Overcoming challenges in gene therapy IND-submissions

April 23rd, 2020 • 11 a.m. PST, 2 p.m. EST

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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

Presenter
Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review
Presenter
Vibhor Gupta, Ph.D.
(Presenter)
Director of Business Operations, Cell and Gene Therapy
Absorption Systems
View Biography