FDLI’s Webinar 5-Part Series on
Issues and Implementation of the
Food and Drug Administration Amendments
Act of 2007
Each session to last ~1.5 hours
1:00-2:30 p.m. Eastern Time
FDLI is pleased to announce the first in a series of five Webinars focusing on how FDA has begun implementing key sections of the Food and Drug Administration Amendments Act of 2007 (FDAAA), and the likely impact of the agency's actions. FDAAA includes major revisions to key components of the Food, Drug, and Cosmetic Act, and has the potential to significantly affect how the regulated industries conduct business.
This Webinar series will examine how FDA is interpreting the new law, the immediate and longer-term implications of agency actions, and the likely timing and substance of future actions. It will be a forum for education, discussion, clarification, and a unique opportunity to ask questions of agency officials and experts from industry. On June 17, the series focused on on Clinical Trial Registration. For the second session, on October 27, the topic is The Big 3 of FDA's Postmarket Authority. Future sessions currently planned include:
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The schedule and order of sessions will be determined in consultation with FDA and will reflect those areas where the agency action is most advanced and the impact is most significant. We invite you to take part in each of these interactive 90 minute interactive Webinars. Sign up for the series today.
Who Should Attend?
Attendance for this Webinar is ideal for intermediate and advanced level professionals in government, corporate management, legal, regulatory affairs, marketing, and scientific research and development who work in the pharmaceutical, biological, food and medical device arenas.
Handouts
Handouts will be made available to registrants by website access/email message. This website may contain bills and public documents of legislative history, as well as any PowerPoint slides from the presenters.
Questions can be submitted throughout the webcast and addressed by appropriate speaker
Webinar Equipment Requirements
Minimum requirements to run Conference America’s WebEcho, the service that delivers visual presentations over the web in combination with a standard conference:
Windows 98 / ME / NT / 2000 / XP
Other compatible Operating Systems:
• SPARC Solaris
• Netscape 4.7
• IRIX and HP-UX
• Netscape 4.7
• Red Hat Linux 7.3
• Netscape 4.7
• Mac OSX
• Internet Explorer 5.1
• Netscape 6.2.3
256 MB RAM
JavaScript and cookies enabled in the browser
Java 1.4 Plug-in (www.java.com)
56K or faster Internet connection (DSL+ Recommended)