Implications of the Trump Administration on the FDA

Event Information
Product Format
Prerecorded Event
Presenter(s)
Length
60 minutes
Product Description

President Trump’s Promise to Streamline FDA, Tom Price, Dr. Scott Gottlieb, and Impacts on Food Safety and Drug Regulations.

Will the Trump administration be a gamé changer for the FDA? President Trump’s promise to overhaul the Food and Drug Administration could create major changes in the regulatory agency. It seems that his focus for now would be to streamline FDA, accelerate drug approvals and encourage manufacture in the United States. With Tom Price being appointed as Secretary of Health & Human Services and Trump picking Dr. Scott Gottlieb to head the FDA, it can have far reaching implications on the Agency’s policies, regulations and enforcement activities.

This webinar by expert speaker Norma Skolnik will put you up-to-speed with the new changes and explore the implications of the Trump Administration on the FDA policies and regulations. It will address Trump’s deregulation task force at federal agencies and the appointment of Tom Price as Secretary of Health & Human Services (HHS) and Dr. Scott Gottlieb as the new commissioner of the FDA. Norma will discuss how the new appointees will impact the future of the FDA, drug regulations, drug approvals and enforcement activities of the Agency.

Norma will also provide a background on Tom Price and Dr. Scott Gottlieb along with references and insights to all relevant FDA laws and regulations.

Session Highlights

  • President Trump’s vow to overhaul the Food & Drug Administration
  • Trump’s deregulation task force for federal agencies
  • Trump’s intentions to upend and streamline the drug approval process
  • HHS Secretary Tom Price and the past policies he has supported, as well as his intentions for HHS programs
  • An analysis of Dr. Scott Gottlieb, Trump’s new pick to head the FDA
  • Potential risks of deregulation for drugs and other FDA regulated products
  • Industry reactions to Trump’s call to cut regulations

Session Agenda:

  • Trump’s regulatory reform plan
  • Trump’s regulatory rollback: Congressional Review Act
  • REINS Act
  • Moratorium on Federal regulations & hiring
  • Budget and regulatory agency cuts
  • FDA law background
  • Regulatory actions
  • Targeting drug prices
  • Tom Price and his goals
  • Tom Price’s influence on policies
  • The 21st Century Cures Act
  • Drug and device approvals
  • Background on Dr. Scott Gottlieb
  • Ethical concerns
  • Compassionate drug use
  • Trump administration and food regulation

Who should attend

  • Regulatory Affairs Managers
  • Directors and Associates
  • Product Safety Managers
  • Compliance Specialists
  • Drug and Food Labeling Managers
  • Marketing Managers
  • Anyone involved in marketing Prescription drugs and OTC drugs, medical devices, or foods in the U.S. (Drug companies, Medical Device, Consumer Healthcare and Biotech firms)

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About Our Speaker

Norma Skolnik - FDA Regulations Expert

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 and...   More Info
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