June 18th 2015 ~ 8:30 – 10:30 UK time
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
We do encourage your participation. If you have questions relating to the Asia-Pacific Development webinar, ahead of the webinar, please email them to Sajda.Ghani@covance.com or jennifer.gilbride@grunenthal.com
We will do our best to discuss them at the webinar.
To register please click here.
June 18th 2015 ~ 8:30 – 10:30 UK time
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
We do encourage your participation. If you have questions relating to the Asia-Pacific Development webinar, ahead of the webinar, please email them to Sajda.Ghani@covance.com or jennifer.gilbride@grunenthal.com
We will do our best to discuss them at the webinar.
To register please click here.
June 18th 2015 ~ 8:30 – 10:30 UK time
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
We do encourage your participation. If you have questions relating to the Asia-Pacific Development webinar, ahead of the webinar, please email them to Sajda.Ghani@covance.com or jennifer.gilbride@grunenthal.com
We will do our best to discuss them at the webinar.
To register please click here.
June 18th 2015 ~ 8:30 – 10:30 UK time
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
We do encourage your participation. If you have questions relating to the Asia-Pacific Development webinar, ahead of the webinar, please email them to Sajda.Ghani@covance.com or jennifer.gilbride@grunenthal.com
We will do our best to discuss them at the webinar.
To register please click here.
June 18th 2015 ~ 8:30 – 10:30 UK time
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
We do encourage your participation. If you have questions relating to the Asia-Pacific Development webinar, ahead of the webinar, please email them to Sajda.Ghani@covance.com or jennifer.gilbride@grunenthal.com
We will do our best to discuss them at the webinar.
To register please click here.
June 18th 2015 ~ 8:30 – 10:30 UK time
Registration fee: None
The webinar is free of charge. However, attendees must register on the PSI website in order to obtain the dial-in details and the webinar link.
Clinical drug development has often had a heavy focus on the needs of the FDA and EMEA. This webinar aims to focus on the needs of the China FDA (cFDA) and Japan’s Pharmaceutical and Medical Device Agency (PMDA) providing both insights into the regulatory requirements, real life examples of local development plans and key things to consider when looking to include these countries in multi-regional trials.
Statistical Challengers and Opportunities on Multi-regional Clinical Trials Including Asian Countries
Dr. Dejun Tang (Novartis Pharma; China)
Multi-regional trials are nowadays widely conducted and many multi-regional clinical trials are carried out including Asian countries. However, along with new opportunities, there are many challenges on scientific, operational, and regulatory aspects for conducting such trials. This presentation will discuss both statistical challenges and opportunities on planning and conducting the multi-regional clinical trials which involve Asian countries. Several examples in some clinical trials will be provided for discussion to illustrate the issues and possible solutions.
Evaluation of a Multi-regional Trial for Global Simultaneous Drug Development
Dr. Norisuke Kawai – (Pfizer Japan Inc.)
In recent years, multi-regional trials (MRCTs) are becoming common for drug development in Japan. The primary objective of MRCT is to evaluate efficacy and safety of the study drug in the overall study population. An important secondary objective of MRCT is to evaluate influential ethnic factors on efficacy and safety of the study drug. It includes investigating whether there is heterogeneity across regions. In this presentation we will discuss a framework, that is, a three-layer approach, to evaluate data from a MRCT. In the three-layer approach, how to interpret data in a MRCT is categorized into three layers: Layer 1 to first look at overall study results, Layer 2 to identify factors which influence overall results from scientific and regulatory perspectives, and Layer 3 to evaluate benefit/risk for a specific country/ region according to the requirements of its regulatory authorities. We will also discuss some statistical approaches for exploring regional heterogeneity of the treatment effect.
Points to Consider in Regional Study Design
Dr. Nicole F. Li – (Roche; China)
ICH E5 stated that data developed in one region can be possibly extrapolated to the new region if a bridging study shows evidence that the drug will behave similarly across regions. However, “Similarity” of efficacy across regions is not clearly defined in ICH E5 guideline. There is lack of regulatory guideline on defining “consistency” in bridging study, and no commonly accepted statistical inference in demonstrating “consistency”. Our work provided statistical, regulatory, clinical considerations and guidance on design and analysis of efficacy bridging trials, and explored how the primary objective should be defined, how to select the consistency criteria, and key considerations on sample size.
We do encourage your participation. If you have questions relating to the Asia-Pacific Development webinar, ahead of the webinar, please email them to Sajda.Ghani@covance.com or jennifer.gilbride@grunenthal.com
We will do our best to discuss them at the webinar.
To register please click here.
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.
The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.
This webinar is organised by the RWD SIG and the Historical Data SIG. We will review recent methods, applications, and tools of integrating subject-level-data from clinical trial with external data using Bayesian methods and/or causal inference methods.
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 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 program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.
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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