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WLH Consulting, Inc. and DMH BioPharm Advisors, LLC are working together to bring the I GLASS Method™ to the biopharm industry.  

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Please read more about making improvements to compliance program effectiveness in the
 
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 Also read our article on the The Changing Pharmaceutical Sales Landscape
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To our clients and colleagues,

WLH Consulting, Inc. is excited about our e-newsletter, designed to share best practices related to compliance issues affecting the life sciences industry.  We are leveraging our twenty years of experience in the biopharm industry, plus expertise in organizational and individual assessment, behavioral-based training, cultural change, and cross-functional alignment to provide compliance information and practical solutions to compliance and commercial colleagues.    

Our first newsletter addresses compliance issues affecting the pharmaceutical sales field force and provides recommendations for improving your compliance program and reducing future risks.
Tips for Improving Your Compliance Program
Government investigations and prosecutions targeting biopharmaceutical sales and marketing practices for violations of federal and state laws continue to focus on both the company and its Boards of Directors, Senior Leaders, and Managers.  The prosecutions have resulted in large fines, reputational damages, and restrictive Corporate Integrity Agreements (CIAs).
CIA requirements and statements from Department of Justice prosecutors provide a picture of what is missing from existing compliance efforts and leave companies and individuals at risk. Missing elements include:
  • Black Hole for I GLASSA gap between written compliance policies and compliant conduct in the field
  • Inadequate monitoring of field conduct for potential violations
  • Inadequate reporting or ability to respond to allegations or evidence of compliance violations
The following improvements to compliance training, monitoring, and reporting efforts can help reduce future risks:

  • To reduce the gap between policy and conduct, compliance training programs need to shift their focus from knowledge transfer to behavior change.  There needs to be a clear definition of compliant behavioral standards with behavioral skill training and reinforced coaching in the field.
  • To improve monitoring efforts, a field-based behavioral monitoring program needs to provide an accurate picture of behavior in the field and enable appropriate corrective action if standards are not being met.
  • To improve responsiveness, real time reporting should be combined with procedures to identify behavioral trends and areas of risk, and procedures to investigate and act on all reports of potential compliance issues.
Creating an interconnected cycle between policy, training, monitoring, and reporting demonstrates to external auditors a commitment to effective compliance implementation and may reduce punitive measures imposed for future violations.
  
We look forward to providing you regular updates on the fast-paced compliance environment.

Feel free to contact WLH Consulting, Inc. for specific information on best practices and lessons learned for pharmaceutical leaders, compliance officers, and trainers.  
 
Sincerely, 
 
Wendy Heckelman, Ph.D.
WLH Consulting, Inc.
Wendy@wlhconsulting.com
954-385-0770
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