BEGIN:VCALENDAR VERSION:2.0 PRODID:-//CiviCRM//NONSGML CiviEvent iCal//EN X-WR-TIMEZONE:UTC METHOD:PUBLISH BEGIN:VTIMEZONE TZID:UTC BEGIN:STANDARD TZOFFSETFROM:+0000 TZOFFSETTO:+0000 TZNAME:UTC DTSTART:20260904T000000 END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:CiviCRM_EventID_343_f4b682d91127999ff83d5e7bc14cb57b@www.darqa.org SUMMARY:GCP Themadag Quality by Design / Risk-Based Qualit y Management in Clinical Trials X-ALT-DESC;FMTTYPE=text/html:

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.

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The 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.

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Since 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\,…).

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AGENDA

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09:30 – 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 – 14.30 Workshop / E xercise Risk-Based Quality Management by Coree For man\, Owner and Principal Consultant at Q-STAR Con sulting
\n 14.30 – 15.30 Placeholder for f inal speaker (confirmation pending)
\n 15.30 – 16.00 Coffee Break
\n 16.00 – 16.45 P lenary Discussion / Q&A led by Coree Forman and He nrieke de Bie
\n 16.45 – 17.00 Closure and Personal take aways by Eveline Krijger\, Director Quality Management at Acerta / Chair DARQA
\ n 17.00 – 18.00 Drinks & Snacks
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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 – 14.30 Workshop / Exercise Risk-Ba sed Quality Management by Coree Forman\, Owner and Principal Consultant at Q-STAR Consulting\n \n 14 .30 – 15.30 Placeholder for final speaker (conf irmation pending)\n \n 15.30 – 16.00 Coffee Bre ak\n \n 16.00 – 16.45 Plenary Discussion / Q&A led by Coree Forman and Henrieke de Bie\n \n 16.45 – 17.00 Closure and Personal take aways by Eve line Krijger\, Director Quality Management at Acer ta / Chair DARQA\n \n 17.00 – 18.00 Drinks & Sn acks\n \n \n \n \n \n \n \n CATEGORIES:Workshop CALSCALE:GREGORIAN DTSTAMP;TZID=UTC:20260904T000000 DTSTART;TZID=UTC:20260904T000000 DTEND;TZID=UTC:20260904T235900 URL:https://www.darqa.org/index.php/language/nl/civicrm/event/info/?reset=1&id=343 END:VEVENT BEGIN:VEVENT UID:CiviCRM_EventID_344_f4b682d91127999ff83d5e7bc14cb57b@www.darqa.org SUMMARY:GCP Webinar: Risk-Based Audit Management in Clinic al Trials X-ALT-DESC;FMTTYPE=text/html:

Deze ac tiviteit vindt volgens de tekst op de eventpagina in oktober plaats. Nadere informatie volgt nog.

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Bron: 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=UTC:20261009T000000 DTSTART;TZID=UTC:20261009T000000 DTEND;TZID=UTC:20261009T235900 URL:https://www.darqa.org/index.php/language/nl/civicrm/event/info/?reset=1&id=344 END:VEVENT BEGIN:VEVENT UID:CiviCRM_EventID_345_f4b682d91127999ff83d5e7bc14cb57b@www.darqa.org SUMMARY:RQA Global Conference - 4 t/m 6 november X-ALT-DESC;FMTTYPE=text/html:

RQA Glo bal Conference — 4 t/m 6 november 2026.

D e aanmelding voor dit event verloopt via RQA Globa l Conference.

Link: https://www.therqa.co m

Bron: 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=UTC:20261104T000000 DTSTART;TZID=UTC:20261104T000000 DTEND;TZID=UTC: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.

Bron: 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=UTC:20261120T000000 DTSTART;TZID=UTC:20261120T000000 DTEND;TZID=UTC:20261120T235959 URL:https://www.darqa.org/index.php/language/nl/civicrm/event/info/?reset=1&id=346 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.

Bron: 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=UTC:20261204T000000 DTSTART;TZID=UTC:20261204T000000 DTEND;TZID=UTC: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=UTC:20270101T000000 DTSTART;TZID=UTC:20270101T000000 DTEND;TZID=UTC:20270101T235959 URL:https://www.darqa.org/index.php/language/nl/civicrm/event/info/?reset=1&id=349 END:VEVENT END:VCALENDAR