FDAnews Expert Insight Series
Pharmaceutical Regulation Under Gottlieb-Trump

Thursday, Nov. 16, 2017 · 1:30 p.m. - 3:00 p.m. EST

In Part III of FDAnews’s Expert Insight Series, our panel takes up drug regulation, policy and enforcement.

It will be 10 months into the Trump administration and the drug regulation picture will be coming clearer. New drug policies will have been established. New Trump-Gottlieb appointees will be assuming office. Many new products will have been approved. And it will be coming clear how fundamental standards for approval will differ from the past.

Perhaps most important, specific policies will be starting to emerge: Product approvals, opioids, drug pricing, and more.

Given the fluid nature of events though, panelists are certain to range beyond the topic of the day. Even if you haven’t participated previously, be certain to take in the final session where panelists look to the shape of things to come — 2018, 2019 and beyond. Multiple registration is a bargain, with special pricing to lower your costs.

Don’t miss out on the other installments in the series:

Available as an audio recording on a flash drive:

Plan to participate in all the sessions. It’s a bargain, with special multiple-session pricing lowering your costs to take in the full series.

Who Will Benefit
  • 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

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24/7 Encore plus Audio Recording/Transcript
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Complete Series Pricing

Plan to participate in all the sessions. It’s a bargain, with special multiple-session pricing lowering your costs to take in the full series.

 

Meet Your Presenters

Wayne Pines

President, Health Care
APCO Worldwide

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

Co-founder and President
Center for Medicine in the Public Interest

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 ...

 
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