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PDA West Coast Chapter: Changes in the Global Excipient Quality and Regulatory Landscape

Mar 04 - Mar 04, 2020
South San Francisco, CA

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Overview

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.

Agenda

    • 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

Travel

Genentech

305 DNA Way, Building 24
South San Francisco, CA

Directions

Registration Fees

Regular Price
Registration Type Price By March 4th
PDA Member FREE
Government & Regulators  FREE
Non-Member $25.00

*Mandatory pre-registration is required. No-Walk-ins allowed at event location. No refunds allowed but substitutes are welcomed.





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