Rauha Tulkki-Wilke

Company: DEEP Measures

Job title: Chief Product Officer

Seminars:

Streamlining Digital Health Assessments: Enhancing Usability, Reducing Burden & Navigating Regulatory Pathways from Validation to Approval 8:00 am

With rapid advancements in the sensitivity of digital health technologies, now is more crucial than ever to ensure device usability and reduced burden on patients, while navigating regulatory requirements for biomarker qualification. Workshop highlights include: Exploring standardization and validation of clinical biomarker measures to qualify decentralized trial requirements Strategizing on how we can best equip…Read more

day: Pre-Conference Day

Interactive Breakout Session: Considerations for Regulatory Acceptance of DHT-Derived Endpoints 3:00 pm

Splitting into breakout groups to solve scenario-based challenges, leveraging diverse cross-functional expertise of stakeholders in the room, presenting back and learning from the experience and approach of each working group. Discussion Questions include: What is the advantage of qualifying vs validating digital endpoint measures for individual drug development programs? What would be the best strategy…Read more

day: Day One

Utilizing a Structured Evidence Model for Regulatory Acceptance of Digital Measures: Learnings from Real-Life Pilots 2:30 pm

Overviewing what defines a structured evidence model Reviewing use cases of structured evidence model in the different stages of a life cycle: including development, validation and acceptance of digital measures and solutions Exploring real life learnings from the regulatory pilot with the EMARead more

day: Day One