What We’ve Learned Since Scott Gottlieb Was Confirmed - Webinar Recording/Transcript

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What We’ve Learned Since Scott Gottlieb Was Confirmed

FDA’s new Commissioner, Dr. Scott Gottlieb, isn’t letting grass grow beneath his feet. With a new occupant in the White House and a new philosophy in Congress, change is in the air. And this is only the beginning.

FDAnews has assembled a standout panel — five top experts, four of them ex-FDAers — to bring their insights to bear on how the Gottlieb FDA will impact your products and programs. In this first-of-four installments, expect a glimpse of:

  • What the Trump-Gottlieb FDA is likely to continue and what will likely change...
  • What’s going on behind closed doors — unannounced priorities Gottlieb & Co. can be expected to cook up...
  • Guidances, regulation, enforcement: What lies ahead...
  • Specific, practical guidance to help you prepare, based on Dr. Gottlieb’s record and regulatory inclinations as well as unfolding events...
  • How to plan now to achieve your goals for 2017, 2018 and beyond...

Plan to tune in once a month every month through December to learn more as events unfold in real time. Other installments include:

  • Device Regulation under Gottlieb & Trump
  • Pharmaceutical Regulation under Gottlieb-Trump
  • Global Regulation under Gottlieb-Trump and a Look Ahead

Given the fluid nature of events though, panelists are sure to range beyond the topic of the day.

  • 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 ...