Pharma companies with aspirations to study and launch a new product must seek and gain approval from FDA prior to initiating phase 1 study of their Investigational New Drug (IND). The planning and preparations prior to these meetings are immense, as FDA looks for specific criteria indicating due diligence in the design and execution of safety studies, data tracking as well as how results are compiled, mined and presented for FDA consideration.
Learn how to strategize and prioritize the steps to preparations for an FDA Pre-IND meeting from EAS pharma experts who have had successful careers in both industry and FDA.
In this course you will:
- Learn the structure and goals of pre-IND meetings
- Prepare your company’s checklist for required documentation
- Anticipate FDA’s questions for better preparation
- Understand “best practices” for navigating and communicating with FDA throughout the Pre-IND process