Changes in the Global Excipient Quality and Regulatory Landscape
South San Francisco, California
8:00am - 6:30pm
IPEC-Americas and the West Coast Chapter of the Parenteral Drug Association (PDA) is offering a 1- day Excipient workshop that will be held at the Genentech facility located in South San Francisco.
The workshop is intended to provide education specifically related to current issues related toexcipients for the respective memberships 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, and a nominal fee 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.
Contact Phone: 6502968044
Contact Email: firstname.lastname@example.org
Genentech [pre-registration online mandatory; no walk-ins]
305 DNA Way
South San Francisco, , CA 94080