Beyond Compliance: PCCs Implications for Leaders
A compliance leader’s role entails building a transparent and risk-intelligent organization.
This underlying mission was the driving force behind the more than 500 global compliance professionals in the Life Sciences industry who met at CBI’s 13th Annual Pharmaceutical Compliance Congress (PCC) in 2016.
Among the high-profile speakers and panelists, the following four key insights and implications for compliance leaders were addressed — as told from Huron’s perspective:
The Evolving Culture of Compliance
Compliance leaders, across the globe, are evolving their role to become that of a business partner embedded deep within an organization. They are helping build their function’s credibility through demonstrating a deep understanding of the organization’s strategy, as well as explicitly outlining how a compliance function furthers an organization’s mission.
Building Proactive Compliance Programs
Federal regulators are changing the way they view voluntary disclosure of illegal activity. As a result of this shift, compliance programs are moving from being a reactive function, to a proactive one, leveraging recently disclosed settlements as guidance for what a strong compliance program should be.
With a clear governance structure and mission statement in place, compliance programs are now primed to be a more sustainable and flexible function — moving beyond traditional compliance responsibilities to a more empowered function with the ability to provide great insight into the strategic planning process.
Leveraging Analytics as a Compliance Tool
To identify product trends, monitor risk, and inform business decisions, compliance leaders are largely turning to data analytics. But in order to collect and glean actionable data, an overall strategy and roadmap must be developed — requiring up-front input from the business regarding what insights are valuable, as well as a firm realization that not everything can, and should, be monitored with data.
Managing Third Party Risk
For many organizations, third parties continue to be a concern from a risk perspective. As compliance functions continue to build out their risk assessment plans, tactics will likely evolve to monitor these entities, including augmenting contractual language to support transparency between the third party and the organization, performing extensive background checks on an entity, and requiring training and certifications as a requirement for business. A major pain point continues to be driven by the globalization of the life sciences industry and the new liabilities presented when working in progressive and developing nations.
The Changing Role of a Medical Affairs Function
Over the last decade, changing industry standards, enforcement activity, and transparency requirements have heightened the compliance risks associated with many medical affairs activities — yet the role of this function continues to expand as relationships between life sciences companies and external stakeholders grow more complicated. For compliance leaders, maintaining the integrity of this function within an organization continues to raise vital questions and rightful concerns.
Download Huron's PCC presentations below:
Value Determinations: FMV of Investigator Payments
John Moose, Director
Laura Skinner, Director
Government Programs for the Compliance Office: A Focus on Pricing
Chris Cobourn, Managing Director
Emerging Monitoring Tools: Data and Analytics
BJ D'Avella, Senior Director
Brian Conner, Director
You can hear more from Huron on this issue by following @Huron for up-to-date webinars, events, and speaking engagements.Contact Us
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