A Look Ahead: The 2018 Pharmaceutical and Medical Device Compliance Congress!

Look for the “elephant in the Exhibit Hall” at the Pharmaceutical and Medical Device Compliance Congress to see demos of our compliance training solutions!

If you haven’t yet registered for the 19th Annual Pharmaceutical and Medical Device Compliance Congress, there is still time to save $600 on the registration fee with our sponsor discount offer. Contact me at smurphy@nxlevelsolutions.com to ask about the details.

The conference kicks off Wednesday, November 7th at the Mandarin Oriental Hotel in Washington DC, and NXLevel’s PharmaCertify team will be there to catch up with friends and clients and showcase our newest compliance training products. If you’re attending, stop by Booth 108 in the Exhibit Hall (you can’t miss us, we’re right next to the food table and by the bar) to say hello and register for a chance to win an Echo Smart Speaker with Alexa!

You will also see us listening attentively throughout the panel sessions and presentations for the latest compliance best practices and suggestions from what is always an impressive list of industry professionals and government representatives. In addition to the keynotes and plenary sessions, PCF has packed the agenda with 27 different mini summits attendees can choose to attend. With that in my mind, we’ve once again scoured the agenda and highlighted a few of the presentations we’re looking forward to in particular.

Day 1: Wednesday, November 7, 2018

Preconference 1: Patient Support Programs: Risk and Risk Management Best Practices

Right out of the gate, PCF is offering attendees the choice of four compelling preconference sessions from 8:00 AM to 12:00 Noon. This Patient Support Programs session is offered as a “deep dive workshop” with timely talking points that include the most common manifestations or structures of Patient Support Programs (PAPs) and the best practices and approvals of the activities. A quick scan of recent corporate integrity agreements highlights the enforcement focus on PAPs, and kudos to PCF for wasting no time addressing it, with a panel that includes Nereyda Garcia from Alnylam Pharmaceuticals, and Nicole Serena from Bayer.

Keynote: OIG Update

Mary Riordan, Senior Counsel, Office of Counsel to the Inspector General for Office of Inspector General, returns for this highly-anticipated review of recent settlement actions and the OIG’s workplan for the upcoming year. From year to year, the presentation is considered one of the cornerstones of the conference as Ms. Riordan discusses the areas currently on the enforcement radar for her office.

Chief Compliance Officer Roundtable

The conference agenda doesn’t provide any details in terms of what topics the CCOs will cover but based on the level of panelist expertise and the fact that it’s scheduled for one hour and fifteen minutes, the roundtable is sure to provide a bevy of useable, first-hand lessons and advice. Panelists include Jill Fallows-Macaluso from Novo Nordisk, Indrani Lall Franchini from Alexion, Jonathan Kellerman of Allergan, Puja Leekha of Lundbeck, and Lori Queisser of Teva.

Networking Reception

The networking reception is a rare, can’t miss opportunity to meet with your peers face-to-face and exchange tips and ideas for strengthening and growing your compliance program. And don’t forget to visit the vendors while you’re in there. They bring a range of innovation and expertise to the industry… and you don’t want to miss those cool giveaways!

Day 2: Thursday, November 8, 2018

During the first half of Day 2, we hear from the government regulators, investigators, and prosecutors with three different sessions: the Assistant US Attorney Roundtable, FCPA Enforcement Update, and the Qui Tam Roundtable.

FCPA Enforcement Update

In light of the recent FCPA case settlement by Stryker, this session should provide interesting insight into the enforcement trend surrounding the Act. Will more cases surface? Is there a renewed focus on the life sciences industry? With panelists from the FBO, the DOJ, and formerly with the SEC, the conversation should prove to be enlightening and educational.

Mini Summit 1: Fostering a Culture of Ethics and Compliance Beyond Just the Laws and Regulations

The first of seven 11:00 AM mini summits, this session captured my attention for its interesting title. The debate over a rules-based approach to compliance versus a values-based approach is not new to the life sciences industry. I will be curious to hear, particularly from a training perspective, how this panel fosters a culture that emphasizes empowerment to always “make the right decision” while still communicating the need to follow the rules and the laws.

Mini Summit IV: Annual Medical Device Compliance Roundtable

This dedicated medical device session features Jonathan Glazier from Philips North America, Marc Levine of Insightec, Laura O’Donnell from GE Healthcare, and David Ryan of Epizyme discussing the topics unique to the industry. The medical device industry faces some of the same compliance issues as their pharmaceutical brethren, but the nature of the products and business process (e.g., reimbursement) present unique challenges. I am anxious to hear how these presenters address risk and strengthen their compliance cultures while facing those challenges.

Mini Summit VII: Compliance 3.0: Managing Promotional Programs, Relationships with Patient Advocacy Groups and New Entrants into the Marketplace.

That title to this session is a mouthful, but it invokes a promise of a forward-thinking approach to the content. Expect this impressive panel, which includes Terra Buckley of Celgene, Michael Clark of Indivior, and Sujata Dayal of Johnson & Johnson to offer bold suggestions beyond the current thinking for the pressing topics listed in the title.

Mini Summit X: Is Your Board of Directors Bored of Your Compliance Dashboards?

Okay, I admit it, the sessions with the creative names tend to catch and pique my interest. Thinking beyond the clever title though, this afternoon mini summit tackles the tricky subject of the board’s involvement and support of the company’s compliance program. It’s a topic that’s been of focus for regulators

Mini Summit XII: The Fine Line of Promotion with Medical Professionals: Avoiding White Coat Marketing   

Since employees who interact with healthcare professionals face a high level of compliance risk, I will be interested to hear how the panelists, including Pamela Lonzer from Alexion, Margaret Sparks from Sanofi, and Ravi Taylor of Ferring, balance the business need for representatives and others to engage with those HCPs, while instituting safeguards to ensure compliance with company policies and regulations.

Mini Summit XXVII: The Compliance Training Revolution

PharmaCertify had the opportunity to sponsor the 3rd Annual Life Science Compliance Training Conference back in June (you can read our key takeaways here), and I came away from that conference pleased that the industry is clearly developing more innovative training with the intent to optimize the learning and create lasting results. It’s been our focus since we started developing compliance training 12 years ago, and I look forward to hearing more about the techniques the panelists utilize to accomplish that same goal.

Summary

Again, these are just a few of the many sessions PCF is offering at the 19th Annual Pharmaceutical and Medical Device Compliance Congress. We look forward to seeing you there and as always, I welcome your feedback on this preview and our blog in general. If you’re attending the conference, don’t forget to stop by the PharmaCertify booth (#108 in the Exhibit Hall) to say hello.

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

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

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

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

Day One, Thursday, September 13

Prosecutors’ Perspectives Panel

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

Coping Strategies for the Lonely Compliance Officer

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

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

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

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

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

Day Two, Friday, September 14

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

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

Explore the Trends in Drug Pricing Legislation and Other State Initiatives

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

Scale Up Your Compliance Program for Global Operations

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

GDPR is Here – Now What Do We Do?

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

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

Thanks for reading!

10 Tips for Creating Transparency Training That Sticks

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

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

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

Thanks for reading!

Sean Murphy
Editor
Compliance Training Insights Blog

Key Tips for Optimizing Your Speaker Programs Training

Life sciences compliance leaders and regulators seem to agree that speaker programs are fraught with the potential for risk and compliance violations. Industry conferences feature sessions dedicated to the off-label, kickback and false claims risks of speaker programs and the trend toward transparency puts the marketing dollars data out there for anyone to review. With the public and regulatory spotlight shining brightly on speaker programs, the need for updated and effective training has grown exponentially. With that in mind, we present the following list of suggestions to keep in mind when building and deploying your speaker program training.

One training does not fit all.

From speaker evaluation and selection, through program organization and execution, different employees, with varying responsibilities, are involved with speaker programs. Those different roles and responsibilities demand different training requirements. For example, Medical Affairs personnel serve a different role at the speaker programs than their colleagues in the commercial group and in marketing. The core training should be customized with content relevant to each of the groups to make it relevant and maximize the effectiveness.

Integrate real-life situations.

Speaking of relevancy, your speaker programs training needs to extend beyond the reciting of rote concepts and policy. To make the training stick, include the situations the employees are likely to face during the programs. For the commercial team, don’t just tell them the FDA’s rules on product promotion apply to speaker programs, include knowledge checks that feature speakers veering off the approved slide deck to discuss anecdotal, unsubstantiated product claims. The same rules that govern their interactions with healthcare professionals also apply to the speaker’s conduct and in their role as program host, sales representatives need to know how to react when it happens.

The devil is in the details…expected and otherwise.

Don’t stop at the obvious when outlining the topics to be covered in your training. The exceptions can be just as problematic as the rule and should be covered in the training as well. On the attendee front for example, commercial representatives need to understand the rules for government employees from agencies like the Department of Defense and Veterans Administration, and what is acceptable for their participation.

Don’t forget the vendors.

With third-party vendors facilitating so many aspects of speaker programs, the risks extend well beyond your own employees. Vendors need to understand the regulatory environment at a high level, and be familiar with your company’s speaker program policy. Along with topics like venue selection, meal limits, and attendee requirements, make sure the training emphasizes their role in meeting transparency requirements and the importance of delivering relevant program data to the company in a timely fashion.

Make the program training continuous.

Speaker program training should not be a one and done event. Studies show that learners forget up to 80% of what they have learned quickly after the completion of the eLearning module or live training event. To raise retention levels and increase the transfer of the knowledge before and during the programs, follow the introductory learning with continuous nuggets of training. These can take the form of brief assessments, contests, and sprints focused on specific details, delivered across the learners’ timelines.

Speaker programs offer companies the opportunity to provide healthcare professionals with education and training on the safe and on-label use of their products, delivered by one of their peers. Engaging, effective and on-going training on the coordination and execution of those programs lowers the potential for risk and strengthens a company’s compliance culture.

If you are interested in learning more about the online and workshop-based speaker program training solutions available from PharmaCertify, please contact Dan O’Connor at doconnor@nxlevelsolutions.com.

Connie the Compliance Training Specialist Returns!

Welcome to a new edition of “Dear Connie the Compliance Training Specialist,” where we answer questions about life science compliance training concepts and discuss new ideas for making that training more effective.

This week: create a campaign to make it stick!

Dear Connie,

I am a compliance training manager for a mid-sized life sciences company in Pennsylvania and I am worried about our training on interactions with HCPs. We rolled out a new policy last year, and in January I launched comprehensive training on that policy. But based on our monitoring and data from our hotline, employees are still forgetting the key concepts and principles from their training. Connie, where do I go from here?

Signed,

Perplexed in Perkiomen

———————————————————————

Dear Perplexed,

Your challenge is a common one, but there are steps you can take to make the training more memorable. Just this month, at the 3rd Annual Life Science Compliance Training Conference, a number of your peers talked about how they use a campaign approach to make training more effective and make it stick with their learners.

Create a Brand

Develop a brand for the training campaign. Branding works for your company’s products, and it will work for your compliance training. Every time employees interact with your compliance training “brand” they form associations. The images you select reinforce those associations. Make sure your brand communicates the importance of integrity, clearly and consistently. Carry that branding throughout the training and on all communication.

Less is More

I suggest smaller training delivered throughout the year, rather than a longer more cumbersome course once or twice a year. When you take a “less is more” philosophy and keep seat times to no more than 15 minutes per module, you’re likely to see an uptick in retention. Don’t forget to keep the training flowing continuously, and build in follow up assessments, microlearning and contests to reset the forgetting curve that inevitably occurs after they complete the initial module or workshop.

Build the Messaging

The communication plan is critical too. Clear and concise messaging about the importance of the training, needs to be delivered in all three stages: pre-launch, launch, and post-launch. You should seek help from the stakeholders to deliver the messaging (one presenter at the conference said her company refers to these people as “compliance connectors”). The district managers are important in the process. They are the ones talking to the sales representatives on a regular basis, so you need to get them on board and funnel the messaging through them. Remember, communication is an ongoing process, you should constantly refine, adjust, and expand communications as you monitor the results of the training.

I could talk for hours about the need for a campaign approach to life sciences compliance training. I haven’t even touched on the need to solicit and evaluate learner feedback. Fortunately, my friends at PharmaCertify (that’s the life sciences compliance training division of NXLevel Solutions) have years of experience building training plans, and they’d be happy to share more ideas with you. Email my buddy Dan O’Connor at doconnor@nxlevelsolutions.com to see what they’ve done for other life sciences compliance clients.

Thanks for the great question and good luck!

Signed,

Connie the Compliance Training Specialist

11 Key Takeaways from the 3rd Annual Life Science Compliance Training Conference

Last week, we sponsored Q1 Production’s 3rd Annual Life Science Compliance Training Conference, where a highly-energized group of compliance training leaders from the pharmaceutical and medical device industries shared their ideas and techniques for making compliance training more engaging, creative and effective.

Here are my key takeaways from two great days of presentations and spirited conversation:

1. Less is more.
The idea of shorter, higher-impact training was reiterated throughout the conference and was a common theme across the presentations. One presenter said her company now limits all compliance training to 15 minutes and another said her company “hasn’t rolled out training longer than 15 minutes in two years.”

2. Remember the tone from the middle.
While “tone from the top” has been a point of emphasis in the industry for a long time, “tone from the middle” was cited as a key in multiple sessions in Chicago. “The immediate manager has to understand the message,” one presenter said, “that is who the people in the field are going to hear the message from.”

3. Communication is training too.
As one presenter put it, “anytime we can connect with an employee with something they can takeaway, it’s training.” Companies are using a variety of methods to make that connection, ranging from quick reminders via email, to video clips, resource websites, and graphic comic novels. Think outside the box and look for continuous touch points.

4. Tell a good story.
Research shows that well written stories improve learning and increase retention of critical compliance content and policies. The quality of the writing is the key. Once you find a good writer, have him or her create a story arc and develop a narrative. To save on budget in the production, use illustration instead of video. It’s less complex. The quality of the writing is as important, if not more important, than the nature of the medium.

5. Measure the metrics.
Data is important and even the “soft” metrics like feedback from the learners and the managers, testing results, changes in audit data, and increases in hotline reports, are important when identifying what curriculum adjustments are necessary. Data is important, so much so that one presenter noted that she recently hired a “data analytics person” to see what else they can learn.

6. The principles-based approach to compliance is here to stay.
The principles-based approach to compliance was introduced years ago and it has clearly become a trend in the life science industry. Multiple presenters discussed the need to empower personnel with the ability to make decisions, rather than just training on the rules. As one presenter put it, “let them make their decisions about what is the right thing to do, and let them know where to get the answers if they are uncomfortable making the decisions.”

7. GXP compliance training requires a different approach.
This one was a surprise and was raised in response to questions from the audience. Several presenters noted that they are also responsible for GXP compliance training and the nature of the content and the expectations of the learners require a much more traditional approach to training. Essentially, a rules-based approach is much more necessary when dealing with manufacturing compliance.

8. Create a brand.
To quote one presenter, “companies spend millions of dollars branding products, so why not brand compliance training?” Branding gives you more opportunities to creatively communicate the key concepts and messaging. Brand the policies and the principles to create a coordinated and clear message.

9. One size does not fit all.
When developing compliance training, keep the learner’s application of the content in mind. In other words, make it relevant to the learners. Use scenarios that reflect risks they are likely to encounter. As one presenter stated, “training needs to be risk-based, and you need to train on the topics that are core to your business.”

10. Relationships count.
Getting stakeholder buy in on the training at every stage (development/delivery/completion) is critical. Don’t just focus on the proverbial seat at the table with upper management, develop relationships across the company, and seek feedback from the business groups, sales managers, and sales training.

11. And finally, beware of the speaker programs!
When evaluating risks, make those speaker programs a priority.

Kudos to Q1 productions, the presenters, and everyone involved in the 3rd Annual Life Science Compliance Training Conference. From the opening audience ice-breaker, to the closing session, it was one of the most informative, focused, and engaging conferences I have attended in ten years of working in life science compliance.

I look forward to next year’s conference and I highly recommend it to anyone interested in sharing ideas and hearing what others in the industry are doing to make their curricula more engaging and more effective.

Thanks for reading!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

The 3rd Annual Life Science Compliance Training Conference: A Preview

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The 3rd Annual Life Science Compliance Training Conference opens Wednesday, June 6, 2018  at the Hilton Garden Inn in Chicago. The PharmaCertify team will be there to catch up with clients and colleagues, and share demos of our newest compliance training solutions. I also always welcome the opportunity to hear from those who are directly responsible for building and maintaining a modern and effective compliance curriculum. It’s always an enlightening experience. Here are a few presentations I am looking forward to in particular:

Day One

Structure and Delivery of Compliance Content for Executive Level

After opening remarks from PharmaCertify’s own Dan O’Connor, who is chairing Day One, the conference begins with this compelling panel presentation. Recent enforcement headlines, and an increasing number of presentations by regulators at large compliance congresses, highlight the importance of training C-Suite executives in compliance. But what topics are most critical and what tools are most effective? I am anxious to hear what delivery and engagement tools the presenter’s company uses to help support and encourage a strong “tone from the top” as part of the effort to build a stronger compliance culture throughout the organization.

Adapting Compliance Training Methods and Materials Based on Evaluated Risk
Gary Mendelsohn, Astellas

Data is trending for good reason. The data gained through extensive auditing and monitoring is an important tool for evaluating whether compliance training methods and content need to be modified to better address organizational risks. This is a timely topic as life sciences companies continue to look to the data for answers on how to better target their training.

Alignment of Compliance Training with Current Areas of Inspection
Kelly Tope, Zimmer Biomet

A medical device perspective on compliance training is always welcome in compliance conferences. While dealing with some of the same challenges of their pharmaceutical counterparts, medical device professionals face unique challenges due to the nature of their HCP interactions and reimbursement arrangements. This session should provide helpful information for both sides of the life sciences fence, as common and industry-specific settlements are reviewed for training topic relevance.

Case Study: Providing Employees Access to Performance and Development Resources
Jackie Bauer and Stacey Leonard, Abbvie

When evaluating a compliance conference agenda, my eyes are always drawn to the words, “case study.” Attendees are there to hear what techniques, programs, and tools work for their peers and case studies offer the best framework for doing so. With the phrase “continuous learning” in this session description, my interest is piqued even more by the potential for learning what tools and materials the presenter deploys on a regular basis to enhance learning and increase retention of key content.

Day Two

Panel: Building Employee Accountability to Support Compliance Training
Kim Ingham, Merck, Sharon Delgado, Orexigen Therapeutics Inc., Susan Novak, Celgene

Industry professionals have been espousing the importance of a “culture of compliance” for about as long as compliance has been a focus for the life sciences. By contrast, a “culture of accountability” is a term I have not seen applied to the compliance space, and at first glance opens the door for exciting possibilities. This session promises “varied perspectives on how to build and engage staff in heightened levels of accountability,” and I am excited to hear what strategies the presenters utilize to encourage accountability across each of their three companies.

Advanced Adult-Learning Practices for Heightened Engagement in Compliance Training
Abby Talanca, Johnson & Johnson

As compliance training tools have advanced, on-going research into adult learning practices has led to the utilization of more effective development methods and delivery mechanisms to enhance learning. Based on the agenda description for this presentation, I will be curious to hear exactly how the Johnson & Johnson compliance team integrates modern methods like continuous learning into their curriculum to increase retention and maximize on-the-job application of the knowledge gained through the training.

Train the Trainer Workshop: Increasing Connection & Retention in Compliance Training
Mona Kay Gorman, Valeritas

Compliance training curriculums are often developed with an understandable focus on internal stakeholders and with a lack of attention paid to the internal trainers – those responsible for delivering the training. Mona Kay Gorman brings extensive experience delivering engaging live compliance training, and hearing her suggestions for how to improve the skills of trainers so workshops and courses are more engaging and effective should prove valuable and worthwhile.

Proactive Approach to Analyzing Compliance Data for Preventative Training
Kevin Ryan, Novo Nordisk

Extending the topic data analysis to the second day, the description for this session promises a review of the data sources available to compliance teams, and how to use that data once its collected to conduct gap analysis studies, and identify trends and potential compliance risks. Data collection and analysis offers forward-thinking compliance training professionals a critical tool for identifying trends and potential risks, then using that information to target training and segmenting trainee groups more accurately. It’s an important and timely presentation.

Next Stop: Chicago

The agenda for the 3rd Annual Compliance Training Conference offers a great lineup of industry professionals sharing the latest in training best practices, suggestions, and tips. If you’re attending, stop by the PharmaCertify booth in between sessions to see demos of our newest compliance training solutions. If you can’t attend this year, watch for my blog post with conference highlights right here on the Compliance Training Insights Blog shortly after we return.

Thanks for reading!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions