How Does PMI Conduct Scientific Assessments?

Quality principles

At each step, rigorous scientific standards are applied to generate data that evaluate whether smokefree products reduce exposure to harmful and potentially harmful constituents or the risk of developing smoking-related diseases.

 

A risk-based Quality Management System has been conceived for smoke-free products to coordinate and guide activities in order to ensure the quality and integrity of the product during its complete lifecycle, from conception to commercialization.

OBSERVATIONAL STUDIES IEA GEP(1);
Applicable National Regulations

 

PERCEPTION AND BEHAVIOR ASSESSMENT
Based on GEP-DGEpi(2);
FDA Guidance on PRO(3);
ISPOR PGP for the TCA(4);
Applicable National Regulations

 

CLINICAL STUDIES
WMA Declaration of Helsinki(5);
Based on ICH-GCP E6 (R1)(6);
Applicable National Regulations

 

REGULATORY TOXICOLOGY ASSESSMENT
OECD GLP(7), INVITTOX 3A/ERGATT/
FRAME; OECD Test Guidelines 412,
413, 451, 453, 471, 487, 490

PRODUCT DESIGN AND CONTROL
Quality by Design (QbD)(8)

 

AEROSOL CHEMISTRY
OECD GLP; ISO(9) 17025; ICH Q2 (R1)(10);
ISO 3308*, 3402, 4387*, 8454,
10315:2013, 10362-1*, 13110, 19290;
CORESTA CRM81(11)

 

INDOOR AIR QUALITY
ISO 17025; EN 15251(12); ISO 15593,
18144, 18145, 16814, 16000-6, 11454

1. IEA Guidelines for proper conduct in epidemiologic research (2007)
2. Good Epidemiologic Practice (GEP) – German Society for Epidemiology (DGEpi)
3. Food and Drug Administration (2009). Guidance for Industry – Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
4. Wild, D., et al. (2005). Principles of good practice for the translation and cultural adaptation process for patient-reported outcomes (PRO) measures: report of the ISPOR task force for translation and cultural adaptation. Value Health 8:94-104.
5. World Medical Association (WMA) Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
6. ICH – Guideline for Good Clinical Practice
7. OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring
8. Juran, J. M. (1992). Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services.
9. International Organization for Standardization
10. ICH – Validation of Analytical Procedures: Text and Methodology
11. CORESTA Recommended Method 81
12. 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.
* With slight modifications needed to adapt to smokefree products