E
EMA Events
Guest
As part of the
Accelerating Clinical Trials in the EU (ACT EU) multi-annual workplan 2022-2026 and acknowledging the important role of ICH E6 as the global regulatory guideline for GCP, a multi-stakeholder workshop on ICH E6 R3 public consultation is being organised by ACT EU Priority Action 4 (PA4). The workshop is planned as a hybrid event, to enable wide participation.
The first session on 13 July will begin at 13:30 CEST and will be live broadcast. The session will include a welcome address by EMA's Executive Director, presentations by the Rapporteur and Regulatory Chair of the ICH E6 R3 Expert Working Group (EWG), in-depth presentations on both the principles of ICH E6 R3 and Annex I, panel discussions with relevant stakeholders and multiple Q&A sessions.
The second session on 14 July will run from 09:30 until 15:30 CEST, and will focus on discussions in a number of breakout sessions. This day will not be publicly broadcast, and pre-registration will be required. The breakout sessions will run on five different tracks held simultaneously, twice during the day, allowing relevant stakeholders to attend different breakout sessions if there are two topics of interest they would like to attend.
The registration process and the outlines of the agendas will be available shortly.
The workshop aims to engage all stakeholders of ICH E6 R3, including but not limited to, patients, healthcare professionals, assessors, inspectors, industry and academia.
Sumber : https://www.ema.europa.eu
The first session on 13 July will begin at 13:30 CEST and will be live broadcast. The session will include a welcome address by EMA's Executive Director, presentations by the Rapporteur and Regulatory Chair of the ICH E6 R3 Expert Working Group (EWG), in-depth presentations on both the principles of ICH E6 R3 and Annex I, panel discussions with relevant stakeholders and multiple Q&A sessions.
The second session on 14 July will run from 09:30 until 15:30 CEST, and will focus on discussions in a number of breakout sessions. This day will not be publicly broadcast, and pre-registration will be required. The breakout sessions will run on five different tracks held simultaneously, twice during the day, allowing relevant stakeholders to attend different breakout sessions if there are two topics of interest they would like to attend.
The registration process and the outlines of the agendas will be available shortly.
The workshop aims to engage all stakeholders of ICH E6 R3, including but not limited to, patients, healthcare professionals, assessors, inspectors, industry and academia.
Sumber : https://www.ema.europa.eu