FDAnews Expert Insight Series
Global Regulation Under Gottlieb-Trump and a Look Ahead

Thursday, Dec. 14, 2017 · 1:30 p.m. - 3:00 p.m. EST

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 five 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. Here are five guides, the savviest hands around concerning drug and device policy and regulation. Take advantage. Pick their brains. Learn from the best. Sign up NOW.

Don’t miss out on the other installment 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.

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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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