Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium – Oct. 16-17, 2019
| Session Recordings | Speakers |
|---|---|
| Keynote: CDER’s Commitment to Pharmaceutical Quality | Patrizia Cavazzoni Deputy Center Director for Operations CDER |
| The Importance of Quality in Our Medicines | Michael Kopcha Director Office of Pharmaceutical Quality (OPQ) | CDER |
| Quality Assessment of BLAs, NDAs, and ANDAs | Lawrence Yu Deputy Director OPQ | CDER |
| Application Manufacturing Assessment | Mahesh Ramanadham Office of Process and Facilities (OPF) OPQ | CDER |
| Policy Initiatives for Pharmaceutical Quality | Ashley Boam Director Office of Policy for Pharmaceutical Quality (OPPQ) OPQ | CDER |
| Panel Questions and Discussion | Lawrence Yu, Mahesh Ramanadham, Ashley Boam |
| How Does FDA Execute Pre- and Post-approval Inspections? | Rakhi Shah OPF | OPQ | CDER |
| Small Molecule Case Studies | Allison Aldridge OPF | OPQ | CDER |
| Integration of Assessment and Inspection for Biological Products | Candace Gomez-Broughton OPF | OPQ | CDER |
| Panel Questions and Discussion | Rakhi Shah, Allison Aldridge, Candace Gomez-Broughton |
| FDA’s Quality Assessment and Knowledge Management - KASA | Geoffrey Wu Office of Lifecycle Drug Products (OLDP) OPQ | CDER |
| Change Management: ICH Q12 and Established Conditions | Bhagwant Rege OLDP | OPQ | CDER |
| Panel Questions and Discussion | Geoffrey Wu, Bhagwant Rege |
| Pharmaceutical Quality Surveillance Program | Lucinda (Cindy) Buhse Director Office of Surveillance (OS) OPQ | CDER |
| Quality-Related Compliance Actions and Trends | Francis Godwin Director Office of Manufacturing Quality (OMQ) Office of Compliance (OC) | CDER |
| Quality Metrics, Quality Culture, and Data-Driven Decisions | Tara Gooen OPPQ | OPQ | CDER |
| Panel Questions and Discussion | Cindy Buhse, Tara Gooen, Francis Godwin |
| Emerging Technology Program | Sau (Larry) Lee Director Office of Testing and Research (OTR) OPQ | CDER |
| Policy Considerations for Continuous Manufacturing | Rapti Madurawe OPF | OPQ | CDER Tara Gooen OPPQ | OPQ | CDER |
| Continuous Manufacturing of Drug Product | Arwa El Hagrasy OPF | OPQ | CDER |
| Case Studies: Continuous Manufacturing of Drug Substance | Vani Mathur Richards OPF | OPQ | CDER |
| Panel Questions and Discussion | Larry Lee, Rapti Madurawe, Tara Gooen, Arwa El Hagrasy, Vani Mathur Richards |
| Assessment of the Multi-Attribute Method | Sarah Rogstad OTR | OPQ | CDER |
| FDA Research Supporting Emerging Technologies with Case Studies | Thomas O’Connor OTR | OPQ | CDER |
| End-to-end Integrated Continuous Manufacturing | Salvatore Mascia CEO Continuus |
| Panel Questions and Discussion | Sarah Rogstad, Thomas O’Connor, Salvatore Mascia |
| Biosimilars and Interchangeables - Regulatory Highlights | Leila Hann Science Policy Analyst Office of Therapeutic Biologics and Biosimilars (OTBB) Office of New Drugs (OND) | CDER |
| FDA Perspectives on Biosimilar BLA-Manufacturing | Rachel Novak Office of Biotechnology Products (OBP) OPQ | CDER |
| Data Quality Expectations for Biosimilars with Case Studies | Merry Christie OBP | OPQ | CDER |
| Panel Questions and Discussion | Leila Hann, Rachel Novak, Merry Christie |
| The “Deemed to be a License” Provision of the BPCI Act | Janice Weiner Office of Regulatory Policy (ORP) CDER |
| Quality Considerations for Transition Biological Products | Leslie Rivera Rosado OBP | OPQ | CDER |
| Panel Questions and Discussion | Janice Weiner, Leslie Rivera Rosado, Susan Kirshner |
About
FDA will discuss the latest developments in pharmaceutical quality and provide case studies that illustrate the most effective ways to address quality issues and interact with the agency.
In this era of globalization, engaging stakeholders is essential to furthering the overall commitment to pharmaceutical quality. FDA’s goal for this event is to share information and emphasize the critical role quality plays in assuring the safety and efficacy of pharmaceutical products.
We look forward to discussing this commitment to quality with you at this symposium.
Topics Covered
- Manufacturing and the Quality Assessment of Applications
- Quality Beyond Application Approval
- Emerging Technologies in Pharmaceutical Manufacturing and Design
- Happenings in Biologics: Biosimilars and Transition Biological Products
Intended Audience
- Regulatory affairs professionals (innovator and generic or biosimilar)
- Manufacturing professionals (domestic and foreign; drug product and API)
- Foreign regulators
- Healthcare professionals interested in learning more about the FDA’s drug quality functions