Actu Pharmacovigilance
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-3 October 2012

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-3 October 2012.

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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

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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 6:53 AM
Merci pour la pub
Philippe Loizon's comment, September 21, 2013 6:54 AM
-)))
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European Medicines Agency - Safer use of medicines by preventing medication errors

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The European Medicines Agency (EMA) has published a good practice guide on medication errors to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU. In parallel, EMA has launched a webpage highlighting measures recommended by the Agency to prevent medication errors for specific medicines. This page will include clear and easy-to-understand information to patients and healthcare professionals to further promote the safe use of medicines.

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Pharmacovigilance : Measures for art 57 data Quality Assurance

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The purpose of this document is to detail the measures taken by the European Medicines Agency (hereinafter the 'Agency') at the pre-submission, submission, and post-submission phases of data entry into the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) to improve data quality in the Article 57 database. The document details the methodologies used by the Agency to validate the medicinal product information submitted to the Article 57 database.

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European Medicines Agency - Updated guidance on good clinical practice released for consultation

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has released an addendum to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 (R2) guideline on good clinical practice (GCP) for a six-month public consultation.

Stakeholders are invited to send their comments using the template provided by 3 February 2016.

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European Medicines Agency - Improving safety of medicines across Europe

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The European Medicines Agency (EMA) has started to publish the outcomes of single assessments of periodic safety update reports (PSURs) for active substances contained only in nationally authorised medicines. This initiative aims to support the harmonised implementation of safety measures for medicines with the same active substance across European Union (EU) Member States.

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European Medicines Agency - Pharmacovigilance - Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance

European Medicines Agency - Pharmacovigilance - Monitoring of medical literature and entry of adverse reaction reports into EudraVigilance | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) will be responsible for monitoring a number of substances and selected medical literature to identify suspected adverse reactions with medicines authorised in the European Union, and for entering the relevant information into the EudraVigilance database. The service is expected to reach full operational levels by September 2015.

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European Medicines Agency provides advice notes on pharmacovigilance annual fees

European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines.
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The European Medicines Agency (EMA) has provided ‘advice notes’ on pharmacovigilance annual fees to the qualified persons for pharmacovigilance.

These ‘advice notes’ contain the line listing of the chargeable units on which annual pharmacovigilance fees will be calculated. Their distribution today gives companies the opportunity to review and correct their product information held by EMA prior to invoicing in July 2015.

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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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European Medicines Agency - Supporting better use of medicines

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has released a draft scientific guideline that outlines how post-authorisation efficacy studies (PAES) should be designed by companies to support regulatory decision making in the European Union (EU). In addition, a guidance that describes the regulatory aspects for the fulfilment of imposed PAES is also published.

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Pharmacovigilance - Patient registries

EVELYNE PIERRON's insight:

Patient registries are organised systems that use observational methods to collect uniform data on a population defined by a particular disease, condition, or exposure, and that is followed over time. Patient registries can play an important role in monitoring the safety of medicines. The European Medicines Agency (EMA) has set up an initiative to make better use of existing registries and facilitate the establishment of high-quality new registries if none provide adequate source of post-authorisation data for regulatory decision-making.

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European Medicines Agency - Public consultation starts on PRIME - a new scheme to optimise development of priority medicines and facilitate patients access

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has launched a public consultation on the key principles of its new PRIME scheme. PRIME aims to strengthen support to medicines that have the potential to benefit patients who presently have no treatment options, or that may offer a major therapeutic advantage over existing treatments. These are considered priority medicines by EMA, hence the name of the scheme.

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European Medicines Agency - Improved electronic reporting of suspected adverse reactions for better health protection

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has published a change management plan to provide stakeholders with comprehensive information to be ready for improvements to the EudraVigilance system. The plan details the technical changes as well as business process changes in relation to reporting, managing and analysing individual case safety reports (ICSRs) from medicines in clinical use and from clinical trials.

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European Medicines Agency - Central repository for safety reports - one year to go before mandatory use

EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) Management Board today gave its green light for the central repository for periodic safety update reports (PSURs) for medicines authorised in the European Union (EU). In one year’s time, on 13 June 2016, the central repository will become the single, central platform for these reports to be used by all regulatory authorities and pharmaceutical companies in the EU to exchange information on the safety of medicines.

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Pharmacovigilance - Safety monitoring of medicines: EMA to screen medical literature for 400 active substance groups

European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines.
EVELYNE PIERRON's insight:

The European Medicines Agency (EMA) has published the list of active substances and a reference to the journals that will be covered by its new medical literature monitoring service. This service will start with a limited number of active substances on 1 July 2015 and will be fully rolled out in September 2015. A guide, a training video and a document detailing the inclusion and exclusion criteria to be used when screening the literature are also available on a dedicated webpage.

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EMA - PHARMACOVIGILANCE PROGRAMME UPDATE n°3 (March 2015)

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This third edition is aimed at providing marketing authorisation holders (MAHs) with
information to help prepare for business
change and give you full awareness of the
projects, their scopes and timelines.
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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, 2015 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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