PDA West Coast Chapter: Changes in the Global Excipient Quality and Regulatory Landscape
Registration Options
Individual Registration
Group Registration
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.
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.
Contact
Chapter Inquiries
Membership Services
Standard Pricing
Standard Member Price
FREENon-Member
$25.00
Day 1
- Event Registration Opens
8:00 AM – 8:30 AM
- Continental Breakfast – sponsored by Genentech
8:30 AM – 8:45 AM
- Introduction
9:00 AM – 9:45 AM
- The Impact of Composition and Excipient Variability on QbD and Drug Performance
- China Excipient Regulation Changes since 2015 – Path Forward
9:45 AM - 10:15 AM
- BREAK – sponsored by Millipore Sigma
10:15 AM – 11:00 AM
- Excipients and Biologics
11:00 AM – 11:45 AM
- PDA-IPEC Excipient Risk Assessment Guide & the Developing Nitrosamines Issue
11:45 AM – 1:00 PM
- LUNCH – Sponsored by Genentech
1:00 PM – 2:30 PM
- Millipore Sigma session – Excipient supplier approaches to providing TUPP information
2:30 PM – 3:00 PM
- BREAK – sponsored by Millipore Sigma
3:00 PM – 4:30 PM
- Emerging Excipient Topics: Novel Excipient Qualification Program with FDA – Nigel Langley (BASF) – IPEC-Americas
4:30 PM – 6:00 PM
- Networking Reception – sponsored by Millipore Sigma
PLEASE READ PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.