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Septembre 2012 : Une meilleure pharmacovigilance après le cas "Mediator" ?

Septembre 2012 : Une meilleure pharmacovigilance après le cas "Mediator" ? | Actu Pharmacovigilance | Scoop.it

Le 10 septembre 2012, le Parlement européen se penchera sur le rapport de l'eurodéputée britannique Linda McAvan concernant la "pharmacovigilance". Il s'agit d'un dossier qui a fait beaucoup couler d’encre en France et en Europe, lors de l'affaire "Mediator" l’an dernier. Aujourd'hui, le Parlement pourrait approuver de nouvelles modifications de la législation européenne dans ce domaine, pour éviter que d'autres médicaments nocifs soient commercialisés dans l'UE.

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Actu Pharmacovigilance
L'actualité réglementaire de la pharmacovigilance en Europe
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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.


Un site à destination du grand public et des professionnels de santé est également disponible www.pharmacovigilancepourtous.fr



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




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 6:53 AM
Merci pour la pub
Philippe Loizon's comment, September 21, 2013 6:54 AM
-)))
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European Medicines Agency - Central repository to facilitate assessment of medicines safety reports (PSURs)

EVELYNE PIERRON's insight:

An electronic repository for periodic safety update reports (PSURs) and their assessment reports is launched by the European Medicines Agency (EMA) today. The central platform was created in accordance with the pharmacovigilance legislation of the European Union (EU) and will contain all information related to PSURs in the EU. It will facilitate the assessment of PSURs by medicines regulatory authorities in the EU.

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ICH guideline E2B (R3) - Questions and answers

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This Q&A document provides clarifications for the harmonized interpretation of the E2B(R3) IG package and should be reviewed in conjunction with the IG package. This will facilitate the implementation of the electronic transmission of Individual Case Safety Reports (ICSRs) in the ICH regions.
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Matinée Débat de l'Ordre des Médecins : “Les enjeux de la santé connectée” | Care Insight

EVELYNE PIERRON's insight:

Ce débat sera organisé autour de six invités qui croiseront leur regard singulier sur la santé connectée et partageront leur expertise.


Olivier Desbiey, responsable de l’innovation et de la prospective à la CNIL

Dominique Dupagne, médecin iconoclaste du Web 2.0

Anne Laude, doyen de l'UFR de Droit de l’Université Paris Descartes et co-directrice de l'Institut Droit et Santé

Philippe Lemoine, président du Forum d'Action Modernités et Président de la Fondation internet nouvelle génération, auteur du rapport "La nouvelle grammaire du succès, La transformation numérique de l'économie française ".

Alexis Normand, responsable des relations santé de Withings, société qui conçoit et produit des applications et objets connectés.

Benoît Thieulinprésident du Conseil national du Numérique et directeur fondateur de l’Agence digitale La Netscouade.


Inscription en ligne avant le 30/01
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Santé Publique Veille-et-sécurité-sanitaire: missions et chiffres clés

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Missions et chiffres clés de l'ARS Ile de France sur la veille et la sécurité sanitaire

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European Agency : Guido Rasi, the head of the EMA is gone after Panel Annulls his Appointment

European Agency : Guido Rasi, the head of the EMA  is gone after Panel Annulls his Appointment | Actu Pharmacovigilance | Scoop.it
In an unexpected development, Guido Rasi, the head of the European Medicines Agency, has been forced to step down after a European Panel annulled his appointment, which was made three years ago.
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European Medicines Agency - New tool for companies to facilitate maintenance of information on authorised medicines

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has made available a new tool to facilitate editing of key data fields by marketing-authorisation holders as part of the maintenance of information on authorised medicines that they have submitted to EMA.

This tool is available to users of the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) Data-Entry Tool (EVWEB).

A user manual explaining how to use this tool has been published.


Information on medicines must be updated by end of December 2014.

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European Medicines Agency Patients to discuss benefit-risk evaluation of medicines with the Committee for Medicinal Products for Human Use

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has launched a pilot project to involve patients in the assessment of the benefits and risks of medicines in its Committee for Medicinal Products for Human Use (CHMP).

Listening to patients enriches the scientific assessment of a medicine with new ways of thinking about benefit and risk from the patient perspective.

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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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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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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 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 - 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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Infography - 50 years of EU Pharmaceutical regulation - Medicinal products for human use - European Commission

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European Medicines Agency - Pharmacovigilance : New international standard to improve safety of medicines- ISO ICSR

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the European Union (EU). The so-called ISO ICSR standard improves the reporting of suspected side effects of medicines in Individual Case Safety Reports (ICSRs). The use of the new international standard will take effect on 1 July 2016.


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European Medicines Agency - Regulatory information - Simplification of submission of product information updates in periodic safety update reports for nationally authorised products

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has updated its procedural guidance on periodic safety update reports (PSURs) to simplify the way marketing authorisation holders present proposed changes to the product information of nationally authorised medicines in PSURs subject to a single assessment.

EMA will start to pilot this simplified approach in January 2015.

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HALMED - Zagreb 10/11 february 2015 The Pharmacovigilance Workshop: Risk Management, Electronic Reporting, XEVMPD updates

EVELYNE PIERRON's insight:

The Pharmacovigilance Workshop: Risk Management, Electronic Reporting, XEVMPD updates will be organised from on the 10 and 11 February 2015 in Zagreb.

Details on fees, venue of the workshop and registration are accessible in the registration form by which all interested participants may register. 

The attendance will be accredited according to regulations of the Croatian Medical Chamber and Croatian Pharmacy Chamber.

 

The workshop programme is accessible here.


This workshop will be managed by:

 

John J. Borg, PhD, Medicines Authority, Malta

Calin LUNGU, MD, DDCS S.A., Luxemburg

 

Agenda

 

Day one

 

8:30 – 9:00          Welcome and registration

9:00 – 9:15          Introduction and overview of the agenda (C. Lungu)

9:15 – 10:00       What’s new in ICSRs and the importance of capturing the best information for causality assessment (John J. Borg)

10:00 – 10:40    Coffee break

10:40 – 11:10    Signal detection in EudraVigilance (C. Lungu)

11:10 – 11:40    Update on the XEVMPD requirements and ongoing activities of data maintenance (C. Lungu) – Part I

11:40 – 12:15    Data quality of ICSRs (C. Lungu)

12:15 – 12:30    Questions and answers

12:30 – 13:30    Lunch break

13:30 – 15:00    Explaining the Risk Management Plan and building the safety specification for abridged applications (John J. Borg)

15:00 – 15:30    Coffee break

15:30 – 16:15    Conditions of marketing authorizations and implementing additional risk minimization methods what do regulators want when stakeholders interact with them? (John J. Borg)

16:15 – 17:00    Electronic reporting in the EEA member states (C. Lungu)

17:00                      End of Day 1

 


 

Day two

 

9:00 – 10:00       Update on the XEVMPD requirements and ongoing activities of data maintenance (C. Lungu) – Part II

10:00 – 10:30    What the regulator looks at during authorizations of the summary of pharmacovigilance system (John J. Borg)

10:30 – 11:10    Coffee break

11:10 – 11:40    Preparing audits and inspections using EudraVigilance (C. Lungu)

11:40 – 12:15    Preparing for pharmacovigilance audits (a regulators’ preparedness) (John J. Borg)

The Regulator’s Audit report to the Commission as per Directive 2010/84/EC (John J. Borg)

12:15 – 12:30    Questions and answers

12:30 – 13:30    Lunch break

13:30 – 14:15    GVP Module I – Quality Systems (C. Lungu)

14:15 – 15:00    Pharmacovigilance systems for MAHs, WHDs, Parallel Importers and 126a Authorization Holders (John J. Borg)

15:00 – 15:30    Coffee break

15:30 – 16:15    GVP Module III – IV – PV audits and inspections (C. Lungu)

16:15 – 17:00    Conditions of marketing authorizations and implementing risk minimization methods risk based inspections carried out by the regulators (John J. Borg)

17:00                      End of Day 2

 

 

 

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WEB-RADR

WEB-RADR | Actu Pharmacovigilance | Scoop.it
  WEB-RADR: Recognising Adverse Drug Reactions Working together to improve pharmacovigilance through new technology Learn More
EVELYNE PIERRON's insight:

The WEB-RADR website went live on 5 December 2014 . The launch of the project website, which offers a tool to disseminate information to stakeholders about the consortium and the project aims and objectives, is part of WP5’s (project management and communication) key deliverables.

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Canada Passes a Drug Safety Law (Vanessa's Law), but Criticism Persists

Canada Passes a Drug Safety Law (Vanessa's Law), but Criticism Persists | Actu Pharmacovigilance | Scoop.it
Following sustained criticism that government oversight of prescription drug safety was lacking, Canada late last week passed Vanessa’s Law, which gives the Health Minister new authority over a wide range of practices involving both the pharmaceutical industry and the national regulatory agency.
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Rapport Weber bientôt sur le bureau du Ministre : Une vigilance à encourager -

Rapport Weber bientôt sur le bureau du Ministre : Une vigilance à encourager - | Actu Pharmacovigilance | Scoop.it
Le rapport sur la réorganisation des vigilances, commandé par Marisol Touraine à Françoise Weber, sera remis prochainement à la ministre de la Santé. Il propose notamment un portail déclaratif unique et la reconnaissance des missions de santé publique des professionnels de santé.
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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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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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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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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 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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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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