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Tuesday, June 21 • 4:15pm - 5:15pm
#275: How to Interact with Regulators to Qualify a Digital Mobility Outcome?

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-588-L04-P ; CME 1.00; RN 1.00

Through stakeholder engagement, the MOBILISE-D consortium has established the roadmap for the implementation of new tools to monitor patient disability and enable cost-effective access to optimal mobility management through personalized healthcare.

Learning Objectives

Describe the challenges faced to develop and qualify digital endpoints; Demonstrate that real-world digital mobility outcomes can successfully predict relevant clinical outcomes and help deliver innovative medicines; Identify the strategy and methodology used to overcome the challenges and the different stakeholders’ expectations.

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Panelist
Anja Schiel, PhD

How to Interact with Regulators to Qualify Digital Outcomes?
Cécile Mathilde Ollivier, MS

Panelist
David Nobbs, PhD



Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchise. Over the past 20 years, moving from the French Medicines Agency/EMA... Read More →
DN

David Nobbs

Digital Biomarker Technology and Science Lead, F. Hoffmann-La Roche Ltd, Switzerland
I am currently Digital Biomarker Technology and Science Lead at Roche, leading the development and validation of digital endpoints for drug development. My cross-functional team has successfully developed and deployed digital health technology solutions in seven clinical trials to... Read More →
avatar for Cécile Ollivier

Cécile Ollivier

Director - Regulatory Science Europe, Critical Path Institute (C-Path), Netherlands
Senior health engineer with 15 years of global drug development experience in children & rare diseases. Cecile joined C-Path as scientific director, prior to C-Path, she was with a medtech company for 2 years and scientific officer in the Paediatric division of Science & Innovation... Read More →
avatar for Anja Schiel

Anja Schiel

Special Advisor, Lead Methodologist; Leader international HTA (iHTA) NoMA, Norwegian Medicines Agency (NoMA), Norway
Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc before starting at the Norwegian Medicines Agency (NoMA) in 2012. At NoMA she is working as... Read More →


Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 185 CD McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Forum |   12: Value-Access, Forum