BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:W. Europe Standard Time BEGIN:STANDARD DTSTART:20251002T030000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=3;BYMINUTE=0;BYMONTH=10 TZNAME:W. Europe Standard Time TZOFFSETFROM:+0200 TZOFFSETTO:+0100 END:STANDARD BEGIN:DAYLIGHT DTSTART:20250301T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=2;BYMINUTE=0;BYMONTH=3 TZNAME:W. Europe Daylight Time TZOFFSETFROM:+0100 TZOFFSETTO:+0200 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:14.00-15.30 UK Time\n\nIn September 2018 the FDA published a gu idance on adaptive design for clinical trials of drugs and biologics\, upd ating (not finalizing) its initial draft from February 2010. \; The ma in focus of the webinar will be to provide an overview of its main content s\, which will be presented by Jü\;rgen Hummel (PPD). In addition\, Ka spar Rufibach (Roche) will introduce an open-source statistical software f or adaptive designs\, RPACT (an R package that enables the design and anal ysis of confirmatory adaptive clinical trials). \; Kit Roes will also comment on the guidance from a European Regulatory perspective\, which wil l be followed by a brief panel discussion.\n\nRegistration\n\nThis Webinar is free to attend\, to register please click here.\n\n \n \n \n  \;\n Jü\;rgen Hummel joined PPD near Glasgow (Scotland) in 2006\, where he is Senior Director\, Statistic al Science. He heads up the statistical science track within PPD Biostatis tics and provides statistical consultancy both internally and externally. Specifically\, he has been leading PPD&rsquo\;s cross-departmental Adaptiv e Design Working Group since it was set up 8 year ago. \; In his caree r he held a variety of technical and managerial positions within the biost atistics department of different organizations\, predominantly within the CRO industry. \; Jü\;rgen earned a Diplom (German equivalent of a master&rsquo\;s degree) in mathematics and economics at Augsburg Universit y\, Germany\, and has been a chartered statistician with the Royal Statist ical Society since 2006.  \;  \;  \;  \;  \;\n \n \n \n  \;\n Kaspar Rufibach is a member of Roche's Methods\, Collaboration\, and Outreach group and l ocated in Basel. He does methodological research\, provides consulting to Roche statisticians and broader project teams\, gives biostatistics traini ngs for statisticians and non-statisticians in- and externally\, mentors s tudents\, and interacts with external partners in industry and the academi c community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 comp anies and works on various topics around estimands in oncology. Research i nterests are methods to optimize study designs\, advanced survival analysi s\, probability of success\, estimands\, estimation of treatment effects i n subgroups\, and general nonparametric statistics. Before joining Roche\, Kaspar received training and worked as a statistician at the Universities of Bern\, Stanford\, and Zurich.\n \n \n \n  \;\n Kit Roes is Professor of Clinical Trial Method ology at the Julius Center of the University Medical Center Utrecht. His r esearch focus is on design and analysis of clinical trials\, with an empha sis of innovative designs\, rare diseases and bridging the gap between cli nical trials and real world evidence. He participates in the Regulatory Sc ience Network Netherlands\, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience i ncludes over 20 years in clinical research and development in the pharmace utical industry and academic life sciences\, serving clinical research and drug development as expert as well as in different (international) senior management positions.\n \n \n\n DTEND:20190704T133000Z DTSTAMP:20260807T191730Z DTSTART:20190704T120000Z LOCATION: SEQUENCE:0 SUMMARY:PSI Webinar: Adaptive design: updated draft FDA guidance and its im plications UID:RFCALITEM639217270507024209 X-ALT-DESC;FMTTYPE=text/html:

14.00-15.30 UK Time
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\nIn Septe mber 2018 the FDA published a guidance on adaptive design for clinical tri als of drugs and biologics\, updating (not finalizing) its initial draft f rom February 2010. \; The main focus of the webinar will be to provide an overview of its main contents\, which will be presented by Jü\;rge n Hummel (PPD). In addition\, Kaspar Rufibach (Roche) will introduce an op en-source statistical software for adaptive designs\, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical tri als). \; Kit Roes will also comment on the guidance from a European Re gulatory perspective\, which will be followed by a brief panel discussion.
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\nRegistration
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\nThis Webinar is free to attend\, to register please click here.< /p>\n\n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n  \;Photo Jurgen Hummel (2019)		Jü\;rgen Hummel joined PPD near Glasg ow (Scotland) in 2006\, where he is Senior Director\, Statistical Science. He heads up the statistical science track within PPD Biostatistics and pr ovides statistical consultancy both internally and externally. Specificall y\, he has been leading PPD&rsquo\;s cross-departmental Adaptive Design Wo rking Group since it was set up 8 year ago. \; In his career he held a variety of technical and managerial positions within the biostatistics de partment of different organizations\, predominantly within the CRO industr y. \; Jü\;rgen earned a Diplom (German equivalent of a master&rsqu o\;s degree) in mathematics and economics at Augsburg University\, Germany \, and has been a chartered statistician with the Royal Statistical Societ y since 2006.  \;  \;  \;  \;  \;

\n  \;Photo Kaspar Rufibach		Kaspar Rufibach is a member of Roche's Methods\, Collaboration\, and Outreach group and located in Basel. He does methodological research\, provides consulting to Roche statisticians and broader project teams\, gives biostatistics trainings for statisticians an d non-statisticians in- and externally\, mentors students\, and interacts with external partners in industry and the academic community in various w orking groups. He has co-founded and co-leads the Oncology estimand Workin g group that currently has 31 members from 19 companies and works on vario us topics around estimands in oncology. Research interests are methods to optimize study designs\, advanced survival analysis\, probability of succe ss\, estimands\, estimation of treatment effects in subgroups\, and genera l nonparametric statistics. Before joining Roche\, Kaspar received trainin g and worked as a statistician at the Universities of Bern\, Stanford\, an d Zurich.

\n  \;RoesK< /td>\n 		Kit Roes is Professor of Clinical Trial Methodology at t he Julius Center of the University Medical Center Utrecht. His research fo cus is on design and analysis of clinical trials\, with an emphasis of inn ovative designs\, rare diseases and bridging the gap between clinical tria ls and real world evidence. He participates in the Regulatory Science Netw ork Netherlands\, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes ov er 20 years in clinical research and development in the pharmaceutical ind ustry and academic life sciences\, serving clinical research and drug deve lopment as expert as well as in different (international) senior managemen t positions.
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