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EMA Events
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Decentralised clinical trials (DCTs) introduce new approaches to the conduct of clinical trials that aim to make clinical trials more easily accessible and convenient for participants to take part in. The DCT methodology is based on elements such as home health visits, direct to patient shipment of study drugs and electronic informed consent.
The ACT EU Programme will host a multi-stakeholder workshop on DCTs on behalf of the EU DCT project, bringing together participants from all areas of the research community to share perspectives on this type of clinical trials. The multi-stakeholder workshop will be hosted by EMA on October 4th 2022. The onsite workshop is open to invited participants only. A live broadcast of the workshop’s plenary session will be provided, open to all interested parties.
During the workshop, the EU DCT project group will present the work of the European Medicines Regulatory Network on decentralised clinical trials collaboration, including the planned publication of a guidance paper on the use of decentralised elements in clinical trials in Q4 2022. The workshop will include breakout sessions with an opportunity for shared discussion on topics of relevance to DCTs facilitated by the core members of the EU DCT project team, consisting of clinical trial experts from the Clinical Trials Coordination Group (CTCG), ethical experts from the Commission Expert Group on Clinical Trials (CTEG) and Good Clinical Practice (GCP) inspectors from the Good Clinical Practice Inspectors Working Group (GCP IWG).
The workshop aims specifically to bring forward the perspective of patient representatives and investigator site experts with the agenda outlined below.
No certificates of attendance will be issued for this workshop or for the live broadcast of the plenary session. A video recording of the plenary session is made available after the event. Processing and publication of the video recording typically take up to 60 days.
Please subscribe to the Clinical Trials Highlights newsletter for updates on the availability of ACT EU event video recordings.
Attendees are invited to fill out a short feedback survey via Slido that will be available after the event.
Sumber : https://www.ema.europa.eu
The ACT EU Programme will host a multi-stakeholder workshop on DCTs on behalf of the EU DCT project, bringing together participants from all areas of the research community to share perspectives on this type of clinical trials. The multi-stakeholder workshop will be hosted by EMA on October 4th 2022. The onsite workshop is open to invited participants only. A live broadcast of the workshop’s plenary session will be provided, open to all interested parties.
During the workshop, the EU DCT project group will present the work of the European Medicines Regulatory Network on decentralised clinical trials collaboration, including the planned publication of a guidance paper on the use of decentralised elements in clinical trials in Q4 2022. The workshop will include breakout sessions with an opportunity for shared discussion on topics of relevance to DCTs facilitated by the core members of the EU DCT project team, consisting of clinical trial experts from the Clinical Trials Coordination Group (CTCG), ethical experts from the Commission Expert Group on Clinical Trials (CTEG) and Good Clinical Practice (GCP) inspectors from the Good Clinical Practice Inspectors Working Group (GCP IWG).
The workshop aims specifically to bring forward the perspective of patient representatives and investigator site experts with the agenda outlined below.
No certificates of attendance will be issued for this workshop or for the live broadcast of the plenary session. A video recording of the plenary session is made available after the event. Processing and publication of the video recording typically take up to 60 days.
Please subscribe to the Clinical Trials Highlights newsletter for updates on the availability of ACT EU event video recordings.
Attendees are invited to fill out a short feedback survey via Slido that will be available after the event.
Sumber : https://www.ema.europa.eu