Transcription of What is CIOMS?
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What is CIOMS?
Global Guidance on patient involvementJoint PCWP-HCPWP Meeting, EMA, Amsterdam, 4 March 2020 Dr LembitR goSecretary-GeneralCouncil for International Organizations of Medical Sciences (CIOMS)Geneva, is CIOMS? Organization, links with other international organizations Areas of work and Working GroupsCIOMS Working Group XI: Patient Involvement in Drug Development and Safe Use Background and scope WG processes, progress Draft content Examples of selected chapters Plans for futureConclusionsEMA 4 March 2020 What is CIOMS? Acronym & LogoEMA 4 March 20204 Council forInternationalOrganizations ofMedical SciencesFounded in 1949 by WHO and UNESCOIn official relations with WHO and UNESCO associated partnerICH Observer since 2016 Mission Statement CIOMS mission is to advance public health through guidance on health research including ethics, medical product develo
Description of pharma adaptation of Failure Mode and Effects Analysis (FMEA) and opportunities for including patient perspective Routine Additional Adequate for most products Reserved for specific products / risks • Product Label • Packaging • Prescription Status • Communication / Educational Measures • Controlled Product Distribution ...
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