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Actu Pharmacovigilance
L'actualité réglementaire de la pharmacovigilance en Europe
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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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ANSM newsletter

ANSM newsletter | Actu Pharmacovigilance | Scoop.it
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EVELYNE PIERRON's curator insight, October 14, 2013 10:41 AM

Publication de la Newsletter n°6 de l'ANSM avec un point sur:

- les contraceptifs oraux

- les nouveaux anticoagulants(NACO)

- les implants mammaires

- le comité interacfe associations de patients

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European Medicines Agency - Signal management - PRAC recommendations on safety signals

EVELYNE PIERRON's insight:

This page lists the recommendations from the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) on safety signals. Each month, the Agency publishes an overview listing all signals discussed during the latest PRAC meeting and the recommendations given for each of them.

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European Medicines Agency publishes a video explaining the concept of medicines under additional monitoring

EVELYNE PIERRON's insight:

The European Medicines Agency has published a video and a factsheet in all official European Union (EU) languages today explaining the meaning of the black triangle, which is now starting to appear in the product information of certain authorised medicines in the EU.


The black triangle has recently been introduced in the EU as part of the concept of medicines under additional monitoring and is an important deliverable of the new European pharmacovigilance legislation.

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Remise à Marisol Touraine du rapport sur la surveillance et la promotion du bon usage du médicament en France

Remise à Marisol Touraine du rapport sur la surveillance et la promotion du bon usage du médicament en France | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:

Ce lundi 16 septembre 2013, les Professeurs Dominique COSTAGLIOLA et Bernard BEGAUD, pharmacologues et épidémiologistes, ont remis à Marisol TOURAINE, Ministre des Affaires sociales et de la Santé, le rapport sur la surveillance et la promotion du bon usage du médicament en France.

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WEBAE_EMA_involvement.pdf

EVELYNE PIERRON's insight:

l'Agence européenne souhaite participer au projet européen de développement d'une application permettant le reporting des effets indésirables intégrant l'enregistrement électronique et l'exploitation des réseaux sociaux.

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UK-MHRA - The Falsified Medicines Directive came into force

UK-MHRA - The Falsified Medicines Directive  came into force | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:


The Falsified Medicines Directive came into force in Europe in January 2013. The new directive introduces measures to prevent the entry of falsified medicines into the legal supply chain. The directive substantially changes the European framework around the supply of medicines and covers businesses that have traditionally not been directly regulated through medicines regulation.

European Directive 2011/62/EU of the European Parliament and of the Council (the Falsified Medicines Directive) amends Directive 2001/83/EC on the Community code relating to medicinal products for human use.

In UK, the Falsified Medicines Directive is transposed through The Human Medicines (Amendment) Regulations 2013 [SI 2013/1855] which came into force on 20 August 2013.

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European Medicines Agency - First information day on the use of the Medical Dictionary for Regulatory Activities (MedDRA) including medication errors

EVELYNE PIERRON's insight:

This Information Day will focus specifically on the use of MedDRA for coding and retrieving adverse reactions and events occurring in the context of medication errors. Specific examples and MedDRA best practice coding principles will be discussed by experts from regulators, the MedDRA MSSO and pharmaceutical industry.

The use of MedDRA in the context of EudraVigilance and other internationaldatabases will be also addressed.

This information day on 22/10/2013 at the EMA (London)
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European Medicines Agency - Post-authorisation - Post Authorisation Safety Study (PASS): questions and answers

EVELYNE PIERRON's insight:

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 - 2012 annual report on EudraVigilance published

EVELYNE PIERRON's insight:

The report published today provides information on the activities undertaken in 2012 in terms of development of new functionalities, data collection and quality, data analysis, transparency, communication and training. The data held in EudraVigilance are key to ensuring the continuous safety monitoring of medicines by the EMA and the Member States, as well as facilitating the decision making of the Pharmacovigilance Risk Assessment Committee (PRAC) and other committees of the EMA.


By 31 December 2012, the EudraVigilance database held a total of

3,867,243 adverse reaction reports, referring to 2,224,670 individual cases. During 2012, the EudraVigilance database received and processed approximately 70,000 expedited adverse reaction reports per month for authorised medicines. These were subsequently made available for signal detection and data analysis by the EMA and medicines regulatory agencies in the Member States.

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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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Décret n° 2013-923 du 16 octobre 2013 pris pour la transposition de la directive 2012/26/UE du 25 octobre 2012 modifiant en ce qui concerne la pharmacovigilance la directive 2001/83/CE instituant u...

EVELYNE PIERRON's insight:


Le texte, qui vise à renforcer le système de pharmacovigilance, transpose la directive 2012/26/UE du Parlement européen et du Conseil du 25 octobre 2012 modifiant, en ce qui concerne la pharmacovigilance, la directive 2001/83/CE instituant un code communautaire relatif aux médicaments à usage humain.

Il modifie:

- les procédures européennes de réévaluation des médicaments à usage humain. 

- à un renforcement des obligations pesant sur les entreprises exportant des médicaments vers des pays tiers à l'Union européenne et sur les entreprises important des médicaments en provenance de ces pays.

- les modalités de déclaration des effets indésirables des préparations hospitalières et des préparations magistrales fabriquées par des entreprises pharmaceutiques. 

- prévoit que l'Agence nationale de sécurité du médicament et des produits de santé publie chaque année, sur son site internet, la liste des médicaments pour lesquels les autorisations de mise sur le marché ont été refusées, retirées ou suspendues, ou dont la délivrance a été interdite ou qui ont été retirés du marché en France et dans l'Union européenne.


Références : les dispositions du code de la santé publique modifiées par le présent décret peuvent être consultées, dans leur rédaction résultant de cette modification, sur le site Légifrance (http://www.legifrance.gouv.fr). Le décret est pris pour l'application des articles 5 et 28 de la loi n° 2011-2012 du 29 décembre 2011 relative au renforcement de la sécurité sanitaire du médicament et des produits de santé.

Le décret entre en vigueur à compter du 28 octobre 2013.

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European Medicines Agency launches a new version of EudraCT

EVELYNE PIERRON's insight:


The European Medicines Agency has launched a new version of the European Clinical Trials Database (EudraCT). This new version, EudraCT V9, marks the initial step of a process through which summary clinical trial results will be made publicly available through the EU Clinical Trials Register (EU CTR).


Dans le cadre de l'accès aux données issues des essais cliniques, une nouvelle version de la base de données EUDRACT.

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PRAC- Pharmacovigilance- European Medicines Agency begins to publish recommendations based on safety signals

EVELYNE PIERRON's insight:

The European Medicines Agency has published the first overview listing the recommendations stemming from the assessment of safety signals by the Pharmacovigilance Risk Assessment Committee (PRAC).


A cumulative list of all signals discussed at the PRAC since September 2012 is also available.

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MÉDICAMENTS SOUS SURVEILLANCE RENFORCÉE - BLACK TRIANGLE .pdf

EVELYNE PIERRON's insight:

Les médicaments sous surveillance renforcée sont identifiables par la présence d’un triangle noir inversé (aussi appelé « black symbol ») dans la notice d’information des patients et dans le résumé des caractéristiques du produit (RCP - informations destinées aux professionnels de la santé).


Ce triangle est accompagné d’une courte phrase explicative :

 "Ce médicament fait l’objet d’une surveillance renforcée"


Ce symbole sera utilisé dans tous les Etats Membres de l’Union européenne. Il commencera à apparaître sur la notice et le RCP des médicaments concernés à partir de l’automne 2013, mais ne figurera pas sur l’emballage des médicaments.

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European Medicines Agency reveals new structure

EVELYNE PIERRON's insight:

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

EVELYNE PIERRON's insight:
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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European Medicines Agency - Changes to Risk-management plans

EVELYNE PIERRON's insight:

There were two important changes to RMPs  in August 2013:

Updates to RMPs and Changes to "important missing information"

1 - An updated RMP should now be submitted:

  • at the request of the Agency or an NCA;
  • whenever the risk-management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile or as a result of an important pharmacovigilance or risk-minimisation milestone being reached.

When justified by risk, the competent authority may still specify a date for submission of the next RMP as a condition of the marketing authorisation in exceptional cases.

If the date for the submission of a periodic safety update report (PSUR) and the need to update a RMP coincide, both can be submitted at the same

time.

2 - Changes to 'important missing information'

The word 'important' has been removed from the phrase 'important missing information' within risk-management documents defining what consitutes a safety concern in an RMP.

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

EVELYNE PIERRON's insight:

 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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The Pharmacovigilance System Master File

The Pharmacovigilance System Master File | Actu Pharmacovigilance | Scoop.it
Derek Woodcock gives an overview of the Pharmacovigilance System Master File in our safety and pharmacovigilance themed month. The requirement for a Pharmacovigilance System Master File (PSMF) has been in place since July 2012 for all Centrally...
EVELYNE PIERRON's insight:

..." Is the PSMF simply a source for more findings during inspection or a useful tool."


Excellent analysis and perspectives of the PSMF from a pharmacovigilance consultant

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