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The PMTA Submission: How Clear Safety Reporting is Important
Session Chair(s)
David Meats
Director, Regulatory Services Management
Certara, United States
The Pre-Market Tobacco Products Application (PMTA) is a new and potentially controversial regulation issued by the FDA governing a wide scope of potentially health-harming products that consumers purchase. The FDA regulation will become effective for these products in the middle of 2020, and regulatory writers may be requested to apply their skills to these applications. This session will describe the scope and purpose of the new PMTA regulation the types of products for which a PMTA submission is required, how regulatory writers are involved, why they are important, and what hurdles need to be surmounted to complete these applications.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Describe the scope and purpose of a PMTA submission
- Describe what regulatory writing skills can be utilized when completing these submissions
- Describe the importance of these applications to further the knowledge of potential adverse effects of these products
Speaker(s)
Premarket Tobacco Product Applications (PMTA) - How Did We Get Here, What is the Present Status, and Where Are We Going?
Ian Fearon, PhD
whatIF? Consulting Ltd, United Kingdom
Structure, Process, and Content for Submission to the Center for Tobacco Products (CTP)
Steve Sibley, MS
Certara , United States
Vice President, Global Submissions and Submissions Leadership
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