Regulatory Reliance: What it is and how to use it to expand to new markets
Venue: Online
Start: Wednesday 22 Jan 2025 16:00
End: Wednesday 22 Jan 2025 17:00
This webinar will provide a clear and concise overview of Regulatory Reliance, highlighting its role in simplifying regulatory pathways, re-using compliance evidence, and accelerating market access to global countries. Participants will learn how reliance enables markets to use existing regulatory conformity assessments, in different jurisdictions, saving time and resources.
Key concepts will be covered in this webinar:
- What is Regulatory Reliance?
- Why is overseas evidence an option for Authorities?
- What are the trends?
- How does the process work?
- Reliance case study
- Manufacturers: Opportunities and Risks
MedBoard and ABHI share a mission to empower and support this industry and its dedicated professionals. Don’t miss this opportunity to learn from industry experts and enhance your knowledge of regulatory strategies for global market success.
Through real-world examples and actionable insights, Ivan and Steve will offer practical steps to leverage reliance for successful global market expansion.
About the Speakers:
Ivan Perez Chamorro is the Founder and CEO of MedBoard, where he leads efforts to empower the healthcare industry with innovative Regulatory Intelligence solutions through Global Data Accessibility and Software Products. With extensive experience across regulatory, development, and strategic roles in start-ups, large manufacturers,
and consultancy, Ivan is dedicated to simplifying complex regulatory landscapes.
Steve Lee brings over 30 years of expertise in IVD regulations, having shaped global standards through his leadership roles, including chairing the EU’s IVD Working Group and serving as Senior Regulatory Manager at MHRA. As Director of Diagnostics and Digital Regulation at ABHI, Steve drives regulatory excellence and compliance strategies. He is also a Fellow of TOPRA and IBMS, engaging with IMDRF and GMTA to influence global policies.
Key Learning Objectives:
- Gain a comprehensive understanding of regulatory reliance in HealthTech.
- Identify benefits and challenges associated with reliance strategies.
- Explore real-world case studies that illustrate successful reliance applications.