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

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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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New medicines to display "black triangle" from September 1st

New medicines to display "black triangle" from September 1st | Actu Pharmacovigilance | Scoop.it
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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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Clinical trials-Points to consider for assessors,inspectors and EMA inspection coordinators on the identifcation of triggers for the selection of applications .pdf

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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 - 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 - Changes to Risk-management plans

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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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European Medicines Agency - Post-authorisation - Post Authorisation Safety Study (PASS): questions and answers

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Updated Q/A regarding Post Authorisation safety Study (PASS)

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

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 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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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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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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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 - Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 July 2013

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The Pharmacovigilance Risk Assessment Committee (PRAC) has marked the successful completion of its first year of operation.


The PRAC also welcomed the full involvement of Croatia in its activities at its July 2013 meeting following the accession of Croatia to the European Union (EU) on 1 July 2013. Croatian delegates have been observers of the PRAC since it began its operations in July 2012.

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European Medicines Agency - Pharmacovigilance Risk Assessment Committee: one year of public health promotion and protection

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European Medicines Agency - Regulatory information - Revision of procedural guidance to reflect update of variations guidelines from the European Commission

EVELYNE PIERRON's insight:

The European Medicines Agency has revised its procedural guidance for pharmaceutical companies to reflect the recent changes to the European Commission’s guidelines on variations to the terms of marketing authorisations for medicines for human and veterinary use. Changes are applicable as of 4 August 2013.

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#Pharmacovigilance Service Desk - MHRA

#Pharmacovigilance Service Desk - MHRA | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:

The aim of the Pharmacoviglance Service Team is to be the first port-of-call for marketing authorisation holders (MAHs), Healthcare Professionals and the General Public enquiring about any pharmacovigilance-related matters. We aim to provide an answer to all enquiries within seven working days of receipt. If we are unable to respond directly we will refer to other relevant areas of the Agency. In such cases, we may need to revise the response timeframe and will keep you informed.

The Service Team can be reached via e-mail at pharmacovigilanceservice@mhra.gsi.gov.uk


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Are clinical trial data shared sufficiently today? No | BMJ

Are clinical trial data shared sufficiently today? No | BMJ | Actu Pharmacovigilance | Scoop.it
EVELYNE PIERRON's insight:

L'accès aux données des essais cliniques est elle optimale. C'est abordé dans le BMJ. Excellent papier de Ben Goldacre qui répond négativement à la question: "Est ce que les essais cliniques sont suffisamment partagés?".

Pour être objectif, les arguments de Ben Goldacre sont mis en miroir avec la tribune de John Castellani (Industrie Pharma) qui répond oui à la question (http://www.bmj.com/content/347/bmj.f1881


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#Regulatory information – European Medicines Agency organises training sessions on eSubmission Gateway and web client for PSUR single-assessment submiss...

EVELYNE PIERRON's insight:

The European Medicines Agency is organising training sessions on the use of the eSubmission Gateway and web clientto submit periodic safety update reports (PSURs) subject to the single-assessment procedure.

These training sessions are intended for all applicants submitting single-assessment PSURs in the electronic-common-technical-document (eCTD) or non-eCTD electronic-submission (NeeS) formats through the eSubmission Gateway and the web client.

The sessions cover aspects such as registration, filename conventions, and receipts and acknowledgements received by applicants.

Two sessions

16th July and 1st August

Each webinar : 95 places

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Using Twitter as a Regulatory Intelligence Tool: 300 Accounts Worth Following

Once, not too long ago, social media was just for being social. A common joke was that Twitter, for example, was the site you needed to check out if you absolutely needed to know what your neighbor
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European Medicines Agency - News and Events - European Medicines Agency creates Healthcare Professionals’ Working Party

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 has established a formal Healthcare Professionals’ Working Party (HCPWP) to further involve this group of stakeholders in its range of activities.


The role of the HCPWP is to provide recommendations to the Agency on all matters of interest to healthcare professionals in relation to medicines.


The creation of this working party represents the formalisation of the current Committee for Medicinal Products for Human Use (CHMP) working group with healthcare professionals and is a key element of the Agency’s formal framework for interaction with this group of stakeholders. A similar framework is in place with patients and consumers through the Patients’ and Consumers’ Working Party.


The HCPWP is composed of representatives from healthcare professionals’ organisations that fulfil the eligibility criteria, as well as from the Agency’s Scientific Committees for human medicines and their secretariats.

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Webdoc : Essais cliniques | LEEM - Les entreprises du médicament

Webdoc : Essais cliniques | LEEM - Les entreprises du médicament | Actu Pharmacovigilance | Scoop.it
Webdoc : Essais cliniques Ce webdocumentaire a pour objectif de : - Replacer les essais cliniques dans le cycle de développement du médicament po...
EVELYNE PIERRON's insight:

Webdoc bien fait, pédagogique articulé sur les différentes étapes de la mise en place d'un essai clinqiue, l'encadrement réglementaire et la protection des personnes.

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European Medicines Agency - Guidance on submission of single assessment PSURs published

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 has given guidance to marketing-authorisation holders on how to submit periodic safety update reports (PSURs) for medicines subject to European Union single assessment via its eSubmission Gateway and web client.

The guidance document has been published on the eSubmission website.

The Agency started carrying out single assessments of PSURs of active substances contained in both centrally and nationally authorised medicines in April 2013.


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European Medicines Agency releases for public consultation its draft policy on the publication and access to clinical-trial data

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 has released a draft policy on the publication and access to clinical-trial data for a three-month public consultation. Stakeholders have until 30 September 2013 to send their comments on the draft policy to the Agency.


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European Medicines Agency - News and Events - Comments invited on good-pharmacovigilance-practice module on reporting of adverse reactions

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 has released a revision of the guideline on good pharmacovigilance practices (GVP) module VI on the management and reporting of adverse reactions to medicinal products for a two-month public consultation. GVP modules are key deliverables of the 2010 pharmacovigilance legislation. They describe the requirements in relation to pharmacovigilance in the European Union.


The revision focuses specifically on the requirements for the management and reporting of suspected adverse reactions occurring in non-interventional studies.


The module currently stipulates that marketing-authorisation holders (MAHs) or academic sponsors on behalf of MAHs conducting non-interventional studies with primary data collection directly from patients, consumers or healthcare professionals should actively seek all adverse events to assess them and report cases of suspected adverse reactions to competent authorities.


The consulation period will end on 5 August 2013

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European Medicines Agency - News and Events - Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders

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

Marketing-authorisation holders of human medicines will now have to declare the reasons that lead them to take any of the actions below to the European Medicines Agency (EMA), in accordance with the amendments to the 2010 pharmacovigilance legislation of the European Union (EU):

  • temporary or permanent marketing cessation or suspension of marketing of a medicine;
  • withdrawal of a medicine from the market;
  • a request to withdraw a marketing authorisation;
  • the intention not to apply for the renewal of a marketing authorisation.

These amendments were adopted in October 2012. The new provisions apply to centrally authorised medicines from today, 5 June 2013, and will apply to nationally authorised medicines from 28 October 2013.

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Essais cliniques: des règles plus claires et une meilleure protection

Essais cliniques: des règles plus claires et une meilleure protection | Actu Pharmacovigilance | Scoop.it
Toute l’actualité du service de presse du Parlement européen: votes, résolutions, débats, commissions parlementaires et sessions plénières.
EVELYNE PIERRON's insight:

Afin de stimuler la recherche de nouveaux médicaments tout en garantissant les droits des patients, de nouvelles règles pour les essais cliniques dans l'UE ont reçu le soutien de la commission de la santé, ce mercredi. Le règlement va remplacer une directive et instaurera un cadre plus simple et uniforme, des règles spécifiques pour les essais à faible risque, plus de clarté quant aux comités éthiques et au consentement éclairé des patients.

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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.