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Tobacco Products

A Public Workshop - Modeling and Statistical Methods for the Regulatory Assessment of Tobacco Products

Registration to attend this workshop is now closed.  There will be no on-site registration.  Registration for the webcast is still open at  The archived webcast and transcripts will be available after the meeting for those individuals who did not register in advance. 

FDA is providing a free, live webcast.  Links to the archived webcast are now available at:

Dec. 5

Dec. 6


December 5-6, 2013
8:30 a.m. to 5 p.m.

Center for Tobacco Products
9200 Corporate Blvd., Room 020B
Rockville, MD   20850

Workshop Objective:  Workshop Agenda 

This conference is intended to stimulate discussion among academic researchers, industry participants, FDA scientists, and other stakeholders of the challenges and opportunities associated with using computer statistical modeling to assess the effects of tobacco products on population health.  Topics to be discussed include:

  • Model development process
  • Documentation of model development and outputs
  • Sources and quality of data for selecting the parameters input into the model
  • Methods for validating and evaluating models
  • Metrics for evaluating population health effects
  • Text analytics and topic modeling
  • Modeling of social networks and opinion dynamics
  • Modeling approaches, such as agent-based and system dynamics 

Who Should Attend this Workshop?
Scientific and medical experts, including mathematicians, statisticians, epidemiologists, computer scientists, social scientists, economists, risk communication experts; other interested participants from academia, public health organizations, federal, state and local government agencies, regulatory affairs professionals, and the tobacco industry; and other interested stakeholders.  

Registration to Attend the Workshop or View the Webcast:
Registration is free, but early registration is recommended because seating is limited.  FDA may limit the number of participants from each organization as well as the total number of participants based on space limitations.  Successful registrants will receive a confirmation email from no later than November 20, 2013.  Onsite registration on the day of the workshop will be based on space availability.  CTP plans to provide a free-of-charge, live webcast of the workshop.  If advance registration reaches maximum capacity, FDA will post a notice closing registration for the workshop on this website.

Register to attend the workshop, or to view the webcast, at  

Nominations for Presenters and Panelists:
CTP believes it is important to hear a broad range of perspectives on the scientific and technical topics to be discussed at the workshop.  We are inviting nominations for both presenters and panelists for the topics listed below.

  1. Challenges and Opportunities in Applying Computer Models in Assessing the Health Effects of Tobacco Products
    In this session, participants would discuss the need for a general framework for developing computer models for use in a regulatory setting.  For example,  the use of computer models as an assessment tool in the context of the totality of evidence on a tobacco product, the need for rigorous and transparent model development, and appropriate metrics for assessing a model.
  2. The Model Development Process
    In this session, participants would discuss key steps of model development from model formulation, implementation, validation, communication, maintenance and standards for documentation.  The need for transparency, comprehensiveness in the documentation of the model development process and the value of community peer-review would also be discussed.
  3. Sources and Quality of Data for Inputs
    Useful models depend on the quality of data used as inputs. In this session, participants would discuss suitable sources of data for population modeling of tobacco products, such as initiation, cessation, switching, and other model input parameters.
  4. Models of the Effects of Tobacco Policy
    In this session, participants would discuss methods for modeling the potential effects of policy actions aimed to reduce tobacco use and/or tobacco-related morbidity and mortality.
  5. Population Models Incorporating Multiple Tobacco Products
    Various modeling approaches may be used to understand and project the effects of multiple tobacco products on the health of the US population. In this session, participants would discuss population models, including Markov models incorporating initiation, cessation and other tobacco use patterns to assess morbidity and mortality outcomes.
  6. Topic Modeling, Sentiment and Opinion Analysis
    Statistical approaches continue to be developed to understand the content of structured and unstructured text document collections. In this session, participants would discuss how mathematical and statistical methods may be applied to document collections and social network data.
  7. Population Models to Account for Quality of Life Measures
    In this session, participants would discuss measures for assessing changes in quality-of-life and other measures of the effects on morbidity due to tobacco use.
  8. Future Directions
    In this session, participants would discuss further development in modeling approaches and/or data collections which could be useful for modeling in the context of tobacco product regulation. 

NOMINATIONS for Presenters and Panelists:

To submit nominations for presenters, please provide the following:

  • A brief abstract for each presentation. The abstract should identify the specific topic(s) to be addressed and the amount of time requested.
  • A one-page biosketch that describes and supports the speaker’s scientific expertise on the specific topic(s) being presented, nature of the individual’s experience and research in the scientific field, positions held, and any program development activities.
    Panelists will sit on a panel to discuss the questions and presentations in each session. To submit nominations for panelists, please provide the following:
  • A one-page biosketch that describes and supports the speaker’s scientific expertise on the specific topic(s) being presented, nature of the individual’s experience and research in the scientific field, positions held, and any program development activities.
    Please submit nominations by November 12, 2013.  Please send nominations to the following email address:  All nominations will be pooled together and speakers will be selected and invited to participate based on their availability and scientific background.
    FDA Invites Public Comments on Modeling and Statistical Methods for the Regulatory Assessment of Tobacco Products 

FDA will announce via a Federal Register notice the availability of a docket for submission of comments on the topic of Modeling and Statistical Methods for the Regulatory Assessment of Tobacco Products.  The forthcoming Federal Register notice will provide information on how to submit comments.  We encourage interested persons to submit comments via the docket, regardless of attendance at the workshop. 
Special Accommodations: 

If you need special accommodations because of disability, please contact Caryn Cohen (Contact information below) at least 7 days before the workshop.   

Contact for Questions:

Caryn Cohen
Office of Science
Center for Tobacco Products
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850
Telephone: 1-877-287-1373 (choose Option 5),
FAX: 240-276-3655

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