Pathways to Successful FDA-CTP Compliance: Product to Process All Industry Workshop

Workshop Agenda


9:00 – 9:15 Opening Remarks – Chris Greer, TMA
9:15 – 12:00

Morning Session: Breakouts by Pathway

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.



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.                            

12:00 – 1:00 Lunch

Afternoon Session: FDA Inspections

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


High Point CTC
Keller & Heckman LLP
Keller & Heckman LLP

Workshop Sponsors

Sponsorship Opportunities


High Point CTC
Keller & Heckman LLP


Latham & Watkins LLP
Fox Rothschild LLP