A Preview of the 4th Annual Life Science Ethics & Compliance Training Conference

PharmaCertify is a proud sponsor of the 4th Annual Life Science Ethics & Compliance Training Conference scheduled for June 5th and 6th in Chicago. As someone who has spent the last 12 years in the field of life sciences compliance training, I find the focus of this annual conference especially compelling as industry leaders and consultants share ideas, tips, and experiences for reducing risk through innovative training. It’s an exciting and energized group of presenters every year. Below are some of the presentations I find to be of note this year. You can learn more about the conference and download a full agenda at https://www.q1productions.com/compliancetraining/. Contact us about our sponsor discount if you are interested in registering.

Day 1: Wednesday, June 5

Day 1 will be chaired by PharmaCertify’s own Dan O’Connor, and after the opening ice-breaker, the conference begins in earnest with a keynote panel titled, Assessing Risk Tolerance & Company Culture as a Driver for Ethics and Compliance Education. Kudos to the conference organizers for scheduling a great kickoff session. Building an effective compliance training curriculum begins with a thorough risk assessment and I am looking forward to hearing the details of each presenter’s process for “shaping training based on tolerance, and conveying liabilities to ultimately create a culture of compliant and ethical behavior…”

Following the keynote panel, a multi-part session from 10:00 AM to Noon begins with the Legal Interpretation of Enforcement Trends & Areas of Inspection presentation. The talking points on the agenda include the first official reference to the new and trending topic of patient assistance programs. That theme continues later in the day with a case study from Catherine Starks of Sidley Austin, Risk Evaluation & Training Approaches for Compliant Patient Assistance Programs.  With PAPs and PSPs programs being the focus of recent corporate integrity agreements, any discussion of the associated risks and the best practices for conducting compliant programs is worthwhile.

The first session after the lunch break, Developing a Compliance Training Cadence Based on Risk & Needs of Business caught my if for only one word: cadence. The rhythm and pace at which compliance training is launched across a life sciences company is critical to the success of that training. Microlearning is all the rage lately and effective microlearning is more about the frequency and schedule at which training is delivered than it is about the length of the individual learning components. In this session, the presenter will discuss the factors affecting that cadence, including establishing a “cadence to coincide with business agendas and timetables to inform stakeholders at optimal moments.”

Two case studies on the topic of “measuring training effectiveness and risk reduction” are scheduled for the afternoon and I am excited to hear the speakers from Exsurco and Gilead detail their strategies for tracking retention and engagement, and as described in the agenda, “translating the data into actionable strategy.”

Day 2: Thursday, June 6

Day 2 kicks off with one of the more intriguingly-titled sessions from this or any conference: Masterclass: Effectively Maintaining Training Priorities Upon Exiting a Corporate Integrity Agreement. The end of a CIA presents a great opportunity for companies to incorporate the lessons learned during the term of the CIA, when training schedules and the modules were under the demands of the agreement and create a curriculum even more dynamic in terms of scope and levels of engagement. I look forward to hearing Maureen Mason of AstraZeneca discuss her philosophy and suggestions for maintaining the diligence of a strict curriculum while expanding and enhancing the company’s compliance curriculum.

“Cadence” isn’t the only word that jumped off the screen when I initially reviewed the conference agenda. The sessions scheduled after the 10:00 AM coffee and networking break (don’t forget to visit us at the PharmaCertify booth to see demos of our newest training products), Multi-Part Case Study: Contextual Compliance Risk Evaluation in Prioritizing Training caught my eye for the use of one word: contextual. In our 15th year developing compliance training for life sciences, the team at PharmaCertify has worked with compliance departments ranging from an “n of 1”, to those that have a full team of internal resources. And while context does matter, ultimately results are what count no matter the number of resources. In this case, the large corporation perspective will be provided by Abbvie, the mid-sized by a speaker from Convatec, and the “limited resources” perspective by Otsuka.

After the lunch break, two breakout groups are divided by industry, in sessions titled, Compliance Considerations Specific to Pharmaceutical & Medical Device Organizations. I am glad to see the focus on the medical device industry, which too often is not as well represented at conferences. Two speakers from Teleflex will provide the me device experience and their talking points include updates to the AdvaMed Code of Conduct; compliant interactions & “no touch;” and the EU General Data Protection Regulation.

The afternoon of Day 2 includes a session on third-party vendors: Managing Distributor Partner Compliance Training. The intricacies of doing business through third-party vendors hold the potential for increased risks compliance violations. It’s a critical topic and any opportunity to hear tips and suggestions related to training, tracking and managing global vendors is worthwhile and valuable.

Discounted Conference Registration

The 4th Annual Life Science Ethics & Compliance Training Conference is scheduled for June 5-6, in Chicago, Illinois and if you’re interested in hearing industry leaders share their experiences and best practices, there is still time to register. Contact me at smurphy@nxlevelsolutions.com to take advantage of our discount registration rate. I can’t recommend this conference more highly!

Thanks for reading!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

PAPs and PSPs: Training Beyond the In‑Program Staff

Patient Assistance Programs (PAPs) and Patient Support Programs (PSPs) are in the news. The programs are under increased scrutiny for violations of the Anti-Kickback Statute, HIPAA, and False Claims Act. Recent settlements and Corporate Integrity Agreements highlight the need for vigilant and more effective training for these programs.

Nicole Serena Waldron & Associates

With that in mind, we recently sat down with Nicole Serena, Senior Consultant for Waldron & Associates and 25-year industry professional, to discuss her suggestions for how to approach PAP and PSP training to better reduce the risks and the red flags associated with the programs.

A Focus on Customer-Facing Staff

Serena began by highlighting the need to extend training beyond those working directly in the programs to other employees who require a fundamental awareness of how they work, why they are important, and the associated risks. Everyone involved, particularly the sales representatives, MSLs, and nurse educators who interact with healthcare professionals need to be aware of the programs and understand that value.

Serena points out that when a company is launching a specialty or biological product, healthcare professionals will often ask if the company has an assistance program for the product. “Depending on the company and what kind of roles are involved when launching a product,” she says, “sales representatives, MSLs, and nurse educators are all part of the team introducing the program to a clinic and discussing how it supports the patients. They all need to be trained on what they can say, and they need to know they can’t give any incentive for patients to be enrolled.”

According to Serena, when representatives don’t have the proper training and they don’t understand their company’s assistance and support programs, their interactions with HCPs hold the potential for increased risk. “Since they are the first people to hear about problems customers have with a PAP or PSP, representatives need to be careful how they react to that information,” she says, “and since they are responsible for managing the relationship with the HCP, they need to be careful about not over promising.”

In addition, the training shouldn’t assume that employees understand the programs just because they have worked in the pharmaceutical industry. “An employee’s previous position may have been with a division of the company that dealt with a general medicine product, like a high blood pressure pill or antibiotic, which would not involve a PAP or PSP,” says Serena, “so when he or she gets moved into a specialty product role, that background training is critical.”

Extend Training Beyond the Field Force

Vendors are sometimes overlooked for training, particularly when they claim to have their own PAP and PSP training in place. Even if that is the case, rolling out the company training to the vendor’s staff helps ensures consistency in messaging and accountability of trainee rosters. In other words, the vendors need to be trained using the same training the inside employees receive.

According to Serena, “vendor work forces have quite a large turnover in the staff working on the programs, so it can be difficult for them to have enough resources to track training.” The pharmaceutical company needs to take responsibility for that, roll out the company’s own training to the vendors, and track it on company systems.

Since marketing departments are often responsible for funding the programs and developing program materials, marketing staff should be included on the training roster. “All marketing staff need a base level of training,” says Serena, “and those tasked with working in partnership with the in-program team need a deeper level of training.”

In addition, since Medical Information is tasked with answering HCP questions that come in by phone, an awareness on how the programs work is critical for them as well. Add the Finance Department employees to the training list as well. They need to understand the reason for the program, its value to the company, and the justification for why it shouldn’t be eliminated when budgets need to be cut. Finally, don’t overlook the need for PAP and PSP training for the Compliance Department. Compliance is often staffed with professionals from other disciplines across the company and their awareness and familiarity with the programs may be limited.

Although this post delves into the broad scope of employee groups who should be trained on PAPs and PSPs, the list should not be considered complete by any means. Every company’s approach to the programs is different and the structure, frequency, and roster lists for program training will vary.

The stakes are high though and careful planning is needed to help ensure a higher level of compliance across the company. As Serena so succinctly puts it, “everyone in the industry talks about the importance of being patient centric. These programs speak to the value of that focus and the company’s reputation and that must be taken into consideration when planning the training.”

Thanks for reading!

Sean Murphy
PharmaCertify by NXLevel Solutions