SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

Phamaceutical Quality Symposium 2019 Header Banner

Regulatory Education for Industry (REdI):
Pharmaceutical Quality Symposium
October 16 & 17, 2019

Agenda

PDF Download
Event Agenda

The agenda is subject to change. Updated versions will be linked here as they become available.
The current version is 8, uploaded on October 9, 2019.

Files, Certificate & Recordings

Session Recordings:

Day One:

  • Keynote from the Center for Drug Evaluation and Research (CDER): Patrizia Cavazzoni
    View Recording

  • Keynote from the Office of Pharmaceutical Quality (OPQ): Michael Kopcha
    View Recording

  • The Quality Assessment of Different Application Types: Lawrence Yu
    View Recording

  • Application Manufacturing Assessment: Mahesh Ramanadham
    View Recording

  • Policy Initiatives for Pharmaceutical Quality: Ashley Boam
    View Recording

  • Panel Questions and Discussion
    View Recording

  • How Does FDA Execute Preapproval and Postapproval Inspections?: Rakhi Shah
    View Recording

  • Integration of Assessment and Inspection: Small Molecule Case Studies: Allison Aldridge
    View Recording

  • Integration of Assessment and Inspection: Biological Products Case Studies: Candace Gomez-Broughton
    View Recording

  • Panel Questions and Discussion
    View Recording

  • The Future of FDA’s Quality Assessment and Knowledge Management: Geoffrey Wu
    View Recording

  • Postapproval Change Management: ICH Q12 and Established Conditions: Bhagwant Rege
    View Recording

  • Panel Questions and Discussion
    View Recording

  • Pharmaceutical Quality Surveillance Program: Lucinda (Cindy) Buhse
    View Recording

  • Quality-Related Enforcement Actions and Trends: Francis Godwin
    View Recording

  • The Importance of Quality Metrics and Quality Culture: Tara Gooen
    View Recording

  • Panel Questions and Discussion
    View Recording

Day Two:

  • Interacting with CDER’s Emerging Technology Program: Sau (Larry) Lee
    View Recording

  • Policy Considerations for Continuous Manufacturing: Rapti Madurawe & Tara Gooen
    View Recording

  • Continuous Manufacturing of Drug Product: Case Studies: Arwa El Hagrasy
    View Recording

  • Continuous Manufacturing of Drug Substance: Case Studies: Vani Mathur Richards
    View Recording

  • Panel Questions and Discussion
    View Recording

  • Emerging Technologies for Biologics: Multi-Attribute Method: Sarah Rogstad
    View Recording

  • FDA Research Supporting Emerging Technologies with Case Studies: Thomas O’Connor
    View Recording

  • Extramural Research Supporting Emerging Technologies: Salvatore Mascia
    View Recording

  • Panel Questions and Discussion
    View Recording

  • FDA’s Biosimilars Program: Leila Hann
    View Recording

  • Biosimilars Manufacturing Issues with Case Studies: Rachel Novak
    View Recording

  • Data Quality Expectations for Biosimilars with Case Studies: Merry Christie
    View Recording

  • Panel Questions and Discussion
    View Recording

  • The “Deemed to be a License” Provision of the BPCI Act: Janice Weiner
    View Recording

  • Quality Considerations for “Deemed to be a License” Applications: Leslie Rivera Rosado
    View Recording

  • Panel Questions and Closing Remarks for Mike Kopcha
    View Recording
Questions & More Information

Questions?

Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at [email protected].

More Information

If you have questions regarding the content of the event or other CDER-specific information, please: