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 website--]){kind=small}
to register to attend the workshop.
Contact:
Pallavi Nithyanandan
Pallavi.Nithyanandan@fda.hhs.gov