Course offering number:0910-702
Course ID:
2268
GO BACK TO BROWSE ONLINE TRAINING COURSES PAGE
FDA Quarterly Briefing–October 2009
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is designed for professionals in the pharmaceutical, device and biologics industries. It will be especially beneficial to:
• Regulatory/QA Managers
• Directors and VPs
• Planning Executives anticipating FDA changes
Description
This quarter's briefing is a careful distillation identifying the three most important new initiatives, regulatory changes and
innovations from the FDA, and places them in context for the pharmaceutical, biological and device professional. This 90-
minute accredited online training is divided into three sections, each section devoted to a new FDA regulation or initiative.
The topics are:
Superdemics and H1N1
• Response and preparation for pandemics,
epidemics, and medical disasters, including H1N1
• Vaccine testing and approval
• Approval of potential therapeutics
Tobacco and Electronic Cigarettes
• FDA regulation of tobacco
• Dangers of electronic (vapor) cigarettes
• Post hoc testing of tobacco products, devices
FDA Transparency Initiative
• New plans under development
• Agency and industry skepticism
• The Government Transparency context
Question and Answer Session