New FDA Commissioner - Online FDA Symposium available free of Charge

When the new US President Biden took office, the previous FDA Commissioner Stephen M. Hahn resigned from his position.

President Biden has now nominated Dr. Robert Califf, an expert in clinical trials (Dr Califf is founding director of the Duke Clinical Research Institute and currently a professor of medicine at Duke University School of Medicine). He brings nearly four decades of experience as a physician, researcher, executive, and public servant, and has previously served as an FDA Commissioner (2016-2017). Source: White House Statement.

Currently, Janet Woodcock is the FDA's Acting Commissioner. As part of her job, she has initiated many projects that have had a direct impact for the GMP area. Most notable is a project in the GMP environment that she initiated while still Director of the FDA Center for Drug Evaluation and Research. The 2002 Pharmaceutical Quality for the 21st Century Initiative is considered a milestone in the renewal of GMP requirements and their interpretation. Pharmaceutical quality and innovation is a theme that continues to drive them today.

Just recently, the video recordings of the Pharmaceutical Quality Symposium - chaired by Dr. Woodcock were posted online (October 26 - 27, 2021).

The ttop topics of the symposium - which are now available online - include:

  • Regulation of Pharmaceutical Quality in the U.S.
  • Policy Updates on Pharmaceutical Quality
  • FDA's Facility Oversight
  • Quality Surveillance Dashboard (QSD)
  • Quality-Related Compliance Updates and Innovations
  • Quality Management Maturity (QMM)
  • Control of Nitrosamine Impurities in Human Drugs

To take a look at the presentations, please visit Pharmaceutical Quality Symposium 2021: Innovations in a Changing World.

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