This interactive two-day course will cover all types of FDA meetings, reasons and requirements. It will help you to prepare an FDA meeting request in accordance with recent FDA proposed guidelines.
Communicating with FDA to determine as much a possible about their expectations regarding product submissions, clinical study design, and other regulatory requirements is a challenge for every regulated business, but critical for drug and device firms. FDA has recently formalized this meeting process and this course will help prepare you to handle the new FDA requirements for meetings, and conduct successful meetings.
How will this benefit your company? FDA meetings can be a critical factor in the timeliness of FDA review and approval. It allows the firm to pose critical questions for FDA and gain more understanding of FDA expectations. In addition, a face to face meeting allows the firm to establish an identity with FDA reviewers that can greatly assist future communications.
What can happen if you are not familiar with FDA meeting reasons and requirements? You may not meet with FDA when a meeting is prudent and necessary or even worse, meet with FDA and have the meeting go badly because you were not properly prepared.