How does PMI conduct its scientific assessments?

      At each step of the scientific assessment approach, scientific rigor is applied to generate data that may support a claim that smoke-free products reduce exposure to harmful and potentially harmful constituents and present less risk of harm than continued smoking. A risk-based Quality Management System has been conceived for smoke-free products to coordinate and guide activities with the aim of ensuring quality and integrity of the product during its complete lifecycle, from the conception through to commercialization. 


      1. Juran, J. M. (1992). Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services. 
      2. OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring. 
      3. International Organization for Standardization. 
      4. ICH – Validation of Analytical Procedures: Text and Methodology. 
      5. European Committee for Standardization (2007). CEN European Standard EN 15251. Indoor Environmental Input Parameters for Design and Assessment of Energy Performance of Buildings Addressing Indoor Air Quality, Thermal Environment, Lighting and Acoustics. European Committee for Standardization, Brussels. 
      6. World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. 
      7. ICH – Guideline for Good Clinical Practice. 
      8. Good Epidemiologic Practice (GEP) – German Society for Epidemiology (DGEpi). 
      9. Food and Drug Administration (2009). Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. 
      10. IEA Guidelines for proper conduct in epidemiologic research (2007). 

      Read our method and protocols

      Our methods and protocols are available in the publications library alongside our publications, presentations, and posters. Just use the filter option to narrow the search results.