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Latest News | 22 May 2012

EMA Releases Guidance on Electronic Submission of Veterinary Applications

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The European Medicines Agency (EMA) released a new question and answer guidance document on 22 May to assist sponsors with submitting their veterinary dossiers in an electronic format.The document, [Read More...]

Tags: Applications Dossier Electronic EMA Guidance Q&A Veterinary
Latest News | 17 May 2012

UPDATED: Report: FDA Quicker Than EMA, Health Canada for Drug Approvals

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A study published in the New England Journal of Medicine (NEJM) claims the US Food and Drug Administration (FDA) is better at approving drugs than the European Medicines Agency (EMA) and Health [Read More...]

Tags: Approval drug EMA FDA Health Canada NEJM Pharmaceutical Review Study
Latest News | 16 May 2012

EMA Launches Mandatory Training Course to Help MAHs Comply with EudraVigilance Regulations

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A new course launched by the European Medicines Agency (EMA) aims to assist Marketing Authorization Holders (MAHs) comply with new Article 57(2) EudraVigilance regulations on the submission of [Read More...]

Tags: Certification Certified Course Dictionary EMA Eudravigilance Modules Training
Latest News | 16 May 2012

EMA Issues Guidance for Companies Seeking Scientific Advice

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The European Medicines Agency (EMA) has released revised guidance to answer questions about the process of seeking scientific advice from the agency, including an overview of the scientific advice [Read More...]

Tags: Application EMA Guidance Scientific Advice submission
Latest News | 14 May 2012

European Parliament Still Dissatisfied With EMA’s Conflict of Interest Policies

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The European Parliament is still refusing to sign off on the European Medicines Agency’s (EMA) 2010 budget expenditures, the latest development in a long-running fight over the agency’s credibility, [Read More...]

Tags: Budget Conflict of Interest EMA Europe European Parliament Lonngren
Latest News | 14 May 2012

EMA's Rasi Moves to Streamline Conflict of Interest Policies at EMA

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The European Medicines Agency (EMA) has released an updated procedure governing how the agency’s employees are investigated for any potential conflicts of interest (COI) relative to their duties [Read More...]

Tags: COI Conflict of Interest Conflicts EMA Rasi SOP
Latest News | 9 May 2012

Usability Upgrades Announced for EMA’s Website

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The European Medicines Agency (EMA) has announced it has rolled out several usability upgrades for its website, allowing regulatory professionals to access a host of new and customizable features that [Read More...]

Tags: EMA Improvements RSS Search Upgrades Website
Latest News | 9 May 2012

EMA Releases New Reflection Paper for Labs Performing Clinical Trial Sample Analysis

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The European Medicines Agency (EMA) announced it has released a new reflection paper to guidance laboratories that evaluate clinical trial samples, which it hopes will establish informal guidelines [Read More...]

Tags: Analysis Clinical Studies Clinical Trials EMA Evaluation GLPs Reflection Paper Samples
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 | 3 May 2012

CBER Wants Better Vaccine Safety, Identify Adverse Events

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The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is announcing its intent to launch a program to ensure the safety of vaccine products manufactured [Read More...]

Tags: Adverse Events AE CBER EMA FDA GRUVSS Pilot Program Program Regulatory Capacity SAE Vaccine VAERS
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