Archives: Agenda

Streamlining success: navigating preclinical to pre-market pathways for study approval

Navigating the journey from preclinical studies to market approval is a critical and complex process for medical devices. This presentation outlines a streamlined approach to ensure regulatory compliance, efficient development, and timely market access

  • The importance of correct device classification and its impact on regulatory pathways.
  • Strategies to define a comprehensive regulatory roadmap tailored to global requirements.
  • Key preclinical tests to establish safety and performance baselines
  • Insights into aligning preclinical findings with a robust clinical protocol
  • Criteria for selecting the right Notified Body to streamline certification
  • Best practices for creating a well-structured technical file to facilitate regulatory review

Panel discussion: Beyond the Agency: From Oversight to Insight

  • Strategic insights for the incoming CTP Director
  • Experience-based recommendations for improving internal processes
  • Recommendations for industry stakeholders on building and sustaining trust through effective communication with CTP

Moderator: Willie McKinney, Ph.D. Founder & CEO, McKinney Regulatory Science Advisors, LLC

Panelists

Dr. Roxana Weil, Chief Regulatory Science Officer, McKinney Specialty Labs

Gabriel Muñiz, Owner & Principal Consultant, QualReg Solutions LLC

Angela Ho-Chen, Managing Counsel – Regulatory, Reynolds American

Melis Coraggio, Consultant, King & Spalding LLP

David Oliveira, Partner, Scrimshaw Strategies

Safe, Specific, and Sovereign: Rethinking AI for FS

As financial services firms look to integrate AI, questions of sovereignty, specialisation, and ethics have never been more important. Generic, off-the-shelf models struggle with the regulatory, compliance, and risk demands of this industry. This session will explore why sovereign AI, built on domain-specific data, and vertically tailored solutions are critical to ensuring safety, transparency, and trust. We’ll also discuss the role of ethically developed LLMs, like FinLLM, in helping financial institutions embed AI responsibly, avoiding common pitfalls while enabling business teams to capture genuine value.