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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
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).
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.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
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.
Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
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 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.
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.
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