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Latest News | 17 May 2012

Committee Calls for Improved Pharmacovigilance, New Labeling Requirements in Europe

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The European Parliament’s Environment, Public Health and Food Safety Committee (ENVI) is calling for new methods to monitor, label and withdraw dangerous medicines on an EU-wide basis.Under new [Read More...]

Tags: Committee ENVI European Parliament Labeling Legislation marketing Pharmacovigilance
Latest News | 4 May 2012

EMA Adopts Guidance on Medical Products Containing Genetically Modified Cells

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The European Medicines Agency (EMA) announced 5 May it has adopted a scientific guideline on aspects relating to the development and testing of medicinal products containing genetically modified [Read More...]

Tags: Cells CHMP Clinical Trial Clinical Trials EMA Genetically Modified Cells GM GMC Manufacturing Non-Clinical Testing Pharmacovigilance Postmarketing Studies Quality Study
Latest News | 24 April 2012

FDA Releases Strategic Plan for Veterinary Medicine Program

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The US Food and Drug Administration (FDA) has released a new strategic plan for its veterinary medicine program for the 2012-2016 period, outlining the regulatory goals for FDA’s Center for Veterinary [Read More...]

Tags: ADE ANADA Animal CVM FDA NADA ORA Pharmacovigilance Plan Strategic Vet Veterinary
Latest News | 5 April 2012

EMA Asks for Feedback on Pharmacovigilance Legislation Implementation

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The European Medicines Agency (EMA) is calling on industry to comment on its draft list of European Union reference dates for Period Safety Update Reports (PSURs) that are being implemented as a [Read More...]

Tags: EMA Europe Legislation Pharmacovigilance PSUR PSURs Safety
Latest News | 2 April 2012

EMA Releases Presentations, Videos from Pharmacovigilance Stakeholder Meeting

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The European Medicines Agency (EMA) today (2 April) released video and presentations from its fourth stakeholder forum on the implementation of the new pharmacovigilance legislation. The meeting was [Read More...]

Tags: Audio EC EMA FMA IMB Meeting MHRA Pharmacovigilance Presentations PV Video
Latest News | 26 March 2012

EMA Strengthens Conflict of Interest Policies

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The European Medicines Agency (EMA) announced Monday, 26 March its Management Board has endorsed a proposal from EMA Executive Director Guido Rasi to strengthen conflict of interest policies [Read More...]

Tags: COI Conflict of Interest EMA Management Board Pharmacovigilance Rasi
Latest News | 1 March 2012

EMA Releases Guideline on Pharmacovigilance Plan Submissions

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The European Medicines Agency (EMA) released guidance 29 February on how Marketing Authorization Holders (MAH) can submit pharmacovigilance (PhV) systems as part of their Marketing Authorization [Read More...]

Tags: EMA Guidance Guideline MAA MAH Pharmacovigilance PhV
Latest News | 22 February 2012

EMA to Focus on Pharmacovigilance, Counterfeiting

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According to a report by PMLIVE Intelligence Online, the European Medicines Agency (EMA) is setting its sights on new pharmacovigilance laws and fighting counterfeit medicines. The goals are outlined [Read More...]

Tags: Counterfeiting EMA Pharmacovigilance
Latest News | 2 February 2012

EMA Prepares for ‘Biggest Change’ to Legal Framework Since Founding

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The European Medicines Agency (EMA) announced on 2 February that it “is preparing for the introduction of the new pharmacovigilance legislation in July this year, which will bring the biggest change [Read More...]

Tags: Changes CHMP EMA Legislation Pharmacovigilance
Latest News | 24 January 2012

EMA Calls for Guidelines on the Use of Pharmacogenomics in Pharmacovigilance Evaluation

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The European Medicines Agency (EMA) issued a concept paper on 23 January that calls for a new guideline to be issued on the use of pharmacogenomics in the conduct of pharmacovigilance.The concept [Read More...]

Tags: Biomarkers Clinical Trials Effectiveness Efficacy EMA Genetics Pharacogenomics Pharmacovigilance Pharmavigilance Risk Safety
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