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Regulatory Update | 27 April 2012

EC: SCENIHR Issues Memorandum on Europe’s Scientific Risk Assessment Process

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A memorandum issued by the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is intended to provide transparency to stakeholders on the Committee risk [Read More...]

Tags: EC Europe European Commission Health RIsks Memorandum Risk Risk Assessment SCENIHR
Latest News | 27 April 2012

EU Looks to Tighten Medical Device Safety With Implant Registry

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The European Parliament is actively looking to pass legislation that would make it easier for regulatory authorities to track both medical devices and patients implanted with medical devices, reports [Read More...]

Tags: EC EMA EP Europe Implant Medical Device Parliament PIP Postmarketing Registry Regulatory Safety Tracking
Latest News | 18 April 2012

European Commission Launches Prize Fund to Encourage Vaccine Temperature Stability

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The European Commission (EC) has launched a €2 million prize in the hopes that the incentive will drive inventors to develop vaccines that can be shipped and stored regardless of the temperature in [Read More...]

Tags: Cold Chain EC Europe Prize Stability Temperature Vaccine
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 | 13 March 2012

Dalli: Commission Looking to Overhaul Clinical Trials Directive

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John Dalli, the European commissioner for health and consumer policy, spoke 7 March about the need to review and modernize the Clinical Trials Directive before a joint event put on by the European [Read More...]

Tags: Clinical Trials Clinical Trials Directive Dalli EC EMA Europe John Dalli Member States Speech
Latest News | 2 March 2012

EC Proposes Streamlining Pricing, Reimbursement Decisions

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The European Commission (EC) wants drugs to reach the market faster and is proposing changes to the pricing and reimbursement process.In a report by PMLive Intelligence Online, revisions to the [Read More...]

Tags: EC Europe European Commission market Pricing Reimbursement
Latest News | 13 February 2012

EU Clinical Trials Directive Leading to Dramatic Decline in Clinical Trials, Says UK Cancer Charity

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The EU Clinical Trials Directive has almost doubled the cost of clinical trials while leading to a 66% drop in clinical trials in the United Kingdom, reports The Telegraph.The Telegraph spoke to the [Read More...]

Tags: Cancer Research UK Clinical Trials Clinical Trials Directive EC EU
Latest News | 10 February 2012

EC’s John Dalli Calls for Stricter Safety Controls, Postmarketing Surveillance for Medical Devices

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The European Commission’s (EC) Commissioner for Health and Consumer Policy John Dalli called for the EC to “look at the sector of medical devices as a whole,” saying that both the EC and national [Read More...]

Tags: Dalli EC EMA Europe John Dalli medical devices Member States Speech
Latest News | 3 February 2012

EC Investigation of PIP Implants Inconclusive, Calls for Further Study

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A European Commission (EC) study of the breast implant products manufactured by French company Poly Implant Prothese (PIP) has come to inconclusive results regarding the rupture rate of PIP’s breast [Read More...]

Tags: Breast Implant EC European Commission France French Investigation PIP Poly Implant Prothese report Scandal Study
Latest News | 19 January 2012

Bloomberg: French Breast Implant Scandal May Alter US Medical Device Regulation Debate

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As the uproar over the faulty breast implants manufactured by French manufacturer Poly Implant Prothese (PIP) continues to unfold, an unwitting casualty may be the US medical device lobby, which has [Read More...]

Tags: AdvaMed Breast Implant EC EMA FDA MDUFA Medical Device PIP Scandal
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