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Session 8: Patient Centricity from a Concept to Reality
Session Chair(s)
Maria Cristina Mota Pina, MBA
Head, Regulatory Policy for Emerging Markets -Japan and Australia
AbbVie, United States
In this session we will reflect on different initiatives for patient-focused drug development defined as a systematic approach to help ensure that patient’s and caregiver’s experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development data and evaluation. We will also discuss the possible approaches for the Latin America Region with the example of rare disease regulation from ANVISA.
Learning Objective :
At the completion of this session, participants should be able to:
- Understand the concept of patient-focused drug development and the FDA approach to the concept
- Know some of the approaches and initiatives that are patient-focused such as eLabeling and rare disease regulationst
- Acknowledge that for a successful Patient-Focused Drug Development collaboration between regulators, industry, and patient groups is needed
Speaker(s)
Rare Disease Regulation and Perspectives
Renata De Lima Soares
Anvisa, Brazil
Regulation and Health Surveillance Specialist
Patient Focused Drug Development and the US Food and Drug Administration
Dwight Abouhalkah, MBA, MSC
Johnson and Johnson, United States
Director, Americas Policy Lead
The Digital Evolution of Product Information-ePI
Ronnie Mundair
Pfizer, United Kingdom
Regional Labelling Head - Canada and LATAM - Senior Director