• PSI Webinar: HTA submissions in Germany, what do statisticians need to know to be successful with their GBA dossiers – Part One

    Dates: 23 – 23 Jan, 2018
    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.

    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 Schwenke

    _wsb_244x367_foto_carstenDr. 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 at 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)


    Click here to register.
  • PSI Webinar: HTA submissions in Germany, what do statisticians need to know to be successful with their GBA dossiers – Part Two

    Dates: 31 – 31 Jan, 2018
    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.

    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 Schwenke

    _wsb_244x367_foto_carstenDr. 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)

    Click here to register.
  • PSI Webinar: HTA submissions in Germany, what do statisticians need to know to be successful with their GBA dossiers – Part Three

    Dates: 13 – 13 Feb, 2018
    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.

    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

    _wsb_244x367_foto_carstenDr. 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)

    Click here to register.
  • Medical Statistics Taster Day 2018

    Dates: 28 Feb, 2018

    Our annual careers event, Medical Statistics Taster Day, will be held at the University of Leicester on Wednesday 28th February 2018.  The half-day event will include a series of talks, panel discussion, exhibition stands, and an interactive workshop.

    This event is open for attendance to all students currently studying for a statistics-related MSc or PhD. Final year BSc students studying a statistics-related course are also welcome (although places may be limited depending on demand).

    This event is open for exhibitors to all UK pharmaceutical companies, CROs, CTUs and other organisations working within the field of Medical Statistics. We would also like to welcome any UK-based universities who run an MSc or PhD in Statistics, or have statistical consulting groups. 

    We would like to invite all of the above to run an exhibition stand to promote working or studying further in the field Medical Statistics, so that students can be made fully aware of their options.  We will also be looking for company volunteers to help with the panel discussion, new starter talk and workshop, so please let us know on your registration form if you are able to help.

    For exhibitors - this is an excellent opportunity to raise the profile of your company or university with students who are interested in a career in medical statistics. 

    For students - this is an excellent opportunity to find out more about the field of medical statistics, talk to people from different organisations and make contacts for the future.

    Click here for further details and to register online. 

    We look forward to seeing you there!

    PSI Careers and Academic Liaison Committee (CALC)

  • A PSI Training Course on Missing Data

    Heathrow | Dates: 06 – 07 Mar, 2018
    The aim of this course is to provide participants with an understanding of missing data, its link with what is to be estimated in a study (the “estimand”), and statistical modelling approaches. The 2 day course includes workshops: participants will undertake a number of practical exercises on missing data in SAS. The course will provide participants the opportunity to gain insight into some of the more useful new methodologies for missing data, with a view to being at the service of the real scientific question of interest. Multiple imputation (MI) will be emphasised – due to this method’s flexibility.

    Attendees will require a laptop with access to SAS.

    The following topics will be covered:
     
    - History of research into missing data
    - Prevention of missing data and impact on study power
    - Missing Data and its relation to the estimand
    - Estimands and their models
    - Multiple imputation I: models for missing data
    - Weighting I: weighting for missing data
    - Multiple imputation II: methods for non-continuous endpoints
    - Weighting II: augmenting weighed data with model estimates
    - Composite endpoints
    - Case studies

    Course runs from:
    10:00 - 17:00 (registration from 09:00) on Day 1
    09:00 - 16:00 on Day 2

    ​​Registration

    Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms until the 31st January 2018 which will be allocated on a first come first served basis.

    Registration BEFORE 31st January 2018 
     PSI Member  £495 plus VAT
     Non-Member  £590 plus VAT
     Registration AFTER 31st January 2018
     PSI Member  £595 plus VAT
     Non-Member  £690 plus VAT

    Please click here to register.
        
    Please click here to view the flyer.
  • PSI Toxicology SIG Workshop 2018

    Stockley Road | Dates: 24 – 25 Apr, 2018

    The Toxicology SIG provides a forum for statisticians working in regulatory and investigative toxicology to discuss issues and interact with one another. 

    This 1.5-day workshop will involve hopefully approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types. 

    The cost will be £225 including VAT per delegate, inclusive of food and one night’s accommodation.  The workshop is being held at the Crowne Plaza Hotel, Heathrow. 

    The agenda and topics that will be discussed is yet to be finalised, but please get in touch with gareth.thomas@envigo.com if you have suggestions.  Full details will be circulated in the coming months.

    Registration Costs
     £225 incl VAT Inclusive of food and one night’s accommodation 


    Please click here to register.