Time: 15:00 - 16:00 UK Time
Presenter: Dr Carsten Schwenke
Early benefit assessment was introduced in Germany in 2011 as a basis for price negotiations between payers and pharmaceutical companies. Since then, all new drug substances have to be assessed at the Federal Joint Committee (G-BA), by indication. This series of webinars by Dr C. Schwenke will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG and should be of particular interest to statisticians who work in HTA and those who deal with requests from their local German team.
Click here to view the presentation slides.
Abstract
The so called early benefit assessment in Germany was introduced in 2011 as basis for price negotiations of the institutionary sick funds and the pharmaceutical company. Since then, all new drug substances are to be assessed at the Federal Joint Committee (G-BA, Gemeinsamer Bundesausschuss) by indication. A new indication always requires a new procedure. In a first step, the additional benefit over a comparator has to be shown based on the rules of evidence based medizine and the available clinical data. The marketing authorization holder has to submit a benefit dossier with all available clinical data for the drug substance in the indication. A template for the dossier is provided by G-BA and defines how the data is to be shown. This template has statistical implications with regards to the presentation of the clinical data including subgroup analyses, surrogate endpoints, direct and indirect comparisons, metaanalyses and others.
The web-seminar will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG. PROs and CONs of certain statistical methods will be discussed in the light of their acceptance by G-BA and IQWiG. The target audience will be statisticians in HTA and statisticians who cope with the requests from their local German affiliate.
About the Presenter: Dr. Carsten Schwenk
Dr. Carsten Schwenke studied statistics at the Universities of Dortmund and Sheffield (UK) with minor subject theoretical medicine (University of Bochum). He completed his studies with a diploma in statistics and gained the certificate Biometry of the University of Dortmund. He received his PhD from the Technical University Berlin in the area public health / health economics at the Berlin School of Public Health.
Dr. Schwenke works as a statistician since 1995, first as a statistical researcher at the statistical consultation center of the University of Dortmund and in the department medical statistics at the University of Göttingen. This was followed by about 10 years as a project biometrician at Chiron-Behring in Marburg, where he headed the biometry, and at Schering AG. After this, he worked as project leader Specialized Therapeutics in the department of Global Health Economics and Outcomes Research at Bayer-Schering Pharma AG in Berlin.
Dr. Schwenke founded SCO:SSiS in 2007. Main areas of work are clinical development and – particularly since introduction of the AMNOG in 2011 – the area of market access and benefit assessment. A list of publications can be found in Medline (http://www.ncbi.nlm.nih.gov/pubmed/?term=Schwenke+C).
| Registration | |
| PSI Member | Free |
| Non-Member | £10 (plus VAT) |
Time: 15:00 - 16:00 UK Time
Presenter: Dr Carsten Schwenke
Early benefit assessment was introduced in Germany in 2011 as a basis for price negotiations between payers and pharmaceutical companies. Since then, all new drug substances have to be assessed at the Federal Joint Committee (G-BA), by indication. This series of webinars by Dr C. Schwenke will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG and should be of particular interest to statisticians who work in HTA and those who deal with requests from their local German team.
Click here to view the presentation slides.
Abstract
The so called early benefit assessment in Germany was introduced in 2011 as basis for price negotiations of the institutionary sick funds and the pharmaceutical company. Since then, all new drug substances are to be assessed at the Federal Joint Committee (G-BA, Gemeinsamer Bundesausschuss) by indication. A new indication always requires a new procedure. In a first step, the additional benefit over a comparator has to be shown based on the rules of evidence based medizine and the available clinical data. The marketing authorization holder has to submit a benefit dossier with all available clinical data for the drug substance in the indication. A template for the dossier is provided by G-BA and defines how the data is to be shown. This template has statistical implications with regards to the presentation of the clinical data including subgroup analyses, surrogate endpoints, direct and indirect comparisons, metaanalyses and others.
The web-seminar will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG. PROs and CONs of certain statistical methods will be discussed in the light of their acceptance by G-BA and IQWiG. The target audience will be statisticians in HTA and statisticians who cope with the requests from their local German affiliate.
About the Presenter: Dr. Carsten Schwenk
Dr. Carsten Schwenke studied statistics at the Universities of Dortmund and Sheffield (UK) with minor subject theoretical medicine (University of Bochum). He completed his studies with a diploma in statistics and gained the certificate Biometry of the University of Dortmund. He received his PhD from the Technical University Berlin in the area public health / health economics at the Berlin School of Public Health.
Dr. Schwenke works as a statistician since 1995, first as a statistical researcher at the statistical consultation center of the University of Dortmund and in the department medical statistics at the University of Göttingen. This was followed by about 10 years as a project biometrician at Chiron-Behring in Marburg, where he headed the biometry, and at Schering AG. After this, he worked as project leader Specialized Therapeutics in the department of Global Health Economics and Outcomes Research at Bayer-Schering Pharma AG in Berlin.
Dr. Schwenke founded SCO:SSiS in 2007. Main areas of work are clinical development and – particularly since introduction of the AMNOG in 2011 – the area of market access and benefit assessment. A list of publications can be found in Medline (http://www.ncbi.nlm.nih.gov/pubmed/?term=Schwenke+C).
| Registration | |
| PSI Member | Free |
| Non-Member | £10 (plus VAT) |
Time: 15:00 - 16:00 UK Time
Presenter: Dr Carsten Schwenke
Early benefit assessment was introduced in Germany in 2011 as a basis for price negotiations between payers and pharmaceutical companies. Since then, all new drug substances have to be assessed at the Federal Joint Committee (G-BA), by indication. This series of webinars by Dr C. Schwenke will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG and should be of particular interest to statisticians who work in HTA and those who deal with requests from their local German team.
Click here to view the presentation slides.
Abstract
The so called early benefit assessment in Germany was introduced in 2011 as basis for price negotiations of the institutionary sick funds and the pharmaceutical company. Since then, all new drug substances are to be assessed at the Federal Joint Committee (G-BA, Gemeinsamer Bundesausschuss) by indication. A new indication always requires a new procedure. In a first step, the additional benefit over a comparator has to be shown based on the rules of evidence based medizine and the available clinical data. The marketing authorization holder has to submit a benefit dossier with all available clinical data for the drug substance in the indication. A template for the dossier is provided by G-BA and defines how the data is to be shown. This template has statistical implications with regards to the presentation of the clinical data including subgroup analyses, surrogate endpoints, direct and indirect comparisons, metaanalyses and others.
The web-seminar will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG. PROs and CONs of certain statistical methods will be discussed in the light of their acceptance by G-BA and IQWiG. The target audience will be statisticians in HTA and statisticians who cope with the requests from their local German affiliate.
About the Presenter: Dr. Carsten Schwenk
Dr. Carsten Schwenke studied statistics at the Universities of Dortmund and Sheffield (UK) with minor subject theoretical medicine (University of Bochum). He completed his studies with a diploma in statistics and gained the certificate Biometry of the University of Dortmund. He received his PhD from the Technical University Berlin in the area public health / health economics at the Berlin School of Public Health.
Dr. Schwenke works as a statistician since 1995, first as a statistical researcher at the statistical consultation center of the University of Dortmund and in the department medical statistics at the University of Göttingen. This was followed by about 10 years as a project biometrician at Chiron-Behring in Marburg, where he headed the biometry, and at Schering AG. After this, he worked as project leader Specialized Therapeutics in the department of Global Health Economics and Outcomes Research at Bayer-Schering Pharma AG in Berlin.
Dr. Schwenke founded SCO:SSiS in 2007. Main areas of work are clinical development and – particularly since introduction of the AMNOG in 2011 – the area of market access and benefit assessment. A list of publications can be found in Medline (http://www.ncbi.nlm.nih.gov/pubmed/?term=Schwenke+C).
| Registration | |
| PSI Member | Free |
| Non-Member | £10 (plus VAT) |
Time: 15:00 - 16:00 UK Time
Presenter: Dr Carsten Schwenke
Early benefit assessment was introduced in Germany in 2011 as a basis for price negotiations between payers and pharmaceutical companies. Since then, all new drug substances have to be assessed at the Federal Joint Committee (G-BA), by indication. This series of webinars by Dr C. Schwenke will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG and should be of particular interest to statisticians who work in HTA and those who deal with requests from their local German team.
Click here to view the presentation slides.
Abstract
The so called early benefit assessment in Germany was introduced in 2011 as basis for price negotiations of the institutionary sick funds and the pharmaceutical company. Since then, all new drug substances are to be assessed at the Federal Joint Committee (G-BA, Gemeinsamer Bundesausschuss) by indication. A new indication always requires a new procedure. In a first step, the additional benefit over a comparator has to be shown based on the rules of evidence based medizine and the available clinical data. The marketing authorization holder has to submit a benefit dossier with all available clinical data for the drug substance in the indication. A template for the dossier is provided by G-BA and defines how the data is to be shown. This template has statistical implications with regards to the presentation of the clinical data including subgroup analyses, surrogate endpoints, direct and indirect comparisons, metaanalyses and others.
The web-seminar will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG. PROs and CONs of certain statistical methods will be discussed in the light of their acceptance by G-BA and IQWiG. The target audience will be statisticians in HTA and statisticians who cope with the requests from their local German affiliate.
About the Presenter: Dr. Carsten Schwenk
Dr. Carsten Schwenke studied statistics at the Universities of Dortmund and Sheffield (UK) with minor subject theoretical medicine (University of Bochum). He completed his studies with a diploma in statistics and gained the certificate Biometry of the University of Dortmund. He received his PhD from the Technical University Berlin in the area public health / health economics at the Berlin School of Public Health.
Dr. Schwenke works as a statistician since 1995, first as a statistical researcher at the statistical consultation center of the University of Dortmund and in the department medical statistics at the University of Göttingen. This was followed by about 10 years as a project biometrician at Chiron-Behring in Marburg, where he headed the biometry, and at Schering AG. After this, he worked as project leader Specialized Therapeutics in the department of Global Health Economics and Outcomes Research at Bayer-Schering Pharma AG in Berlin.
Dr. Schwenke founded SCO:SSiS in 2007. Main areas of work are clinical development and – particularly since introduction of the AMNOG in 2011 – the area of market access and benefit assessment. A list of publications can be found in Medline (http://www.ncbi.nlm.nih.gov/pubmed/?term=Schwenke+C).
| Registration | |
| PSI Member | Free |
| Non-Member | £10 (plus VAT) |
Time: 15:00 - 16:00 UK Time
Presenter: Dr Carsten Schwenke
Early benefit assessment was introduced in Germany in 2011 as a basis for price negotiations between payers and pharmaceutical companies. Since then, all new drug substances have to be assessed at the Federal Joint Committee (G-BA), by indication. This series of webinars by Dr C. Schwenke will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG and should be of particular interest to statisticians who work in HTA and those who deal with requests from their local German team.
Click here to view the presentation slides.
Abstract
The so called early benefit assessment in Germany was introduced in 2011 as basis for price negotiations of the institutionary sick funds and the pharmaceutical company. Since then, all new drug substances are to be assessed at the Federal Joint Committee (G-BA, Gemeinsamer Bundesausschuss) by indication. A new indication always requires a new procedure. In a first step, the additional benefit over a comparator has to be shown based on the rules of evidence based medizine and the available clinical data. The marketing authorization holder has to submit a benefit dossier with all available clinical data for the drug substance in the indication. A template for the dossier is provided by G-BA and defines how the data is to be shown. This template has statistical implications with regards to the presentation of the clinical data including subgroup analyses, surrogate endpoints, direct and indirect comparisons, metaanalyses and others.
The web-seminar will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG. PROs and CONs of certain statistical methods will be discussed in the light of their acceptance by G-BA and IQWiG. The target audience will be statisticians in HTA and statisticians who cope with the requests from their local German affiliate.
About the Presenter: Dr. Carsten Schwenk
Dr. Carsten Schwenke studied statistics at the Universities of Dortmund and Sheffield (UK) with minor subject theoretical medicine (University of Bochum). He completed his studies with a diploma in statistics and gained the certificate Biometry of the University of Dortmund. He received his PhD from the Technical University Berlin in the area public health / health economics at the Berlin School of Public Health.
Dr. Schwenke works as a statistician since 1995, first as a statistical researcher at the statistical consultation center of the University of Dortmund and in the department medical statistics at the University of Göttingen. This was followed by about 10 years as a project biometrician at Chiron-Behring in Marburg, where he headed the biometry, and at Schering AG. After this, he worked as project leader Specialized Therapeutics in the department of Global Health Economics and Outcomes Research at Bayer-Schering Pharma AG in Berlin.
Dr. Schwenke founded SCO:SSiS in 2007. Main areas of work are clinical development and – particularly since introduction of the AMNOG in 2011 – the area of market access and benefit assessment. A list of publications can be found in Medline (http://www.ncbi.nlm.nih.gov/pubmed/?term=Schwenke+C).
| Registration | |
| PSI Member | Free |
| Non-Member | £10 (plus VAT) |
Time: 15:00 - 16:00 UK Time
Presenter: Dr Carsten Schwenke
Early benefit assessment was introduced in Germany in 2011 as a basis for price negotiations between payers and pharmaceutical companies. Since then, all new drug substances have to be assessed at the Federal Joint Committee (G-BA), by indication. This series of webinars by Dr C. Schwenke will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG and should be of particular interest to statisticians who work in HTA and those who deal with requests from their local German team.
Click here to view the presentation slides.
Abstract
The so called early benefit assessment in Germany was introduced in 2011 as basis for price negotiations of the institutionary sick funds and the pharmaceutical company. Since then, all new drug substances are to be assessed at the Federal Joint Committee (G-BA, Gemeinsamer Bundesausschuss) by indication. A new indication always requires a new procedure. In a first step, the additional benefit over a comparator has to be shown based on the rules of evidence based medizine and the available clinical data. The marketing authorization holder has to submit a benefit dossier with all available clinical data for the drug substance in the indication. A template for the dossier is provided by G-BA and defines how the data is to be shown. This template has statistical implications with regards to the presentation of the clinical data including subgroup analyses, surrogate endpoints, direct and indirect comparisons, metaanalyses and others.
The web-seminar will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG. PROs and CONs of certain statistical methods will be discussed in the light of their acceptance by G-BA and IQWiG. The target audience will be statisticians in HTA and statisticians who cope with the requests from their local German affiliate.
About the Presenter: Dr. Carsten Schwenk
Dr. Carsten Schwenke studied statistics at the Universities of Dortmund and Sheffield (UK) with minor subject theoretical medicine (University of Bochum). He completed his studies with a diploma in statistics and gained the certificate Biometry of the University of Dortmund. He received his PhD from the Technical University Berlin in the area public health / health economics at the Berlin School of Public Health.
Dr. Schwenke works as a statistician since 1995, first as a statistical researcher at the statistical consultation center of the University of Dortmund and in the department medical statistics at the University of Göttingen. This was followed by about 10 years as a project biometrician at Chiron-Behring in Marburg, where he headed the biometry, and at Schering AG. After this, he worked as project leader Specialized Therapeutics in the department of Global Health Economics and Outcomes Research at Bayer-Schering Pharma AG in Berlin.
Dr. Schwenke founded SCO:SSiS in 2007. Main areas of work are clinical development and – particularly since introduction of the AMNOG in 2011 – the area of market access and benefit assessment. A list of publications can be found in Medline (http://www.ncbi.nlm.nih.gov/pubmed/?term=Schwenke+C).
| Registration | |
| PSI Member | Free |
| Non-Member | £10 (plus VAT) |
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.
Who is this event intended for? Statisticians with an interest understanding dose-finding in oncology. What is the benefit of attending? Learn about the state of oncology dose finding, particularly in light of current FDA guidance.
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 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 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.
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 Institute of Cancer Research are seeking to appoint a Research Group Leader to join The CRUK Clinical Trials and Statistics Unit at the ICR.
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.
The BioMarin internship programme will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, whilst gaining an insight into the pharmaceutical/biotech industry.
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