Day 1Monday, 28 April 2025 - ET (Eastern Time, GMT-05:00)

• Given that fewer high-profile CIAs and fines exist, do you see functional leadership / the Executive Committee’s attitude changing towards Compliance and, if so, how are you managing that change?
• What do Compliance teams have to put in place today to withstand future scrutiny of regulators?
• How can Compliance leaders ensure they are in better shape to address future challenges and improve resilience to adverse events?
• What is the remit for Compliance: where should and where shouldn’t Compliance be involved in a business?
• Strategies for embracing the expanding remit of Compliance while also maintaining focus on core Compliance competencies
  • Differentiating “Legal Compliance” risks from “Quality Compliance” risks when the CCO oversees QA
  • Identifying employee matters that can/should be handled by Compliance versus those that should be handled by HR
  • Sharing business insights with Commercial while respecting their independent business judgment
• How, if at all, has Loper Bright changed your Compliance program or your personal approach?

The panel will address how Legal and Compliance Departments should be considering compliance with federal guidance and regulation in the wake of the Supreme Court’s Loper Bright decision and the changes being affected by the Trump Administration. The panel’s perspectives will be drawn from a group with diverse expertise relating to (1) DOJ and OIG regulation and enforcement, (2) FDA regulation, guidance, and enforcement, and (3) federal appellate legal cases challenging federal agencies.

• Opportunities for (bio)pharmaceutical and medical device companies to challenge rulemaking through federal agencies
• Practical compliance implication of Loper Bright Enterprises v. Raimondo
• Legal opportunities to challenge Medicare Price Negotiation Under the Inflation Reduction Act (IRA)
• Risks and potential challenges to changing Lab Developed Testing (LDT) rules

• Key components of DOJ self-disclosure and whistleblower programs
• How will DOJ’s new whistleblower program fill the gaps with existing programs?
• Are there any ‘grey zones’ between self-disclosure and whistleblower programs for organizations to navigate?
• Practical monitoring activities that companies can do that provide investigators with assurances that the company’s Compliance and control environment is adequately designed and implemented

• Hear directly from U.S. Attorneys on the most recent CIA’s and an analysis of settlement trends
• What is currently being closely looked at by investigators?
• What methods, analysis, and data are being utilized during investigations?

The CCO and GC Summit Exchange and Networking Lunch* provides world-class thought leadership and is designed to deliver high-quality information that C-suite leaders can develop into an action plan. Collaborate with your distinguished colleagues to gain valuable insights through an interactive and engaging working group. Attendees must be a CCO, VP, or GC and currently employed by a life sciences manufacturer. *By invitation only

• Establish a foundation of Compliance using the seven elements of a Compliance framework
• Examining the three foundational questions in the DOJ Evaluation of Effective Compliance Programs
• Managing risk: what is your Compliance philosophy in response to risk?

• How do you take a codified framework and put it into action?
• Reality of operationalizing your Compliance program: resources needed for implementation, realities of monitoring and auditing, pragmatic approaches to new trends and risks

• Where should we be using analytics to enhance effectiveness?
• What are you doing to measure Compliance effectiveness and analytics of risk?
• Leveraging data: how are departments leveraging data in their Compliance programs?

• Strategies and tactics on what should be monitored and how
• Practical monitoring activities: in-person, document reviews, and big data
• Role of data analytics in monitoring programs
• Advancing monitoring activities across the business: is it possible to reframe monitoring to business insight gathering?
• Meeting OIG guidance: utilizing CIAs as roadmaps to deliver holistic monitoring programs
• How can audit and monitoring work together in partnership?