The FDA Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript

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The FDA Under Gottlieb-Trump and a Look Ahead

In Part IV of FDAnews’s Expert Insight Series, our panelists venture educated guesses concerning the direction of drug and device regulation in 2018 and beyond.

The Trump administration will have been in office nearly a year. Major trends will be taking shape at both the FDA and abroad. Budgets for fiscal 2018 will be in place and regulators will be formulating goals for the year to come. This final session in the Expert Insight series will help you suss out the future, as well as look back on the year that was.

You’ll be busy planning your future too. The forecasts and insights of our experts will be invaluable in shaping your approach to product development, compliance and more. Even if you didn’t participate in prior sessions, be certain to take this one in. If you do find it worthwhile, take a lookback to preceding sessions. Check out special pricing on audio recordings and transcripts of the first three webinars.

You wouldn’t venture into the unknown without a guide. Join some of the savviest hands around concerning drug and device policy and regulation. Take advantage. Pick their brains. Learn from the best.

Other installments include:

  • What We’ve Learned Since Scott Gottlieb Was Confirmed
  • Device Regulation under Gottlieb & Trump
  • Pharmaceutical Regulation under Gottlieb-Trump
  • Executive Suite
  • Planning/Strategy
  • Regulatory Affairs
  • Legal Counsel
  • Marketing/Sales
  • QA/QR/QC
  • Manufacturing – GMP/QSR/GCP
  • Inspections/Audits
  • Clinical Trial Design
  • Data Integrity
  • Postmarket Safety
  • Submissions/Approvals
  • R&D
  • Commercial Operations

Meet Your Presenters

Wayne Pines, chief FDA spokesman for seven years. Mr. Pines was FDA Alumnus of the Year (2004). He now advises FDA-regulated clients on crisis communications ...

Steven Grossman is President of HPS Group, LLC, a consultancy that provides strategic counsel, analysis and advocacy on regulatory and policy issues involving the U.S. Food and Drug Administration and assists companies in resolving regulatory issues associated with product development. Mr. Grossman serves on the Board of Directors of the National Organization for Rare Disorders (NORD) and sits on the board’s executive committee. He is also a founder and deputy executive director of the Alliance for a Stronger FDA, a multi-stakeholder coalition that advocates for increased resources for the FDA.