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Veille Pharmacovigilance, web formation, formation, expertise Pharmacovigilance


La réglementation du médicament ne cesse de s'enrichir et vous n'avez pas toujours le temps de trouver l'information, de la digérer et de la transmettre à vos équipes.


La société Evelyne Pierron Consultants met à la disposition des départements PV, Affaires Réglementaires une plateforme d'information et des outils vous permettant de vous tenir à jour sans panique. Visitez mon site www.epconsultantsonline.fr et rejoignez la communauté.


De nombreux services vous attendent.


En attendant votre visite, Evelyne Pierron Consultants continue de veiller sur sa communauté.


Evelyne Pierron

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Linkedin:http://fr.linkedin.com/in/evelynepierron

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EVELYNE PIERRON's insight:

Cette sélection d'actualités vous intéresse alors suivez moi sur Scoopit. L'enregistrement et l'inscription sont gratuits.

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EVELYNE PIERRON's comment, September 21, 2013 3:53 AM
Merci pour la pub
Philippe Loizon's comment, September 21, 2013 3:54 AM
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Actu Pharmacovigilance
L'actualité réglementaire de la pharmacovigilance en Europe
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Scooped by EVELYNE PIERRON
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Veille Pharmacovigilance, web formation, formation, expertise Pharmacovigilance


La réglementation du médicament ne cesse de s'enrichir et vous n'avez pas toujours le temps de trouver l'information, de la digérer et de la transmettre à vos équipes.


La société Evelyne Pierron Consultants met à la disposition des départements PV, Affaires Réglementaires une plateforme d'information et des outils vous permettant de vous tenir à jour sans panique. Visitez mon site www.epconsultantsonline.fr et rejoignez la communauté.


De nombreux services vous attendent.


En attendant votre visite, Evelyne Pierron Consultants continue de veiller sur sa communauté.


Evelyne Pierron

Tikimee: http://www.tikimee.com/evelyne-pierron-consultants

Linkedin:http://fr.linkedin.com/in/evelynepierron

Rebelmouse: https://www.rebelmouse.com/EVEPIE/


EVELYNE PIERRON's insight:

Cette sélection d'actualités vous intéresse alors suivez moi sur Scoopit. L'enregistrement et l'inscription sont gratuits.

Are you enjoyed? If yes,  follow me. Register is free. Let's go!

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EVELYNE PIERRON's comment, September 21, 2013 3:53 AM
Merci pour la pub
Philippe Loizon's comment, September 21, 2013 3:54 AM
-)))
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Regulatory information - European Medicines Agency updates guidance on European Union periodic-safety-update-report single assessment for nationally authorised medicines

EVELYNE PIERRON's insight:


The European Medicines Agency (EMA) has updated its procedural guidance to ensure that marketing-authorisation holders are prepared for the submission of periodic safety update reports (PSURs) for nationally authorised medicines subject to European Union (EU) single assessment.

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European Medicines Agency : Report of the EMA workshop of pharmacovigilance in the paediatric population

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The aim of this workshop was to address the needs and priorities for Pharmacovigilance in the paediatric population.

The objectives were to outline the current work performed at the EMA with regard to paediatric safety, and to discuss the potential for improvement in terms of active paediatric Pharmacovigilance.


A Specific focus on ADRs in pediatric oncology was discussed.

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Pharmacovigilance - Boxed Warnings and Withdrawals for Novel Drugs

Pharmacovigilance - Boxed Warnings and Withdrawals for Novel Drugs | Actu Pharmacovigilance | Scoop.it
Letter from JAMA Internal Medicine — Trends in Boxed Warnings and Withdrawals for Novel Therapeutic Drugs, 1996 Through 2012
EVELYNE PIERRON's insight:

The objective of this study was to determine the frequency of premarket and postmarket boxed warnings and safety-related withdrawals for novel therapeutics approved between 1996 and 2012.


Our study demonstrates that boxed warnings are common, affecting more than one-third of recent drug approvals. While nearly three-quarters of boxed warnings had been applied to novel therapeutics at the time of approval, more than 40% acquired the warning after a median market period of 4 years.

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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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Recherche : Google lance "Baseline Study" pour tenter d’identifier des "biomarqueurs de bonne santé" - Actualités - Vidal.fr

Recherche : Google lance "Baseline Study" pour tenter d’identifier des "biomarqueurs de bonne santé" - Actualités - Vidal.fr | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:
Baseline Study", une étude centrée sur les caractéristiques génétiques, physiologiques, médicales de 175 personnes.

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EMA - Description of the Pharmacovigilance system of the European Medicines Agency

EVELYNE PIERRON's insight:

Available on the EMA website, description of the Pharmacovigilance system (version 1.1) according to the current PV legislation.

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European Medicines Agency launches public consultation on rules of procedures for public hearings

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has  launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC).

The rules of procedures describe the process and practical arrangements for the preparation, conduct and follow-up of public hearings.


Citizens are invited to review the proposed draft rules and send their comments to the Agency by 15 October 2014. Comments should be sent to public-hearings@ema.europa.eu using the comments submission form.

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European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014

European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014 | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:

Thirty-nine medicines for human use were recommended for marketing authorisation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in the first half of 2014, compared with 44 in first half of 2013 and 33 in first half of 2012.

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European Medicines Agency welcomes publication of pharmacovigilance fee Regulation in Official Journal of the EU

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) welcomes the publication of the Regulation on pharmacovigilance fees in the Official Journal of the European Union (EU) .

The pharmacovigilance legislation foresees that pharmacovigilance activities conducted at EU level for medicinal products for human use should be financed by fees paid by marketing-authorisation holders.


The Regulation will allow the EMA to collect these fees.

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European Medicines Agency - Posting of clinical trial summary results in European Clinical Trials Database (EudraCT) to become mandatory for sponsors as of 21 July 2014

EVELYNE PIERRON's insight:

As of 21 July 2014, it will become mandatory for sponsors to post clinical trial results in the European Clinical trials Database (EudraCT), managed by the European Medicines Agency (EMA).

This date corresponds to the finalisation of the programming of the database as referred to in a European Commission guideline, in application of the current clinical trials Directive 2001/20/EC and the Paediatric Regulation.

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Re: Adverse effects of statins | BMJ

Re: Adverse effects of statins | BMJ | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:

La réponse du Formindep à un récent éditorial sur un effet indésirable (effet diabétogène)  des statines et le retard de modification de l'information médicale (RCP/notice) par l'ANSM. 

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Tweet #Risks as Well as #Benefits, FDA Tells Drugmakers

Tweet #Risks as Well as #Benefits, FDA Tells Drugmakers | Actu Pharmacovigilance | Scoop.it
“Don’t use Viagra if your heart isn’t healthy enough for sex.” After that warning, Pfizer Inc. will have just 81 letters left to tweet about the benefits of its erectile dysfunction drug, say U.S. regulators.
EVELYNE PIERRON's insight:

Drug and device makers who send social media messages on services like Twitter will be required to include the risks and benefits of their products when they do so, the Food and Drug Administration proposed today in two draft guidelines.

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ANSM Matinée 20/06/2014 - L'accès aux médicaments et à l'innovation thérapeutique

EVELYNE PIERRON's insight:

L'ANSM organise une Matinée le 20/06 sur l'accès aux #médicaments et à l'#innovation thérapeutique(RTU, ATU, procédure centralisée, essais cliniques).

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VIDEO : Pull openFDA API Data into a Microsoft Excel Pivot Table - YouTube

The FDA has launched a new open data portal called openFDA which provides easier and better access to their data. This video demonstrates the process by whic...
EVELYNE PIERRON's insight:

Comment accéder à ces données? Une vidéo vous explique comment les transférer dans un fichier Excel.

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European Medicines Agency - Regulatory information “ Companies now required to update, complete and improve quality of information on authorised medicines submitted to the European Medicines Agency"

EVELYNE PIERRON's insight:

 The European Medicines Agency requires marketing-authorisation holders to update the information on authorised medicines that they have submitted in accordance with Article 57(2) of the 2010 pharmacovigilance legislation.

Companies need to complete this process by the end of 2014.


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Public consultation opens on European Medicines Agency's draft guide on monitoring of medical literature

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has released a draft guide on the monitoring of medical literature and the entry of relevant information into the EudraVigilance database, for a two-month public consultation.

All stakeholders are invited to send comments on the draft guidance document no later than 27 July 2014.

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Essai Clinique - Parution du nouveau réglement n°536/2014 abrogeant la directive 2001/20/CE

EVELYNE PIERRON's insight:

Parution ce jour dans le Journal Officiel de l'union Européenne du nouveau réglement Essai Clinique n°536/2014, abrogeant la directive 2001/20/CE

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Evénements indésirables médicamenteux en Ile-de-France : un site de déclaration en ligne désormais disponible

Pour faciliter la notification de ces événements indésirables médicamenteux, les 6 centres de pharmacovigilance d’Ile de France se sont regroupés au sein d’une coordination et mettent à disposition depuis Février 2014 un site internet de télé-déclaration : www.pharmacovigilance-iledefrance.fr.
EVELYNE PIERRON's insight:


Ce site s’organise en 2 espaces:

- l’un destiné au grand public,

- l’autre aux professionnels de santé.


Pour accéder à l’espace qui lui est dédié, le professionnel de santé se crée un compte à l’aide de son n° RPPS (pour les médecins, pharmaciens, chirurgien-dentistes, sages-femmes) ou de son n° ADELI (pour les infirmiers(ères)). Il pourra ensuite déclarer un effet indésirable avec un formulaire spécifique aux professionnels de santé, poser une question sur la iatrogénèse médicamenteuse et le bon usage des médicaments, ou encore accéder à des informations utiles à sa pratique quotidienne.


Par ailleurs, un abonnement au flux RSS permettra à ces professionnels de santé de recevoir les alertes et les brèves de pharmacovigilance dès leur mise en ligne.

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EVELYNE PIERRON's curator insight, May 19, 8:43 AM


Ce site s’organise en 2 espaces:

- l’un destiné au grand public,

- l’autre aux professionnels de santé.


Pour accéder à l’espace qui lui est dédié, le professionnel de santé se crée un compte à l’aide de son n° RPPS (pour les médecins, pharmaciens, chirurgien-dentistes, sages-femmes) ou de son n° ADELI (pour les infirmiers(ères)). Il pourra ensuite déclarer un effet indésirable avec un formulaire spécifique aux professionnels de santé, poser une question sur la iatrogénèse médicamenteuse et le bon usage des médicaments, ou encore accéder à des informations utiles à sa pratique quotidienne.


Par ailleurs, un abonnement au flux RSS permettra à ces professionnels de santé de recevoir les alertes et les brèves de pharmacovigilance dès leur mise en ligne.

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PHARMACOVIGILANCE - Experience with the PRAC after 18 months of operation

EVELYNE PIERRON's insight:
The new EU pharmacovigilance legislation became operational in July 2012, and after 18 months of operation, the authors suggest that this initiative is starting to demonstrate results in terms of patient safety, and that there could be wider implications in terms of more safe and effective drugs being made available in the future.
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EMA - Questions/Réponses sur le Résumé public du Plan de gestion des risques - Questions/Answers on the Risk Management Plan summary

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These are intended to allow stakeholders wider access to the information behind the decision-making process of European regulatory authorities when they review the safety of a medicine or active substance.

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European Medicines Agency - Monitoring the safety of medicines: European Medicines Agency presents first report on implementation of pharmacovigilance legislation to the European ...

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has presented the European Commission with its first report on the tasks it undertook during the first year of application of the EU’s new pharmacovigilance legislation. The EMA, the national competent authorities in the Member States and the European Commission have collaborated closely in fulfilling their responsibilities for implementing the new legislation.

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European Medicines Agency - News and Events - EMA publishes 2013 annual report

European Medicines Agency - News and Events - EMA publishes 2013 annual report | Actu Pharmacovigilance | Scoop.it
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European Medicines Agency -

EVELYNE PIERRON's insight:

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

EVELYNE PIERRON's insight:

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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Communiqué de presse - Questions & Answers: Fees for Pharmacovigilance activities

Communiqué de presse - Questions & Answers: Fees for Pharmacovigilance activities | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:

 The European Parliament voted in favour of an EU Regulation on fees payable to the European Medicines Agency (EMA) for the conduct of pharmacovigilance activities for medicinal products for human use, which lays down the level and structure of these fees.


It defines two types of fees, in view of the diversity of the pharmacovigilance activities: procedure-based fees and an annual fee. The procedure-based fees are aimed at covering the cost of the EU-wide assessments including financial compensation of the national competent authorities for the rapporteurships.

The annual fee covers mainly EMA’s information technology-related activities for pharmacovigilance.


Therefore, the first procedure-based fees should be charged around August or September 2014. The annual fee will be charged as of 1 July 2015.

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Curated by EVELYNE PIERRON
Médecin, veilleur de sa communauté #pharmacovigilance, passionnée de #sécurité sanitaire, de #santé publique et GEEK à mes temps perdus.