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Ema Clinical Trial Portal

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

Laatst bijgewerkt: 2022-02-05 05:16:00

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Toegevoegd door: David Robson

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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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Toegevoegd door: Jodie Wall

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Clinical trials in human medicines | European Medicines Agency

13-01-2022 · Clinical trials are studies intended to discover or verify the effects of one or more investigational medicines.. The regulation of clinical trials aims to ensure that the rights, safety and well-being of trial subjects are protected and the results of clinical trials are credible.. Regardless of where they are conducted, all clinical trials included in applications for …
Url: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials-human-medicines
Clinical trials in human medicines | European Medicines Agency

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Toegevoegd door: Samantha Scanu

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Clinical Trials Information System (CTIS): online modular ...

EMA is delivering an online modular training programme to help clinical trial sponsors, national competent authorities, ethics committees, European Commission and EMA staff prepare for using the Clinical Trials Information System (CTIS). The training programme consists of several modules, covering the full lifecycle of clinical trial submission, authorisation and supervision.
Url: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-ctis-online-modular-training-programme
Clinical Trials Information System (CTIS): online modular ...

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Toegevoegd door: Nick Goiran

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Development of the Clinical Trials Information System

31-01-2022 · EMA originally published the CTIS functional specifications in December 2014, following a public consultation, to be formally audited in line with the Clinical Trials Regulation.. An initial go-live in December 2015 was postponed due to technical difficulties with the development of the IT system.
Url: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system/development-clinical-trials-information-system
Development of the Clinical Trials Information System

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Toegevoegd door: Ross Blake

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Home - Clinical Data Publication - clinicaldata.ema.europa.eu

25-02-2021 · EMA has published updated documents for Comirnaty with fewer redactions, following the unblinding of a trial that was ongoing when EMA first released the data supporting its authorisation. Further information on this medicine is available on the EMA corporate website. 18/08/2021: Clinical data for COVID-19 medicine published
Url: https://clinicaldata.ema.europa.eu/web/cdp/home
Home - Clinical Data Publication - clinicaldata.ema.europa.eu

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Toegevoegd door: Lorne Mcclurg

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Clinical Trials Information System: training and support

16-12-2021 · EMA is delivering an extensive online modular training programme for self-study to help clinical trial sponsors, national competent authorities, ethics committees, European Commission and EMA staff prepare for using CTIS.. The online training modules cover the various stages of a clinical trial as well as the preparatory steps needed to use CTIS, such as user …
Url: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support
Clinical Trials Information System: training and support

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Toegevoegd door: Alan Yu Yu

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EudraCT Public website - Home page - Europa

07-05-2020 · The EMA will be closed from 23/12/2020 to 03/01/2021. Please note: Requests sent after 21/12/2020 for assignment as a primary user to post results and for EudraCT/EU CTR related queries will be processed after the 03/01/2021. 07-12-2020. From January 1st, 2021, for all clinical trials recorded in EudraCT that are ongoing in the EU/EEA:
Url: https://eudract.ema.europa.eu/
EudraCT Public website - Home page - Europa

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Toegevoegd door: Carlos Humphrey

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EMA's new Clinical Trials Portal with IDMP Data Integration

28-01-2018 · EMA’s new Clinical Trials Portal is going to be rolled out in Q3 of 2018 according to EMA’s “Delivery time frame for the EU portal and EU database”(under revision). Such as in the Falsified Medicines and the Electronic Application Form ( eAF ), the Clinical Trial Portal is a likely candidate to make use of SPOR’s OMS data when it comes to Clinical Trial Sponsors.
Url: https://www.idmp1.com/clinical-trials-portal/
EMA's new Clinical Trials Portal with IDMP Data Integration

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Toegevoegd door: Carmen Tevere

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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 …
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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Toegevoegd door: European Medicines Agency

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Implementation of the clinical trials regulation

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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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: 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

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: PEPGRA Healthcare

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What are the EMA Guidelines for Clinical Trial Management? Pepgra Healthcare