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EURORDIS - La voix des patients atteints de maladies rares en Europe

EURORDIS - La voix des patients atteints de maladies rares en Europe | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:

La nouvelle section du site d’EURORDIS dédiée à la pharmacovigilance, disponible en sept langues, sensibilise à la nécessité de signaler tout problème rencontré par un patient avec son médicament – qu’il s’agisse d’un médicament prescrit sur ordonnance ou vendu librement en pharmacie.


La nouvelle section Pharmacovigilance explique comment signaler un effet indésirable. Les patients peuvent rapporter eux-mêmes un effet secondaire, ou demander à leur professionnel de santé de le faire pour eux. Beaucoup d’associations de patients aident aussi à signaler ces effets. La nouvelle section du site dresse la liste des services d’assistance téléphonique en Europe pouvant aider à signaler un effet indésirable.

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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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UK - Pharmacovigilance_Inspection metrics report 2013-2014.pdf

EVELYNE PIERRON's insight:
In the period April 2013 to March 2014, the MHRA conducted a total of 56 pharmacovigilance
inspections. Approximately 21% of these inspections were of MAHs that had not previously
undergone a MHRA pharmacovigilance inspection. T
he largest proportion of inspections were
performed as routine re-inspections (i.e. of MAHs who had previously undergone a
pharmacovigilance inspection).
The number of Critical findings identified during this reporting period was slightly higher than the
previous period, reporting 19 Critical findings ve
rsus 18 in the previous period. The largest
proportion of Critical findings remained in the topi
c area of reference safety information, representing
42% of all reported Critical findings. Critical find
ings associated with reference safety information
were again characterised by failures and significant
delays to submit safety variations to update the

safety sections of SPCs and PILs

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Pharmacovigilance - Monitoring FDA Medwatch reports : A critique of a key drug safety reporting system

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The main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the Food and Drug Administration, according to a new study by a nonprofit group that tracks drug safety issues.


The study, by the Institute for Safe Medication Practices, found that only about half of reports of serious side effects submitted by manufacturers met basic standards for completeness, containing a patient’s age, sex and the date the event took place. Reports collected by the F.D.A. itself, by contrast, were found to meet those basic standards in 85 percent of cases.

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EVELYNE PIERRON's curator insight, February 9, 9:31 AM

The main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the Food and Drug Administration, according to a new study by a nonprofit group that tracks drug safety issues.


The study, by the Institute for Safe Medication Practices, found that only about half of reports of serious side effects submitted by manufacturers met basic standards for completeness, containing a patient’s age, sex and the date the event took place. Reports collected by the F.D.A. itself, by contrast, were found to meet those basic standards in 85 percent of cases.

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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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#RVS15 - MONTPELLIER - 1ères Rencontres autour des Vigilances Sanitaires : bilan

#RVS15 - MONTPELLIER - 1ères Rencontres autour des Vigilances Sanitaires : bilan | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:

Une semaine après les 1ères rencontres des Vigilances Sanitaires, Quelques photos.....

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European Medicines Agency - Patients and consumers - Training and support for patients and consumers

EVELYNE PIERRON's insight:

This page contains information for patient and consumer representatives who have been invited to be involved in activities at the European Medicines Agency, either as individual experts or as representatives of patient or consumer organisations. The information aims to help them understand the work of the Agency, the different types of activities where patients and consumers are involved and what the Agency expects of them.

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Drop the Fine Print: FDA Wants Consumer-Friendly Drug Ads

Drop the Fine Print: FDA Wants Consumer-Friendly Drug Ads | Actu Pharmacovigilance | Scoop.it
In a new draft guidance, the agency suggests that drug makers run “consumer-friendly” summaries in print ads and promotional materials
EVELYNE PIERRON's insight:

.....The “FDA believes that the brief summary should focus on the most important risk information rather than an exhaustive list of risks and that the information should be presented in a way most likely to be understood by consumers… Exhaustive lists that include even minor risks detract from, and make it difficult for, consumers to comprehend and retain information about the more important risks.”.....

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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

EVELYNE PIERRON's insight:
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

EVELYNE PIERRON's insight:

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

EVELYNE PIERRON's insight:


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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