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Addressing Compliance Risks Across
the Sales Execution Cycle
 

 BEST PRACTICES FORUM

pharma congress  

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Washington, D.C. 


WLH Consulting, Inc.

will be at the:  

Thirteenth Annual Pharmaceutical Regulatory and Compliance Congress
 Find us at Booth #6 in the Exhibit Hall

November 5-7, 2012

Grand Hyatt,
Washington, D.C. 
IN THE NEWS 

Rx for Compliance

May, 2012

Creating a Culture of Compliance with Lessons from NASA and the OIG

 

August, 2011

 
February, 2011
 
Optimizing Sales Performance with Field Based Monitoring
 

October 2010

Cross-Functional Alignment for Compliance Program Improvements  

 

May, 2010

Compliance Program Improvements for Reducing Risks

   

Pharm Rep

Inspect What You Expect:   Field Based monitoring programs can help companies avoid problems before they start

To see additional Compliance Publications from WLH Consulting, Inc. please click here.
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I GLASS Field Based Monitoring Program™

 

This program proactively meets the requirements of recent CIAs for field force monitoring and is a comprehensive solution for training, coaching, monitoring, and reporting compliant field behaviors.

 

Call 954-385-0770 or contact WLH to arrange a live demonstration.

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Government regulators have been aggressively investigating the sales practices of biopharmaceutical companies for several years.  Recently, they have been increasing the scope of their investigations.  For example, in addition to traditional detailing conversations, they are also looking at the non-traditional ways that a company can interact with HCPs (e.g., contracting, managed care relationships), how companies handle requests for medical information, and internal communications.  To proactively mitigate risks, companies need to ensure that all of their sales activites are compliant, not just traditional customer-facing detailing.

 

Sales professional's duties can be classified based on a Cycle of Execution that includes planning, implementation, and follow-up/recalibration.  To proactively mitgate risks, you should monitor sales activities across this cycle.  To maximize sales performance and avoid "sales paralysis," ensure sales professionals know what they can and cannot do across this cycle.

 

Tips and techniques for mitigating risks and maximizing performance are provided for each stage of this cycle:

 

Planning:

  • Identify appropriate targets based on product label and indication
  • Plan activities that are consistent with regulations and guidelines, e.g., HCP / HCO interactions, speaker programs
  • Train on compliant business plan creation and documentation practices
  • Ensure appropriate coordination and information is shared across all internal stakeholders
  • Conduct regular reviews of business plans to provide feedback and enable course corrections

 

Implementation:

  • Monitor all interactions with health care providers and organizations, e.g., payors, P&T committee members, for compliant practices 
  • Understand how to avoid subtle off-label selling behaviors and more nuanced false claims, e.g., targeting inappropriate patient populations or making unsubstantiated claims of economic superiority over other products
  • Use approved sales and marketing materials with appropriate audiences
  • Provide product specific training on behavioral expectations (e.g., what sales professionals can and cannot do) for sales performance
  • Ensure there is a match between sales incentives and compliant behavioral expectations
  • Connect your training and monitoring programs so you "inspect what you expect"
  • Verify the use of good documentation practices for recording field behavior

 

Follow-up/Recalibration:

  • Expand sales managers' monitoring role to include activities across the sales cycle
  • Train managers on proper monitoring, coaching, and feedback procedures
  • Ensure proper recording of coaching and feedback sessions
  • Create closed loop procedures for following up on all potential issues identified through monitoring
  • Record follow-up and resolution reached on all investigations of potential compliance issues
  • Create timely and complete reports on the findings from monitoring efforts and follow-up actions, and ensure distribution to all "certifying officers" of the company

 

Behavior based training, field monitoring, and good documentation practices connect the stages of this cycle together and reinforce a culture of compliance throughout the sales organization.

 

WLH Consulting, Inc. has worked with biopharmaceutical sales organizations on all stages of the Cycle of Execution. Please feel free to contact Dr. Wendy Heckelman to learn more about how to create a compliant cycle of execution for your sales organization. Call 954-385-0770 or email to wendy@wlhconsulting.com.

 

 

Sincerely, 
 
Wendy Heckelman, Ph.D.
WLH Consulting, Inc.
Wendy@wlhconsulting.com 

954-385-0770  

 

 

 

 

 

 

 

 

 

 

WLH Consulting, Inc. has twenty years of experience consulting in the biopharm industry.  We combine this with our expertise in organizational and individual assessment, behavioral-based training, cultural change, and cross-functional alignment to provide recommendations and practical solutions to our compliance and commercial clients.
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