Dorothee Oberdhan

Company: Otsuka

Job title: Director, Patient-Centric Outcomes

Seminars:

Exploring the FDA’s Patient-Focused Drug Development Guidance Series to Ensure More Consistent & Systematic Measuring of Patient Engagement 10:35 am

This workshop will discuss: What the new FDA guidance document is, why it is needed and how it will be implemented Exploring how to navigate initial discussions with the FDA to ensure alignment on data collection methods that meet their expectations and criteria for future evaluations Illuminating the challenges of trying to apply this guidance…Read more

day: Pre-Conference Workshop Day