COURSE DESCRIPTION

OVERVIEW

An Investigational New Drug (IND) submission is the first major effort in a long line of regulatory product filings to receive FDA marketing approval.  A high-quality IND submission is imperative as this will be your first real impression with FDA, and a substandard effort will stall the process and lead to costly regulatory delays.  It is important to obtain the cooperation of several disciplines either within the organization or outside consultants when writing and assembling an IND, which include staff in non-clinical, clinical, CMC/manufacturing, and regulatory affairs.  These disciplines will play pivotal roles in guaranteeing the submission is complete and on-time for filing.   Most importantly, an understanding of what it takes to assemble the various components of a successful IND – a step-by-step procedure – will give you an opportunity to stand out in the eyes of FDA.

LEARNING OBJECTIVES

This course will enable the you to have an appreciation/understanding of the IND process that includes:

1. Project planning – managing timelines, mitigating risk
2. Work teams – getting the right people working on the right parts of the submission
3. Introduction to FDA interactions – What to say, what not to say
4. Structured review process across disciplines – building organization and accountability
5. Working in an electronic environment

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

1. The pre-IND meeting with FDA (ensuring your initial success with the Agency)
2. Preparing a high quality and comprehensive IND…step-by-step
3. Investigator’s Brochure
4. Clinical Protocol
5. CMC information – how much is enough
6. Pharm/Tox Information
7. Previous Human Experience
8. Versioning and preparing to publish your IND
9. Submitting and Maintaining the IND – keeping the Agency informed