ADVOCATE. CONNECT. INNOVATE.

Changes in the Global Excipient Quality and Regulatory Landscape

South San Francisco, California

3/4/2020

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.

Click Here for More Information

Contact: Fabio
Contact Phone: 6502968044
Contact Email: demartinofab@gmail.com

Event Address:

Genentech [pre-registration online mandatory; no walk-ins]

305 DNA Way

Building 24

South San Francisco, , CA 94080