Agenda for Day Two - Friday September 18th, 2026Friday, September 18, 2026

Pharmacovigilance teams can't afford to miss a reportable signal, but manually reviewing every patient interaction isn't realistic. In this session, Andrew Larty of Authenticx will walk through how AI-driven conversation intelligence is automating safety event detection, agent acknowledgment verification, and structured data extraction across 100% of voice and chat interactions today. He'll also walk through the likely future of PV automation, including possibilities like MedDRA pre-coding, auto-drafted clinical narratives, and direct regulatory submission.

• Learn all about automation within Compliance programs and the emerging risk areas that follow
• Glean new ideas on where to focus and consolidate resources
• Evaluate current team capabilities against future skill requirements
• How can you best maintain an agile program?

• Best practices for identifying and mitigating Compliance risks when engaging third-party vendors and partners
• Effective monitoring strategies that extend beyond initial due diligence and onboarding
• Examine the benefits and challenges of ongoing monitoring approaches versus point-in-time assessments to optimize your third-party risk management program
• Enterprise risk management – do compliance teams have that responsibility?

• Updates from the DOJ and OIG on free testing- are there implications for diagnostic testing as a whole? What are the anti-kickback risks?
• Analyze implications of recent OIG opinion on one-time genetic test or treatment approval
• What is the current relationship status between diagnostics and labs as a result?
• Inducement risk beyond free testing – copay assistance, patient support and value-added services
• Safe harbor protections and exceptions – when do free testing programs qualify for regulatory protection?

• Explore new go-to market strategies and how to best maintain existing guardrails
• How are commercial and medical relationships evolving?
• Delineate the differences between medical education and sales/promotion and discuss best practices moving forward

• Examining the ongoing debate between federal and state privacy laws and their implications
• Regulatory, privacy and promotional risks raised with the applications of digital therapeutics, wearables, companion apps and RWE collection
• Explore the intersections between telemedicine and privacy
• Addressing the California Consumer Privacy Act (CCPA) and its interplay with sector-specific federal regulations (i.e. HIPAA) - how this impacts the creation of harmonized compliance frameworks

• Trace the transformation of patient advocacy functions from pure philanthropy to strategic partnerships – understanding the Compliance implications of this shift
• Fair market value considerations, testimonial restrictions, and guardrails for patient advocacy
• Learn essential strategies for maintaining clear separation between patient advocacy funding and commercial/promotional activities
• Examining the roles between Patient Advocate v. Patient or Caregiver

• Practical ways to incorporate Adult Learning Principles into your training program
• Explore outside the box ideas to develop engaging training modules– where can I implement AI?
• Novel approaches to promote retention of materials

• Hear enforcement and programmatic implications for patient‑facing and diagnostic initiatives, covering Patient Speaker/Patient Ambassador programs, free testing and inducement risks (copay assistance, value‑added services), and recent DOJ/FDA/OIG/OPDP enforcement trends with compliance guardrails
• Discover recent legislative and regulatory developments impacting the biopharmaceutical industry such as drug pricing, reimbursement and access, including launch and PDUFA readiness and funding/pre-launch considerations