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Hyatt Regency Miami

Feb 24, 2020 7:00 AM - Feb 25, 2020 5:45 PM

400 S.E. Second Ave, Miami, FL 33131

Latin America Regulatory Conference

Session 8: Patient Centricity from a Concept to Reality

Session Chair(s)

Maria Cristina  Mota Pina, MBA

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)

Renata De Lima Soares

Rare Disease Regulation and Perspectives

Renata De Lima Soares

Anvisa, Brazil

Regulation and Health Surveillance Specialist

Dwight  Abouhalkah, MBA, MSc

Patient Focused Drug Development and the US Food and Drug Administration

Dwight Abouhalkah, MBA, MSc

Johnson and Johnson, United States

Director, Americas Policy Lead

Ronnie Harprit Mundair

The Digital Evolution of Product Information-ePI

Ronnie Harprit Mundair

Pfizer, United Kingdom

Regional Labelling Head - AfME, Canada and LATAM - Senior Director

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