Global Regulation Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript

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Global Regulation under Gottlieb-Trump and a Look Ahead

Want to attend the live webinar on Dec. 14? Click here to register.

In Part IV of FDAnews’s Expert Insight Series, our panelists look overseas to evaluate drug and device regulation globally, and 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 four 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 CDs and transcripts of the first three webinars.

You wouldn’t venture into the unknown without a guide. Here are five guides, 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 ...
  • Peter Pitts, top policy adviser to FDA Commissioner McClellan among other FDA leadership positions. While at the FDA Mr. Pitts worked directly with Scott Gottlieb. He now heads the Center for Medicine in the Public Interest ...
  • Marc Scheineson Esq., partner, Alston & Bird LLP. As FDA associate commissioner for legislative affairs, Mr. Scheineson was active on Rx user fees, debarment, medical device amendments and nutrition labeling, among other innovative policies. He has also served as a counsel to the House Ways & Means Committee ...
  • Jill Hartzler Warner Esq., VP of Regulatory Policy, Catalyst Healthcare Consulting. Over 30+ years as an international regulatory policy specialist, Ms. Warner held FDA leadership roles including Associate Commissioner, Senior Advisor, and Associate Chief Counsel. She oversaw policy on orphan products development, combination products, pediatric therapeutics, good clinical practice, regenerative medicine, and advisory committee oversight and management, among other responsibilities ...
  • Dan Kracov Esq., Partner, Arnold & Porter Kaye Scholer LLP. As one of the nation’s foremost FDA legal practitioners, Mr. Kracov is known for expertise in development, approval and marketing of FDA-regulated products — not only drugs and devices but also foods, dietary supplements and cosmetics ...