Pharmaceutical Compliance Congress 2017 Preview

The 14th Annual Pharmaceutical Compliance Congress (PCC 2017) is just around the corner. Whether you work in Compliance, R&D, or Medical Affairs, this year’s conference has sessions for you. We’ll be there as well, catching up with friends and colleagues and learning the latest trends and best practices from industry and government professionals. Here are just a few of the sessions and content streams we have on our to-do list.

Preconference

If you’re there for the preconference sessions on Wednesday, we humbly suggest the session titled Accelerated Learning – Healthcare Compliance and Policy Applications. Dan O’Connor, Senior Vice President for PharmaCertify™, will join a panel of industry leaders and legal consultants in what promises to be a valuable primer for those new to the compliance function or those not in the compliance department who need to understand the responsibilities of their compliance colleagues. We’ve seen the previews!

Day One

Plan to arrive early on Day One, since the opening session, Ignite and Infuse – Integrating a Compliant Culture within Company DNA features an impressive panel of leaders from the industry, including Beth Levine from Regeneron, Jim Massey from AstraZeneca, and Michael Shaw from GlaxoSmithKline.

Following the lunch break, we’re interested in the First Amendment and Off-label Promotion – Caronia and Beyond session occurring in the Promotional Compliance content stream. Considering the recent news around the final rule for off-label promotion and the introduction of a bill in Congress on the topic, it promises to be a timely discussion. We’re also interested the HEOR, Real World Evidence and Comparative Research Effectiveness session in the Clinical Research and R&D Compliance content stream to learn more about how health economic and outcomes research affects the compliance space.

The Small to Mid-Sized Bio/Pharma Boot Camp offers sessions dedicated to issues of concern to a significant portion of the attendees. Compliance professionals working in smaller companies face the same issues as their counterparts in large companies, but are challenged to do more with less as they strive to build or expand their compliance programs. We’re looking forward to hearing how they deal with the challenges of training with such limited resources.

The late afternoon Global Compliance content stream includes several sessions covering anticorruption laws around the globe. (And by the way, when you can work a nod to Walt Disney World in your session title, you’ve got our attention.) Anticorruption efforts are increasing rapidly around the world. The Department of Justice has indicated it doesn’t intend to end the FCPA Pilot Program anytime soon, signaling its intention to continue the aggressive pursuit of corruption cases. Also, the Serious Fraud office in the UK recently entered into its first corporate Deferred Prosecution Agreement, adding even more muscle to the UK Bribery Act.

Since training around speaker programs is a consistent concern and need for our clients, we’ll also be listening carefully and taking copious notes in the Compliance Concerns Regarding Speaker Programs session in the Medical Affairs content stream.

Day Two

On Day Two, we’ll be in our seats bright and early again, and we don’t expect to need extra coffee for a session titled, Cardiac Arrest – Surviving Five Years as a Medical Device CEO on the DOJ’s Hit List. We are particularly interested to hear how prosecutors use the Yates Memo to focus on individuals during an investigation. If that isn’t enough to wake you up, the Data Protection, Privacy Risks and Cyber Crime session should do the trick, considering the vast amounts of data those in the industry are required to manage and protect.

The use of third parties and other intermediaries is one of the top bribery risks facing life sciences companies, so as Day Two wraps up, we’ll be sure to catch the Third-Party Due Diligence in the U.S. and Abroad workshop.

If you’re attending the conference, we want to know what you think. Stop by Booth 10 in the Exhibit Hall and let us know what sessions you found to be most intriguing and useful. If you can’t make it this year, watch for updates on the PharmaCertify™ Twitter feed and our annual post conference highlights and notes here on our blog.

We hope to see you in Washington!

Compliance News in Review, April 19, 2017

The city of Chicago releases sales representative licensure rules; review and dispute time is here again; opioid manufacturers receive letters and negotiate settlements; and Australia proposes changes to its bribery law, in this edition of the Compliance News in Review.

April showers may bring may flowers, but they also bring something else…the Boys of Summer. Major League baseball is back! Much of the buzz seems to center around a former Heisman Trophy winning quarterback and his homerun prowess. Whether your team is off to a hot start (we’re looking at you Yankees fans) or surprisingly struggling (are the Blue Jays already too far out?), there’s plenty of time for the standings to change as the temperatures warm. For now, buy me some peanuts and Cracker Jack and settle in for this edition of the Compliance News in Review.

Our first story comes from Chicago, home of the 2016 World Series champion Cubs. The City has released draft rules for its pharmaceutical sales representative licensure ordinance. The initial license is $750.00. Like the rules in place for detailers in Washington DC, Chicago’s ordinance has a continuing professional education provision. Education provided by the rep’s company will not suffice in meeting the requirement unless the company applies for and receives approval from the city. The draft rules also require sales representatives to track their interactions with healthcare professionals.

April 1st was opening day for the Open Payment’s review and dispute period. Physicians and teaching hospitals are free to review recent submissions to the system and dispute items they believe are incorrect. The review and dispute period for the 2016 Program Year ends on May 15th.

Senator Claire McCaskill sent letters to a lineup of opioid manufacturers requesting that they provide information related to sales, marketing and education strategies used to promote their products. from which she wants some information. McCaskill acknowledged that most of the players in the opioid market act responsibly and she said the purpose of her investigation is to learn if any of the practices

Mallinckrodt has agreed to settle a DEA probe for $35 million. The settlement involved the company’s suspicious order monitoring program for controlled substances. The settlement is under review by the DOJ and DEA. In a statement, Mallinckrodt said it had not violated the law, and the settlement does not include an admission of liability.

Australia appears to be poised to move its bribery law up to the major leagues. Government officials there announced that several reforms were being considered to deal with bribery of foreign public officials. The reforms include the addition of a “corporate failure to prevent bribery” offence and use of deferred prosecution agreements to encourage self-reporting. Among the changes proposed, the definition of a foreign public official would include political candidates and bribery offences would extend to those that offer a “personal advantage,” not just a “business advantage.”

The anticorruption landscape continues to evolve. The PharmaCertify Compliance Foundations™ eLearning module, Global Anticorruption Laws, covers the concepts common to most anticorruption/anti-bribery laws, as well as the specifics related to laws such as the FCPA and the UK Bribery Act. In addition, our new Compliance QuickTake™, Recognizing and Reducing Third-Party Risks, covers the risks associated with working with third parties, in a targeted microlearning format.

The PharmaCertify™ team will be offering demos of our compliance training products at the Pharmaceutical Compliance Congress in Washington next week. Stop by Booth 10 in the Exhibit Hall to say hi, and while you’re there, enter our drawing to win a JBL SPLASHPROOF PORTABLE SPEAKER.

See you in Washington!

Move Beyond the Basics to Make Compliance Training Stick

We’ve come a long way in life sciences compliance training in a relatively short time. Fifteen years ago, the common approach to compliance training often involved lawyers from the legal department, using PowerPoint slide decks to train large groups, once a year at POA sessions. Somewhere along the way, the industry recognized the importance of instructional design, and the power of technology, as the focus shifted to eLearning and the on-going search for ways to use it in an engaging and creative manner. That pursuit continues.

Instructionally-sound, creatively-scripted eLearning still represents an effective method for training large groups across a company, but to truly reduce risk, micro-learning concepts need to be strategically integrated to your curriculum. More targeted training, focused on specific subjects, and smaller audiences, is key. Let’s use anticorruption training as an example.

Anti-bribery legislation is on the rise around the world, and the increasing risks associated with the growing number of laws requires a comprehensive approach to your anti-bribery/anticorruption (ABAC) training. Core ABAC training, by nature, needs to address an expansive topic list, and it needs to be targeted to audiences as diverse as sales and marketing; medical affairs; regulatory; logistics; and manufacturing. Once that core training is launched though, the audiences that represent the highest risk (i.e., sales and marketing), and the topics that present the greatest risks to those audiences, (e.g., third-party red flags) need to be identified. As one example, deploying a smaller module on “recognizing and reducing third-party red flags,” to the sales and marketing audience after the broader ABAC module is completed, reduces risk for the one audience that has direct contact with third-party intermediaries.

Micro-learning doesn’t have to end with mini-modules. Employees are seeking information and training differently than they did back in those PowerPoint-driven years. Tools such as infographics and scenario-based video sequences offer more opportunity to make the focused learning stick, especially when spaced appropriately across a learner’s timeline and blended with other learning components. In addition, reinforcement doesn’t end with training. Apps offer an ideal method for delivering “just-in-time” reference content where the employees need it most – in the field and at their fingertips. In this case, offering access to a list of red flags, and tips for how to identify them, would drive down the risk for that sales and marketing audience.

The PharmaCertify team will be exhibiting at the 14th Annual Pharmaceutical Compliance Congress in Washington April 26-28. If you’re attending, stop by Booth 10 (it’s back there where CBI keeps all the good food!) to share your ideas for reinforcing compliance learning in your organization. After all, we’re compliance learning geeks – we want to hear them! And don’t miss Dan O’Connor, Senior Vice President for PharmaCertify™ at NXLevel Solutions, as he and his co-presenters offer a conference prelude session on healthcare compliance and policy applications.

See you in Washington!

Sean Murphy, Product and Marketing Manager

Compliance News in Review, March 27, 2017

Everything’s coming up roses, off-label speech, and corruption, in this edition of the News in Review.

We’ve got the fever…Spring fever! Spring has sprung, and we couldn’t be happier. Warmer weather, more daylight, budding trees and flowers, what’s not to love (besides the severe weather, commuting in the dark, and pollen)? This Spring, the flowers aren’t the only thing blooming, though. A new edition of the Compliance News in Review has appeared in our garden.

Arizona gets to claim the first “bloom” for sharing truthful off-label information with the governor signing the Free Speech in Medicine Act into law. The law protects the free speech rights of those in the medical community to discuss truthful off-label information about FDA approved drugs. It covers speech that is “not misleading, not contrary to fact, and consistent with generally accepted scientific principles,” and only deals with discussions between pharmaceutical companies and healthcare professionals. It does not cover off-label discussions or advertisements targeted to consumers.

The FDA has stemmed the implementation of a new off-label regulation. The agency announced in the Federal Register that it would delay the effective date of a final rule related to “intended use” regulations until March of 2018. It is delaying the effective date to consider public commentary. In February, industry trade groups petitioned the FDA to indefinitely stay and reconsider the rule.

Is a late season chill on the horizon for Novartis? According to a media report, the South Korean government is considering additional penalties against the company in relation to a kickback case. The government’s Ministry of Food and Drug Safety has already imposed a fine against the company and suspended the sale of some of the company’s products. A source at the Ministry of Health and Wellness said the government was considering lowering the price of the drugs involved in the kickback case. Novartis said the court case was on going, and it wasn’t aware of an “imminent” decision from the Health Ministry.

“New life” is being breathed into the FCPA Pilot Program. At the American Bar Association’s National Institute on White Collar Crime , Acting Assistant Attorney General, Kenneth Blanco said the DOJ will evaluate the Pilot Program and determine what, if any, changes should be made. Until the evaluation is complete, the Pilot Program will remain in force. The Pilot Program, the common name for the DOJ Fraud unit’s guidance on FCPA investigations and prosecutions, was due to expire on April 5. The Pilot Program is intended to encourage individuals and companies to voluntarily self-disclose instances of corruption, and establishes requirements for voluntary self-disclosure, cooperation with investigations, and the resolution of FCPA cases.

The growth in global anticorruption settlements and activity is sure to be a hot topic at the Pharmaceutical Compliance Congress, April 26-28 in Washington, DC. The PharmaCertify™ team will be providing demos our new Compliance Foundations™ module, Global Anticorruption Laws, along with all our new and updated compliance training products, at Booth 10 on the Exhibit Floor.

See you in Washington!

The Forgetting Curve and Compliance Training

 

What exactly does a 167-year-old German scientist have to do with your compliance training? As a chief compliance officer, or training manager, the answer may keep you up at night – especially if you haven’t integrated micro-learning elements continuously into your company’s compliance learning curriculum.

Hermann Ebbinghaus was a German psychologist who is credited with theorizing fundamentals of human learning, including the learning curve, the spacing effect, and the forgetting curve. The Ebbinghaus Forgetting Curve essentially states that what humans remember after a learning event drops steeply soon after completion of that event. His research shows that memory loss continues to increase until it finally flattens around 30-days post event.

 

Steven Just, Ed.D., Chief Learning Officer at Intela Learning, a developer of continuous learning platforms, writes, “What gets stored in our long-term memories is subject to decay (i.e. forgetting)… deep learning occurs when memories are stored in long-term memory and stabilized. This is called memory consolidation.”

Fortunately for those of us seeking to reduce compliance risks across a company, spacing follow up micro-learning components, in smaller chunks, across a learner’s timeline helps flatten that forgetting curve and increase retention. As Dr. Just writes, “Retrieve the memory from long-term memory, bring it into working memory, process it, and then re-store (re-encode) it in long-term memory.”

Micro-learning Tools

Short “sprints” of learning deployed in follow up to foundational compliance training provides that opportunity for the concepts to be “re-stored” in the learner’s long-term memory. Micro-learning can include brief mini modules focused on one topic that you’ve identified as needing reinforcement. If gifts and meals are a high risk for your HCP-facing employees, a scenario-based mini module built around a common situation they face in the field, deployed soon after the comprehensive training, is one method for alleviating their concerns and reinforcing the appropriate behaviors. Mini modules aren’t the only effective tools for flattening the curve though. Short learning nuggets like quizzes and gaming, strategically deployed over time serve to heighten retention as well. As another option, sprint activities and scenario-based mysteries can be delivered in a competitive workshop format to reinforce participants’ understanding of policies and principles. (We call it the Compliance Reality Challenge).

Code of Conduct

Considering the range of topics covered in a typical code of conduct, from workplace violence; to harassment; and gifts and hospitality, a more creative and engaging approach to reinforcing the initial code training is not only a good idea, it’s crucial to improving the learning. One approach we’ve deployed to successful reviews is what we’ve titled Know the Code. Working with the client, we target specific topics within the broader code of conduct to create a “streaming” series, with each 7-minute “episode” built around those topics. Each animated scene in a scenario lasts approximately one minute. A narrator character tells the story and when necessary, directs the learner to take part in on-screen activities, with individual character voices employed to bring life and realism to the scenarios. The episodes are strategically released across a timeframe designed to once again, “re-store the concepts originally covered in the core module into the learners’ long-term memories.”

Keep it Continuous

The bottom line: to make compliance training as effective as possible in terms of reducing risk across the company, the learning nuggets you continuously rollout after the initial event (eLearning module, instructor-led training, etc.) are as important as the initial event itself. PharmaCertify offers the reinforcement tools, instructional expertise and an exciting new system that uses the most widely-accepted algorithm for creating and delivering post-training learning sprints to accomplish that goal. If you’re attending the 14th Annual Pharmaceutical Compliance Congress April 26-28, stop by Booth 10 to see demos of the products and platform, and ask how we can help reduce risk and strengthen the compliance culture in your company.

Thanks for reading and we’ll see you in Washington!

Sean Murphy, Product and Marketing Manager, PharmaCertify™

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!

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