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Session 9: 21st Century Communication for Medical Product Development: Getting Better and Better
Session Chair(s)
Cristiana Mayer, DrSc, PhD
Head of Biostatistics
Johnson & Johnson Vision, United States
The 21st Century Cures Discussion Document states that “FDA’s current rules and policies governing what drug and device developers may say about their own products were designed decades ago. Since then, the way that medicine is practiced and delivered and the way that information is communicated have fundamentally changed.” We need to effectively communicate complex, multi-faceted concepts and issues in developing new therapeutics. We need to talk about science, guidance, clinical trial design, regulatory experience, submissions, data standards, and analysis. We need to make the right decisions. We need to know where we are and we need to get better. This is our opportunity!
Learning Objective :
At the conclusion of this session, participants should be able to:
- Become familiar with multiple aspects of scientific and regulatory communication with different audiences involved in drug development
Speaker(s)
Session Co-Chair
Steve Wilson, PhD
FDA, United States
Senior Staff Fellow, OB, OTS, CDER
Panelist
Frank W. Rockhold, PhD, MSc
Duke Clinical Research Institute, Duke University Medical Center, United States
Professor of Biostatistics
Panelist
Vladimir Dragalin, PhD
Janssen R&D, at Johnson & Johnson, United States
Vice President, Scientific Fellow
Panelist
Frank E Harrell, PhD
FDA, United States
Expert Statistical Consultant
Panelist
John Scott, PhD, MA
FDA, United States
Division Director, Office of Biostatistics, CBER
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