is relevant and optimized for the risks your learners face every day as they interact with healthcare professionals and conduct their work-related activities.

But don’t just take my word for it when you can see for yourself. Follow the four steps below to access demos of the Compliance Foundations™, and see first-hand, the level of industry focus we bring to our modules.

  1. Visit http://www.pharmacertify.com/demo/interactions_hcps/start_course.htm
  2. Follow the navigation prompts to review the demo.
  3. Visit http://pharmacertify.com/foundations-compliance-training.html to see short descriptions of all of our Compliance Foundations modules.
  4. Contact Tessa Hoyer at thoyer@nxlevelsolutions.com for course outlines and to learn more.

Thanks for reading!