“Ensuring Successful FDA Meetings”
Wednesday, June 20, 2012
12 p.m. (EDT) | 9 a.m. (PDT) | 5 p.m. (GMT)
FDA meetings, regardless of when they occur — from pre-IND, to End-of-Phase 2, to pre-NDA meetings — can make or break your chances of bringing your product to final approval. Ensuring successful meetings is therefore a key part of your overall product development plan. Please join:
Joel Falk, EVP of Product Regulation & Compliance, and Lauren Wind, Senior Consultant, as they discuss key tactics, such as:
• Assuring your submissions provide compelling support to your goals for the meeting
• Structuring your questions to maximize unambiguous responses
• Preparing for the actual meeting — the “Tiger Team”
• Deciding whether to commit or not to commit
• How to best utilize the participants on your side of the table
As well as other methods to increase your success with the FDA.
This complimentary, one-hour webinar is designed to help life science executives understand how to maximize success when meeting with FDA regulators.
To join the webinar, please register here. Upon receipt of registration, a dial-in number and log-in information will be sent.