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Transforming Regulatory Worries into Success Stories

When:

October 3, 2019 8:00 amOctober 3, 2019 10:00 am (PDT)

Where:

Biocom – McGraw Conference Room
10996 Torreyana Road Suite 200
San Diego, California 92121

Registration Closed

Is your drug product development program keeping you up at night? Sleep easy by learning how to turn potential regulatory nightmares into successful FDA submissions

Drug sponsors work closely with the FDA to bring their products to market. Along the way, there are a number of stumbling blocks that can thwart the development process thereby halting the progression of commercialization of even the most promising blockbuster drugs. While it is imperative to know what the agency requires, it is equally important to understand what can go wrong so that drug product information can be presented in the most comprehensive and complete manner.

We will discuss:
  • Overview and definitions
  • Tips for a successful pre-IND meeting
  • FDA concerns with nonclinical and CMC information and how to avoid a clinical hold during the initial IND
  • Important topics to discuss with FDA at end of phase meetings (nonclinical, clinical, and CMC concerns)
  • Common agency questions resulting in deficiency letters
  • Common agency questions resulting in complete response letters

Speakers:
Andrea Young, Supervisor, Regulatory Compliance, Alcami Corporation
Kristi Miller, PhD, Head of Regulatory Affairs, Regulatory Professionals, A Division of Premier Research



Price of Admission

Biocom Member

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Non-Member (Industry) ONLY

Today’s Price: 30

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Amount

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30

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30

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Registration Closed