Halloran Consultant, Sam Zappia, presents a webinar in partnership with the Life Science Training Institute on April 7, 2015, when she will teach the course
Halloran Consultant, Sam Zappia, presents a webinar in partnership with the Life Science Training Institute on April 7, 2015, when she will teach the course Got a Date with the FDA? Conducting Successful Meetings.
You’ve sent in a request to the FDA for a meeting, just to find you only have 60 minutes to address your long list of questions. Budgets and timelines suggest your product’s development is both lengthy and costly. How do you know you’re on the right track? With few opportunities to obtain the Agency’s buy-in, you need to get the most you can out of each meeting with the Agency. Whether you are attending a Pre-IND Meeting, an End of Phase 1 Meeting, an End of Phase 2 Meeting or a Pre-BLA/Pre-NDA Meeting, this session will cover key strategies to help you streamline the development of your background materials and conduct an effective meeting with the Agency. It’s your meeting, make the most of it!
This detailed, 90-minute session will help you navigate complex relationship strategies and brainstorm ideas to set you up for success. Topics include:
- How to effectively write and present you background materials including questions to the Agency
- How to effectively respond to Agency comments
After attending this interactive live session you will be able to:
- Apply regulatory strategy to streamline your questions and background material
- Prioritize items to discuss during the 60 minute
- Conduct a successful meeting with the FDA
WHO SHOULD ATTEND
This course will benefit anyone who plans to request or attend a meeting with the FDA Center for Drug Evaluation and Research (CEDR) or the Center for Biologics Evaluation and Research (CEBR). This session is specifically beneficial for sponsors with novel products in discovery and early stages of product development who are looking ahead to next steps.
Time: 1:00-2:30pm EDT
Date: April 7, 2015
Duration: 90 minutes
Price: $299 Introductory Rate
For more information and to register, please click here.
(Tuesday) 10:00 am - 11:30 am