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 Schwenke\n\nEarly 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. S chwenke will focus on the statistical implications and how to deal with th e requirements by G-BA and their methodological support institute IQWiG an d should be of particular interest to statisticians who work in HTA and th ose who deal with requests from their local German team.\n\nClick here&nbs p\;to view the presentation slides\nAbstract\nThe so called early benefit assessment in Germany was introduced in 2011 as basis for price negotiatio ns of the institutionary sick funds and the pharmaceutical company. Since then\, all new drug substances are to be assessed at the Federal Joint Com mittee (G-BA\, Gemeinsamer Bundesausschuss) by indication. A new indicatio n always requires a new procedure. In a first step\, the additional benefi t over a comparator has to be shown based on the rules of evidence based m edizine and the available clinical data. The marketing authorization holde r 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 statist ical implications with regards to the presentation of the clinical data in cluding subgroup analyses\, surrogate endpoints\, direct and indirect comp arisons\, metaanalyses and others. \nThe web-seminar will focus on the sta tistical implications and how to deal with the requirements by G-BA and th eir methodological support institute IQWiG. PROs and CONs of certain stati stical methods will be discussed in the light of their acceptance by G-BA and IQWiG. The target audience will be statisticians in HTA and statistici ans who cope with the requests from their local German affiliate. \n\n\nAb out the Presenter: \;Dr. Carsten Schwenke\nDr. Carsten Schwenke studie d 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 cer tificate Biometry of the \; University of Dortmund. He received his Ph D from the Technical \; University Berlin in the area public health / health economics at \; the Berlin School of Public Health. \nDr. Schwe nke works at 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 \n Registration\n \n \n PSI Member\ n Free\n \n \n Non-Member\n £\;10 (plus VAT)\n \n \n \n\n\n\nTo access the recording\, please visit the Video-on-Demand Library. DTEND:20180123T160000Z DTSTAMP:20260905T081217Z DTSTART:20180123T150000Z 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 One UID:RFCALITEM639241927373392730 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 Jo int Committee (G-BA)\, by indication. This series of webinars by Dr C. Sch wenke 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 thos e who deal with requests from their local German team.
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\nClick here \ ;to view 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 basis for price negotiations of the institutionary sick funds and the p harmaceutical company. Since then\, all new drug substances are to be asse ssed at the Federal Joint Committee (G-BA\, Gemeinsamer Bundesausschuss) b y 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 av ailable 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 sho wn. This template has statistical implications with regards to the present ation of the clinical data including subgroup analyses\, surrogate endpoin ts\, direct and indirect comparisons\, metaanalyses and others.

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T he web-seminar will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute I QWiG. PROs and CONs of certain statistical methods will be discussed in th e 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 th eir local German affiliate.
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About the Pre senter: \;Dr. Carsten Schwenke

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_wsb_244x367_foto_carste nDr. Ca rsten Schwenke studied statistics at the Universities of \;  \; Do rtmund and Sheffield (UK) with minor subject theoretical \; medicine ( University of Bochum). He completed his studies with a diploma in statisti cs and gained the certificate Biometry of the \; University of Dortmun d. He received his PhD from the Technical \; University Berlin in the area public health / health economics at \; the Berlin School of Publi c Health.

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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 Gö\;ttingen. 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 S pecialized Therapeutics in the department of Global Health Economics and O utcomes Research at Bayer-Schering Pharma AG in Berlin.

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Dr. Schwen ke founded SCO:SSiS \;in 2007. Ma in areas of work are clinical development and &ndash\; particularly since introduction of the AMNOG in 2011 &ndash\; the area of market access and b enefit assessment. A list of publications can be found in Medline (http://www.ncbi.nl m.nih.gov/pubmed/?term=Schwenke+C). \;
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\nTo access the recording\, please visit the Video-on-Demand Library.
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