Jai Pandey

Company: Sanofi

Job title: Global Head of Device Regulatory for In Vitro Diagnostics & Companion Diagnostics, Digital Health

Seminars:

Assessing Challenges in Existing Regulatory Frameworks for Rare Diseases to Facilitate CDx Approval Across Diverse Therapeutic Domains & Navigating the Complex Landscape of Diagnostics in Gene Therapies 9:00 am

What are the critical challenges associated with obtaining patient samples for rare diseases to meet the validation requirements for regulatory approval? Navigating innovative approaches in overcoming evidentiary hurdles specific to rare diseases within the CDx regulatory framework- a shift from oncology, evolving global regulatory landscape, decision on centralized versus point of care testing Analysing the…Read more

day: day 2

Panel Discussion: Overcoming Challenges in a Shifting Regulatory Landscape to Gain CDx Approval Across Diverse Markets 9:30 am

Discussing the dynamic nature of the regulatory landscape and strategies for adapting to changes, ensuring successful CDx approvals across different markets How can we strive towards a unified regulatory framework – where could regulatory bodies collaborate to drive harmonious efforts in CDx regulation? Exploring the advantages and disadvantages of different approaches to CDx regulation Standardization…Read more

day: day 1