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

• Update on new OIG Advisory Opinions
• Lessons learned from OIG guidance for effective compliance
• Updated DOJ (guidance March 2023) and OIG guidance – a year and a half on what progress has the industry made?
• How to apply guidance in practice, communicate it to the C-Suite, how do you gain support for initiatives and push for real change using guidance?
• Focus on Compliance incentives and rewards and the use of data analytics

• How to measure the effectiveness of your Compliance program
• Who is best placed to measure Compliance effectiveness?
• Practical steps and processes to identify vulnerabilities and develop a plan to improve
• Evidencing continual growth to your Executives and Board

• What is the actual role of the CCO and other leadership roles in 2024 and beyond?
• How to structure senior roles differently and still operate with authority and independence
• To what extent are the GC and CCO functions being separated?
• Examining the specificities and variances in roles of a GC and CCO: Is Compliance more operational or strategic?
• Typically, as companies grow the GC and CCO function split – what is the threshold for the split?
• What fits into Compliance? Traditional Compliance vs. expanding remit to organizational risk

• How can Compliance functions help Executive leaders and Boards meet their obligations?
• What data to supply and at what level of granularity to help business insight
• Government guidance on expectations of Board members
• Training new board members on Compliance: practice information and guidance to fulfill responsibilities
• How to get cross-functional assurance presentations up to the Board/Executive Committee level

• Examining approach, key focuses, key roles and top challenges
• How do you operationalize 3^rd party engagement and risk management?
• What are the risks: emerging sanctions as part of 3^rd party risks – Russia and Iran, modern slavery and human trafficking
• How do you work together (if at all) with Internal Audit and Enterprise Risk Management and/or Quality?

• Deep dive into how you are truly evaluating entities that you are giving money to
• Managing your reputational risk: practicalities of vetting organizations
• What governance do you have in place to ensure 3^rd parties are free from improper inducement?

• Examining field interactions i.e. Sales, Market Access, Medical Science Liaison, Nurse Educators, Field Reimbursement Manager etc.
• What functions exist? How do they work together? How do you address "fatigue" from Customers who only want one point of contact and remain compliant?
• How are commercial and medical relationships developing? Examining guardrails and blurring boundaries between medical education and sales/promotion
• Developing a cohesive international strategy: what is your approach and how does this work outside the US?
• How do you strike the right balance and still position your company to be aggressive and competitive

• How are organizations managing Compliance surrounding patient advocacy and patient education groups?
• Examining differing approaches on transfer of value in meals, speaker honorarium etc
• Internal guidelines and what are they spending on patients, are they allowing alcohol etc?
• How is this spend tracked, and by whom to make sure you don't pay patients "too much"?
• Is there a cap for overall spend per patient/caregiver?
• How is FMV determined?
• What is the role of the Patient Advocate vs Patient or Caregiver?
• How, if at all, does the analysis change post-approval vs. during research?

A step-by-step illustration of where Compliance can play a role to mitigate risk in engineering of GenAI business solutions

• Understand the development process of GenAI business solutions
• Learn how GenAI engineering can limit compliance risk
• Explore ways to design GenAI controls
• Build your AI capabilities to be a strategic partner to the business

• Nuances for communications for unapproved use of approved products
• What are people doing in the field? What is being allowed to be shared by Medical Science Liaison professionals (MLS) and what practical guardrails can be put into place