FDAnews Announces — Off-Label Drug Promotion After Amarin: From Settlement to Guidance and Beyond Webinar, Nov. 30, 2015

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The federal court ruling on in Amarin allows the drugmaker to make truthful and not misleading statements on Vascepa. Mark the calendar for Nov. 30, 2015 when Darshan Kulkarni, an expert on strategic regulatory and pharmaceutical counseling, discusses the impact of Amarin on off-label promotion.

Off-Label Drug Promotion After Amarin:
From Settlement to Guidance and Beyond
Nov. 30, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/offlabeldrugpromo

The federal court ruling in Amarin (Amarin Pharma Inc., et. al v. Food and Drug Administration et. al 15-cv-3588 (PEU) (S.D.N.Y. August 7, 2015)) allows the drugmaker to make truthful and not misleading statements on Vascepa.

But the case raises questions about what truthful off-label promotion really means. FDA guidance recommends that manufacturers carefully vet and script advance statements for sales reps about a drug’s off-label use.

Mark the calendar for Nov. 30, 2015 when Darshan Kulkarni — an expert on strategic regulatory and pharmaceutical counseling — discusses the impact of Amarin on off-label promotion. He will cover:

  • When does distributing information become promotion?
  • Six essential dos and don’ts for distributing scientific articles
  • Why the “safe harbor” turned out not to be so safe
  • Five practice scenarios to work through — how to respond
  • How and why off-label rules have evolved from 2008 to the present day
  • Six pivotal court cases and how they’ve shaped the law

Register today and stay on top of the FDA’s latest rules on what speech is and is not protected.

Who Will Benefit:

  • Compliance officers
  • Consultants/service providers
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Sales/marketing personnel
  • Strategic planning and business development staff

Meet the Instructor:
Darshan Kulkarni of the Kulkarni Law Firm is a leading expert on strategic regulatory and pharmaceutical counseling.

With a background in both the law and hands-on healthcare experience (over 10 years as a pharmacist, including participation as a clinician in clinical trials), Mr. Kulkarni is versed in the needs of international device, pharmaceutical and biopharmaceutical companies and their service providers, including contract manufacturing organizations and contract research organizations.

Webinar Details:
Off-Label Drug Promotion After Amarin:
From Settlement to Guidance and Beyond
Nov. 30, 2015 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/offlabeldrugpromo

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/offlabeldrugpromo
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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