Gefragt von: David Eames
Fragesteller Allgemeines

Mhra Portal Pharmacovigilance

Der Link der Mhra Portal Pharmacovigilance-Seite ist unten angegeben. Seiten, die sich auf Mhra Portal Pharmacovigilance beziehen, werden ebenfalls aufgelistet.

Zuletzt aktualisiert: 2021-04-20

Added by: Ashley Clisdell

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©2000-2021 IntraLinks, Inc. All Rights Reserved. Use subject to End User Agreement. legal notices updated privacy policy
Url: https://services.intralinks.com/branding/3997623225/?clientID=3997623225
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Contact MHRA - GOV.UK

[email protected] Regulatory information service (RIS) RIS acts as the single main point of contact for marketing authorisation holders of medicines and their representatives.
Url: https://www.gov.uk/guidance/contact-mhra
Contact MHRA - GOV.UK

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Guidance on qualified person responsible for ...

Where the pharmacovigilance system is shared by several MAHs, a single request for a UK PSMF number should be submitted to the MHRA. A UK PSMF number can be requested via the MHRA Submissions Portal .
Url: https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf
Guidance on qualified person responsible for ...

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MHRA Process Licensing: useful information - …

The MHRA Process Licensing Portal. The MHRA Process Licensing Portal is part of the government's Digital by Default agenda and is a web application which provides a secure environment and an easy to use platform which allows customers to submit new applications and variations to existing wholesale distribution authorisations electronically via https://pclportal.mhra.gov.uk/ The portal should ...
Url: https://mhrainspectorate.blog.gov.uk/2019/10/04/mhra-process-licensing-useful-information/
MHRA Process Licensing: useful information - …

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Pharmacovigilance | Courses | University of …

Pharmacovigilance Activities (routine & additional). Risk minimisation measures (routine & additional), selection of tools and indicators (GVP XVI). Safety communication (GVP XV) including communication of risk and public participation in PV (GVP XI). Communication of risk via digital channels/technologies. Supporting stakeholders in putting risk into context, crisis management (e.g. product ...
Url: https://www.herts.ac.uk/courses/postgraduate-masters/pharmacovigilance
Pharmacovigilance | Courses | University of …

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Regulation and Prequalification

To improve reporting and stakeholder engagement, the Pharmacovigilance team in WHO has been supporting Low- and Middle-income Countries (LMICs) to implement a smart phone based adverse reactions reporting app, called the Med Safety App in collaboration with the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the WHO Collaborating Centre, Uppsala Monitoring Centre …
Url: https://www.who.int/teams/regulation-prequalification/pharmacovigilance
Regulation and Prequalification

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Clinical Research Regulation For United …

Pharmacovigilance reporting; Per the G-SubtlAmndmt, the UK requires the sponsor or legal representative of a clinical trial to be in the UK or country on an approved country list that will initially include the European Union and European Economic Area countries. A change in sponsor or legal representative for a UK trial is a substantial amendment requiring submission to both the MHRA and …
Url: https://clinregs.niaid.nih.gov/country/united-kingdom
Clinical Research Regulation For United …

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Added by: Prof.Karan Ajay Gupta

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MHRA BRITAIN I Medicines and Healthcare products Regulatory Agency

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Pharmacovigilance requirements for UK authorised products from 1 January 2021 Webinar

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Post Transition: Pharmacovigilance Requirements for UK Authorised Products - October 2020

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UK MHRA #pharma #pharmacovigilance #medicines #UK #MHRA

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Webinar: The Impact of Brexit on Pharmacovigilance

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MHRA Innovation Office

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EU Pharmacovigilance Awareness Campaign - what have we learnt?

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EU Exit and post-transition guidance, clinical trials webinar - October 2020

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Regulatory Requirements of MHRA | Regulatory Affairs | Pharmaceutics @Pharma Wins

Added by: European Medicines Agency

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1.4 Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action