A Plan for Maximizing Your Time at PCF’s 2020 Compliance Congress

For this year’s Virtual 21st Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, the Pharmaceutical Compliance Forum (PCF) has planned an impressive agenda, chock full of keynote presentations, mini summits, plenary sessions, fireside chats, and updates from an impressive array of industry leaders and government representatives with the OIG, FDA, DOJ, and US Attorney offices. So, what’s a busy compliance professional like you to do when looking at that agenda and deciding which sessions are most worthwhile? The solution: approach the conference as if you were building a training plan.

As someone who has spent many years with a company that designs and develops compliance training solutions that reduce risk and strengthen ethical cultures, I understand that most critical step in any successful training project is having a plan. Getting the most out of this virtual compliance congress is no different. That begins with determining just what you hope to learn over the three days.

Decide on Your Learning Objectives

As you peruse the agenda, determine which topics and presentation titles align with the information you hope to gain from the conference. The conference covers a plethora of topics, from GDPR, to the FCPA, recent CIAs, state pricing transparency, and the Sunshine Act, just to scratch the surface. In addition, some sessions, like Mini Summit VIII on Day 1: Compliance Considerations for Rare and Ultra and Ultra Rare Drugs, will be on your list simply based on your product profile or company description. At the same time, if you work for a medical device company, you’ll obviously want to make Mini Summit XI: Annual Medical Device Roundtable on Day 2 a priority.

Implement Your Plan

A “virtual” conference does hold some advantages. For example, with the morning mini summits available on demand throughout the conference, you won’t be locked into one summit during each concurrent time slot. Kudos to the conference organizers for structuring the mornings this way! So if training and speaker programs are both high on your needs list, you can watch Mini Summit I: State of the Art Compliance Training (In Dynamic Times) at 10:00 AM on Monday, then come back later during the conference for the Mini Summit III: Key Considerations and Best Practices in Operationalizing Speaker Programs.

While the afternoon sessions are scheduled one after another each day, the demands of your job and life outside the conference may make attending each one unrealistic. The broader topics presented in the afternoon will therefore require planning as to which ones move to the top of your needs list. Of course, if you are attending with colleagues, I suggest dividing the sessions between yourself and those colleagues and sharing notes later to maximize the learning.

Based on my experience, there are certain sessions I suggest you prioritize no matter your objectives. For example, the OIG Update on Day 1 always offers a valuable review of the agency’s legal actions from the previous year and a peak into its priority list for the year to come.  In addition, expect the Annual AUSA Roundtable on Day 3 to be filled with insights into the topics regulators are moving to the forefront of enforcement as the industry continues to navigate the challenges of doing business during a pandemic.   

As with in-person conferences, PCF has integrated time to visit the Exhibit Hall into the agenda every day. I know I am biased here, but those visits absolutely need to be in your plan. The list of sponsors includes renowned law firms, consultants, software companies, and training developers like us who often offer the critical advice, service, or product you need to help develop and maintain a successful compliance program.

In fact, if you’re attending the Virtual 21st Annual Pharmaceutical and Medical Device Ethics and Compliance Congress, I invite you to stop by the PharmaCertify booth to learn more about our training solutions and see a demo of the newest addition to our Compliance Foundations™ library of off-the-shelf modules, Patient Programs and Their Risks.

Evaluate the Results

The benefits of building a plan to maximize conference learning and networking opportunities are not unique to virtual events. When the industry (and the world) blessedly puts this pandemic in its rearview mirror, and we have the opportunity to travel to conferences again, the challenges of conquering the amount of content made available at large conferences, such as this one, will remain.

Just as effective compliance training plans need to constantly be evaluated and updated, you need to analyze the way in which you approached this impressive agenda. Did the sessions you attended meet your needs? Do you feel they were worth your time commitment? What would you do differently? Are more attendees needed from your organization? And perhaps most importantly, do you now have a notebook full of actionable best practices, suggestions, and tips applicable to your compliance program, your company, and its products?

Thanks for reading, I look forward to seeing you at the conference!

Sean Murphy
PharmaCertify By NXLevel Solutions

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

Compliance News in Review, October 14, 2016

Ghouls, goblins and ghosts galore…the haunting season is here! Enjoy it while you can, before you know it, reindeer, snowmen, and gingerbread men will be scattered across the landscapes. (Poor Thanksgiving…it gets no respect!) No tricks from us though, just treats. And by treats we mean delicious bites of news! So before you head out to wait for the Great Pumpkin, join us for this not-so-scary edition of the Compliance News in Review.

The FDA has carved out time for a public hearing on November 9th and 10th to discuss the subject of communicating off-label uses of drugs and devices. The agency hopes to hear from a variety of stakeholders, including industry representatives, healthcare professionals, patients, and research institutions. Approximately 30 topics will be discussed, ranging from the effect that increased communications will have on patient enrollment in clinical trials to how patients should be made aware that they are receiving information about an off-label use.

GSK is feeling a bit of a chill in the air. The company reached an agreement with the SEC to pay $20 million to resolve FCPA-related charges its Chinese subsidiary paid bribes to increase sales. As part of the settlement, GSK is also required to provide the SEC with reports regarding its implementation of anticorruption measures for the next two years.

Dermatologists are receiving lots of treats from the industry. A study of 2014 Open Payments data reveals that nearly three-quarters of the country’s dermatologists received payments in 2014. Most were under $50.00, but a few of the doctors received payments totaling more than $90,000.00. The study appears in JAMA Dermatology.

These are frightful times at Mylan as the company agrees to pay $465 million to settle claims it overcharged Medicaid for EpiPen. The company has come under intense fire for its pricing practices related to the product. In agreeing to the settlement, Mylan did not admit to wrongdoing.

The news of the FDA’s public hearing on communication related to the unapproved uses of drugs and devices is encouraging. Hopefully, after the forum, the agency will move quickly on the release of new guidance. As court decisions are discussed in the media and more public hearings are announced, now is a great time to reinforce appropriate promotional communication through the release of updated training.

With that, we close our autumnal edition of the Compliance News in Review. One final note – if you’re attending the Pharmaceutical and Medical Device Compliance Congress next week, stop by Booth 404 in the exhibit hall and say “boo!”

Thanks for reading and stay compliant!