BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 13.3//EN BEGIN:VTIMEZONE TZID:Eastern Standard Time BEGIN:STANDARD DTSTART:20231102T020000 RRULE:FREQ=YEARLY;BYDAY=1SU;BYHOUR=2;BYMINUTE=0;BYMONTH=11 TZNAME:Eastern Standard Time TZOFFSETFROM:-0400 TZOFFSETTO:-0500 END:STANDARD BEGIN:DAYLIGHT DTSTART:20230301T020000 RRULE:FREQ=YEARLY;BYDAY=2SU;BYHOUR=2;BYMINUTE=0;BYMONTH=3 TZNAME:Eastern Daylight Time TZOFFSETFROM:-0500 TZOFFSETTO:-0400 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Please save the date: March 15\, 2018 from 11:00 am &ndash\; 12 :30 pm US EDT \nSpeakers:\nRobert Hemmings\, Unit Manager\, Statistics and Pharmacokinetics Unit\, Medicines and Healthcare products Regulatory Agen cy (MHRA)\, UK \nWolfgang Kothny\, \;Clinical Development Medical Dire ctor\, Novartis Pharma\, Switzerland \nAbstract:\nThis first webinar in a series of planned events discusses the steps to improve transparency and e nsure alignment between trial objectives and statistical approaches in ter ms of clearly defining the treatment effect(s) targeted in a clinical tria l.\nThis substantive evolution to traditional clinical trial design\, cond uct and analysis requires a multi-disciplinary effort and a common underst anding beyond the statistics community. This first webinar in the series w ill refer to the draft addendum to the main statistical guidance in drug d evelopment &ndash\; ICH E9 (link).  \;It will provide a non-technical introduction and encompass clinical\, statistical and regulatory perspecti ves.  \;In addition\, a structured framework to articulate precise mea sures of clinically meaningful endpoints will be presented. \nDue to the i mportance and broad interest of this webinar\, this webinar is being offer ed to all DIA Communities and the general public\, at no cost to anyone wh o wishes to join the call. DIA is a not-for-profit organization. We\, the leaders of partnering DIA Communities (Statistics\, Patient Engagement\, R egulatory Affairs\, Study Endpoints\, Clinical Research and Clinical Data Management communities\, as well as the DIA/ASA Biopharma Safety Assessmen t WG) are grateful to DIA for this generosity and interest in advancing sc ience\, as we all consider how to design better trials via clear objective s and statistical plan.\nThe session promises to be an interesting and inf ormative one. Please join* us! \n* Regular events like this special\, one- time open-to-all event\, occur many months of the year as a free benefit t o any DIA member who joins a DIA Community. \nRegistration (two-step proce ss):\nPart 1 \;&ndash\; Enter information at the following link to rec eive a calendar invite and follow up email for Part 2: \;engage.diaglo bal.org/DIA-Stats-Community-Webinar-1.html\n \;Part 2 \;&ndash\; E nter brief information to receive Zoom login and call in details.\n DTEND:20180315T163000Z DTSTAMP:20240329T064927Z DTSTART:20180315T150000Z LOCATION: SEQUENCE:0 SUMMARY:DIA Multi-Community Webinar UID:RFCALITEM638472917673860415 X-ALT-DESC;FMTTYPE=text/html:
Please save the date: March 15\, 20 18 from 11:00 am &ndash\; 12:30 pm US EDT
\nSpeake rs:
\nRobert Hemmings\, Unit Manager\, Sta tistics and Pharmacokinetics Unit\, Medicines and Healthcare products Regu latory Agency (MHRA)\, UK
\nWolfgang Kothny\,  \;Clinical Development Medical Director\, Novartis Pharma\, Switzerland p>\n
Abstract:
\nThis first webinar in a series of
planned events discusses the steps to improve transparency and ensure ali
gnment between trial objectives and statistical approaches in terms of cle
arly defining the treatment effect(s) targeted in a clinical trial.
Due to the importance and broad interest of this w ebinar\, this webinar is being offered to all DIA Communities and the gene ral public\, at no cost to anyone who wishes to join the call. DIA is a no t-for-profit organization. We\, the leaders of partnering DIA Communities (Statistics\, Patient Engagement\, Regulatory Affairs\, Study Endpoints\, Clinical Research and Clinical Data Management communities\, as well as th e DIA/ASA Biopharma Safety Assessment WG) are grateful to DIA for this gen erosity and interest in advancing science\, as we all consider how to desi gn better trials via clear objectives and statistical plan.
\nThe se ssion promises to be an interesting and informative one. Please join* us!
\n* Regular events like this special\, one-time open-to-all event\, occur many months of the year as a free benefit to any DIA member who joi ns a DIA Community.
\nRegistration (two-step process):
\nPart 1 \;&ndash\; Enter information at t he following link to receive a calendar invite and follow up email for Par t 2: \;engage.diagloba l.org/DIA-Stats-Community-Webinar-1.html
\n \;Part 2  \;&ndash\; Enter brief information to receive Zoom login and call in details.
\n