FDA Quarterly Briefing–April 2009
In Conjunction with Wiley-Blackwell
April 07 - 07, 2009
90 Minute Accredited Online Training
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This course is available as a client site course. Please click here for more information.
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