Panel Discussion: Regulatory Landscape for Combination Products – Insights from FDA Experts
Program Speakers:
Binh Nguyen, PharmD, M.S. Reg Sci, BCSCP, FHPE
President, Wynngate Corporation
20+ year Ex-FDA, Level III Drug Investigator, Level II Drug Auditor, Educator
Joey Quitania
Senior CSO and Certified Pharmaceutical Inspectorate Level III Drug Investigator,
FDA’s Office of Inspections and Investigations
Event Agenda:
DATE: Tuesday 10 December 2024
TIME:
6:00 – 6:05 PM Welcome and Announcements
6:05 – 6:10 PM Introductions of Panelists
6:10 – 7:05 PM Program Presentation
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- Overview of Combination Products: Definition and Regulatory Pathways (Both Panelists)
- Evolution of Combination Product Regulation at FDA (Dr. Binh Nguyen)
- Current Regulatory Environment and Future Trends (Joey Quitania)
- Global Regulatory Considerations (Both Panelists)
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7:05 – 7:35 PM Q and A
7:35 – 7:45 PM Closing Remarks and End of Session
LOCATION: This event is being offered virtually. The zoom link will be shared with you via email 1-2 days before the event.
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Click here to register for this event.
Program Topic:
This panel discussion, Regulatory Landscape for Combination Products – Insights from FDA Experts, brings together a former and a current FDA employee to explore the evolving regulatory environment for combination products. The seminar covers key topics, including the definition and classification of combination products, historical developments in FDA regulations, and the current approval pathways. Attendees will gain valuable insights into regulatory challenges, global harmonization efforts, and emerging trends such as digital health integration. Through real-world case studies and an interactive Q&A session, participants will leave with a deeper understanding of how to navigate the complex landscape of combination product approvals and compliance.
Speaker Biography:
Dr. Binh Nguyen runs a bio/pharmaceutical consulting firm Wynngate Coporation as of March 2024 after working as a Sr. Director for Lachman Consultants for 1 year. He retired from FDA in March 2023 after 20 years specializing in bio/pharmaceutical training, compliance, management, and inspectional audits for CDER (Center for Drugs Evaluation and Research) and ORA (Office of Regulatory Affairs). He was a Level III Certified Pharmaceutical Inspectorate, a Level II Drug Auditor, drug branch chief, and director regulatory review officer for biotech, sterile injectable, sterile compounding, positron emission tomography, combination products, and other dosage forms. He also worked as a clinical and compounding pharmacist at a UCI Hospital, a 400-bed acute care hospital for 21 years. He served as a counsel member in sterile compounding pharmacy for the Board of Pharmacy Specialties for 3 years. He completed his doctorate in pharmacy and master in regulatory science at the University of Southern California. He is the founder and developer for the global inspection software with AI called ieQip (intelligent electronic Quality inspection platform) which can be used as independent third party or internal audit.
Joey Quitania is a Senior CSO and Certified Pharmaceutical Inspectorate Level III Drug Investigator at the FDA’s Office of Inspections and Investigations, Division of Human and Animal Drug Inspectorate VI. He is also QSIT certified to perform Medical Device inspections. With over 22 years in the Agency, he has held various roles, including generalist investigator, drug investigator, and drug specialist. From 2017 – 2023, he served as the Pre-approval Manager for ORA’s OPQO Pharma Division IV covering the entire West Coast: Los Angeles, San Francisco, Seattle, and Denver Legacy districts. Joey conducts surveillance, pre-approval, post-approval, and for-cause inspections at domestic and foreign facilities. His experience spans the full gamut of drug products such as intermediates, small molecule and biotech drug substances, sterile and nonsterile drugs, radiopharmaceuticals, combination drug/medical devices, and contract testing laboratories. He is involved in creating and delivering training for FDA investigators, collaborates with foreign inspection partners, participates in policymaking, and engages with external stakeholders. Prior to joining the Agency, he worked for several years in the Pharmaceutical Industry gaining experience in the Production and Quality departments. He is a graduate from San Diego State University with a BS in Biology and UCSD College of Extension in Quality Assurance for the Drug and Biologic Industry Certificate Program.
Registration Information:
- Register for the event here
Contact
Pricing – Online – Registration (ends Monday, December 09, 2024)
| Registrant Type | Event Price | |
| Member | $10.00 | |
| Lifetime | $10.00 | |
| Non-Member |
$20.00
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Cancellation Policy
There will be no refunds for cancellations.
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