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
Registration is payable by credit card only. Registration fee includes the full two-day program, meeting materials, coffee breaks and lunches. Registration fees for this workshop have been set as follows:
Please contact USP directly at firstname.lastname@example.org to register
Government Rate: Complimentary
Academia Rate: $595.00
Non-Government Industry Rate $695.00
When registering colleagues (not yourself), please create your own Access Point account and then check the “I am registering others – not myself” box at the top of the registration form. If you are registering multiple people, please select “add additional registrants” on the final page of the registration form (before submitting payment).
Advance Registration Deadline
Advance registration will be available through February 23, 2017. After that date, registration will be available on site at the USP Meetings Center.
Please note that registering for a USP event requires an Access Point account. Please follow the instructions after clicking the "Register" button.
Cancellation and Substitution Policy
Cancellation must be received on or before February 6, 2017 (21 days prior to the event) via email to email@example.com. Refunds will not be issued for cancellations received after this date. There is a $50.00 processing fee on all cancellations. However, it is permissible to send a substitute registrant from your same organization. Substitutions must be submitted in writing via email to firstname.lastname@example.org.
Invitation Letters for Visas
USP cannot provide an invitation letter to potential workshop attendees; however, once you are registered, USP will provide a registration confirmation that may be utilized to obtain a visa.
Please contact email@example.com or +1 301-816-8130.
12601 Twinbrook Parkway
Rockville, MD 20852
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