Date: Tuesday 21st June 2022
Time: 14:00-15:00 BST | 15:00-16:00 CEST
Speaker: Bernard Francq
Who is this event intended for? Statisticians and others working on assay qualification within the Pharmaceutical Industry.
What is the benefit of attending? Attendees will learn about robust assay qualification methodology.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
In the pharmaceutical industry, all analytical methods must be shown to deliver unbiased and precise results. In an assay qualification or validation study, the trueness, accuracy and intermediate precision are usually assessed by comparing the measured concentrations to their nominal levels. Trueness is assessed by using confidence intervals of mean measured concentration, accuracy by prediction intervals for a future measured concentration, and the intermediate precision by the total variance.
ICH and USP guidelines alike request that all relevant sources of variability must be studied, e.g. the effect of different technicians, the day-to-day variability or the use of multiple reagent lots. Those different random effects must be modeled as crossed, nested or a combination of both.
Confidence, prediction and tolerance intervals in linear mixed models will be detailed with a focus on the interpretation of statistical results. Their relationships will be discussed together with the POOS (out-of-specification probability). Two real datasets from assay validation study during vaccine development are used to illustrate the statistical intervals and the POOS.
|
Speaker |
Biography |
|
|
Bernard G Francq is Lead Statistician with GSK Biologicals, driving statistical innovation for CMC projects worldwide. He holds a PhD in Statistics (UCLouvain, 2013). His work on errors-in-variables (EIV) regressions in method comparison studies has been awarded Best MSc Thesis Biostatistics (Quételet 2008, Belgium), Best Chemometrician Prize (Chimiométrie 2009, Paris) and Best Young Researcher (Agrostat 2012, Paris). His communication skills have been recognized with the Greenfield Challenge Award (ENBIS 2012, Ljubljana). Recent work on tolerance intervals in bridging studies was awarded Best GSK Statistical Paper (2020). He lectures at UCLouvain and regularly offers trainings to statisticians in the (bio)pharmaceutical industry. |
Date: Tuesday 21st June 2022
Time: 14:00-15:00 BST | 15:00-16:00 CEST
Speaker: Bernard Francq
Who is this event intended for? Statisticians and others working on assay qualification within the Pharmaceutical Industry.
What is the benefit of attending? Attendees will learn about robust assay qualification methodology.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
In the pharmaceutical industry, all analytical methods must be shown to deliver unbiased and precise results. In an assay qualification or validation study, the trueness, accuracy and intermediate precision are usually assessed by comparing the measured concentrations to their nominal levels. Trueness is assessed by using confidence intervals of mean measured concentration, accuracy by prediction intervals for a future measured concentration, and the intermediate precision by the total variance.
ICH and USP guidelines alike request that all relevant sources of variability must be studied, e.g. the effect of different technicians, the day-to-day variability or the use of multiple reagent lots. Those different random effects must be modeled as crossed, nested or a combination of both.
Confidence, prediction and tolerance intervals in linear mixed models will be detailed with a focus on the interpretation of statistical results. Their relationships will be discussed together with the POOS (out-of-specification probability). Two real datasets from assay validation study during vaccine development are used to illustrate the statistical intervals and the POOS.
|
Speaker |
Biography |
|
|
Bernard G Francq is Lead Statistician with GSK Biologicals, driving statistical innovation for CMC projects worldwide. He holds a PhD in Statistics (UCLouvain, 2013). His work on errors-in-variables (EIV) regressions in method comparison studies has been awarded Best MSc Thesis Biostatistics (Quételet 2008, Belgium), Best Chemometrician Prize (Chimiométrie 2009, Paris) and Best Young Researcher (Agrostat 2012, Paris). His communication skills have been recognized with the Greenfield Challenge Award (ENBIS 2012, Ljubljana). Recent work on tolerance intervals in bridging studies was awarded Best GSK Statistical Paper (2020). He lectures at UCLouvain and regularly offers trainings to statisticians in the (bio)pharmaceutical industry. |
Date: Tuesday 21st June 2022
Time: 14:00-15:00 BST | 15:00-16:00 CEST
Speaker: Bernard Francq
Who is this event intended for? Statisticians and others working on assay qualification within the Pharmaceutical Industry.
What is the benefit of attending? Attendees will learn about robust assay qualification methodology.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
In the pharmaceutical industry, all analytical methods must be shown to deliver unbiased and precise results. In an assay qualification or validation study, the trueness, accuracy and intermediate precision are usually assessed by comparing the measured concentrations to their nominal levels. Trueness is assessed by using confidence intervals of mean measured concentration, accuracy by prediction intervals for a future measured concentration, and the intermediate precision by the total variance.
ICH and USP guidelines alike request that all relevant sources of variability must be studied, e.g. the effect of different technicians, the day-to-day variability or the use of multiple reagent lots. Those different random effects must be modeled as crossed, nested or a combination of both.
Confidence, prediction and tolerance intervals in linear mixed models will be detailed with a focus on the interpretation of statistical results. Their relationships will be discussed together with the POOS (out-of-specification probability). Two real datasets from assay validation study during vaccine development are used to illustrate the statistical intervals and the POOS.
|
Speaker |
Biography |
|
|
Bernard G Francq is Lead Statistician with GSK Biologicals, driving statistical innovation for CMC projects worldwide. He holds a PhD in Statistics (UCLouvain, 2013). His work on errors-in-variables (EIV) regressions in method comparison studies has been awarded Best MSc Thesis Biostatistics (Quételet 2008, Belgium), Best Chemometrician Prize (Chimiométrie 2009, Paris) and Best Young Researcher (Agrostat 2012, Paris). His communication skills have been recognized with the Greenfield Challenge Award (ENBIS 2012, Ljubljana). Recent work on tolerance intervals in bridging studies was awarded Best GSK Statistical Paper (2020). He lectures at UCLouvain and regularly offers trainings to statisticians in the (bio)pharmaceutical industry. |
Date: Tuesday 21st June 2022
Time: 14:00-15:00 BST | 15:00-16:00 CEST
Speaker: Bernard Francq
Who is this event intended for? Statisticians and others working on assay qualification within the Pharmaceutical Industry.
What is the benefit of attending? Attendees will learn about robust assay qualification methodology.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
In the pharmaceutical industry, all analytical methods must be shown to deliver unbiased and precise results. In an assay qualification or validation study, the trueness, accuracy and intermediate precision are usually assessed by comparing the measured concentrations to their nominal levels. Trueness is assessed by using confidence intervals of mean measured concentration, accuracy by prediction intervals for a future measured concentration, and the intermediate precision by the total variance.
ICH and USP guidelines alike request that all relevant sources of variability must be studied, e.g. the effect of different technicians, the day-to-day variability or the use of multiple reagent lots. Those different random effects must be modeled as crossed, nested or a combination of both.
Confidence, prediction and tolerance intervals in linear mixed models will be detailed with a focus on the interpretation of statistical results. Their relationships will be discussed together with the POOS (out-of-specification probability). Two real datasets from assay validation study during vaccine development are used to illustrate the statistical intervals and the POOS.
|
Speaker |
Biography |
|
|
Bernard G Francq is Lead Statistician with GSK Biologicals, driving statistical innovation for CMC projects worldwide. He holds a PhD in Statistics (UCLouvain, 2013). His work on errors-in-variables (EIV) regressions in method comparison studies has been awarded Best MSc Thesis Biostatistics (Quételet 2008, Belgium), Best Chemometrician Prize (Chimiométrie 2009, Paris) and Best Young Researcher (Agrostat 2012, Paris). His communication skills have been recognized with the Greenfield Challenge Award (ENBIS 2012, Ljubljana). Recent work on tolerance intervals in bridging studies was awarded Best GSK Statistical Paper (2020). He lectures at UCLouvain and regularly offers trainings to statisticians in the (bio)pharmaceutical industry. |
Date: Tuesday 21st June 2022
Time: 14:00-15:00 BST | 15:00-16:00 CEST
Speaker: Bernard Francq
Who is this event intended for? Statisticians and others working on assay qualification within the Pharmaceutical Industry.
What is the benefit of attending? Attendees will learn about robust assay qualification methodology.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
In the pharmaceutical industry, all analytical methods must be shown to deliver unbiased and precise results. In an assay qualification or validation study, the trueness, accuracy and intermediate precision are usually assessed by comparing the measured concentrations to their nominal levels. Trueness is assessed by using confidence intervals of mean measured concentration, accuracy by prediction intervals for a future measured concentration, and the intermediate precision by the total variance.
ICH and USP guidelines alike request that all relevant sources of variability must be studied, e.g. the effect of different technicians, the day-to-day variability or the use of multiple reagent lots. Those different random effects must be modeled as crossed, nested or a combination of both.
Confidence, prediction and tolerance intervals in linear mixed models will be detailed with a focus on the interpretation of statistical results. Their relationships will be discussed together with the POOS (out-of-specification probability). Two real datasets from assay validation study during vaccine development are used to illustrate the statistical intervals and the POOS.
|
Speaker |
Biography |
|
|
Bernard G Francq is Lead Statistician with GSK Biologicals, driving statistical innovation for CMC projects worldwide. He holds a PhD in Statistics (UCLouvain, 2013). His work on errors-in-variables (EIV) regressions in method comparison studies has been awarded Best MSc Thesis Biostatistics (Quételet 2008, Belgium), Best Chemometrician Prize (Chimiométrie 2009, Paris) and Best Young Researcher (Agrostat 2012, Paris). His communication skills have been recognized with the Greenfield Challenge Award (ENBIS 2012, Ljubljana). Recent work on tolerance intervals in bridging studies was awarded Best GSK Statistical Paper (2020). He lectures at UCLouvain and regularly offers trainings to statisticians in the (bio)pharmaceutical industry. |
Date: Tuesday 21st June 2022
Time: 14:00-15:00 BST | 15:00-16:00 CEST
Speaker: Bernard Francq
Who is this event intended for? Statisticians and others working on assay qualification within the Pharmaceutical Industry.
What is the benefit of attending? Attendees will learn about robust assay qualification methodology.
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
In the pharmaceutical industry, all analytical methods must be shown to deliver unbiased and precise results. In an assay qualification or validation study, the trueness, accuracy and intermediate precision are usually assessed by comparing the measured concentrations to their nominal levels. Trueness is assessed by using confidence intervals of mean measured concentration, accuracy by prediction intervals for a future measured concentration, and the intermediate precision by the total variance.
ICH and USP guidelines alike request that all relevant sources of variability must be studied, e.g. the effect of different technicians, the day-to-day variability or the use of multiple reagent lots. Those different random effects must be modeled as crossed, nested or a combination of both.
Confidence, prediction and tolerance intervals in linear mixed models will be detailed with a focus on the interpretation of statistical results. Their relationships will be discussed together with the POOS (out-of-specification probability). Two real datasets from assay validation study during vaccine development are used to illustrate the statistical intervals and the POOS.
|
Speaker |
Biography |
|
|
Bernard G Francq is Lead Statistician with GSK Biologicals, driving statistical innovation for CMC projects worldwide. He holds a PhD in Statistics (UCLouvain, 2013). His work on errors-in-variables (EIV) regressions in method comparison studies has been awarded Best MSc Thesis Biostatistics (Quételet 2008, Belgium), Best Chemometrician Prize (Chimiométrie 2009, Paris) and Best Young Researcher (Agrostat 2012, Paris). His communication skills have been recognized with the Greenfield Challenge Award (ENBIS 2012, Ljubljana). Recent work on tolerance intervals in bridging studies was awarded Best GSK Statistical Paper (2020). He lectures at UCLouvain and regularly offers trainings to statisticians in the (bio)pharmaceutical industry. |
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.
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 will be a 45 minute webinar which will explain the topic presented in the published paper, ‘Applying the Estimand Framework to Clinical Pharmacology Trials with a Case Study in Bioequivalance’. There will be 15 minutes for a panel Q&A with some of the authors following the presentation.
This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.
This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.
Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.
This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
The webinar is targeted at statisticians working in the pharmaceutical industry, and the objective is to 1) provide a basic understanding of IV methodology including how it relates to causal inference, and 2) present two inspirational pharma-relevant applications.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.
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