While we are celebrating the first anniversary of the implementation of revision 3 of ICH E6 Good Clinical Practice in Europe, many companies are still looking for the best way to implement a proportionate risk-based approach in the design and activities of their trials. 

The next onsite event that is organised by the DARQA GCP-committee will therefore focus on Quality by Design (QbD) and Risk-Based Quality Management (RBQM) according to ICH E6 R3 in Clinical Trials. 

Since RBQM and QbD are multidisciplinary activities, we would explicitly also like to invite individuals involved in clinical trials working outside quality assurance / compliance (e.g., Project Managers, Clinical Trial Managers, Medical Writers, Data Managers,…). 

AGENDA

09:30 – 10.00    Arrival with coffee / tea
10.00 – 10.30    Introduction: Activate your Critical Thinking mindset by Henrieke de Bie, Owner and Consultant Quality & Culture at Beyond Compliance / Chair DARQA GCP Committee
10.30 – 11.30    Making RBQM work: a practical methodology aligned with ICH E6(R3) by Leire Zuñiga, Founder and Managing Director at Pharmity / Co-Founder and CQO at Qlarix
11.30 – 11.45    Short Break
11.45 – 12.45    Practical applications of Quality by Design / Risk-Based Quality Management by Natalia Buchneva, Risk Management Lead Global Clinical Science & Operations at UCB
12.45 – 13.45    Lunch
13.45 – 14.30    Workshop / Exercise Risk-Based Quality Management by Coree Forman, Owner and Principal Consultant at Q-STAR Consulting
14.30 – 15.30    Placeholder for final speaker (confirmation pending)
15.30 – 16.00    Coffee Break
16.00 – 16.45    Plenary Discussion / Q&A led by Coree Forman and Henrieke de Bie
16.45 – 17.00    Closure and Personal take aways by Eveline Krijger, Director Quality Management at Acerta / Chair DARQA
17.00 – 18.00    Drinks & Snacks