Search Results for EudraVigilance

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EMA Makes Final Preparations Ahead of New EudraVigilance Launch By Michael Mezher - Published 04 October 2017

With the 22 November launch date for its revamped EudraVigilance system rapidly approaching, the European Medicines Agency (EMA) on Wednesday provided some last minute updates on what to expect during the transition to the new system.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Postmarket surveillance

Tags: EudraVigilance, Pharmacovigilance, ICSRs, SUSARs, Adverse Event Reporting

EMA Offers New EudraVigilance Checklist for Sponsors, MAHs By Zachary Brennan - Published 26 June 2017

The European Medicines Agency (EMA) on Monday published a checklist to help marketing authorization holders (MAHs) and sponsors prepare for the technical changes ahead of the launch of the new EudraVigilance adverse event system on 22 November 2017.

Categories: News, Europe, EMA, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: EudraVigilance, marketing authorisation holders, individual case safety reports

EMA to Launch Revamped EudraVigilance System to Monitor Adverse Events By Zachary Brennan - Published 22 May 2017

The European Medicines Agency’s (EMA) management board on Monday endorsed the launch on 22 November 2017 of an improved system for collecting and monitoring suspected adverse events.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: EudraVigilance, ICSR, adverse events, marketing authorisation holders

European Regulatory Roundup: EMA and FDA Discuss Joint Accelerated Assessments (20 April 2017) By Nick Paul Taylor - Published 20 April 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, FDA, MHRA, Biologics and biotechnology, Drugs

Tags: European Regulatory Roundup, EMA and FDA, EudraVigilance, information security

European Regulatory Roundup: EU Trade Groups Propose Criteria for Deciding EMA’s New Home (2 March 2017) By Nick Paul Taylor - Published 02 March 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs

Tags: EFPIA, veterinary drugs, Eudravigilance

EMA Releases List of Medical Events for Pharmacovigilance Monitoring By Michael Mezher - Published 19 August 2016

The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Postmarket surveillance

Tags: Pharmacovigilance, EudraVigilance, Designated Medical Events, Important Medical Events

EMA Begins Pharmacovigilance Training Courses By Zachary Brennan - Published 08 April 2016

The European Medicines Agency (EMA) this week began running a series of pharmacovigilance training sessions to help companies and regulators meet their obligations when using EudraVigilance, a centralized European database of suspected adverse reactions to medicines in the European Economic Area (EEA).

Categories: News, Europe, EC, EMA, MHRA, Drugs, Postmarket surveillance, Product withdrawl and retirement

Tags: EMA, pharmacovigilance, EudraVigilance

Access to EudraVigilance Data: EMA Will Review Some Academic Uses By Zachary Brennan - Published 13 January 2016

The European Medicines Agency (EMA) on Wednesday released all 393 stakeholder comments on its proposal to change how a database of adverse drug reactions can be accessed, though the final draft of the proposal, released in late December, shows EMA backtracking on some of its controversial language that commenters disputed, particularly with EMA’s plan to possibly restrict academic studies using the database.

Categories: News, Europe, EC, EMA, Clinical, Crisis management, Drugs, Ethics, Government affairs

Tags: EudraVigilance, EMA and academia, EMA reviews, adverse event database access

EMA Explains Centralized Product Database, Talks Future Changes By Michael Mezher - Published 18 February 2015

The European Medicines Agency (EMA) released a new document intended to clarify data submission requirements for medicines authorized in the European Economic Area (EEA).

Categories: News, Europe, EMA, ISO, Drugs, Postmarket surveillance

Tags: Pharmacovigilance, EudraVigilance, XEVMPD, ISO IDMP

EMA Establishes Pharmacovigilance Framework for New Literature Monitoring Efforts By Alexander Gaffney, RAC - Published 09 June 2014

In regulatory circles, reading literature isn't something that's necessarily done for fun. Instead, regulatory professionals are frequently charged with reading up on the latest literature—scientific literature, that is—mentioning their products in the hopes of discovering reports of dangerous side effects or other potential problems, such as mix-ups or inadequate use or abuse.

Categories: News, Europe, EMA, Drugs, Postmarket surveillance

Tags: Literature, Adverse Events, Safety, Medical Literature, EudraVigilance, Postmarket Surveillance, Pharmacovigilance Legislation

Countries Responsible for EU-wide Safety Monitoring Announced By Ansis Helmanis, RegLink - Published 08 October 2012

Categories: EMA

Tags: List, Eudravigilance, Latest News, safety, EU, pharmacovigilance

New EMA-Run Website Looks to Boost Adverse Event Reporting Transparency By Alexander Gaffney - Published 31 May 2012

Categories: EMA

Tags: Side Effect, ADR, ADRreports, AER, Eudravigilance, Adverse Event, Latest News, website

EMA Launches Mandatory Training Course to Help MAHs Comply with EudraVigilance Regulations By Alexander Gaffney - Published 16 May 2012

Categories: EMA

Tags: Certified, Modules, Course, Dictionary, Eudravigilance, Latest News, certification, training

EMA Releases New Eudravigilance Medicinal Product Dictionary SOPs By Alexander Gaffney - Published 31 January 2012

Categories: EMA

Tags: Checklist, Procedure, Dictionary, Eudravigilance, Latest News, SOPs