Workshop Agenda
| 9:00 – 9:15 | Opening Remarks – Chris Greer, TMA |
| 9:15 – 12:00 |
Morning Session: Breakouts by Pathway |
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Grandfathering and Substantial Equivalence
This panel will discuss the process of grandfathering products based on currently-regulated products and the lessons that can be transplanted to deemed products – mainly cigars. Pros and cons of pathways from companies that have experience in both pathways and how future policy changes might impact decisions. |
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PMTA
This panel will discuss the process and science behind PMTA applications from the mechanics of application production to the product and population science and current process. |
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| 12:00 – 1:00 | Lunch |
Afternoon Session: FDA Inspections |
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| 1:00 – 1:15 | Session Overview and Introductions – Chris Greer PDF Presenters: Dean Cirotta of EAS Consulting Group and Carl Ioos of Top Tobacco LP |
| 1:15 – 1:45 |
1. Product Quality in an FDA Regulatory Environment - the US Tobacco Control Act |
| 1:45 – 2:15 | 2. Current FDA cGMP Regulations and How They May Influence the Tobacco GMP Regulations |
| 2:15 – 2:45 | 3. FDA Inspections and Enforcement – Current Experience |
| 2:45 – 3:00 | Break |
| 3:00 – 4:00 | 4. Managing FDA Inspections |
| 4:00 – 4:30 | 5. Interacting with the FDA – Real World Experience |
| 4:30 – 5:00 | 6. Panel Q & A Facilitated by Chris Greer |
Workshop Partners
