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

• 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?

• 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

• 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

• 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 CCO and GC Summit Exchange and Networking Lunch Hosted by RLDatix* 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

• Getting to grips with the basics: practical questions to be asking the data to get meaningful outputs
• 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?