Medication Error Guideline
Contents |
networksAbout us Pre-authorisationQ&A: Presubmission medication error in nursing guidanceQuestions 1-11Questions 12-23Questions 24-33Questions 34-44Questions 45-56Questions
Types Of Medication Errors
57-68Q&A: Generic / hybrid applicationsGeneric medicinesQuestions 1-10Questions 11-22Questions 23-33Questions 34-42Q&A:
Medication Error Definition
Similar biological productsBiosimilar medicinesQuestions 1-10Questions 11-20Questions 21-30Questions 31-43Templates for assessorsTemplates for industrySubmission datesTimetablesGuidancePre-submission Data exclusivity /
Intercepted Medication Error Meaning
Generics / BiosimilarsDossier FormatApplication and EvaluationPost-opinion Post-authorisation Templates for assessorsTemplates for industryDossier submission requirementsImproving quality of submissionsPost-authorisation procedural Q&AArticle 5 procedureVariations regulation Type-IA variations Type-IB variationsType-II variations GuidanceExtension applications GuidanceGrouping of variationsWorksharingClassification medication errors in care homes of changesPre-submission queries serviceChanging the name of a medicinal productAnnual re-assessmentGuidancePost-authorisation measuresRenewalsGuidanceAnnual renewal of conditional marketing authorisationsPASSPAESArticle 46 paediatric study submission Risk management plan (RMP)PSURsGuidanceTransfer of marketing authorisations GuidanceTransparency GuidancePharmacovigilance systemArticle 61(3) NotificationsGuidanceWithdrawals and cessationMarketing and cessation notificationGuidanceSunset clause monitoringGuidanceUrgent safety restrictionsOtherCertificates for productsRequesting certificatesWhat we publishProduct information TemplatesHow to prepare an SmPCExemptionsLinguistic reviewMock-ups and specimensReference and guidelinesExcipients labellingScientific advice and protocol assistance How to submit a requestNovel methodologies / biomarkersParallel scientific advice with HTA bodiesGuidanceSupport for early accessPRIME: priority medicinesAccelerated assessmentConditional marketing authorisationCompassionate useAdaptive pathwaysScientific guidelines Search guidelinesQualityActive SubstanceManufacturingImpuritiesSpecifications, analytical procedures and analytical validationExcipientsPackagingStabilityPharmaceut
Chemical APIs Drug Delivery Excipients Formulation Manufacturing |Aseptic/Sterile Equipment Fill/Finish Process Development Scale Up/Tech Transfer Packaging & Labeling Process Control Facilities medication errors examples Supply Chain Quality/GMPs |Standards/Regulations GMPs QA/QC Validation/Compliance Analytics |Analytical classification of medication errors Tools Method Development Outsourcing |Analytical Labs Clinical Trial Services Development Services Manufacturing Services Outsourcing good practice guide on risk minimisation and prevention of medication errors Outlook 2016 Outsourcing Resources Partnerships in Outsourcing 2016 Contract Services Fast Locator Pharma Marketplace Current Issue Digital Edition Archive PharmTech Europe News Events http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000570.jsp Multimedia Whitepapers Webcasts Magazine App Author's Guidelines News Bio/Pharma News Industry News Supplier News PharmTech Talk Peer-Reviewed Research US Regulatory Watch EU Regulatory Watch Outsourcing Outlook API Synthesis & Manufacturing Troubleshooting Global Report Industry Insider Q&A Viewpoints Inside Standards Statistical Solutions Share Printer-friendly version Send by http://www.pharmtech.com/ema-releases-medication-error-guidelines email EMA Releases Medication Error Guidelines Apr 14, 2015 By Pharmaceutical Technology Editors Pharmaceutical Technology The European Medicines Agency has released two draft guidelines addressing the reporting, assessment, and prevention of medicine errors. The agency defines medicine errors as “unintended mistakes in the prescribing, dispensing and administration of a medicine that could cause harm to a patient.”The EMA guidelines are part of the EMA/Heads of Medicines Agencies joint action plan, developed with the European Commission’s Patient Safety Quality of Care Working Group. The first guide describes sources of medicine errors and provides suggestions for minimizing the risk of these errors throughout a drug’s lifecycle. The guideline states, “This good practice guide is one of the key deliverables of the agency’s medication error initiative and offers stand-alone guidance on risk minimization and prevention of medication errors, including
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