FDAnews Announces — Responding to an OPDP Titled/Untitled Letter Webinar, Jan. 29, 2016

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It’s a changing landscape when it comes to regulating drug promotion. How should a company respond when despite its best efforts it finds itself on the receiving end of a single titled or untitled letter from the Office of Prescription Drug Promotion (OPDP)?

Responding to an OPDP Titled/Untitled Letter
Jan. 29, 2016 — 11:00 a.m. – 13:30 p.m. EST
http://www.fdanews.com/respondingopdpletter

It’s a changing landscape when it comes to regulating drug promotion.

Johnson & Johnson, GSK and Pfizer have faced fines for their promotions and Pacira and Amarin are changing the law in new ways.

How should a company respond when despite its best efforts it finds itself on the receiving end of a single titled or untitled letter from the Office of Prescription Drug Promotion (OPDP)?

Join Darshan Kularni of the Kulkarni Law Firm on Jan. 28 when he breaks down the types of possible enforcement activities and recent trends. Attendees will find out the following:

  •     Should a company always respond to an enforcement action?
  •     What is the time frame for and goal of the response?
  •     What exactly needs to be included in the response and what should be left out?
  •     Who should sign the response?
  •     When does a company need outside help?

Drug promotion rules are growing more complicated. Register today for a detailed breakdown of what a drug promotion warning letter response needs to include.

Meet the Presenter:
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.

Who Will Benefit:

  •     Compliance officers
  •     Consultants/service providers
  •     Executive management
  •     General/corporate counsel
  •     Managers
  •     Personnel new to the industry
  •     Regulatory/legislative affairs professionals
  •     Risk management specialists
  •     Sales/marketing personnel
  •     Strategic planning and business development staff

Webinar Details:
Responding to an OPDP Titled/Untitled Letter
Jan. 29, 2016 — 11:00 a.m. – 13:30 p.m. EST
http://www.fdanews.com/respondingopdpletter

Tuition:
$287 per site

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