AZBioPEERS: Regulatory Science Series: Part 1

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Date(s) - 17 Jan 2023
8:00 AM - 9:00 AM


Regulatory Science Series: Part 1

Tuesday, January 17, 2023   08:00 – 09:00 AM

Location:  Virtual via Zoom

Featured Speaker:

Director Of Business Development at Cardinal Health Regulatory Sciences

Drug Development:  US Regulatory Overview and Guidelines

This presentation will provide a brief overview of the drug development process and address the regulatory requirements for drug manufacturers throughout each phase of drug development. 

Ø  What is required by the FDA?

Ø  What are the timelines for submitting regulatory documents and receiving approval?

Ø  How much are the regulatory costs?

Ø  What pitfalls can be avoided?