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 – 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
\n
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 END:VCALENDAR