FDAnews Announces — FDAnews Expert Insight Series: What We’ve Learned Since Scott Gottlieb Was Confirmed Webinar, Sept. 14, 2017

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It’s Scott Gottlieb’s FDA now, to take where he will. 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.

FDAnews Expert Insight Series:
What We’ve Learned Since Scott Gottlieb Was Confirmed
**An FDAnews Webinar**
Sept. 14, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/whatwevelearned        

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 manufacturers, there’s one burning question: How will they 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, 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.

Starting Thursday, Sept. 14, with a big-picture overview and continuing once each month through December, the panel tackles policy questions from macro to micro as they arise.

Attendees will discover:

  •     What the Trump-Gottlieb FDA is likely to continue, 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 manufacturers prepare, based on Dr. Gottlieb’s record and regulatory inclinations as well as unfolding events...

Here’s the schedule:

  •     Thursday, Sept. 14: What We’ve Learned Since Scott Gottlieb Was Confirmed
  •     Thursday, Oct. 12: Device Regulation Under Gottlieb & Trump
  •     Thursday, Nov. 16: Pharmaceutical Regulation Under Gottlieb-Trump
  •     Thursday, Dec. 14: Global Regulation Under Gottlieb-Trump and a Look Ahead

Do not miss this special series. As an FDA-regulated health sciences firm anticipating the agency’s direction is vital to 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 Details:
FDAnews Expert Insight Series:
What We’ve Learned Since Scott Gottlieb Was Confirmed
**An FDAnews Webinar**
Sept. 14, 2017 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/whatwevelearned        

Tuition:
Attend 1 session: $287 per site
Attend 4 sessions: $487 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/whatwevelearned                                                                                        
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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