So Many Anticorruption Laws, So Little Training Time

On January 12th, Zimmer Biomet reached a $30 million settlement with the Department of Justice and the Securities and Exchange Commission over business activities in Mexico. A few days later, an $800 million multijurisdictional settlement was announced with Rolls-Royce. That case involved the United Kingdom, the United States and Brazil, with the UK’s Serious Fraud Office (SFO) taking the investigative lead. Clearly, enforcement agencies around the globe remain committed to aggressively investigating and pursuing bribery cases.

In years past, the Foreign Corrupt Practices Act (FCPA) was the primary enforcement tool for anticorruption efforts around the world, and companies were wise to focus their resources on that legislation. As the Rolls-Royce settlement reminds us though, other countries are actively pursuing enforcement of their own laws. Simply covering the requirements of the FCPA in ABAC training is no longer practical or advisable.

Our clients are in the process of developing or strengthening their ABAC programs, and training is an important part of their efforts. With the overall volume of compliance training rising every year, we offer a few tips for maximizing the impact of ABAC training.

  1. Address common concepts one time. Training should be structured to first address the common concepts across all anticorruption laws. For example, most laws define a “bribe” and a “foreign official” similarly and most define the same type of actions as illegal. In addition, most laws do not absolve companies of responsibility of actions conducted by third parties. There is no need to cover each of these concepts in conjunction with each law. Doing so makes the content redundant, and only serves to make the training more cumbersome and frustrating for the learners. By presenting this common content from a wider perspective, in context of all bribery laws and principles, you establish a base of knowledge as the starting point, before delving into the particulars associated with each of the laws.
  2. Address specific laws individually. The nuances from country to country are plentiful and can be tricky. For example, learners need to know that the FCPA includes a “books and records provision,” and the UKBA punishes a company for failure to prevent bribery. After the common concepts are sufficiently covered, training then needs to address the specific aspects of each law, separately. Otherwise, those details will be lost in a sea of definitions or concepts that the learners were already presented in relation to other laws.
  3. Reinforce key concepts and laws via micro-learning. On-going reinforcement is key. When developing training plans, integrate micro-learning tools like mini modules and learning sprints (mini assessments) across the learner’s timelines. As an example, topics that affect how the learners conduct their daily business activities need to be addressed through scenario-based, more targeted tools, not just in the foundational training.

As the list of global anticorruption laws has multiplied, we’ve put the principles into practice and updated our Compliance Foundations™ module, Global Anticorruption Laws, with the content restructured to maximize learner engagement. If you’re in the process of developing, or updating, your global anticorruption training, we’re happy to share a content outline of our module and speak with you about our experience. Just contact my colleague Dan O’Connor at doconnor@nxlevelsolutions.com.

Thanks for reading!

Lauren Barnett
Compliance Content Specialist
PharmaCertify™ by NXLevel Solutions

Compliance News in Review, January 27, 2017

The Serious Fraud Office leads the charge on Rolls-Royce’s multi-jurisdictional bribery settlement; the FDA releases new draft guidance; and a new transparency law is on the way in Maine.

While most obscure, strange, and funny “holidays” may be dismissed as whimsy, and fodder for creative water cooler conversations, Chocolate Cake Day is one that we here at the News in Review celebrate with vigor and enthusiasm. From Devil’s Food to Black Forest, we look forward to marking the occasion with more than one variation on theme. In fact, why not just make a weekend of it? Meanwhile, if a day dedicated to the splendors of chocolate cake isn’t sweet enough for you, we offer a delectable morsel of a different type, with this edition of the Compliance News in Review.

Rolls-Royce is getting its just desserts on three continents. The company recently entered into a $800 million multi-jurisdictional settlement with the UK’s Serious Fraud Office (SFO), the Department of Justice (DOJ) in the U.S. and Brazil’s Ministério Público Federal, to resolve charges it paid bribes to foreign officials in Eastern Europe, the Middle East, South America and Asia. In a twist on the usual tale, the SFO, not the DOJ was the agency spearheading the investigation. In addition to the financial penalties paid to each country, Rolls-Royce entered into deferred prosecution agreements with the U.K. and US governments, and a leniency agreement with Brazil.

The FDA is working on a new recipe for sharing healthcare economic information (HCEI). The agency released draft guidance for the sharing of HCEI with payors, formulary committees and similar entities. The guidance includes questions and answers about sharing HCEI related to investigational products with payors. The comment period for the draft guidance began January 17 and will remain open for 90 days.

On the state level, a legislator in Maine read a newspaper report about the increase in promotional spending by companies that manufacture opiods, and decided to introduce a law intended to curtail gifts from the industry to physicians. The language in the bill is based on the Minnesota gift prohibition law

Anticorruption efforts around the world are moving full steam ahead in 2017 and the fact that the SFO is spearheading investigational efforts presents a new twist. We don’t know yet if this is the start of a new trend, but we do know the SFO has the means to investigate and resolve large cases like the one with Rolls-Royce. Since the passage of the UK Bribery Act in 2011, the news around potential investigations has been quiet, but that is clearly changing. Like the U.S. Foreign Corrupt Practices Act, the UK Bribery Act has a wide reach.

Now is the time to review the training components of your anticorruption program to ensure employees, vendors and other third parties are being trained regularly about bribery laws and your company’s policies. Is that training engaging and based on real-world scenarios? Is deployment spaced over time to maximize effectiveness and retention? Have you mixed in smaller, more-focused micro-learning to reinforce topics like “identifying red flags?” Taking proactive steps now will strengthen help reduce risk and strengthen your culture around the globe for years to come.

With that, we put the wraps on this tasty edition of the Compliance News in Review. Until next time, we say, “let them (and us) eat cake!”

Thanks for reading and have a great weekend!

Compliance News in “Preview”

As we wistfully wish 2016 a fond farewell, we welcome 2017 and wonder what compliance surprises, developments, and news the year might hold. What will be the hot topics debated around the water cooler in your office? The team at the Compliance News in Review has dusted off its crystal ball once again and we offer a few suggestions on what we see as the hot topics for 2017.

Drug Pricing Transparency

Drug pricing was at the top of the list in 2016. CEOs were brought before Congressional panels to explain exorbitant price hikes, and in several states, laws were proposed that will companies to disclose factors related to drug pricing for certain drugs. Vermont was the only state to pass such legislation, but California has reintroduced the bill for this session. The federal government also got in on the act with a bipartisan bill introduced in the Senate. While some of the fervor has quieted, we don’t think we’ve heard the last of pricing transparency. The passage of Vermont’s law could be the catalyst other states need to get their own laws passed.

Off-label Guidance/Revised Regulations

We don’t expect to see new guidance or regulations in 2017, but the FDA did at least start a conversation with the industry in 2016. A two-day meeting with stakeholders in November resulted in a list of diverse statements and opinions from companies, the medical community, and patient groups. The meeting with stakeholders was a step in the right direction, but a few high-profile cases (Caronia, Amarin, and Pacira) that resulted in wins for the industry, only led to more confusion and questions. We are cautiously optimistic that the FDA will at least continue the conversation and somewhat clarify the regulations.

Warning Letters and Notice of Violation Letters

The FDA’s Office of Prescription Drug Promotion (OPDP) wasn’t very active in 2016…until December, that is. At the end of the year, the agency made up for lost time by sending six letters for non-compliance with drug promotion regulations, signaling (in our humble opinion) a more aggressive approach in 2017. Most of the letters that were sent in December were related to the use of digital media.

Bribery and Corruption Enforcement

In 2016, several companies settled with the Department of Justice over Foreign Corrupt Practices Act (FCPA) violations. Most notable was a $500 million plus settlement with Teva that occurred near the end of the year. We expect to see more settlements this year, with half a dozen life sciences companies already under investigation for FCPA violations, according to the most recent Corporate Investigations List on the FCPA Blog. One wonders if the Serious Fraud Office (SFO) will join the trend as well and pursue more UK Bribery Act cases now that the agency has dipped its feet into the pool of U.S.-style Deferred Prosecution Agreements. We wouldn’t be surprised to see SFO dive right into the deep end.

The 2017 year in life sciences compliance looks to be an interesting one, and we’ll be tracking the news and headlines through our Compliance News in Review updates. Don’t forget to “follow” our blog so you don’t miss any news or our tips and best practices for building and deploying the compliance training you need to reduce risk and strengthen your compliance culture.

Thanks for reading and best wishes for a compliant and successful 2017!

Compliance News in Review: the 2016 Year-End Summary

Here we are again. Another 584 million-mile (940 million km for our metric friends) trip around the sun is nearly complete. It seems like just yesterday we were celebrating the beginning of 2016 and now we’re picking out our favorite brand of champagne to celebrate its end. Before we break out the noisemakers and party favors, let’s take one last nostalgic look back at some of the life sciences compliance-related developments of 2016.

A new milestone was reached regarding HCP spend disclosure. The first disclosure reports under the EFPIA Disclosure Code were released in 2016. Gaining disclosure authorization from individual HCPs proved to be a challenge for the industry and the numbers of doctors who granted authorization ranged widely between countries. According to Britain’s pharmaceutical trade association, ABPI, 70% of their HCPs granted authorization and in Ireland, just over half of HCPs did so. In other transparency developments, ten of Canada’s top drug firms announced plans to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and other multinational firms including Abbvie, Purdue, BMS, and Lilly followed.

Drug pricing was a big story in 2016. Former CEOs from Turing and Valeant were called to testify before Congress about drug price hikes, and Mylan’s CEO was called to testify over dramatic increases in the cost of an EpiPen. Laws that would require drug companies to disclose information about their pricing decisions were proposed in several states, and a bill was introduced at the federal level with similar requirements. Even with those high profile stories making headlines, only one pricing disclosure law successfully passed this year – Vermont. That law requires a select group of manufacturers to provide information about the factors related to price increases.

A handful of former Insys employees had an eventful year. A former sales representative entered a guilty plea to charges of fraud, and a district sales manager and a several of top executives were all arrested on charges they paid kickbacks to doctors. The drug at the center of the charges is the opioid painkiller, fentanyl. Prosecutors and enforcement agencies claim the individuals offered a variety of kickbacks to doctors to increase prescriptions and encouraged them to prescribe it for unapproved uses.

2016 was an active year for settlements related to bribery cases. GSK, AstraZeneca, SciClone, and Novartis all entered into settlements with the SEC over activities conducted by subsidiaries in China. Orthofix and Teva both set aside cash in anticipation of resolving the FCPA-related charges. Olympus entered into a $22.8 million settlement with the DOJ to resolve charges that a subsidiary covering Latin America paid bribes to healthcare professionals working in government facilities in order to increase sales of product.

We saw a couple of legal “victories” for the industry in the debate over sharing truthful off-label information. In the Amarin case, the FDA decided not to appeal a judge’s decision that allowed the company to share truthful off-label information about its fish oil product. In addition, in proposed jury instructions for a medical device case, the DOJ indicated that it is “not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device.”

With a string of legal decisions favoring the industry, the FDA held a public forum in November concerning the ability of drug and device makers to share off-label information. The primary topic was whether the agency needs to revise its regulations considering recent legal decisions and the forum was attended by various stakeholders representing both sides of the argument.

With that, we complete our look back at 2016 and the stories that made headlines in the world of life science compliance. It was an eventful year, and everyone at the Compliance News in Review is excited to see what the new year holds. Thanks for joining us throughout the year and best wishes for a happy, healthy, and compliant 2017!

Compliance News in Review, December 12, 2016

If you’re dancing “The Beagle,” and you can’t break away from all of the movies starring Candace Cameron Bure on the Hallmark Channel, it can only mean one thing; it’s Christmas time! Despite what Staples would have you believe, THIS is the Most Wonderful Time of the Year. Before you fill your heads with dreams of sugarplums, we have a quick yuletide tale to share. Gather round friends to hear the tome; our newsy, Compliance News in Review Christmas poem.

T’was the News before Christmas, and all through the land,

Our readers waited for the first story at hand.

The story was chosen with the utmost of care,

In the hopes of bringing joy and not causing despair.

In Congress a healthcare bill was just passed,

But not without a change that left some hopes dashed.

Despite efforts to exempt, companies will still report

Payments for textbooks, reprints and speaking fees of a sort.

Senators exclaimed the payments we must heed

With the exemption removed, the bill passed with ease.

With the healthcare bill passed and well on its way,

We will move on to news from Californ-i-a.

Away went a bill in the last governing session,

Requiring disclosure of drug pricing information.

Not one to give up, an intrepid senator said,

“I’ll make minor changes. This bill is not dead!”

Change his bill he did, and returned it to the floor.

Companies must report price hikes of 25% or more. (if passed)

Then over at Teva there arose such a clatter!

We wondered out loud what could be the matter?

After one bribery investigation and setting aside cash

A tip came in – to Romania Teva should dash!

Bribes of travel and consulting fees were paid.

Teva is investigating all of these claims.

On the “nice” list of St. Nick we all hope to be,

But this group of execs will be found on “naughty.”

Six from Insys were arrested for inducements

Paid to docs to write scripts for unapproved uses.

The former CEO is one of the six, yes really.

His lawyer exclaimed he would plead “not guilty.”

Others in trouble are from marketing and sales.

Don’t buy the business is the moral of this tale.

With that last story our tale must come to an end.

We’ve enjoyed sharing it with you our dear friends.

So until we return with more news and insights,

Merry Christmas to all, and to all a good night!

Compliance News in Review, November 18, 2016

Bring on the turkey, cranberries and uncomfortable family interactions! Thanksgiving is almost here. Soon enough, the stress of all that preparation will melt away as we share meals with friends and family, and depending on how you look at it, a day of crazed shopping the day after will either offer a little more relief or send the stress level right back to record levels. Before your planning kicks into full gear, we offer this small helping of all the compliance news fit to blog, in this edition of the Compliance News in Review. Get it while it’s hot!

The FDA and industry representatives gathered around the table for a two-day public hearing regarding off-label marketing. The agency’s long held opinion remains the same – sharing information about a use that has not been proven safe and effective presents a risk to public health. Industry representatives argued that in a changing healthcare environment, where prescribing decisions are not made exclusively by physicians, the FDA needs to end regulatory barriers and issue clear regulations permitting the sharing of truthful, non-misleading information. The FDA also expressed concerns about the effect that sharing off-label information would have on the industry’s incentive to conduct well-controlled, randomized studies, and that physicians may not have the time to discern what information is misleading.

Former Valeant executives and employees of the specialty pharmacy, Philidor, are being charged with engaging in a kickback scheme to the tune of millions of dollars. According to the FBI, a Valeant executive received $10 million from Philidor. The payments were allegedly laundered through a series of shell companies to avoid detection. In response, Valeant noted that the company itself had not been charged, and documents related to the case made it clear the two former executives attempted to defraud the company.

Teva is setting aside a substantial amount of “leftovers” in the form of $520 million to settle bribery allegations from the DOJ and SEC. The allegations are related to activities in Russia, Mexico and the Ukraine. The company said the allegations did not involve its U.S. business, and implied the issues stemmed from third-parties subsidiaries. Teva also announced that its governance program and processes have since been revamped and it has severed ties with the problematic third-party agents.

Pass the lawsuit, please. A Pennsylvania judge has denied GSK’s motion to dismiss a lawsuit brought by 41 insurers over medications manufactured at a now closed GSK facility in Puerto Rico. The medications were allegedly defective, and the insurers claim GSK induced them to purchase the drugs, and then failed to react when the defective drugs were discovered.

Pharmaceutical sales representatives will now need an invitation from the city to work in Chicago. City Council has passed an ordinance requiring all representatives to obtain a license as part of an effort to help stave off improper opioid prescribing. Reps will have to undergo training on ethics, marketing regulations, and other laws. The fee will be $750, and the license must be renewed annually. The ordinance will go into effect in July 2017. Revenue will be used to educate physicians and patients about opioids.

With that, we close this edition of the Compliance News in Review. Thanks for reading and we wish you and your family a happy and healthy Thanksgiving holiday!

Notes and News from the Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress

If the overriding theme of the Seventeenth Pharmaceutical and Medical Device Compliance Congress could be summed up in three phrases, they might be “partnering with the businesses,” “a seat at the table,” and “a principles-based approach to compliance.” On that last one – note the change from “values-based approach” to “principles-based approach.”

Watching recent conferences (and the industry in general) evolve to the point where these themes are at the forefront is refreshing and encouraging. As someone who has worked in life sciences compliance training for ten years, I’ve looked forward to the shift to an all-inclusive approach that considers all ideas and voices in the organization, and ultimately leads to the creation of more valuable and engaging compliance training. Below are a few of my observations and highlights from this year’s conference. The conference organizers offer the opportunity to purchase an archive of individual sessions or the full conference at www.pharmacongress.com. You can preview video clips of those sessions at www.pharmacongress.com/post-con-individual.html.

CCO Roundtable

The Chief Compliance Officer Roundtable on Day 1 featured industry leaders sharing lessons on building and executing a modern and effective compliance program. The panel included representatives from both the pharmaceutical and medical device industries and the conversation focused on two concepts: the practice of thinking from a perspective of risk (the “gestalt of risk,” as one panelist defined it), and the need to focus on what is meaningful to the business when developing and executing a compliance example. One speaker used the example of monitoring sample dates, and how that practice is not necessarily worthwhile to the business. That same panelist emphasized the need for hiring individuals with business experience when staffing compliance positions. Another looked at compliance training as what employees “should stop doing based on prioritized risk.”

Finally, one panelist stressed “prevention” over “detection” and how his staff uses data analytics to help identify problems based on the area of risk. “Defining guardrails, and risk tolerance, is necessary to get out in front of the issues,” he said.

FCPA Enforcement

During the FCPA Enforcement Panel, Joseph Beemsterboer, JD of the Department of Justice, Terry Price, JD of the SEC, and Gejaa Gobena, JD, of Hogan Lovells, discussed the growing number of cases related to the Foreign Corrupt Practices Act. To this point in Fiscal 2016, 24 FCPA cases have been filed, 6 of them against pharmaceutical companies. 85-90% of the 24 cases were related to conduct in China. Pharmaceutical and medical device industries represent such a significant portion of these cases because large numbers of their employees must interact with foreign officials, according to one of the presenters.

Anti-bribery

Day 2 opened with a much-anticipated session titled Behind the Bribe: Multiple Real-World Perspectives on How Foreign Bribery Occurs, Is Investigated, and Could Be Prevented. Regulators emphasized that anti-bribery remains an area of focus, “we are still seeing the same behaviors, and issues with gifts, travel, and entertainment,” according to one panelist. The FBI representative made it clear that the Agency is “committed to going after global bribery” and the “storm that is coming” will focus on the prosecution of individuals. “Culture is critical,” he said, “just publishing a video from the CEO doesn’t cut it anymore.”

The panel included former executive, Richard Bistrong, who spent time in prison for conspiring to bribe officials to win contracts from the United Nations, and spent 2.5 years as a government witness. Mr. Bistrong stressed the need for diligence as foreign cultures can be misleading. Distributors will often sign FCPA documents, then do something else in the practice. “Don’t let get the business done, drown out how to get the business done,” was one of his key points.

First Amendment Update

During the Truthful and Non-Misleading Communications and Recent First Amendment Cases session, a panel of industry attorneys discussed and debated the ambiguity regarding off-label promotion in FDA policy. After revealing the reasoning behind the FDA’s policy (patient safety and advancement of science), a lively discussion led to speculation that the Agency’s recent public hearing and announcement in the Federal Register signals gridlock and tension among leadership. This lack of direction is what led companies such as Amarin and Pacira to believe they needed to litigate their cases, according to one attorney. The session closed with the moderator asking each panelist if he or she thought the FDA would publish any clear guidance in the next year. The responses ranged from “I just don’t know,” to “highly unlikely,” to “no, they’re not.” Don’t expect clarification anytime soon folks.

Managed Markets

The Compliance Considerations for the Managed Markets Business opened with panelists first defining their definition of managed markets and how it differed for each of their companies. The bottom line was that no matter the particulars, it is defined as the functions responsible for “ensuring patients have access to the therapies the physicians write.” One industry representative said her company defines healthcare professionals to include anyone paying for the products, and another included anyone who can influence prescribing decisions – making compliance policies and the regulations pertinent to the managed markets business.

The expanded movement to the use of specialty pharmacies creates more risk, according to the panel, and companies are thinking about those issues in more detail after Novartis’ Corporate Integrity Agreement was made public. Pharmacy Benefit Managers (PBMs), Patient Assistant Programs (PAPs) and Reimbursement HUBs were covered as well, with the panelists stressing that government is starting to examine the relationships established through these entities, and companies need to be aware that laws never meant for managed markets are now being applied to that sector of the industry. As an example, one panelist mentioned, “the data that goes back and forth with charities is a risk area, and measures need to be put in place to ensure it is not used inappropriately by anyone involved with the data.” The session ended with a compelling question from the audience, “how do you ensure copay cards aren’t used for off-label purposes?” The answer came down to extensive monitoring to make sure that anyone who was supposed to be excluded was indeed excluded.

Compliance Training

As the compliance training division of NXLevel Solutions, the PharmaCertify™ team is always eager to attend sessions such as this conference’s What’s New for Training Programs. Since our mission is to help life sciences companies strengthen their compliance cultures and reduce risk, we are always encouraged to hear pharmaceutical and medical device professionals espousing techniques that support that goal. This session was no exception. While each company varied in the particular details, the panelists’ remarks made it clear that a true movement toward a blended approach to compliance, spread across a learner’s timeline, is growing. As one professional described it, “training to the right people, with the right content, the right amount of times.”

While panelists varied on the degree of live training over computer-based training, most agreed that the use of small vignettes, or small “bursts of information,” as one described them, are critical. The live training options included a Family Feud type game rolled out on a regular basis to streaming scenarios. The millennial generation was referenced, and the need for mentoring programs and live training that makes millennials’ transition into the industry a more compliant one.

Training content was a focal point, with one panelist stating “you have to make the content relevant, so people can do their jobs,” as he stressed the need to survey the learners on what else they actually want to learn about, along with questions about whether or not they feel more knowledgeable and if they have the support of their managers.

And let’s not forget about culture and tone of the organization – at the top, middle, and bottom. For example, training needs to emphasize that employees should feel comfortable reporting violations and asking questions.

The PharmaCertify™ compliance training professionals and subject matter experts are always anxious to discuss your compliance training curriculum and plans. To discover how we can help evolve your approach to training, contact Dan O’Connor at doconnor@nxlevelsolutions.com or visit http://www.pharmacertify.com/ to learn more about our products and services.

Compliance 2.0

It’s time for “partnering with the business” and “a seat at the table!” During the Compliance 2.0: Shared Ownership of Effective Compliance Across Business Functions presentation, six panelists (representatives from compliance and business) detailed case studies on how their companies made compliance concepts and programs more concrete and effective. Throughout each example, the importance of bringing the business into the planning from the start was stressed. One team who used the development of a new monitoring tool as their example said, “you have to know and understand the business in order to build a tool that meets their needs as well as your needs.”

One particularly interesting panelist was recently added to his company’s compliance team from the field, as part of the organization’s efforts to foster a strategic relationship between the business and compliance. He represented a compelling example of how that type of program is an opportunity to “infuse ethics and compliance into the company when the business pulls him back,” as he effectively put it. As another eloquently stated, “we have to raise our business partner’s compliance IQ and we can’t do that by ourselves.”

“Access to leadership” was referenced as a key component of Compliance 2.0, as more than one panelist discussed the need for those involved to feel comfortable questioning everything from leadership as the initiatives got started.

Beyond Transparency

My final breakout session was Beyond Transparency: HCP Interaction Risk Management. The session was centered on the use of data and how the transparency data can be used to track issues, then leveraging the auditing results to enhance policies and create more training. One panelist addressed it succinctly when he said, “our goal is to get to the point to where we use data to identify issues faster.” Another used the example of speaker programs and how the data could be used to raise questions about the number of times an individual HCP attended a speaker program, and raise the question of whether that was a concern.

The audience was reminded that “transparency isn’t just TOV data, it refers to sample data as well, and there is a need to overlay sample data with TOV data to reveal more than occasional interactions with one HCP.”

With representatives from both large and small companies on the panel, much of the discussion centered on the tools needed to keep the data organized and up-to-date. One panelist summarized it nicely, “when you do your hiring, make sure you find a person with excellent Microsoft Excel skills.”

The Evolution of Compliance Programs

The first presentation during the closing plenary session, Driving the Evolution of Compliance Programs into Systems Supporting Business Integrity, covered the oft-referenced theme of a “principles-based approach to compliance.” Representatives from three different companies touted the benefits of moving away from a “rules-based approach.”

As a foundation, in a principles-based system, decisions are not based on policy, but more on how individuals think and make decisions. “They need to be given the skills to make decisions,” according to one Vice President of Compliance, and “they need to be empowered to make those decisions and it’s a cultural shift for all stakeholders.” This is approach requires “a high level of trust and respect by leadership for the rank and file,” one panelist noted; and, he pointed out, writing shorter and more concise policies associated with such an approach takes discipline and time – quoting Winston Churchill, he referenced, “I would have written a much shorter speech if I had the time.”

The shift isn’t an easy one and the panelists stressed the need to “get leadership’s buy-in and help them see that a rules-based policy was holding the company back and the new policy will help patients, caregivers, and shareholders.” When an audience member asked “what kind of practical training would you offer to support such a shift,” the panel responded with “go back to the guiding principles of honor, trust, and integrity.”

Summary

While we weren’t able to attend all the sessions at the Seventeenth Annual Pharmaceutical and Medical Device Compliance Congress, we couldn’t help but be impressed with the level of content the conference provided to an audience hungry for any best practices and advice they could garner from their colleagues and subject matter experts. From a vendor standpoint, the foot traffic on the exhibit floor was steady and we appreciated the unique opportunity to engage current and prospective clients in meaningful conversation about their compliance programs and how we can help strengthen their compliance culture and reduce risk.

I welcome your thoughts and feedback. Please contact me at smurphy@nxlevelsolutions.com.

Thanks for reading and stay compliant!

Sean Murphy, Product and Marketing Manager, PharmaCertify™ by NXLevel Solutions

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