Symposium | Virtual
Event Title
Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing
October 31, 2023 - November 1, 2023
- Date:
- October 31, 2023 - November 1, 2023
- Day1:
- - ET
- Day2:
- - ET
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Topics & Presentations Day 1 |
Speakers |
|---|---|
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Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D1 – Part 1 |
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FDA Keynote Address |
Robert Califf, MD |
|
Michael Kopcha, PhD, RPh |
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|
Neil Stiber, PhD |
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Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D1 – Part 2 |
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|
Sau “Larry” Lee, PhD |
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Susan Kirshner, PhD, MSc |
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|
Hong Cai, PhD |
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Collaborating for Generic Drug Development and Approval Success: A Regulatory Perspective.pdf |
Yue “Helen” Teng, PhD |
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Q&A Discussion Panel |
Same as above |
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Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D1 – Part 3 |
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|
Alonza Cruse |
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Christopher Downey, PhD |
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Q&A Discussion Panel |
Same as above |
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Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D1 – Part 4 |
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Overview of Policy Document Options, Development, and Oversight.pdf |
Leila Wieser |
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International Harmonization: Ensuring Availability of Quality Medicine.pdf |
Theresa Mullin, PhD |
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Mahesh Ramanadham, PharmD, MBA |
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Nitrosamine Research Studies Inform FDA on Potential Strategies and BE Approaches.pdf |
Dongmei Lu, PhD |
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Pallavi Nithyanandan, PhD |
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|
Xiaoming Xu, PhD |
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Q&A Discussion Panel |
Same as above |
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Day One Closing |
Adam Fisher, PhD |
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Topics & Presentations Day 2 |
Speakers |
|---|---|
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Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D2 – Part 1 |
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|
Angelo De Claro, MD |
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Testing of High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.pdf |
Matthew Dionne, PharmD |
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Microbiological Quality Considerations in Non-Sterile Drug Manufacturing.pdf |
Timothy Pohlhaus, PhD |
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Q&A Discussion Panel |
Matthew Dionne and Timothy Pohlhaus |
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Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D2 – Part 2 |
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|
Nandini Rakala, PhD, MS |
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Stephen Cahill, MBA |
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|
John Wan, MBA |
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Q&A Discussion Panel |
Nandini Rakala, Stephen Cahill, John Wan, And Wendy Wilson, PhD |
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Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing – D2 – Part 3 |
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|
Tom O’Connor, PhD |
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Adam Fisher, PhD |
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Implementation of ICH Q13 Continuous Manufacturing Guidance.pdf |
Rapti Madurawe, PhD |
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Continuous Manufacturing to Improve Pharmaceutical Quality: Research Examples and Opportunities.pdf |
Geng “Michael” Tian, PhD |
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AI in Manufacturing of Pharmaceutical Products: Challenges and Opportunities.pdf |
Jayanti Das, PhD |
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Q&A Discussion Panel |
Same as above |
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Closing Remarks |
Michael Kopcha, PhD, RPh |
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ABOUT THIS EVENT
Pharmaceutical quality assures the availability, safety, and efficacy of every dose of medicine. Everyone deserves confidence in their next dose of medicine. Problems with pharmaceutical quality can impact the availability of medicine to patients and consumers. The mission of CDER’s Office of Pharmaceutical Quality (OPQ) is to assure quality medicines are available to the American public. This symposium, held every two years, will explore topics related to pharmaceutical quality regulation, supply chains, and advanced manufacturing technologies. Attendees will become familiar with the regulatory quality assessment, inspection, policy, surveillance, and research activities that impact the pharmaceutical supply chain and assure drug quality.
Learn more about the FDA’s pharmaceutical quality toolbox. OPQ’s quality assessment of drug applications uses tools that streamline risk assessment and knowledge management. OPQ policy conveys the most current thinking on pharmaceutical quality topics to enable manufacturers to provide high-quality drugs. Market surveillance and enforcement tools work to support the health of pharmaceutical supply chains while protecting the public. Programs focused on advanced pharmaceutical manufacturing provide tools for regulators and drug developers so that patients and consumers can benefit from promising new technologies. This pharmaceutical quality toolbox helps assure that quality medicines are available to the American public.
INTENDED AUDIENCE
- Manufacturing professionals focused on drug products, including new drug applications (NDAs), abbreviated new drug applications (ANDAs) and biologics license applications (BLAs) marketed in the U.S. and regulated by CDER
- Regulatory affairs professionals interested in FDA’s pharmaceutical quality policy and surveillance programs
- Foreign regulators and other international bodies interested in pharmaceutical quality harmonization
- Healthcare professionals and others interested in medicine quality, the U.S. supply chain, and advanced pharmaceutical manufacturing technologies
TOPICS COVERED
- Quality assessment of drug product marketing and licensing applications and how it relates to FDA innovations and facility evaluations
- Pharmaceutical quality policy and how new domestic and international efforts drive toward improved quality outcomes for patients and consumers
- Pharmaceutical supply chains and how FDA market surveillance activities help to assure drug quality
- Advanced pharmaceutical manufacturing technologies and how FDA is preparing for industry’s use of technologies such as AI for pharmaceutical manufacturing
FDA RESOURCES
- Protecting Patients & Consumers from Drug Quality Risks (video)
- FDA’s Office of Pharmaceutical Quality
- CDER’s Drug Quality Sampling and Testing Programs
- 2022 Report on the State of Pharmaceutical Quality
- Pharmaceutical Quality Resources
- Framework for Regulatory Advanced Manufacturing Evaluation
- Emerging Technology Program