2019 AER Conference

A Dialogue With FDA

Speaker(s)

• 

  Joanne R. Less, PhD
  

  Director, Office of Good Clinical Practice, US Food and Drug Administration
  
• 

  Diane M. Maloney, JD
  

  Associate Director for Policy, Food and Drug Administration
  
• 

  Kevin A. Prohaska, DO, MPH
  

  Senior Medical Policy Advisor/Bioethics Consultant, Food and Drug Administration
  
• 

  Soma Kalb, PhD
  

  Director, Division of Clinical Science and Quality, Center for Devices and Radiological Health, US Food and Drug Administration
  
• 

  Kavita C. Dada, Pharm, D. RAC
  

  Associate Director for Regulatory Operations , Food and Drug Administration
  
• PM

  Patrick J. McNeilly, PhD
  

  Senior Health Policy Analyst, Food and Drug Administration
  

This interactive session will be an open forum led by a panel of FDA representatives, and who will provide brief updates on FDA activities within their Center/Office. The session will then open up for audience questions. Attendees are encouraged to come with questions of interest to all. During this session, speakers and attendees will:

Learning Objectives:

• Hear from FDA representatives about new and evolving issues, initiatives, regulations, and guidance
• Participate in an open discussion about topics relevant to FDA stakeholders
• Ask questions about evolving issues and initiatives at the FDA