This co-Sponsored Excipient Workshop is intended to provide education specifically related to current issues pertaining to excipients for the respective members and regulators; however, non-members are encouraged to attend as well.
There will be no charge for the workshop for IPEC-Americas, PDA Members and Regulators. A nominal fee will apply for non-members.
The program will highlight the following topics:
- The Impact of Composition and Excipient Variability on QbD and Drug Performance
- Chinese Pharmacopeia – Changes and Impact on Excipients
- China Excipient Regulation Changes Since 2015 – Path Forward
- Excipients and Biologics
- PDA-IPEC Technical Report on Risk Assessment and the Developing Nitrosamines Issue
- Excipient supplier approaches to providing TUPP information
- Emerging Excipient Topics such as FDA’s Draft Novel Excipient Qualification Pilot
- Program and Excipient Contamination
It is hoped that this inaugural workshop will become an annual event, providing outreach to the important biopharma industry.