Life sciences compliance professionals representing 175 companies recently came to Washington, D.C., for the 2018 CBI Pharmaceutical Compliance Congress (PCC). Jim Massey, global vice president of sustainability engagement and strategy at AstraZeneca, helped kick off the conference with a familiar theme in healthcare: change. Massey pointed to “megatrends” at the political, social, organizational, and individual levels that have radically impacted life sciences companies. Increased connectivity, for example, has led to previously unimaginable power of the individual patient’s voice — influencing everything from patient access and pricing scrutiny to patient-focused drug development.
Just as the healthcare landscape is evolving, so too are the expectations of company compliance departments — both internally in the business and from external stakeholders. People are looking to organizations to provide ethical leadership, Massey said, and compliance is on the front lines.
Compliance leaders at the conference stressed that the compliance function should no longer be solely focused on monitoring and controls, but on being trusted advisors to the business. Compliance professionals need to immerse themselves in their organization, engage early on to understand their business partners’ needs, and help guide the business to achieve goals in a compliant and ethical manner.
Useful advice for earning (and keeping) a seat at the table and demonstrating value included:
In addition to providing a forum for fellow compliance professionals to share learnings, the PCC gave attendees an opportunity to hear government representatives discuss enforcement trends and compliance expectations. Valuable insights from the government panels include: