This two day seminar will provide valuable tips about the logistics, planning, conduct and best practices for all kinds of meetings with the FDA. Throughout the workshop, the author will discuss case studies and examples to highlight the common errors and potential solutions. This workshop contains a collection of practical tips from the instructor’s extensive FDA meeting experience. This one-of-a-kind workshop will provide step-by-step instructions and practical tips to the most productive meeting with FDA for all FDA-regulated organizations.

• Understanding all kinds of FDA meetings for drugs, biologics, medical devices, and all FDA-regulated meetings
• When to and not to do meetings with FDA
• Creating, managing and defending rationale for meetings with FDA
• Requesting process for FDA meetings
• Creating a meeting information package and its regulatory requirements
• Logistics of an FDA Meeting
• Best practices for FDA meeting follow up