Safety Scientific Working Group

(to be updated)

Workstream 1: Interdisciplinary safety evaluation

  1. Presentation at ISBS Conference (August, 2017)
  2. Invited Session at Joint Statistical Meetings (July, 2017)
    1. Sources of Safety Data and Statistical Strategies for Design and Analysis in Clinical Trials
  3. Two Presentations at DIA Annual Meeting (June, 2017)
    1. Sources of Safety Data and Statistical Strategies for Design and Analysis in Clinical Trials
  4. Invited Session at DIA China Quantitative Sciences Forum (August, 2016)
  5. Session/Panel at the BIOP Regulatory-Industry Statistics Workshop (September, 2016)
  6. Topic-Contributed Session/Panel at Joint Statistical Meetings (August, 2016)
  7. Invited Session at Trends and Innovations in Clinical Trial Statistics Conference (May, 2016)
  8. Session/Panel at the BIOP Regulatory-Industry Statistics Workshop (September, 2015)
  9. Assessing the cardiovascular risk of anti-diabetic therapies in patients with type 2 diabetes mellitus, UNC-Chapel Hill Department of Biostatistics (September, 2015)
  10. Invited Session/Panel at Joint Statistical Meetings (August, 2015)
  11. Invited Session at ISBS Conference (June, 2015)
  12. Invited Session/Panel at SCT Annual Conference (May, 2015)
  13. Assessing the cardiovascular risk of anti-diabetic therapies in patients with type 2 diabetes mellitus, Poster at PSI Annual Meeting (May, 2015)
  14. Invited Session/Panel at SCT/QSPI Conference (December, 2014)
  15. Session at Trends and Innovations in Clinical Trial Statistics Conference (April, 2014)
  16. Poster at the DIA/FDA Statistics Forum (April, 2014)

Workstream 2: Safety statistical methodology



  1. Presentation at ISBS Conference (August, 2017)
  2. Invited Session at Joint Statistical Meetings (July, 2017)
    1. Sources of Safety Data and Statistical Strategies for Design and Analysis in Clinical Trials
  3. Two Presentations at DIA Annual Meeting (June, 2017)
    1. Sources of Safety Data and Statistical Strategies for Design and Analysis in Clinical Trials
  4. Invited Session at DIA China Quantitative Sciences Forum (August, 2016)
  5. Session/Panel at the BIOP Regulatory-Industry Statistics Workshop (September, 2016)
  6. Topic-Contributed Session/Panel at Joint Statistical Meetings (August, 2016)
  7. Invited Session at Trends and Innovations in Clinical Trial Statistics Conference (May, 2016)
  8. Session/Panel at the BIOP Regulatory-Industry Statistics Workshop (September, 2015)
  9. Assessing the cardiovascular risk of anti-diabetic therapies in patients with type 2 diabetes mellitus, UNC-Chapel Hill Department of Biostatistics (September, 2015)
  10. Invited Session/Panel at Joint Statistical Meetings (August, 2015)
  11. Invited Session at ISBS Conference (June, 2015)
  12. Invited Session/Panel at SCT Annual Conference (May, 2015)
  13. Assessing the cardiovascular risk of anti-diabetic therapies in patients with type 2 diabetes mellitus, Poster at PSI Annual Meeting (May, 2015)
  14. Invited Session/Panel at SCT/QSPI Conference (December, 2014)
  15. Session at Trends and Innovations in Clinical Trial Statistics Conference (April, 2014)
  16. Poster at the DIA/FDA Statistics Forum (April, 2014)
Workstream 3: Linking and bridging RWE & RCT for safety decision making



  1. Tutorial: Likelihood-Based Methods for Continuous Safety Monitoring of Pharmaceutical Products, Deming Conference (December, 2017)
  2. Quantitative Sciences for Safety Monitoring during Clinical Development, Webinar for the Biopharmaceutical Section of the American Statistical Association (October, 2017)
  3. Likelihood Ratio Test on Safety Data at DIA China Quantitative Science Forum (Aug 2017)
  4. Analytical Framework : Safety Assessment Committee in Drug Development at JSM (Aug 2017)
  5. JSM Panel: Quantitative Safety Monitoring: Regulatory Landscape, Statistical Methodology and Cross-Disciplinary Scientific Engagement (August, 2017)
  6. Biopharm Safety Monitoring Working Group: Bayesian and Graphics Approaches Based on Regulatory Guidance at Joint Statistical Meetings (August, 2017)
    1. Enhancing Visual Analytics Approaches in Safety Monitoring (Aug 2017)
    2. Type-1 Error Control in Safety Signal Detection in Clinical Trial Data A Talk from the ASA Biopharm Safety Monitoring Working Group (Aug 2017)
    3. When to alert a Safety Assessment Committee –A Bayesian Approach with Example at JSM (Aug 2017)
    4. Biopharm Safety Monitoring Working Group: Bayesian and Graphics Approaches Based on Regulatory Guidance — Regulatory Discussant (Aug 2017)
  7. Update on progress of ASA Biopharm Safety Monitoring Working Group at International Chinese Statistics Association Applied Statistics Symposium (June, 2017)
  8. Tutorial: Quantitative Sciences for Safety Monitoring during Clinical Development. An ICSA One-day short course from the ASA Biopharm Safety Monitoring Working Group (June, 2017)
  9. Visual Analytics in Safety Monitoring – Beyond the Usual Graphs and Available Tools at Midwest Biopharmaceutical Statistics Workshop (May, 2017)
  10. Global Regulatory Landscape for Safety Monitoring: A Quantitative Perspective on behalf of the ASA Biopharm Safety Monitoring Working Group (April, 2017)
  11. Tutorial: Quantitative Sciences for Safety Monitoring in Clinical Development. Half-day short course at 72nd Annual Deming Conference on Applied Statistics (December, 2016)
  12. DIA All Hands Meeting: Safety Monitoring During Clinical Development (September, 2016)
  13. DIA China: ASA Biopharm's Safety Monitoring working group: Survey of statisticians, thought leaders and regulatory guidance (August, 2016)
  14. ASA Biopharm's Safety Monitoring working group: Survey of statisticians, thought leaders and regulatory guidance at Joint Statistical Meetings (August, 2016)
  15. Safety Monitoring in Clinical Development at DIA Statistics All Hands Webinar (May, 2016)