While w e are celebrating the first anniversary of the imp lementation of revision 3 of ICH E6 Good Clinical Practice in Europe\, many companies are still look ing for the best way to implement a proportionate risk-based approach in the design and activities o f their trials.
\n \nThe next onsite event that is organised by the DARQA GCP-committee will therefore focus on Quality by Design (QbD) and Ri sk-Based Quality Management (RBQM) according to IC H E6 R3 in Clinical Trials.
\n \nSince RBQ M and QbD are multidisciplinary activities\, we wo uld explicitly also like to invite individuals inv olved in clinical trials working outside quality a ssurance / compliance (e.g.\, Project Managers\, C linical Trial Managers\, Medical Writers\, Data Ma nagers\,…).
\n \nAGENDA
\n \n09:30
– 10.00 Arrival with coffee / tea
\n 10.00
– 10.30 Introduction: Activate your Critical T
hinking mindset by Henrieke de Bie\, Owner and Con
sultant Quality & Culture at Beyond Compliance / C
hair DARQA GCP Committee
\n 10.30 – 11.30
Making RBQM work: a practical methodology aligned
with ICH E6(R3) by Leire Zuñiga\, Founder and Mana
ging Director at Pharmity / Co-Founder and CQO at
Qlarix
\n 11.30 – 11.45 Short Break
\
n 11.45 – 12.45 Practical applications of Quali
ty by Design / Risk-Based Quality Management by Na
talia Buchneva\, Risk Management Lead Global Clini
cal Science & Operations at UCB
\n 12.45 – 13
.45 Lunch
\n 13.45 – 15.00 Workshop / E
xercise Risk-Based Quality Management by all
\n 15.00 – 15.30 Coffee Break
\n 15.30 – 1
6.15 Excercise 'When RBQM goes wrong' by Coree
Forman\, Owner and Principal Consultant at Q-STAR
Consulting
\n 16.15 – 16.45 Plenary Discus
sion / Q&A led by Coree Forman and Henrieke de Bie
\n 16.45 – 17.00 Closure and Personal tak
e aways by Eveline Krijger\, Director Quality Mana
gement at Acerta / Chair DARQA
\n 17.00 – 18.
00 Drinks & Snacks
This eve nt is free of charge for DARQA-members. The fee fo r non-DARQA members is 100 EUR (no VAT).
\n \nLanguage: This event will be held in English.
DESCRIPTION:While we are celebrating the first anniversary of the implementation of revision 3 of ICH E6 Good Cl inical Practice in Europe\, many companies are sti ll looking for the best way to implement a proport ionate risk-based approach in the design and activ ities of their trials. \n \n \n \n The next onsite event that is organised by the DARQA GCP-committe e will therefore focus on Quality by Design (QbD) and Risk-Based Quality Management (RBQM) according to ICH E6 R3 in Clinical Trials. \n \n \n \n Sinc e RBQM and QbD are multidisciplinary activities\, we would explicitly also like to invite individual s involved in clinical trials working outside qual ity assurance / compliance (e.g.\, Project Manager s\, Clinical Trial Managers\, Medical Writers\, Da ta Managers\,…). \n \n \n \n AGENDA\n \n \n \n 09: 30 – 10.00 Arrival with coffee / tea\n \n 10.00 – 10.30 Introduction: Activate your Critical T hinking mindset by Henrieke de Bie\, Owner and Con sultant Quality & Culture at Beyond Compliance / C hair DARQA GCP Committee\n \n 10.30 – 11.30 Mak ing RBQM work: a practical methodology aligned wit h ICH E6(R3) by Leire Zuñiga\, Founder and Managin g Director at Pharmity / Co-Founder and CQO at Qla rix\n \n 11.30 – 11.45 Short Break\n \n 11.45 – 12.45 Practical applications of Quality by Des ign / Risk-Based Quality Management by Natalia Buc hneva\, Risk Management Lead Global Clinical Scien ce & Operations at UCB\n \n 12.45 – 13.45 Lunch \n \n 13.45 – 15.00 Workshop / Exercise Risk-Ba sed Quality Management by all\n \n 15.00 – 15.30 Coffee Break\n \n 15.30 – 16.15 Excercise 'Wh en RBQM goes wrong' by Coree Forman\, Owner and Pr incipal Consultant at Q-STAR Consulting\n \n 16.15 – 16.45 Plenary Discussion / Q&A led by Coree Forman and Henrieke de Bie\n \n 16.45 – 17.00 C losure and Personal take aways by Eveline Krijger\ , Director Quality Management at Acerta / Chair DA RQA\n \n 17.00 – 18.00 Drinks & Snacks\n \n \n \n This event is free of charge for DARQA-members. The fee for non-DARQA members is 100 EUR (no VAT) . \n \n \n \n Language: This event will be held in English.\n \n CATEGORIES:Workshop CALSCALE:GREGORIAN DTSTAMP;TZID=Europe/Amsterdam:20260904T093000 DTSTART;TZID=Europe/Amsterdam:20260904T093000 DTEND;TZID=Europe/Amsterdam:20260904T180000 LOCATION:Barchman Wuytierslaan 2\n Eenhoorn\n Amersfoort\, UT 3818LH\n Netherlands\n URL:https://www.darqa.org/index.php/language/nl/civicrm/event/info/?reset=1&id=343 END:VEVENT BEGIN:VEVENT UID:CiviCRM_EventID_352_f4b682d91127999ff83d5e7bc14cb57b@www.darqa.org SUMMARY:Data & Kwaliteit: Audit-ready AI-workflows: van da ta-soevereiniteit naar toetsbare AI-bewijsvoering X-ALT-DESC;FMTTYPE=text/html:AI word t steeds vaker ingezet voor zoeken\, samenvatten\, vergelijken en beslisondersteuning in kwaliteitsp rocessen. Maar een overtuigend AI-antwoord is nog geen bewijs. In deze interactieve workshop onderzo eken we wat nodig is om een AI-workflow auditwaard ig te maken.
\n \nNiet alleen het model tel t\, maar ook brondata\, documentversies\, mapping\ , retrieval\, prompt\, modelconfiguratie\, output\ , menselijke beoordeling en logging. Aan de hand v an een herkenbare kwaliteitscasus laten we zien ho e een ogenschijnlijk correct AI/RAG-antwoord toch kan ontsporen door verkeerde bronversies\, oude in dexdata\, zwakke metadata of verloren provenance.< /p>\n \n
Deelnemers krijgen praktische handvatt en om betere vragen te stellen aan leveranciers\, IT\, data governance en QA\, en werken toe naar ee n eerste set eisen voor aantoonbare AI-bewijsvoeri ng in de eigen organisatie.
\n \nHans de Raad\, CEO van OpenNovations en l id van de sectie Data en Kwaliteit van NNK.
\n \nThis e vent is free of charge for DARQA-members. The fee for non-DARQA members is 100 EUR (no VAT).
\n < p>Inschrijven: tot en met vrijdag 11 september 2026\nRQA Glo bal Conference — 4 t/m 6 november 2026.
\nD e aanmelding voor dit event verloopt via RQA Globa l Conference.
\nLink: https://www.therqa.co m
\nBron: darqa.org
DESCRIPTION:RQA Global Conference — 4 t/m 6 november 2026.\n \ n \n De aanmelding voor dit event verloopt via RQA Global Conference.\n \n \n Link: https://www.ther qa.com (https://www.therqa.com)\n \n \n Bron: darq a.org (https://darqa.org/evenementen-top/evenement detail/246/rqa-global-conference-4-t-m-6-november) \n \n CATEGORIES:Conferentie CALSCALE:GREGORIAN DTSTAMP;TZID=Europe/Amsterdam:20261104T000000 DTSTART;TZID=Europe/Amsterdam:20261104T000000 DTEND;TZID=Europe/Amsterdam:20261106T235959 URL:https://www.darqa.org/index.php/language/nl/civicrm/event/info/?reset=1&id=345 END:VEVENT BEGIN:VEVENT UID:CiviCRM_EventID_346_f4b682d91127999ff83d5e7bc14cb57b@www.darqa.org SUMMARY:GMP themadag 'Sustainability' - 20 november X-ALT-DESC;FMTTYPE=text/html:Nadere informatie over dit event volgt nog.
\nBron: darqa.org
DESCRIPTION:Nadere informatie over dit event volgt nog.\n \n \ n Bron: darqa.org (https://darqa.org/evenementen-t op/evenementdetail/247/gmp-themadag-sustainability -13-november)\n \n CATEGORIES:Conferentie CALSCALE:GREGORIAN DTSTAMP;TZID=Europe/Amsterdam:20261120T000000 DTSTART;TZID=Europe/Amsterdam:20261120T000000 DTEND;TZID=Europe/Amsterdam:20261120T235959 URL:https://www.darqa.org/index.php/language/nl/civicrm/event/info/?reset=1&id=346 END:VEVENT BEGIN:VEVENT UID:CiviCRM_EventID_351_f4b682d91127999ff83d5e7bc14cb57b@www.darqa.org SUMMARY:Webinar ICH E6 R3 Good Clinical Practice: Annex 2 CATEGORIES:Conferentie CALSCALE:GREGORIAN DTSTAMP;TZID=Europe/Amsterdam:20261127T143000 DTSTART;TZID=Europe/Amsterdam:20261127T143000 DTEND;TZID=Europe/Amsterdam:20261127T160000 URL:https://www.darqa.org/index.php/language/nl/civicrm/event/info/?reset=1&id=351 END:VEVENT BEGIN:VEVENT UID:CiviCRM_EventID_347_f4b682d91127999ff83d5e7bc14cb57b@www.darqa.org SUMMARY:GLP Themadag - 4 december X-ALT-DESC;FMTTYPE=text/html:Nadere informatie over dit event volgt nog.
\nBron: darqa.org
DESCRIPTION:Nadere informatie over dit event volgt nog.\n \n \ n Bron: darqa.org (https://darqa.org/evenementen-t op/evenementdetail/248/glp-themadag-27-november)\n \n CATEGORIES:Conferentie CALSCALE:GREGORIAN DTSTAMP;TZID=Europe/Amsterdam:20261204T000000 DTSTART;TZID=Europe/Amsterdam:20261204T000000 DTEND;TZID=Europe/Amsterdam:20261204T235959 URL:https://www.darqa.org/index.php/language/nl/civicrm/event/info/?reset=1&id=347 END:VEVENT BEGIN:VEVENT UID:CiviCRM_EventID_349_f4b682d91127999ff83d5e7bc14cb57b@www.darqa.org SUMMARY:GCP webinar - Januari 2027 X-ALT-DESC;FMTTYPE=text/html:Nadere inf ormatie over dit event volgt nog. DESCRIPTION:Nadere informatie over dit event volgt nog. CATEGORIES:Conferentie CALSCALE:GREGORIAN DTSTAMP;TZID=Europe/Amsterdam:20270101T000000 DTSTART;TZID=Europe/Amsterdam:20270101T000000 DTEND;TZID=Europe/Amsterdam:20270101T235959 URL:https://www.darqa.org/index.php/language/nl/civicrm/event/info/?reset=1&id=349 END:VEVENT BEGIN:VEVENT UID:CiviCRM_EventID_344_f4b682d91127999ff83d5e7bc14cb57b@www.darqa.org SUMMARY:GCP Webinar: Risk-Based Audit Management in Clinic al Trials – Q1 2027 X-ALT-DESC;FMTTYPE=text/html:Deze ac tiviteit vindt volgens de tekst op de eventpagina in oktober plaats. Nadere informatie volgt nog.
\n \nBron: darqa.org
DESCRIPTION:Deze activiteit vindt volgens de tekst op de event pagina in oktober plaats. Nadere informatie volgt nog.\n \n \n \n Bron: darqa.org (https://darqa.org /evenementen-top/evenementdetail/245/gcp-webinar-r isk-based-audit-management-in-oct-2026)\n \n CATEGORIES:Conferentie CALSCALE:GREGORIAN DTSTAMP;TZID=Europe/Amsterdam:20270115T000000 DTSTART;TZID=Europe/Amsterdam:20270115T000000 DTEND;TZID=Europe/Amsterdam:20270115T235900 URL:https://www.darqa.org/index.php/language/nl/civicrm/event/info/?reset=1&id=344 END:VEVENT END:VCALENDAR