BEGIN:VCALENDAR VERSION:2.0 PRODID:-//PYVOBJECT//NONSGML Version 1//EN BEGIN:VTIMEZONE TZID:Europe/Brussels BEGIN:STANDARD DTSTART:20001029T030000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYMONTH=10 TZNAME:CET TZOFFSETFROM:+0200 TZOFFSETTO:+0100 END:STANDARD BEGIN:DAYLIGHT DTSTART:20000326T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYMONTH=3 TZNAME:CEST TZOFFSETFROM:+0100 TZOFFSETTO:+0200 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT UID:20260823T235153Z - 44262@5dac2d9de651 DTSTART;TZID=Europe/Brussels:20260723T160000 DTEND;TZID=Europe/Brussels:20260723T173000 CREATED:20260823T235153Z DESCRIPTION:SCDM Webinar | Closing the RBQM Adoption Gap: An AI-Guided Action Path from Risk Signals to Supervised Execution\nAc cess the Session Recording To view the recording of this session\, please complete the form below. Once the form is submitted\, you will be redirect ed to the recording. Request Recording Access SCDM Webinar Closing the RBQ M Adoption Gap: An AI-Guided Action Path from Risk Signals to Supervised E xecution Description: "Clinical development does not lack visibility into operational risk. Risk-Based Quality Management has given study teams more dashboards\, key risk indicators\, and central monitoring signals than at any point in the industry’s history. What remains constrained is the ca pacity to translate those signals into timely\, coordinated\, and document ed action across functions and systems. This constraint is now a regulator y one. ICH E6(R3) Principles and Annex 1 reached final adoption in January 2025\, became effective across the EU on July 23\, 2025\, and were publis hed by the FDA in September 2025\, with the MHRA and Health Canada followi ng. RBQM is no longer encouraged practice - it is the operating model regu lators expect across the trial lifecycle. Yet adoption remains uneven\, an d the gap sits precisely where it matters most. Industry research from the Tufts Center for the Study of Drug Development\, conducted with CluePoint s and PwC across 206 respondents and 32 distinct RBQM components\, found t hat organizations implement RBQM in 57% of clinical trials on average. Ado ption is highest in documentation and resolution at 60% and lowest in exec ution at 52%. Smaller sponsors running fewer than 25 trials a year sit at 48%\, against 63% at organizations running more than 100. The barriers ide ntified are organizational rather than technical: limited cross-functional knowledge and awareness\, mixed perceptions of the value proposition\, an d weak change management in planning and execution. This is the RBQM adopt ion gap - the distance between regulatory expectation\, [...] DTSTAMP:20260823T235153Z SUMMARY:SCDM Webinar | Closing the RBQM Adoption Gap: An AI-Guided Action P ath from Risk Signals to Supervised Execution X-ALT-DESC;FMTTYPE=text/html:SCDM Webinar | Closing the RB QM Adoption Gap: An AI-Guided Action Path from Risk Signals to Supervised Execution\nAccess the Session Recording To view the recording of this session\, please complete the form below. Once the form is submitted\, you will be redirected to the recording. Request Recording Access SCDM Webina r Closing the RBQM Adoption Gap: An AI-Guided Action Path from Risk Signal s to Supervised Execution Description: "Clinical development does not lack visibility into operational risk. Risk-Based Quality Management has given study teams more dashboards\, key risk indicators\, and central monitorin g signals than at any point in the industry’s history. What remains cons trained is the capacity to translate those signals into timely\, coordinat ed\, and documented action across functions and systems. This constraint i s now a regulatory one. ICH E6(R3) Principles and Annex 1 reached final ad option in January 2025\, became effective across the EU on July 23\, 2025\ , and were published by the FDA in September 2025\, with the MHRA and Heal th Canada following. RBQM is no longer encouraged practice - it is the ope rating model regulators expect across the trial lifecycle. Yet adoption re mains uneven\, and the gap sits precisely where it matters most. Industry research from the Tufts Center for the Study of Drug Development\, conduct ed with CluePoints and PwC across 206 respondents and 32 distinct RBQM com ponents\, found that organizations implement RBQM in 57% of clinical trial s on average. Adoption is highest in documentation and resolution at 60% a nd lowest in execution at 52%. Smaller sponsors running fewer than 25 tria ls a year sit at 48%\, against 63% at organizations running more than 100. The barriers identified are organizational rather than technical: limited cross-functional knowledge and awareness\, mixed perceptions of the value proposition\, and weak change management in planning and execution. This is the RBQM adoption gap - the distance between regulatory expectation\, [ ...] END:VEVENT END:VCALENDAR