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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:20240328T121437Z
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:RFCALITEM638472248780424792
X-ALT-DESC;FMTTYPE=text/html:Time: 15:00 - 16:00 UK Time\nPresenter: \;Dr Carsten Schwenke
\n
\
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 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.
\n
\nClick here&
nbsp\;to view the presentation slides.
Abstract p>\n
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 b e assessed at the Federal Joint Committee (G-BA\, Gemeinsamer Bundesaussch uss) by indication. A new indication always requires a new procedure. In a first step\, the additional benefit over a comparator has to be shown bas ed 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 te mplate 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 p resentation of the clinical data including subgroup analyses\, surrogate e ndpoints\, direct and indirect comparisons\, metaanalyses and others.
\ nThe web-seminar will focus on the statistical implications and how to
deal with the requirements by G-BA and their methodological support instit
ute 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 wi
ll be statisticians in HTA and statisticians who cope with the requests fr
om their local German affiliate. \;
\n
\n
Ab
out the Presenter: \;Dr. Carsten Schwenk
\n
\nDr. Carsten Schwenke studied statistics at the Unive
rsities of \;  \; Dortmund and Sheffield (UK) with minor subject t
heoretical \; medicine (University of Bochum). He completed his studie
s with a diploma in statistics and gained the certificate Biometry of the&
nbsp\; 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 stat istician since 1995\, first as a \; statistical researcher at the stat istical consultation center of the University of Dortmund and in the depar tment medical statistics at the University of Gö\;ttingen. This was fo llowed by about 10 years as a project biometrician at Chiron-Behring in Ma rburg\, where he headed the biometry\, and at Schering AG. After this\, he worked as project leader Specialized Therapeutics in the department of Gl obal 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 development and & ndash\; particularly since introduction of the AMNOG in 2011 &ndash\; the area of market access and benefit assessment. A list of publications can b e found in Medline (http://www.ncbi.nlm.nih.gov/pubmed/?term=Schwenke+C). \;< /p>\n
 \;
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PSI Member | \nFree | \n
Non-Member | \n£\;10 (plus VAT) | \n