Bethesda North Marriott Hotel and Conference Center5701 Marinelli Rd., Rockville, MD 20852onFRIDAY DECEMBER 7th, 8:30 to 10:30 a.m.
For emerging biotech companies, the importance of the Pre-IND Meeting cannot be overstated. This meeting is the first encounter with FDA. The difference between a mediocre and a great Pre-IND Meeting is measured in years of time and millions of dollars in development. We have conducted hundreds of successful Pre-IND Meetings on behalf of our clients.
Join us for breakfast on Friday, December 7th as we discuss the ways to optimize your time with the Agency.
Our discussion will include:
Key elements of a successful meeting
What you need to have in place before considering a Pre-IND Meeting
Logistics, timing, & regulatory requirements
Preparing a Meeting Request Letter
What makes a great Briefing Document
How to prepare for the meeting
Who should attend the meeting as well as attendee roles & responsibilities
Pre-IND Meeting formats & their implications
How to present ideas & answer questions at the meeting
Communicating with the FDA after the meeting
Presentation and Discussion by:
EVP, Head of Regulatory Consulting
Meet and greet with our senior staff following the presentation, including: