Pre-Conference Workshop Day

Tuesday June 24, 2025

8:00 am Check In & Coffee

Workshop A

9:00 am Harmonizing Global Regulatory Strategies to Simplify Medical Device Submissions & Expand Market Reach

  • Joshua Gao Associate Director, Emerging Technologies Regulatory & Quality Lead, Biogen
  • Eleonora Chakraborty Associate Director, Regulatory Affairs, Strategic Global Labeling, Combination Products & Devices, Abbvie
  • Michael Iglesias Associate Director, Quality Assurance, Merck

Synopsis

  • Navigating complex regulatory landscapes across key global markets by discussing advanced strategies for interpreting and applying the regulatory requirements and submission processes for the FDA, EU, Japan, and other regions
  • Harmonizing global submissions by gaining insights into streamlining regulatory submissions across multiple regions, minimizing redundancy, and optimizing time-to-market
  • Managing cross-jurisdictional challenges by exploring common hurdles in managing multi-market regulatory approvals, including varying requirements for clinical trials, risk management, and post-market surveillance, and discovering strategies to overcome these challenges effectively

11:00 am Morning Break

Workshop B

12:00 pm Harnessing AI in Medical Device Software Development: Innovation, Efficiency & Ethical Boundaries

  • Ephrat Most Director, Software Quality Program, Medtronic
  • Adam Heroux Vice President Regulatory and Quality Assurance, Kheiron Medical

Synopsis

  • Explore how AI is currently being integrated into medical device software to improve automation, efficiency, and quality – and where the ethical and regulatory boundaries lie
  • Move beyond high-level guidance with actionable steps for validating AI systems, including incorporating PCCPs to manage model updates effectively
  • Balance innovation and oversight by addressing ethical considerations, regulatory readiness, and the long-term adaptability of AI systems in a changing global landscape
  • Learn how leading teams are building systems and frameworks that ensure AI tools are safe, compliant, and continuously evolving with future standards

2:00 pm Lunch Break & Networking

Workshop C

3:00 pm Building Resilient AI-Cybersecurity Frameworks: Practical Strategies for Development teams Amid Regulatory Gaps

  • Andrew O’Keeffe Executive Director, Global Digital Quality, Olympus
  • Stephen Odaibo Founder, Chief Executive Officer & Software Architect, RETINA-AI Health, Inc

Synopsis

  • How to fit AI development into a traditional secure product development lifecycle
  • Explore how development teams can proactively secure AI-driven medical devices, focusing on unique risks at the intersection of cybersecurity and AI when regulatory guidance is unclear
  • Gain insights into structuring software development workflows to anticipate future cybersecurity and AI compliance requirements, ensuring systems are audit-ready without overengineering
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DAY ONE