AAV Gene Therapy; A Road Map to IND Submission

Previously Aired on April 23rd, 2020

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Overview

The webinar will focus upon the common issues which might delay the IND submission or pre-IND interaction with FDA. We will discuss how to design your in-vitro or in-vivo studies timely and effectively to overcome these issues, with a view toward current regulatory guidelines and the expectations of regulatory agencies.

In this webinar you’ll learn:

Common roadblocks & mitigation strategies
Designing studies effectively and efficiently
Compiling the IND package & interactions with FDA

Who should attend?

Scientists, Postdoctoral fellows, PIs (Cell & Molecular Biologist)
Project/Account Managers
Regulatory personnel
CGT start-up aspirants

Presenters

Vibhor Gupta, Ph.D.

(Presenter)
Director of Business Operations, Cell and Gene Therapy
Absorption Systems
View Biography

Mike Auerbach

(Moderator)
Editor-in-Chief,
American Pharmaceutical Review