How does USP name pharmaceutical excipients? ?Who determines what is “right”? Do you really know what is on your label? Questions surrounding nomenclature of pharmaceutical excipients can have far-reaching effects in drug formulation development, manufacturing and distribution, including setting specifications for identification, assays and impurities, as well as labeling requirements and overall drug safety. Non-U.S. perspectives are also important in addressing nomenclature issues, which can equally impact international manufacturing, quality and supply chain sites.
At this workshop, USP will provide a unique opportunity for formulators, innovators, quality and regulatory affairs professionals from generic, innovative and OTC drug product and excipient manufacturers to understand and provide input to FDA and USP on procedures and issues surrounding the official nomenclature of pharmaceutical excipients.
You are invited to join us at USP to share your questions, concerns and perspectives during this impactful, interactive event. Topics planned for USP’s comprehensive all-day workshop in Rockville, MD include:
- Introduction to G-SRS (UNII code), their purpose and role in naming pharmaceutical excipients
- How are decisions made for naming excipients?
- When is grade important for pharmaceutical excipient naming?
- Relationship, roles, and alignment among G-SRS (UNII code), FDA CDER IID and USP in determining excipient naming
- Identification of stakeholder challenges with excipient nomenclature – open discussion
- Case studies identifying current challenges and opportunities with naming excipients?
- G-SRS – Global Substance Registration System?
- IID – Inactive Ingredient Database
Workshop Registration Information
Advance registration will be available through Monday, August 6, 2018 at 12:00pm, Eastern. After that date, registration will be available on site at the USP Meetings Center.?If you would like to register as a Virtual Participant after the cut-off date, please contact us via e-mail at [email protected].
Registration is payable by credit card only. Registration fee includes the one-day program, meeting materials, coffee breaks and lunches. Registration fees for this workshop have been set as follows:
|Participant Type||Regular Fee Per Person
(1-2 individuals from the same organization)
(3 or more individuals from the same organization*)
A WebEx link will be sent prior to the event
*All attendees must register at the same time to receive the discount
Cancellation and Substitution Policy
Cancellation must be received on or before July 17, 2018 (21 days prior to the event) via email to [email protected]. 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 [email protected].
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 protected] or +1 301-816-8130.
Hotel & Travel Information
Please note that the headquarter hotel for this workshop is the Cambria?Rockville. Daily Shuttle service will be provided between USP and the Cambria?only.
For information on additional local hotels, please click here.
Please note that transportation?will not be offered from any hotel except the Cambria.