Actu Pharmacovigilance
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Actu Pharmacovigilance
L'actualité réglementaire de la pharmacovigilance en Europe
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European Medicines Agency - PHARMACOVIGILANCE PROGRAMME UPDATE : First numero

EVELYNE PIERRON's insight:

The EMA releases on its website the first Pharmacovigilance Programme Update, which will be issued quaterly.

This document will help MAH to prepare for the business changes to come.

In the first numero , following topics are presented:

- art 57(2) : database of medicinal products

- PSUR repository

- Medical literature monitoring

- Pharmacovigilance fees

- Public ADR database (adreureports)

- ADR reporting and signal management

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European Medicines Agency 2013 annual report on EudraVigilance: over 1 million adverse reaction reports received and processed

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The report, covering the period from 1 January to 31 December 2013, shows a 26% increase in expedited ADR reports over 2012, resulting in the highest ever annual figure. The greatest increase occurred within the European Union (EU), showing the combined effort of the EU medicines regulatory network to encourage reporting to of suspected adverse reactions to medicines.

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European Medicines Agency reveals new structure

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The European Medicines Agency (EMA) has announced details of its new organisational structure.


The new structure has at its core four new Divisions with responsibilities right through the lifecycle of a medicine for human use from development to use in patients. Those are:

  • Human Medicines Research and Development Support Division,
  • Human Medicines Evaluation Division,
  • Procedure Management and Business Support Division,
  • Inspections and Human Medicines Pharmacovigilance Division.
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European Medicines Agency - Post-authorisation - Post Authorisation Safety Study (PASS): questions and answers

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Updated Q/A regarding Post Authorisation safety Study (PASS)

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European Medicines Agency - Regulatory information - European Medicines Agency revises rules on fees

EVELYNE PIERRON's insight:

The European Medicines Agency has revised the rules on fees payable to the Agency. The revised rules, which come into force on 4 August 2013, provide for full waiver of fees for pharmacovigilance-related type-IA (immediate-notification) variations to the terms of marketing authorisations with the following scopes:

  • C.I.8, i.e. introduction of, or changes to, a summary of pharmacovigilance system for medicinal products for human use;
  • C.I.10, i.e. change in the frequency or date of submission of periodic safety update reports (PSURs) for human medicinal products;
  • C.I.12, i.e. inclusion or deletion of the black symbol and explanatory statements for medicinal products in the list of medicinal products that are subject to additional monitoring;
  • C.I.z, i.e. inclusion of the statements of adverse-drug-reaction reporting.
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European Medicines Agency - Pharmacovigilance Risk Assessment Committee: one year of public health promotion and protection

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European Medicines Agency - Tackling medication errors: European Medicines Agency workshop calls for coordinated EU approach

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A close collaboration between national patient safety authorities, national competent authorities, the European Medicines Agency, and the European Commission is necessary to tackle the issue of medication errors causing harm in Europe. This collaboration should engage patients and healthcare professionals. This was the conclusion of the workshop on medication errors organised by the Agency from 28 February 2013 – 1 March 2013.

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EMA - Position paper on potential medication errors

This position paper is intended to provide guidance on how potential medication errors should be addressed in the context of benefit-risk balance assessment and risk minimisation measures. Specifically, the paper focuses on potential medication errors caused by confusion of a newly introduced medicinal product with established medicines that contain the same active substance and are similar in appearance or name but different in some other attributes such as strength, dosing or route of administration.


Consultation end date: 30 november 2012

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European database of suspected adverse drug reaction reports

European database of suspected adverse drug reaction reports | Actu Pharmacovigilance | Scoop.it

On this website you can view data on suspected side-effects also known as suspected adverse drug reactions for authorised medicines in the European Economic Area (EEA).

This data is presented in a format called a web report.


Currently the data only relates to medicines approved through the centralised authorisation procedure.


The information on this website relates to suspected side effects, i.e. medical events that have been observed following the use of a medicine, but which are not necessarily related to or caused by the medicine.


Information on suspected side effects should not be interpreted as meaning that the medicine or the active substance causes the observed effect or is unsafe to use. Only a detailed evaluation and scientific assessment of all available data allows for robust conclusions to be drawn on the benefits and risks of a medicine.


The European Medicines Agency publishes this data so that its stakeholders, including the general public, can access information that European regulatory authorities use to review the safety of a medicine or active substance. Transparency is a key guiding principle of the Agency.

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European Medicines Agency -

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This guidance specifies the technical requirements and the process of transmission of Individual Case Safety Reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the EEA.

Public consultation until 30 june 2014

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European Medicines Agency - News and Events - European Medicines Agency explores ways to further involve patients in the benefit-risk assessment of medicines

EVELYNE PIERRON's insight:

The European Medicines Agency has published a report of the workshop held on 26 September 2013 to discuss further development of patient involvement in the evaluation of medicines, in particular in the assessment of benefit and risk that lies at the heart of the regulatory process.

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Clinical trials-Points to consider for assessors,inspectors and EMA inspection coordinators on the identifcation of triggers for the selection of applications .pdf

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This document provides a non-exhaustive overview of the potential pre-defined factors that can be used for the selection of marketing authorisation applications (MAAs) to be part of a programme of routine inspections and non-exhaustive overview of potential triggers that can be detected at the different stages of the assessment process and that can help the assessor to decide on the need for “for cause” inspections and be used to prepare an inspection.


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Questions and Answers on variations to an existing pharmacovigilance system as described in the DDPS (update july 2013).pdf

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 Available on the EMA website  a Q/A updated on variations to an existing pharmacovigilance system as described in the DDPS.

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European Medicines Agency - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2013

EVELYNE PIERRON's insight:

The Pharmacovigilance Risk Assessment Committee (PRAC) has marked the successful completion of its first year of operation.


The PRAC also welcomed the full involvement of Croatia in its activities at its July 2013 meeting following the accession of Croatia to the European Union (EU) on 1 July 2013. Croatian delegates have been observers of the PRAC since it began its operations in July 2012.

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European Medicines Agency - LISTE DES MÉDICAMENTS SOUMIS À SURVEILLANCE SUPPLÉMENTAIRE

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EVELYNE PIERRON's curator insight, April 25, 2013 5:31 AM

Conformément à la nouvelle législation européenne de pharmacovigilance, l'agence européenne (EMA) a publié sur son site la liste des médicaments qui font l'objet d'une surveillance supplémentaire.


Les médicaments sous surveillance supplémentaire sont identifiables par la présence d’un triangle noir inversé sur les notices et sur les résumés des caractéristiques du produit (c’est-à-dire les informations destinées aux professionnels de la santé).


Ce triangle est complété d’une courte phrase expliquant sa signification : Ce médicament fait l’objet d’une surveillance supplémentaire.

Le triangle noir sera utilisé dans tous les États membres de l’UE pour identifier les médicaments sous surveillance supplémentaire.

Il commencera à apparaître sur les notices des médicaments concernés à partir de l’automne 2013. Il ne figurera pas sur l’emballage des médicaments.


La liste des médicaments sous surveillance supplémentaire, revisée tous les mois, peut en permanence être consultée sur le site internet de l’Agence européenne des médicaments. Elle est également publiée par les autorités de santé nationales dans chacun des États membres de l’UE.


Les patients et les professionnels de santé sont encouragés à déclarer toute suspicion d’effet indésirable observé avec un médicament. Conformément à la nouvelle législation relative à la pharmacovigilance, les patients ont le droit, dès qu’ils le souhaitent, de déclarer des effets indésirables directement à l’autorité de santé de leur pays. Des informations sur les modalités de déclaration doivent figurer dans la notice et le résumé des caractéristiques du produit de chaque médicament.

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European Medicines Agency - European Medicines Agency website on suspected side effect reports now in all 23 EU official languages

The European Medicines Agency has launched its website on suspected side-effect reports for medicines authorised in the European Economic Area (EEA) in the remaining 22 official European Union (EU) languages.

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European Medicines Agency - News and Events - Annual report 2011 shows continuously high level of activities


The report shows continuously high levels of activities in almost all of the Agency’s business areas. There was a slight increase in the number of applications for initial marketing authorisations for medicines for human use, from 91 applications in 2010 to 100 applications in 2011. Most of this increase was due to applications received for new medicines: this number rose by over 40% from 34 in 2010 to 48 in 2011

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Agence Européenne (EMA: Communiqué de presse sur l'état d'avancement de la mise en place de la nouvelle législation Pharmacovigilance

Communiqué de presse disponible sur le site de l'Agence Européenne à propos de l'état d'avancement de la mise en place de la nouvelle législation concernant la pharmacovigilance.

Le compte à rebours a démarré pour être prêt d'ici Juillet 2012.

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