COURSE DESCRIPTION

OVERVIEW

Interactions with the Food and Drug Administration (FDA) are extremely important for the success of developing your new drug, biologic or device.  These interactions could include a simple telephone call, a face to face meeting, a teleconference, or written communication.  Regardless of the medium, each is important in establishing a good rapport with FDA, and each has different pitfalls and challenges.

How one approaches the Agency will dictate the success or failure of any desired outcome with FDA.  Equally as important are the people you select to interact with FDA.  Good communication and listening skills are paramount in this endeavor and having the wrong people represent your position is a recipe for disaster.

The course will explore each interaction separately, taking a specific look at important strategies to help you shape and deliver your message.  By attending this course, you will know what to say, what not to say, how to say it, and which communication vehicle will best suit your needs.

LEARNING OBJECTIVES

Key learning objectives include:

1. Practical advice on dealing with FDA – Lessons learned
2. An introduction to FDA interactions:  Where do you start?
3. Developing a positive attitude – Making the Agency “feel good” about communicating with you
4. Utilizing good science to win the day
5. Quality of your submissions to FDA – Ensuring positive outcomes

Additionally, this course will cover some of the following challenges:

1. Submitting the right amount of data
2. Premature vs. complete applications
3. Putting your best foot forward
4. Taking a proactive approach with the Agency
5. Speeding product applications
6. Planning, scheduling and attending FDA meetings and teleconferences
7. Poker – a dangerous game to play
8. Negotiating with FDA
9. Being proactive with FDA
10. Winning at FDA – a win-win situation for industry and the Agency