FDAnews Expert Insight Series

Drug and device pricing. Expedited new product approvals. Off-label communications. Drug and device development. Enforcement priorities. Opioid policy and enforcement. And much ... much ... more.

It’s Scott Gottlieb’s FDA now, to take where he will. For you, there’s one burning question:

How will YOU fare?

Here’s how to find out — in advance.

Register now for an extraordinary series of FDAnews webinars featuring an all-star panel — five of the most insightful FDA experts at work today — as they track the path of the Gottlieb FDA in real time:

  • Wayne Pines
  • Peter Pitts
  • Marc Scheineson Esq.
  • Jill Hartzler Warner Esq.
  • Dan Kracov Esq.

Here’s the schedule. Click on individual dates for details:

Because these webinars take place in real time though, panelists are likely to go beyond the topic of the day. Special multiple-session pricing makes it economical to take part in the entire series.

Whatever you do, do not miss this special series. As an FDA-regulated health sciences firm anticipating the agency’s direction is vital to your success going forward.

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

Webinar plus Audio Recording/Transcript
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Webinar only
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24/7 Encore plus Audio Recording/Transcript
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24/7 Encore Presentation
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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.

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.

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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