BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:GMT Standard Time BEGIN:STANDARD DTSTART:20251002T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=2;BYMINUTE=0;BYMONTH=10 TZNAME:GMT Standard Time TZOFFSETFROM:+0100 TZOFFSETTO:+0000 END:STANDARD BEGIN:DAYLIGHT DTSTART:20250301T010000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=1;BYMINUTE=0;BYMONTH=3 TZNAME:GMT Daylight Time TZOFFSETFROM:+0000 TZOFFSETTO:+0100 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Time: 15:00 - 16:00 UK Time\nPresenter: \;Dr Carsten Schwen ke\n\nEarly benefit assessment was introduced in Germany in 2011 as a basi s for price negotiations between payers and pharmaceutical companies. Sinc e 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. Schwenk e will focus on the statistical implications and how to deal with the requ irements by G-BA and their methodological support institute IQWiG and shou ld be of particular interest to statisticians who work in HTA and those wh o deal with requests from their local German team.\n\nClick here \;to view the presentation slides.\nAbstract\nThe so called early benefit asses sment 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 Committe e (G-BA\, Gemeinsamer Bundesausschuss) by indication. A new indication alw ays requires a new procedure. In a first step\, the additional benefit ove r a comparator has to be shown based on the rules of evidence based medizi ne 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 includi ng subgroup analyses\, surrogate endpoints\, direct and indirect compariso ns\, metaanalyses and others.\nThe web-seminar will focus on the statistic al implications and how to deal with the requirements by G-BA and their me thodological support institute IQWiG. PROs and CONs of certain statistical methods will be discussed in the light of their acceptance by G-BA and IQ WiG. The target audience will be statisticians in HTA and statisticians wh o cope with the requests from their local German affiliate. \;\n\n\nAb out the Presenter: \;Dr. Carsten Schwenk\n\nDr. Carsten Schwenke studi ed 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 ce rtificate Biometry of the \; University of Dortmund. He received his P hD from the Technical \; University Berlin in the area public health / health economics at \; the Berlin School of Public Health.\nDr. Schwe nke works as a statistician since 1995\, first as a \; statistical res earcher at the statistical consultation center of the University of Dortmu nd and in the department medical statistics at the University of Gö\;t tingen. This was followed by about 10 years as a project biometrician at C hiron-Behring in Marburg\, where he headed the biometry\, and at Schering AG. After this\, he worked as project leader Specialized Therapeutics in t he department of Global Health Economics and Outcomes Research at Bayer-Sc hering Pharma AG in Berlin.\nDr. Schwenke founded SCO:SSiS \;in 2007. Main areas of work are clinical development and &ndash\; particularly sinc e introduction of the AMNOG in 2011 &ndash\; 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). \;\n \;\n\n \n \n Registration\n \n \n PSI Me mber\n Free\n \n \n Non-Member\n £\;10 (plus VAT)\n \n \n\n\nTo access the recording\, please visit the Video-on-Demand Library. DTEND:20180306T160000Z DTSTAMP:20260721T165245Z DTSTART:20180306T150000Z LOCATION: SEQUENCE:0 SUMMARY:PSI Webinar: HTA submissions in Germany\, what do statisticians nee d to know to be successful with their GBA dossiers – Part Three UID:RFCALITEM639202495656597938 X-ALT-DESC;FMTTYPE=text/html:Time: 15:00 - 16:00 UK Time\nPresenter: \;Dr Carsten Schwenke
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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 Co mmittee (G-BA)\, by indication. This series of webinars by Dr C. Schwenke will focus on the statistical implications and how to deal with the requir ements 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.
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\nClick here \;to vi ew the presentation slides.

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Abstract

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The so called early benefit assessment in Germany was introduced in 2011 as ba sis for price negotiations of the institutionary sick funds and the pharma ceutical company. Since then\, all new drug substances are to be assessed at the Federal Joint Committee (G-BA\, Gemeinsamer Bundesausschuss) by ind ication. 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 r ules of evidence based medizine and the available clinical data. The marke ting authorization holder has to submit a benefit dossier with all availab le 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. T his 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.

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The web -seminar will focus on the statistical implications and how to deal with t he requirements by G-BA and their methodological support institute IQWiG. PROs and CONs of certain statistical methods will be discussed in the ligh t of their acceptance by G-BA and IQWiG. The target audience will be stati sticians in HTA and statisticians who cope with the requests from their lo cal German affiliate. \;
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About the Pre senter: \;Dr. Carsten Schwenk
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\n_wsb_244x367_foto_ carsten Dr. Carsten Schwenke studied statistics at the Universities of \; &nbs p\; Dortmund and Sheffield (UK) with minor subject theoretical \; medi cine (University of Bochum). He completed his studies with a diploma in st atistics and gained the certificate Biometry of the \; University of D ortmund. He received his PhD from the Technical \; University Berlin i n the area public health / health economics at \; the Berlin School of Public Health.

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Dr. Schwenke works as a statistician since 1995\, first as a \; statistical researcher at the statistical consultation c enter of the University of Dortmund and in the department medical statisti cs at the University of Gö\;ttingen. This was followed by about 10 yea rs as a project biometrician at Chiron-Behring in Marburg\, where he heade d the biometry\, and at Schering AG. After this\, he worked as project lea der Specialized Therapeutics in the department of Global Health Economics and Outcomes Research at Bayer-Schering Pharma AG in Berlin.

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Dr. S chwenke founded SCO:SSiS \;in 200 7. Main areas of work are clinical development and &ndash\; particularly s ince introduction of the AMNOG in 2011 &ndash\; the area of market access and benefit assessment. A list of publications can be found in Medline (http://www.nc bi.nlm.nih.gov/pubmed/?term=Schwenke+C). \;

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\n< table class="PSI-default-table">\n \n \n Registration\n \n \n PSI Member\n Free\n \n \n N on-Member\n &poun d\;10 (plus VAT)\n \n \n\n
\nTo access the recording\, please visit the Video-on-Demand Library. END:VEVENT END:VCALENDAR