Gefragt von: Frouke Gill
Fragesteller Allgemeines

Eu Portal Clinical Trials

Der Link der Eu Portal Clinical Trials-Seite ist unten angegeben. Seiten, die sich auf Eu Portal Clinical Trials beziehen, werden ebenfalls aufgelistet.

Zuletzt aktualisiert: 2022-02-04

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Added by: Ken Lane

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EU Clinical Trials Register - Update

2022-1-7 · The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area. ... For support, please visit the EMA Service Desk portal using your user credentials for a …
Url: http://www.clinicaltrialsregister.eu/
EU Clinical Trials Register - Update

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Clinical trials - European Commission

2022-1-31 · Clinical trials are scientifically controlled studies undertaken in humans to establish or confirm the safety and effectiveness of investigational medicinal products (IMPs). The conduct of clinical trials in the EU is currently governed by the Clinical Trials Directive Search for available translations of the preceding link EN •••.
Url: https://ec.europa.eu/health/medicinal-products/clinical-trials_en
Clinical trials - European Commission

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Leaflet - The EU clinical trial portal and database

The European Union (EU) clinical trial portal and database will support a coordinated approach to clinical trial authorisation and supervision via a single application form for each clinical trial. The European Medicines Agency (EMA) will manage information stored in the database, and will make it publicly available subject to trans-parency rules.
Url: https://www.ema.europa.eu/en/documents/leaflet/eu-clinical-trial-portal-database_en.pdf
Leaflet - The EU clinical trial portal and database

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EU clinical trial portal and database declared functional ...

2021-4-21 · The European Medicines Agency (EMA) announced that its long-delayed EU clinical trial portal and database are fully functional, paving the way for the launch of the EU Clinical Trial Information System (CTIS) and the application of the EU Clinical Trial Regulation early next year. The CTIS was originally expected in September 2018; however, a ...
Url: https://www.raps.org/news-and-articles/news-articles/2021/4/eu-clinical-trial-portal-and-database-declared-fun
EU clinical trial portal and database declared functional ...

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Clinical trials - Regulation EU No 536/2014

The Clinical Trials Regulation is set to replace the Clinical Trials Directive once it comes into application.. Although the Regulation entered into force on 16 June 2014 the timing of its application depends on the development of a fully functional EU clinical trials portal and database.
Url: https://ec.europa.eu/health/medicinal-products/clinical-trials/clinical-trials-regulation-eu-no-5362014_en
Clinical trials - Regulation EU No 536/2014

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Clinical Trials Regulation | European Medicines Agency

The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into application on 31 January 2022. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS).
Url: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation
Clinical Trials Regulation | European Medicines Agency

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EMA confirms the EU clinical trial portal and database is ...

2021-4-22 · The portal and database are one of the main deliverables of the 2014 Clinical Trial Regulation (Regulation (EU) No 536/2014), which was enforced to harmonise the assessment and supervision processes for clinical trials throughout the EU. This is supposed to be achieved using a Clinical Trials Information System (CTIS), which will contain the ...
Url: https://www.europeanpharmaceuticalreview.com/news/151922/ema-board-confirms-the-eu-clinical-trial-portal-and-database-is-fit-for-purpose/
EMA confirms the EU clinical trial portal and database is ...

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New EU portal for clinical trials launches on Monday

2022-1-28 · A new shared EU portal for the registration of clinical trials in all countries within the European Economic Area (EEA) is being launched on Monday. The new system heralds the end of the days where companies had to register studies in individual countries. At the same time, the new Clinical Trials Regulation comes into force, which is designed ...
Url: https://medwatch.com/News/regulation/article13686367.ece
New EU portal for clinical trials launches on Monday

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EU Clinical Trials Application Process | Pharmaceutical ...

2016-6-7 · One of the major changes the EU Clinical Trial Regulation2 will introduce is a new clinical trial (CT) application procedure. Under the Regulation, Sponsors will be required to apply, via a new EU portal for authorisation to conduct an interventional clinical trial with medicines in …
Url: https://ispe.org/pharmaceutical-engineering/ispeak/eu-clinical-trials-application-process
EU Clinical Trials Application Process | Pharmaceutical ...

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New EU Clinical Trials Regulation: What’s New?

New EU Clinical Trials Regulation: What’s New?

Added by: Taylor Wessing LLP

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Developments in clinical trials regulation

Developments in clinical trials regulation

Added by: European Medicines Agency

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Module 05 - Clinical trials in the EU

Module 05 - Clinical trials in the EU

Added by: European Medicines Agency

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Implementation of the clinical trials regulation

Implementation of the clinical trials regulation

Added by: European Medicines Agency

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Accelerating clinical trials in the EU (ACT-EU) by I. Den Rooijen (EMA)

Accelerating clinical trials in the EU (ACT-EU) by I. Den Rooijen (EMA)

Added by: Blog de la recherche clinique

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New European Union regulation on clinical trials of drugs - Applicable on 31 January 2022

New European Union regulation on clinical trials of drugs - Applicable on 31 January 2022

Added by: GCP-Mindset - All About Clinical Research

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Clinical Trials in Central Europe

Clinical Trials in Central Europe

Added by: HPRA Ireland

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Clinical Trial Regulation: General principles and new concepts

Clinical Trial Regulation: General principles and new concepts

Added by: inScience Communications

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Clinical trials - Regulation EU No 536/2014 and EMA Policy/0070

Clinical trials - Regulation EU No 536/2014 and EMA Policy/0070

Added by: European Medicines Agency

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Clinical Trials in the EU - ES version

Clinical Trials in the EU - ES version
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