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08-Oct-2018

FDAnews Announces The CDER Reorganization: What It Means for Drugmakers Webinar, Oct. 18, 2018

FDAnews Announces The CDER Reorganization: What It Means for Drugmakers Webinar, Oct. 18, 2018 What does the CDER is reorganization mean for drugmakers? Here's how to prepare now.

PR Newswire

FALLS CHURCH, Va., Oct. 8, 2018

FALLS CHURCH, Va., Oct. 8, 2018 /PRNewswire-PRWeb/ -- The CDER Reorganization: What It Means for Drugmakers
**An FDAnews Webinar**
Oct. 18, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/cderreorganization

Drug, biologics and combination product makers with new drug approvals (NDA) in the pipeline are bracing for fallout from the planned reorganization of CDER, the Center for Drug Evaluation and Research.

Discover how a reorganized Office of New Drugs could affect drugmakers.

Mark the calendar for a deep dive into the CDER reorganization. The guide is Ricki A. Chase, formerly an FDA investigator, specialist, manager and Director in the Office of Regulatory Affairs (ORA) and now a consultant helping drug, biologics and combo-product makers work with and get more from the FDA. Over the course of 90-minutes, Ms. Chase will cover:

  •     Why a reorganization? Why now? How the Office of New Drugs is organized now, how it will change, how drugmakers view the changes
  •     Day-to-day impact: Specific changes expected to the Office of New Drugs and how they'll impact what drugmakers do every day
  •     Is there an upside here? What the FDA says is the goal of restructuring, and opportunities and challenges that could result
  •     NDAs: The specific impact on new drug application reviews
  •     Drug product quality and compliance: How the restructuring may affect these critical CDER and FDA functions, and others beside
  •     And much more

The CDER reorganization will hit NDAs first and hardest.

Meet the Presenter:
Ricki A. Chase, a former FDA investigator, specialist, manager and director in the Office of Regulatory Affairs (ORA), is a Director in the Compliance Practice of Lachman Consultant Services Inc. advising Big Pharma clients on successful FDA interactions. Her FDA experience combines with her private-sector perspective for unique insights into agency operations and considerations.

Who Will Benefit:
Drug, biologic and combination product makers with current or pending NDAs. Target attendees include but aren't limited to:

  •     C-Suite
  •     Quality executives
  •     Regulatory/compliance
  •     Manufacturing/operations
  •     Design engineers

Webinar Details:
The CDER Reorganization: What It Means for Drugmakers
**An FDAnews Webinar**
Oct. 18, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/cderreorganization

Tuition:
$287 per site

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

 

SOURCE FDANEWS

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Last Updated: 08-Oct-2018