Actu Pharmacovigilance
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Actu Pharmacovigilance
L'actualité réglementaire de la pharmacovigilance en Europe
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European Medicines Agency publishes first summary of a risk-management plan for a medicine

EVELYNE PIERRON's insight:

The European Medicines Agency has published the first summary for the public of the risk-management plan (RMP) of a newly authorised medicine. This RMP summary, which concerns the medicine Neuraceq, describes what is known and not known about the medicine’s safety and states what measures will be taken to prevent or minimise its risks.

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Regulation of medicines and medical devices: contrasts and similarities

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This review will summarise the key issues through a comparison of how both are regulated and monitored.


Excellent article à lire.

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European Medicines Agency and US Food and Drug Administration strengthen collaboration in pharmacovigilance area

EVELYNE PIERRON's insight:

"The European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) have set up a new 'cluster' on pharmacovigilance (medicine safety) topics.

Building on the experience of previous regular videoconferences between the EMA and the FDA in this area and the recent creation of the EMA's dedicated committee for pharmacovigilance, the Pharmacovigilance Risk Assessement Committee (PRAC), this cluster will provide a forum for a more systematic and focused exchange of information on the safety of medicines."....

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Sanctions pénales et financières applicables aux produits de santé - JO du 31/01/2014, texte 14 | Legifrance

EVELYNE PIERRON's insight:

Publics concernés :

opérateurs économiques intervenant dans la fabrication et la mise sur le marché de produits de santé, professionnels de santé, Agence nationale de sécurité du médicament et des produits de santé, direction générale de la concurrence, de la consommation et de la répression des fraudes, agences
régionales de santé.

Objet :
harmonisation des sanctions applicables aux produits de santé et des modalités de mise en œuvre des sanctions financières.
Entrée en vigueur : 1er février 2014
Notice :
le texte s’inscrit dans le cadre de l’harmonisation des sanctions applicables aux produits de santé et de l’adaptation des prérogatives des agents et autorités chargés de constater les manquements punis par ces sanctions et complète, pour ce qui relève du niveau réglementaire, l’ordonnance n°2013-1183 du 19 décembre 2013 relative à l’harmonisation des sanctions pénales et financières relatives aux produits de santé et à l’adaptation des prérogatives des autorités et des agents chargés de constater les manquements.
Il prévoit les conditions dans lesquelles les agences régionales de santé et l’Agence nationale de sécurité du médicament et des produits de santé (ANSM) peuvent prononcer des sanctions financières.
Il adapte en outre les sanctions contraventionnelles qui concernent les médicaments, les dispositifs médicaux et les dispositifs médicaux de diagnostic  in vitroet crée une contravention de cinquième classe en cas de défaut de signalement de pharmacovigilance, de matériovigilance ou de réactovigilance par un professionnel de santé.


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Regulatory information - EMA clarifies interpretation of new variation classification categories

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The European Medicines Agency has clarified, in agreement with the European Commission, a number of points related to the new categories of variations to the terms of marketing authorisations that were introduced in August 2013. The related question and answer document has been updated to reflect these adjustments.


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Regulatory information “ EMA introduces product numbers to track medicines through pre-authorisation procedures

EVELYNE PIERRON's insight:

The European Medicines Agency has introduced unique product identifiers (UPIs) to track medicines through pre-authorisation procedures. The assignment of UPIs contributes to the Agency’s initiatives to improve the efficiency of its processes as part of the ongoing reorganisation.

It will also help create a unique platform for all pre-authorisation activities.


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EMA releases guidance on the use of pharmacogenomics to improve safety monitoring of medicines

EVELYNE PIERRON's insight:

The European Medicines Agency has released a draft guideline for public consultation (until 30 july 2014) which addresses how pharmacogenomics can support pharmacovigilance activities and in particular how the results of pharmacogenomic studies can help optimise the use of medicines.


The guideline describes how pharmacogenomics can be implemented in risk-management plans, risk-minimisation measures, signal detection and the benefit-risk evaluation of medicines with an established link between genetic features and efficacy and safety.

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Les Cobayes de Benacquista et Barral : quand des essais pharmaceutiques tournent mal !

Les Cobayes de Benacquista et Barral : quand des essais pharmaceutiques tournent mal ! | Actu Pharmacovigilance | Scoop.it
Il a déjà un nom : le tripazepan vivanol. Mais il est connu pour l'instant sous le nom de code de M2 C2 T. Un anxiolytique nouvelle génération qui devrait selon ses concepteurs être plus performant...
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EVELYNE PIERRON's curator insight, February 5, 2014 6:47 AM

Une BD à découvrir sur le développement des molécules, l'industrie pharmaceutique et les effets indésirables #pharmacovigilance

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Pour une meilleure transparence, vers un règlement européen pour les essais cliniques de médicaments à usage humain - www.sante.gouv.fr

Pour une meilleure transparence, vers un règlement européen pour les essais cliniques de médicaments à usage humain - www.sante.gouv.fr | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:


Ce nouveau réglement abrogera la directive européenne 2001/20/CE relative aux essais cliniques de médicaments.

Ce projet de texte dont l’adoption formelle interviendra au printemps 2014 prévoit notamment une simplification administrative pour réaliser une recherche en Europe et une plus grande transparence des résultats des essais.

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European Medicines Agency - Release of data from clinical trials

EVELYNE PIERRON's insight:

The Agency has been releasing clinical-trial reports on request as part of its access-to-documents policy since late 2010 and is now working towards its goal of publishing clinical-trial data proactively for the medicines it has assessed. As part of this process, it released a draft policy on the publication and access to clinical-trial data in June 2013 for a three-month public consultation.

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#Pharmacovigilance European Medicines Agency finalises review of medicines concerned by Roche pharmacovigilance inspection

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EVELYNE PIERRON's curator insight, November 20, 2013 9:16 AM

..."The assessment by the Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) of the impact of the additional data provided by Roche on the medicines concerned has not identified any important new safety concerns. The balance of benefits and risks of these medicines has not been affected and there is no new advice regarding their use. Patients should continue to take these medicines as previously advised. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has agreed with these conclusions by the PRAC...."

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European Medicines Agency - Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders and changes to scope of European safety referrals

EVELYNE PIERRON's insight:

Entrée en vigueur de la Directive 2012/26 avec notamment :

- de nouvelles obligations pour le titulaire d'AMM en terme de transparence sur les motifs de retrait des AMM,

- les procédures d'urgences

-  extension de la liste des médicaments faisant l'objet d'une surveillance supplémentaire (médicaments ayant fait l'objet d'une procédure accélérée, PASS)

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ANSM Bulletin des vigilances.pdf

EVELYNE PIERRON's insight:

Dispo sur le site de l'ANSM, le bulletin sur l'actualité des vigilances (médicaments, dispositif médical, produits biologiques...)

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Pouvait-on détecter la dérive du Mediator ?

Pouvait-on détecter la dérive du Mediator ?
EVELYNE PIERRON's insight:

William Dab conclut ainsi : "Il est temps d’organiser sérieusement le recueil et l’interprétation des signaux relatifs aux bénéfices et aux risques des médicaments."

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ANSM - Nouvelles modalités de déclaration des effets indésirables survenus lors des essais cliniques (SUSARs) portant sur un médicament ou ne portant pas sur un produit de santé

EVELYNE PIERRON's insight:

Les déclarations des SUSARS étaient jusqu’à présent adressées par les promoteurs d’essais cliniques à l’ANSM par voie postale ou par télécopie. Afin de faciliter la transmission de ces déclarations, l’ANSM met à disposition une adresse électronique unique. 

Ainsi, les fiches de déclarations d’effet(s) indésirable(s) devront dorénavant être adressées uniquement par courriel et accompagnées du nouveau formulaire d’accompagnement.


Accessible depuis les rubriques Internet "Activités" et "Déclarer un effet indésirables" du site de l’Agence, ce dernier permettra de faciliter le suivi et le traitement de ces déclarations.


En résumé, à compter du 17 mars 2014, les SUSARS devront être déclarés à l’ANSM 

  • Par messagerie électronique (courriel) à l’adresse : declarationsusars@ansm.sante.fr
  • Chaque SUSARS devra faire l’objet d’un message électronique individuel.
  • Les pièces annexées au message seront les suivantes :
    - La fiche CIOMS (format PDF)
    - Le formulaire d’accompagnement 
  • L’objet du message, les noms de la fiche CIOMS et du formulaire d’accompagnement devront être libellés selon les règles définies dans le manuel d’utilisation.
  • Une traduction en anglais de ces documents est disponible.


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Comment Teva a piloté une situation de crise

Comment Teva a piloté une situation de crise | Actu Pharmacovigilance | Scoop.it
L’affaire avait fait grand bruit en juin 2013. Un malade était décédé après avoir avalé un comprimé de Furosémide, un... Articles liés Pharmacie, France, Bourgogne - L'information de l'industrie
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European Medicines Agency - Post-authorisation - Periodic safety update reports: questions and answers

EVELYNE PIERRON's insight:

This page lists questions that marketing-authorisation holders (MAHs) may have on periodic safety update reports (PSURs).

It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.

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European Medicines Agency - Post-authorisation - Post-authorisation safety studies (PASS)

EVELYNE PIERRON's insight:

A post-authorisation safety study (PASS) is a study that is carried out after a medicine has been authorised to obtain further information on a medicine's safety, or to measure the effectiveness of risk-management measures.

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) is responsible for assessing the protocols of imposed PASSs and for assessing their results.


Guidance for MAH and template for assessors are available on this page.

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European Medicines Agency - Referral procedures - Questions and answers: Article 31 pharmacovigilance referral

EVELYNE PIERRON's insight:

Questions and answers are being updated continuously, and will be marked by “New” or “Rev.” with the relevant date upon publication.

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European Medicines Agency - Data submission on authorised medicines - Reporting requirements for marketing-authorisation holders

European Medicines Agency - Data submission on authorised medicines - Reporting requirements for marketing-authorisation holders | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:

Marketing-authorisation holders of medicines authorised in the European Union (EU) have been required to submit information on medicines to the European Medicines Agency (EMA) since July 2012.


The current objective is to ensure that the Agency receives up-to-date, complete and high-quality data by the end of 2014. Following this, the focus will be on maintaining the data so that it is kept up-to-date and of high quality.

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Good Pharmacovigilance Practice: Risk-based inspections : MHRA

Good Pharmacovigilance Practice: Risk-based inspections : MHRA | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:

Marketing authorisation holders are encouraged to complete a compliance report every two years. The Compliance Report is in an MS-Excel format and contains the questions that need to be completed. Guidance notes on completing the questionnaire are also available and should be read before completing the questionnaire.


The 2013 compliance report is now available for completion, the deadline for submissions is 30 May 2014.


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European Medicines Agency - Best expertise vs conflicts of interests: Striking the right balance

EVELYNE PIERRON's insight:

The European Medicines Agency  published a report highlighting the outcomes of its workshop on conflicts of interests, which was hosted at the Agency on 6 September 2013.

The report gives an overview of the issues debated at the workshop and summarises the key interventions of the panellists and other speakers.

The Agency has also published a video recording of the workshop.

The slides presented by the Agency’s Executive Director, Guido Rasi, and all other participants at the workshop, are also available.

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L’ANSM rappelle la place centrale de la pharmacovigilance dans la mise à disposition de l’innovation thérapeutique - Publication d'article

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European Medicines Agency - Post-authorisation - Withdrawals and cessation of centrally and nationally authorised medicines: questions and answers

EVELYNE PIERRON's insight:

This page lists questions relating to marketing cessation, marketing suspension and withdrawals of medicinal products from the market and of marketing authorisations in the context of the implementation of Directive 2012/26/EU and Regulation (EU) No 1027/2012 amending the pharmaceutical legislation with respect to pharmacovigilance.

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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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