Course offering number:0904-701
Course ID:
2233
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FDA Quarterly Briefing–April 2009
In Conjunction with Wiley-Blackwell
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:
Module 1: New Administration:
• How will the Obama administration change FDA and
regulation?
• What are Tom Daschel's plans for top level changes in
personnel and philosophy?
• What new policies will emerge?
• What previous strategies will survive?
Module 2: Shake Up in Medical Devices:
• Has the Medical Devices group approved some products
without adequate testing?
• What new 510(k)/PMA requirements will emerge?
• What changes are coming in the approval process?
Module 3: FDA/EMEA Harmonization:
• Risk Based (Q8, Q9, Q10) and Quality by Design new
approaches
• The fundamental philosophical differences between FDA
and EMEA
• Steps backward (and tiny steps forward) toward
harmonization
• How to make dual submissions
Question and Answer Session