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”
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.
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.
Session I: General Introduction
Session II: Toxicity and Pharmacology
Session III: Considerations for complex drug products
Session IV: Emerging topics with respect to excipients
- Novel Excipients
- Application to biotechnology products
Cancellation and Substitution Policy
Invitation Letters for Visas
Local Area Information
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