Agenda for Day 1 - Thursday September 17th, 2026Thursday, September 17, 2026

• Insight into what is top of mind for Chief Compliance Officers (CCOs)
• Examine priorities when it comes to building your own compliance program
• Executive insight into building the next generation of compliance
• CCOs’ perspectives on the big questions everyone is asking: “What is coming down the pike? And what should we be looking out for as a compliance program?”

• Examine recent investigations from the DOJ and their implications
• What are the methods, analysis and data being utilized during investigations?
• Insight into DOJ’s enforcement and crackdown on “Fraud, Waste & Abuse”

• Expert legal insight into the current enforcement landscape
• Latest updates from the FDA and the OIG
• Analyze trends and themes from the receipt of Untitled Letters from OPDP and determine the practical considerations and consequences
• Glean vital next steps to update your Compliance program to withstand future scrutiny

• Implication of the increased scrutiny from the FDA with DTC advertising
• An overview of the intersections between DTC, telehealth and TrumpRx
• What does the future of the promotional landscape look like with continued focus in this area?
• How will these shifts impact compliance for the foreseeable future
• What is off-label promotion these days?

FDA and the life sciences industry are navigating a period of rapid change driven by evolving technologies, new therapeutic modalities, and increasingly complex stakeholder communications. Hear directly from former and current FDA officials as they discuss the agency's current enforcement priorities, emerging compliance expectations, and key areas of regulatory risk. Panelists will share practical insights on common compliance pitfalls, lessons learned from recent enforcement actions, and strategies for building agile compliance programs that support innovation while maintaining regulatory integrity.

• Learn how to best prepare your program to move beyond U.S. approvals
• Gain insight into key differences between the U.S and European compliance process
• Hear how to establish compliance standards across varied geographies – develop a core program with regional flexibility

• Share best practices to embed compliance into the fabric of your culture
• Practical approaches to foster transparency and help your employees feel comfortable when highlighting ethical concerns

• Current AI initiatives in Compliance – benefits, challenges, and lessons learnt
• Examining pros, cons and best practice for moving toward automation and quality data
• The path forward - exciting possibilities and key risks to consider
• How can AI be used for audit, investigation and training preparations?
• Leveraging cross-departmental collaboration through AI

• The evolving interactions between commercial teams and patients
• Practical Compliance considerations for Patient Speaker and Patient Ambassador Programs
• Practical guardrails to help unblur the lines between medical, commercial and patient engagement

• New product launches 101: key essentials for success
• Examine launch, inspection and PDUFA readiness initiatives
• Learn about funding considerations in the pre-launch environment
• Practical dos and don’ts to avoid common trip points