FDA's New Commissioner under Trump's Administration: The way forward for the FDA

Product Id : FDA101
Instructor : Norma Skolnik
Apr 05, 2018 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes

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Overview

How will the FDA change under the Trump administration and the new FDA Commissioner? This event will explore the implications of the Trump Administration and President Trump's pick of Dr. Scott Gottlieb as new FDA Commissioner and Tom Price as Secretary of Health & Human Services on the future of the FDA. The event will cover Trump's regulatory agenda, his deregulation task force at federal agencies and his proposed budgetary cuts. Trump's new pick for commissioner of the FDA will be discussed in detail as well as his intention to ease drug regulations and streamline the agency and the drug approval process.

Anyone interested in the workings of the FDA and how the agency may be impacted by the Trump administration and the new FDA commissioner could benefit from this presentation.

Learning Objectives:

  • To learn about President Trump's regulatory agenda
  • To understand how the Congressional Review Act may impact the FDA
  • To gain an understanding of Trump's intentions for the drug & device approval process
  • To learn about Tom Price, the new head of Health & Human Services
  • To learn about Dr. Scott Gottlieb, the new FDA Commissioner and how he may influence the FDA

Session Highlights:

  • President Trump's stated goal to overhaul the Food and Drug Administration
  • Trump's intentions to upend and streamline the drug approval process
  • Dr. Scott Gottlieb, Trump's new pick for FDA Commissioner, and his potential influence on FDA What Gottlieb's recent Senate confirmation hearing reveals about his ideas.
  • HHS Head Tom Price and past policies that he's supported: Price's intentions for HHS programs
  • Trump's proposed budget cuts, regulatory restrictions & the FDA
  • Potential risks of deregulation for drugs and other FDA regulated products
  • Industry reactions to Trump's call to cut regulations and streamline the agency

Who Will Benefits:

  • Regulatory Affairs managers
  • Directors & Associates
  • Research & Development managers
  • Compliance Specialists
  • Drug and Food labeling managers
  • Marketing managers
  • Anyone involved in marketing Prescription drugs and OTC drugs, medical devices, biologics or foods in the U.S
Speaker Profile:

Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that, she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Affairs for the Warner-Lambert company.

She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare, as Associate Director of Marketed Product Support for Lederle Laboratories and as Associate Director of Regulatory Affairs for Wyeth.

Norma currently works as a regulatory consultant and also enjoys coaching those who are just starting out in the consulting field


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