Drugs

FDA and USP Workshop on Standards for Pharmaceutical Products-Critical Importance of Excipients in Product Development – Why Excipients are Important Now and In the Future

February 27-28, 2017

Location:
Rockville, MD

Overview:
A discussion of how the quality and variability of excipients currently impact medicines and how they are expected to impact new technologies such as Continuous Manufacturing and Novel Delivery systems.

Objectives:
After this workshop, participants will be able to:

  • Develop strategy on excipients selection for complex drug products
  • Understand FDA’s position on Q1/Q2/Q3 in terms of risk assessment for product quality and clinical performance
  • Recognize and understand importance of excipient selection suitable to the drug product and process

Who Should Participate:
Both brand and generic drug industries as well as excipient makers and suppliers, formulators, regulators, analytical chemists, manufacturers and clinical pharmacologists, toxicologists, project management staff.

Registration:
Please visit USP’s websitedisclaimer icon to register to attend the workshop.
 

Contact:

Pallavi Nithyanandan
Pallavi.Nithyanandan@fda.hhs.gov

Page Last Updated: 01/25/2017
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