Joint PSI Pharmaceutical Statistics & DIA Statistics Community
DIA Chair: Susan Duke, GSK
Speaker: Paul Gallo, Novartis:
DIA (industry perspective): Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials
Hui Quan, Mingyu Li, Joshua Chen, Paul Gallo, et al
Drug Information Journal, Vol. 44, pp. 617-632, 2010 Abstract | Paper+ | Slides
PSI Chair: Stephen Pyke, Pfizer Speaker: James Hung, FDA
PSI (FDA perspective): Consideration of regional differences in design and analysis of multi-regional trials
James Hung, Sue-Jane Wang, Robert O’Neill
Pharmaceutical Statistics, Vol. 9, Issue 3, pp. 173-178, 2010 Abstract | Paper+ | Slides
+ Papers available to view from 29th March 2011 to 26th April 2011.
For a flier advertising the event, please click here.
Scientific Meetings
Journal Club - Multiregional Trials (Joint DIA Event)
Joint PSI Pharmaceutical Statistics & DIA Statistics Community
DIA Chair: Susan Duke, GSK
Speaker: Paul Gallo, Novartis:
DIA (industry perspective): Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials
Hui Quan, Mingyu Li, Joshua Chen, Paul Gallo, et al
Drug Information Journal, Vol. 44, pp. 617-632, 2010 Abstract | Paper+ | Slides
PSI Chair: Stephen Pyke, Pfizer Speaker: James Hung, FDA
PSI (FDA perspective): Consideration of regional differences in design and analysis of multi-regional trials
James Hung, Sue-Jane Wang, Robert O’Neill
Pharmaceutical Statistics, Vol. 9, Issue 3, pp. 173-178, 2010 Abstract | Paper+ | Slides
+ Papers available to view from 29th March 2011 to 26th April 2011.
For a flier advertising the event, please click here.
Training Courses
Journal Club - Multiregional Trials (Joint DIA Event)
Joint PSI Pharmaceutical Statistics & DIA Statistics Community
DIA Chair: Susan Duke, GSK
Speaker: Paul Gallo, Novartis:
DIA (industry perspective): Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials
Hui Quan, Mingyu Li, Joshua Chen, Paul Gallo, et al
Drug Information Journal, Vol. 44, pp. 617-632, 2010 Abstract | Paper+ | Slides
PSI Chair: Stephen Pyke, Pfizer Speaker: James Hung, FDA
PSI (FDA perspective): Consideration of regional differences in design and analysis of multi-regional trials
James Hung, Sue-Jane Wang, Robert O’Neill
Pharmaceutical Statistics, Vol. 9, Issue 3, pp. 173-178, 2010 Abstract | Paper+ | Slides
+ Papers available to view from 29th March 2011 to 26th April 2011.
For a flier advertising the event, please click here.
Journal Club
Journal Club - Multiregional Trials (Joint DIA Event)
Joint PSI Pharmaceutical Statistics & DIA Statistics Community
DIA Chair: Susan Duke, GSK
Speaker: Paul Gallo, Novartis:
DIA (industry perspective): Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials
Hui Quan, Mingyu Li, Joshua Chen, Paul Gallo, et al
Drug Information Journal, Vol. 44, pp. 617-632, 2010 Abstract | Paper+ | Slides
PSI Chair: Stephen Pyke, Pfizer Speaker: James Hung, FDA
PSI (FDA perspective): Consideration of regional differences in design and analysis of multi-regional trials
James Hung, Sue-Jane Wang, Robert O’Neill
Pharmaceutical Statistics, Vol. 9, Issue 3, pp. 173-178, 2010 Abstract | Paper+ | Slides
+ Papers available to view from 29th March 2011 to 26th April 2011.
For a flier advertising the event, please click here.
Webinars
Journal Club - Multiregional Trials (Joint DIA Event)
Joint PSI Pharmaceutical Statistics & DIA Statistics Community
DIA Chair: Susan Duke, GSK
Speaker: Paul Gallo, Novartis:
DIA (industry perspective): Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials
Hui Quan, Mingyu Li, Joshua Chen, Paul Gallo, et al
Drug Information Journal, Vol. 44, pp. 617-632, 2010 Abstract | Paper+ | Slides
PSI Chair: Stephen Pyke, Pfizer Speaker: James Hung, FDA
PSI (FDA perspective): Consideration of regional differences in design and analysis of multi-regional trials
James Hung, Sue-Jane Wang, Robert O’Neill
Pharmaceutical Statistics, Vol. 9, Issue 3, pp. 173-178, 2010 Abstract | Paper+ | Slides
+ Papers available to view from 29th March 2011 to 26th April 2011.
For a flier advertising the event, please click here.
Careers Meetings
Journal Club - Multiregional Trials (Joint DIA Event)
Joint PSI Pharmaceutical Statistics & DIA Statistics Community
DIA Chair: Susan Duke, GSK
Speaker: Paul Gallo, Novartis:
DIA (industry perspective): Assessment of Consistency of Treatment Effects in Multiregional Clinical Trials
Hui Quan, Mingyu Li, Joshua Chen, Paul Gallo, et al
Drug Information Journal, Vol. 44, pp. 617-632, 2010 Abstract | Paper+ | Slides
PSI Chair: Stephen Pyke, Pfizer Speaker: James Hung, FDA
PSI (FDA perspective): Consideration of regional differences in design and analysis of multi-regional trials
James Hung, Sue-Jane Wang, Robert O’Neill
Pharmaceutical Statistics, Vol. 9, Issue 3, pp. 173-178, 2010 Abstract | Paper+ | Slides
+ Papers available to view from 29th March 2011 to 26th April 2011.
For a flier advertising the event, please click here.
Upcoming Events
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Introduction to Industry Training (ITIT) Course - 2024/2025
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
PSI Training Course: Regulatory Guidelines for Statisticians
This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.
In this event, we’ll start with a general introduction to hierarchical composite endpoints and an overview of common analysis methods including win ratio, win odds, and net benefit. Then, the practical considerations will be illustrated through case studies from clinical trials in heart failure and chronic kidney disease. We conclude with a discussion and a Q&A.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK