Day One: Monday, June 2, 2025Monday, 2 June 2025 - ET (Eastern Time, GMT-05:00)

• Discuss the increasing importance of ethics in today's complex and dynamic healthcare landscape as a driver of organizational success, examining the impact of emerging technologies, globalization, and stakeholder expectations
• Explore essential skills and capabilities for compliance professionals in navigating complex ethical dilemmas, and strategies for developing this crucial skillset
• Discuss strategic approaches to fostering a culture of ethical conduct across your organization, including in leadership development, employee engagement, and the integration of ethical considerations into all business decisions

• Review the new framework and gain insights on timelines and compliance requirements
• Understand critical changes that pharma and device manufacturers must adapt to in order to maintain compliance
• Hear strategies to streamline processes while ensuring risk mitigation and operational impacts

Hear directly from the Competition Bureau on updates to the Competition Act and implications for the pharmaceutical and MedTech industry.

• Stay ahead of the curve as EU and US guidelines evolve to ensure global 12:20-12:50 alignment and operational success
• US governance and regulatory updates
  • Update on recent OIG guidance
  • Review relevant DOJ enforcement and potential impact for Canadian affiliates
• Stay aligned with latest codes and guidelines from EMA, IFPMA, MedTech Europe and AdvaMed

• Explore critical guardrails for engaging with patient organizations, focusing on maintaining regulatory adherence, ensuring transparency and independence, and mitigating potential conflicts of interest
• Develop a robust governance framework for managing these interactions, including defining clear policies and procedures, establishing appropriate internal controls, and implementing effective monitoring and reporting mechanisms
• Examine key risk areas such as data collection and privacy and potential conflicts of interest, and discuss strategies for mitigating risk and building ethical and sustainable relationships with patient organizations

• Analyze the evolution of Patient Support Programs in Canada and assess the increasing compliance risks associated with these shifts
• Discuss pressing compliance challenges related to Patient Support Programs, including risks in commercialization, patient privacy, and third-party oversight
• Hear case studies and develop a deep understanding of best practices for conducting internal audits and investigations related to patient support program activities, including data analysis and risk assessment

• Examine critical guardrails for engagement with key opinion leaders and healthcare providers in the promotion of products
• Learn best practices for internal communication between commercial and medical/scientific affairs functions in product promotion to mitigate risk

• Define acceptable timelines for engagement, permissibility of different promotional activities, and eligible individuals for leading or attending these activities (such as Advisory Boards, Learning Programs, Disease State Discussions/Campaigns, and PSPs)
• Explore common practical questions Pharma and MedTech are facing regarding pre-launch activities in the lead-up to commercialization