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Eu Clinical Trial Portal

Link van Eu Clinical Trial Portal pagina wordt hieronder gegeven. Pagina's met betrekking tot Eu Clinical Trial Portal worden ook vermeld.

Laatst bijgewerkt: 2021-04-23 09:42:19

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Toegevoegd door: Claire Limbrick

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Clinical Trial Regulation | European Medicines …

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

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Toegevoegd door: Wendy Jane Whalley

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EU Clinical Trials Register - Update

The EU Clinical Trials Register provides a free and accurate search of clinical trials in European Union member states and the European Economic Area.
Url: https://www.clinicaltrialsregister.eu/
EU Clinical Trials Register - Update

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Toegevoegd door: Katarzyna Rettig

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Clinical trials - Regulation EU No 536/2014 | …

EU Clinical Trial Portal and Database. Articles 80 and 81 of the Regulation assign the EMA the task of creating an EU Portal and Database. The EU Portal will be a single entry point for submission of data and information relating to clinical trials required by the Regulation.
Url: https://ec.europa.eu/health/human-use/clinical-trials/regulation_en
Clinical trials - Regulation EU No 536/2014 | …

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Toegevoegd door: Michael Strickland

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Guideline for the notification of serious breaches of ...

108 to a temporary halt in the trial. 109 . 1 EU CT system encompasses the EU CT portal and database. Guideline for the notificatio n of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol EMA/430909/2016 Page 4/13
Url: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-notification-serious-breaches-regulation-eu-no-536/2014-clinical-trial-protocol_en.pdf
Guideline for the notification of serious breaches of ...

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Toegevoegd door: Alan Yu Yu

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EudraCT Public website - Home page

Sponsors of clinical trials on COVID-19 are requested to include the term "COVID-19" in the title of their trial (section A.3 of the CTA). Sponsors are also reminded of the importance of timely reporting of SAEs (Serious Adverse Events) and of SUSARs (Suspected Unexpected Serious Adverse Reactions) to the competent authorities, in order to protect the safety of the participants.
Url: https://eudract.ema.europa.eu/
EudraCT Public website - Home page

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Toegevoegd door: Travis Mcintyre

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Clinical Data Publication - Home - …

For further information, please use the EMA Service Desk portal. 19/03/2021: Clinical data for withdrawn application for dexamethasone for COVID-19 published The clinical data for Dexamethasone Taw correspond to the withdrawn marketing authorisation application for treating hospitalised adult patients with COVID-19 and several inflammatory conditions or conditions where the immune system is ...
Url: https://clinicaldata.ema.europa.eu/web/cdp
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Toegevoegd door: Treasurer Lrocv

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About the EU Clinical Trials Register

The EU Clinical Trials Register website was launched to provide the public with information held in the EudraCT database, the application that is used by national competent authorities to enter clinical trial data. The EudraCT database was established in Article 11 of the Clinical Trial …
Url: https://www.clinicaltrialsregister.eu/about.html
About the EU Clinical Trials Register

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Toegevoegd door: Sunil Madhok

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Listing of Clinical Trial Registries | HHS.gov

The 24 clinical trial registries that are national, regional, or international in scope are listed below, along with relevant laws and guidance documents . Some, such as the WHO Search Portal and the Canadian Clinical Trial Database, are not technically classified as a “registry,” but are included in this Listing for the purpose of comprehensiveness.
Url: https://www.hhs.gov/ohrp/international/clinical-trial-registries/index.html
Listing of Clinical Trial Registries | HHS.gov

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Toegevoegd door: European Medicines Agency

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Implementation of the clinical trials regulation

Toegevoegd door: European Medicines Agency

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

Toegevoegd door: European Medicines Agency

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Module 05 - Clinical trials in the EU

Toegevoegd door: MMS Holdings

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New EU Clinical Trials Regulation: What’s New?

Toegevoegd door: European Medicines Agency

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Clinical Trials in the EU - ES version

Toegevoegd door: Medpace, Inc.

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2022 European Union Clinical Trials Regulation

Toegevoegd door: European Medicines Agency

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Clinical Trials in the EU - MT version

Toegevoegd door: Perlow Productions

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Xerimis: EU Clinical Trial Regulation (CTR)

Toegevoegd door: Xerimis Inc

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Xerimis EU Clinical Trial Regulation CTR

Toegevoegd door: Taylor Wessing LLP

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Developments in clinical trials regulation