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MHRA Begins Regulation Overhaul with Simplified Clinical Trial Scheme

MHRA Begins Regulation Overhaul with Simplified Clinical Trial Scheme
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United kingdomJanet messerJune raineRegulatory agencyHealth research authorityCommission on human medicinesResearch ethics serviceBioindustry associationVaccines expert advisory groupChief executive officerUnited kingdom regulation conferenceHuman medicinesClinical trials

Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research

These international, consensus-based, patient-reported outcomes (PRO)–specific guidelines aim to lay out the ethical considerations that researchers, research e

Eteläuomen läiUnited kingdomWest midlandsUnited kingdom generalAmanda hunnDaiichi sankyoHaf daviesMelaniej calvertCruz riveraResearch council experimental medicineNipro corpJapan media corpLanguage summaries for the research participantsInternational delphiBirmingham health partners centre for regulatory scienceBirmingham biomedical research centre

Clinical trials for medicines: apply for authorisation in the UK

Clinical trials for medicines: apply for authorisation in the UK
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United kingdomUnited kingdom research ethics committeeHealth research authorityResearch ethics committeeVaccines expert advisory groupCommission on human medicinesRegulatory agencyResearch application systemClinical trialsInvestigational medicinal productsHealth researchInvestigational medicinal productHuman useEuropean economic areaMake it publicIntegrated research application system

Membership - Commission on Human Medicines

Membership - Commission on Human Medicines
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United kingdomCity ofNorth yorkshireEast sussexSouth australiaTunbridge wellsWeston parkAustralian capital territoryBrighton and hoveNewcastle upon tyneUniversity collegeNew south walesJohn paul leachSara payneMichael jacobsBchir msc

Keeping pace

Environmental risk, biosafety and other key regulatory considerations  for cell and gene therapy trials - Magazine Article - PharmaTimes

United kingdomExceptional technologyGene therapy advisory committeeVaccines expert advisory groupEuropean parliamentGene therapy modification safety committeeInstitutional biosafety committeeDrug administrationAdvisory committeeRegulatory agencyResearch advisory committee nexCommission declarationEuropean unionEuropean medicines agencyCommittee of advanced therapiesCouncil directive