Day 3 - Wednesday 17th June - CEST Time Zone
- Steve Weber - Assistant Professor, The Johns Hopkins School of Medicine
- Strategies for navigating diverse regulatory frameworks while ensuring compliance and market access
- Dealing with infrastructure gaps - how to leverage local partnerships and adapting to regional requirements to capitalize on emerging market growth
- IP risk and ensuring protection
- Navigating supply chain turbulence
- Sharing perspectives on cost-reduction
- Ed Woo - Regulatory Consultant, Independent
- Menna Bahr - Regional Regulatory Affairs GCC, Medtronic
- Priscilla Lemes - Regulatory Affairs Specialist - Product Life Cycle EMEACLA, Edwards Lifesciences
- Rene Zoelfl - Senior Director, Global Industry Advisor Life Science, PTC
As global regulatory frameworks rapidly evolve, and disruptive technologies like generative AI reshape how we work, MedTech organizations face increasing complexity in bringing safe, effective innovations to market. Navigating this landscape requires a more strategic, forward-looking approach to regulatory planning.
In this session, we’ll explore how to:
· Think beyond traditional markets by identifying and aligning with country-specific regulations outside of the US and EU, while tailoring requirements to product types and therapeutic areas
· Shift regulatory strategy by embedding global regulatory planning early in the product design phase to accelerate and de-risk worldwide launches
· Harness AI pragmatically to streamline regulatory operations, accelerating requirements gathering, adapting to regulatory and manufacturing changes, and unlocking institutional knowledge to enable faster, more efficient global registration approvals
Join us to discover practical strategies that blend regulatory expertise with emerging technology, helping your organization move faster, stay compliant, and compete globally with confidence.
- Michael King - Senior Director, Product & Strategy (Quality, Regulatory, Safety & Detect), IQVIA
- From complexity to clarity: How to navigate fundamentally different PFAS reporting systems in the EU (restriction-driven) and the US (data-driven)
- Who really reports — and why it matters: Demystifying roles across the value chain and avoiding the biggest compliance pitfalls
- From reporting to strategy: Turning PFAS data into a competitive advantage for substitution, supply chain control, and future-proof compliance
- Chaojun Li - Senior Director, Global Head of Sustainability, WSA
- Outlining key FDA expectations for medical device design and development, focusing on aligning innovation with regulatory requirements.
- Discussing strategies for integrating regulatory considerations early in the design process to streamline approval pathways.
- Practical take-aways for best practices to balancing device functionality, safety, and compliance to meet FDA standards effectively.
- Steve Weber - Assistant Professor, The Johns Hopkins School of Medicine