Claudia Dollins

Company: GSK

Job title: Vice President, Global Regulatory Affairs, Precision Medicine & Digital Health

Seminars:

Fireside Chat + Round Table Discussion: A Global Perspective on the Interface Between Drug & Device Regulation in Clinical Studies 9:30 am

Significance of global clinical design in device regulatory affairs Discussing strategies for incorporating digital technologies into clinical studies and patient care Addressing challenges in patient selection, monitoring, and data collection when integrating devices into clinical trials Exploring strategies for addressing unmet patient needs through innovative drug-device combinations Expectations from CDx partnerships, with respect to diagnostic…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