New Webinar from Pharmaceutical Education Associates: FDAAA 2007 Expansion of Clinical Trial Registration and Clinical Trial Results Posting Requirements: Complying with new FDA regulations regarding clinical trial registration and results posting
Tuesday, December 12, 2007, 1:00 p.m. ET
On September 27, 2007, the President signed into law the Food and DrugAdministration Amendments Act of 2007 (FDAAA). Title VIII of the FDAAA rewrites section 402(j) of the Public Health Service Act (PHSA) to include an expanded clinical trial registry data bank and a clinical trial results data bank.
Join this interactive, online event and interact with clinical trial experts! Learn how these legislative amendments affect your company and ask questions directly to a senior representative from Clinical Trials.gov.
Specific topics include:
* A layman’s review of FDAAA 2007’s revisions to Title VIII
* ClinicalTrials.gov requirements and implementation
* How to respond to FDAAA 2007’s preemption language
In just 90 minutes and without having to leave your office, you will gain the knowledge necessary to ensure compliance with the new FDA regulations.
Presenters:
Tracy Beck, PhD, Associate Medical Business Operations Consultant, Clinical Trial Registry Results
ELI LILLY
Rebecca Williams, PharmD, Assistant Director, ClinicalTrials.gov
NATIONAL LIBRARY OF MEDICINE
Pamela Rose, RN, FNP, ASQ-CMQOE, Director, Clinical Trial Information Registries
TAP PHARMACEUTICAL PRODUCTS INC.
Who Should Attend:
Senior management at pharmaceutical and biotech companies with responsibilities in the following areas: Registries, Medical Information, Clinical Research, Clinical Trials, Publications, Clinical Trial Information, Counsel, Clinical Affairs, Clinical Communications/ Marketing, Clinical Operations, Clinical Science, Information Management, Outcomes Research, Regulatory Affairs
This webinar will also interest technology vendors who implement registries and databases.
Prerequisites: Basic understanding of clinical trial registration and results posting requirements.
Advanced Preparation: General knowledge of the changes brought forth by FDAAA 2007.
Course Level: Intermediate
Learning Objectives:
* To understand the latest developments in Clinical Trial Registration and Clinical Trial Results Registry Database legislation and how to achieve compliance.
Individual price: $395
Site License: $1995
Webinar Code: WP173
For more information or to register, please visit the Pharmaceutical Education Associates website.
