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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 negotiati
ons of the institutionary sick funds and the pharmaceutical company. Since
then\, all new drug substances are to be assessed at the Federal Joint Co
mmittee (G-BA\, Gemeinsamer Bundesausschuss) by indication. A new indicati
on always requires a new procedure. In a first step\, the additional benef
it over a comparator has to be shown based on the rules of evidence based
medizine and the available clinical data. The marketing authorization hold
er has to submit a benefit dossier with all available clinical data for th
e 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 statis
tical implications with regards to the presentation of the clinical data i
ncluding subgroup analyses\, surrogate endpoints\, direct and indirect com
parisons\, 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\nAbout the Presenter: \;Dr. Carsten Schwenke\nDr. Carsten Schwenke
studied statistics at the Universities of \;  \; Dortmund and Shef
field (UK) with minor subject theoretical \; medicine (University of B
ochum). He completed his studies with a diploma in statistics and gained t
he certificate Biometry of the \; University of Dortmund. He received
his PhD from the Technical \; University Berlin in the area public hea
lth / health economics at \; the Berlin School of Public Health.\nDr.
Schwenke works as a statistician since 1995\, first as a \; statistica
l researcher at the statistical consultation center of the University of D
ortmund and in the department medical statistics at the University of G&ou
ml\;ttingen. This was followed by about 10 years as a project biometrician
at Chiron-Behring in Marburg\, where he headed the biometry\, and at Sche
ring AG. After this\, he worked as project leader Specialized Therapeutics
in the department of Global Health Economics and Outcomes Research at Bay
er-Schering Pharma AG in Berlin.\nDr. Schwenke founded SCO:SSiS \;in 2
007. Main areas of work are clinical development and &ndash\; particularly
since introduction of the AMNOG in 2011 &ndash\; the area of market acces
s 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 P
SI Member\n Free\n \n \n Non-Member\n
£\;10 (plus VAT)\n \n \n \n\n\nTo acc
ess the recording\, please visit the Video-on-Demand Library.
DTEND:20180131T160000Z
DTSTAMP:20240328T203918Z
DTSTART:20180131T150000Z
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 Two
UID:RFCALITEM638472551589767853
X-ALT-DESC;FMTTYPE=text/html:Time: \;15:00 - 16:00 UK
Time
\nPresenter: \;Dr Carsten Schwenke
\n<
br />\n
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.
\n
\nClick here \;to view the presentation slides.
A bstract
\nThe so called early benefit assessment in Germany was introduced in 2011 as basis for price negotiations of the institution ary sick funds and the pharmaceutical company. Since then\, all new drug s ubstances are to be assessed at the Federal Joint Committee (G-BA\, Gemein samer Bundesausschuss) by indication. A new indication always requires a n ew procedure. In a first step\, the additional benefit over a comparator h as to be shown based on the rules of evidence based medizine and the avail able clinical data. The marketing authorization holder has to submit a ben efit dossier with all available clinical data for the drug substance in th e indication. A template for the dossier is provided by G-BA and defines h ow the data is to be shown. This template has statistical implications wit h regards to the presentation of the clinical data including subgroup anal yses\, surrogate endpoints\, direct and indirect comparisons\, metaanalyse s and others.
\nThe web-seminar will focus on the statistical implic
ations and how to deal with the requirements by G-BA and their methodologi
cal 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 wi
th the requests from their local German affiliate. \;
\n
\n<
/p>\n
About the Presenter: \;Dr. Carsten Sc hwenke
\nDr. Carsten Schwenke studied statistics at the Universities of \;  \; Dortmund and Sheffield (UK) with min or subject theoretical \; medicine (University of Bochum). He complete d his studies with a diploma in statistics and gained the certificate Biom etry of the \; University of Dortmund. He received his PhD from the Te chnical \; University Berlin in the area public health / health econom ics at \; the Berlin School of Public Health.
\nDr. Schwenke wor ks 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 Gö\;ttingen. This was followed by about 10 years as a project biometrician at Chiron-B ehring in Marburg\, where he headed the biometry\, and at Schering AG. Aft er this\, he worked as project leader Specialized Therapeutics in the depa rtment of Global Health Economics and Outcomes Research at Bayer-Schering Pharma AG in Berlin.
\nDr. Schwenke founded SCO:SSiS \;in 2007. Main areas of work are clinical devel opment and &ndash\; particularly since introduction of the AMNOG in 2011 & ndash\; the area of market access and benefit assessment. A list of public ations can be found in Medline (http://www.ncbi.nlm.nih.gov/pubmed/?term=Schwenke+C a>). \;
\n \;
\nPSI Member | \nFree | \n
Non-Member | \n£\;10 (plus VAT) \n | \n