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Ema Portal Clinical Trial

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

Laatst bijgewerkt: 2021-04-22 14:29:48

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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: Travis Mcintyre

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Home - Clinical Data Publication - …

EMA has published the clinical data supporting the granting of a conditional marketing authorisation. These include interim results from an ongoing clinical trial containing temporary redactions to protect the blinded nature of the study, as explained in the Anonymisation Report.
Url: https://clinicaldata.ema.europa.eu/web/cdp
Home - Clinical Data Publication - …

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Toegevoegd door: Alan Yu Yu

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EudraCT Public website - Home page

Brexit preparedness: Joint Technical Notice to Sponsors by the European Commission, EMA and HMA and Notice to stakeholders of 7 May 2020. What's New . 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).
Url: https://eudract.ema.europa.eu/
EudraCT Public website - Home page

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Toegevoegd door: Dale Crosby

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Guideline on GCP compliance in relation to trial master ...

31 March1 2017. 2 EMA/15975/2016 3 Good Clinical Practice Inspectors Working Group (GCP IWG) 4 Guideline on GCP compliance in relation to trial master file 5 (paper and/or electronic) for content, management, 6 . archiving, audit and inspection of clinical trials 7 . Adopted by GCP Inspectors Working Group (GCP IWG) 30 January 2017
Url: https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-good-clinical-practice-compliance-relation-trial-master-file-paper/electronic-content-management-archiving-audit-inspection-clinical-trials_en.pdf
Guideline on GCP compliance in relation to trial master ...

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Toegevoegd door: Namisha Singh

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EU Clinical Trials Register - Joining a clinical trial

Joining a clinical trial. If you have found information on a specific clinical trial and are interested in joining a trial, ... For technical support, please visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance).
Url: https://www.clinicaltrialsregister.eu/joiningtrial.html
EU Clinical Trials Register - Joining a clinical trial

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Toegevoegd door: David Del Castillo

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EudraCT

Before any functionality of EudraCT can be used for a given clinical trial, a EudraCT number must be created in order to provide a unique reference for that trial. Protocol-related information ... Contact:EMA Service Desk portal telephone: (+31) (0) 88781 6000. Result-related information.
Url: https://eudract.ema.europa.eu/results-web/
EudraCT

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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: European Medicines Agency

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Implementation of the clinical trials regulation

Toegevoegd door: GCP-Mindset - All About Clinical Research

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Clinical trials in times of Corona - FDA and EMA Update

Toegevoegd door: European Medicines Agency

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Clinical Trials Information System CTIS bitesize talk: Initial clinical trial application

Toegevoegd door: European Medicines Agency

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Clinical Trials in the EU - CZ version

Toegevoegd door: European Medicines Agency

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Implementation of EMA policy on publication of clinical data – Current status Stakeholder Webinar

Toegevoegd door: European Medicines Agency

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

Toegevoegd door: Alliance for Aging Research

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EMA Perspectives/Clinical Trials and Frailty

Toegevoegd door: European Medicines Agency

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Elderly Patients and Clinical Trials - EMA Notes for Guidance

Toegevoegd door: inScience Communications

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

Toegevoegd door: European Medicines Agency

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Module 05 - Clinical trials in the EU