Search Results - "Authority"

The Human Fertilisation and Embryology Authority

Subjects: “…Human Fertilisation & Embryology Authority. 110871…”
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Inspection procedures

Table of Contents: “…Contents: Inspection procedures -- The organization of official authorities -- The performance of official authorities -- How to assess compliance with the OECD principles of Good Laboratory Practice.…”
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Performing, Standard Operating Procedures

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Avoidable deaths and harm due to medical negligence

Table of Contents: “…Contents: Introduction to medical negligence -- Importance and frequency -- Individual & systemic reasons for negligence -- The cost and the causes of negligence -- Cognitive psychology, decision-making, bias, critical thinking and clinical reasoning -- Responsible authority -- Recommendations.…”
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Regulatory requirements in Japan and its compliance monitoring programmes

Table of Contents: “…Contents: Complexity of Japanese GLP monitoring programmes -- Review and comparison of all four GLP programmes -- Detailed explanation of medical products programme -- Compliance Monitoring Authority, legal bases, and regulatory requirements of medical products programme -- Normal practices and follow-ups of GLP inspection in medical products programme.…”
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GLP in the European Union

Table of Contents: “…Contents: Good Laboratory Practice -- Definition and development -- Differences and similarities to laboratory accreditation -- The role of the EU Member States, the European Commission and the OECD -- Cooperation with European agencies and regulatory authorities.…”
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Reporting of study results

Table of Contents: “…Contents: Definitions and basic principles -- Legal requirements -- Integration of reporting in the whole GLP process -- Responsibilities -- Planning, structure, content and deviations related to reports -- Rejection of studies by the Regulatory Authorities if reports fail.…”
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Institutional repositories

Table of Contents: “…Contents: Open access -- Research literature -- Journal articles -- Open data -- Citation impact -- Research impact -- Research visibility -- EPrints -- DSpace -- University profile -- Author profile -- Digital repositories -- Business planning for repositories -- Open licensing -- SMEs.…”
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Moolaade how teenage girls see themselves /

Table of Contents: “…Sembene has made a masterpiece, both a critique of traditional forms of authority and a celebration of the warmth and dynamism of African village life.…”

SOPs and outsourcing

Table of Contents: “…-- SOP: CRO selection -- SOP: QA considerations -- SOP: audit of vendors -- CRO/third party vendor assessments -- Delegation of authority to CRO -- SOP training -- Considerations for CROs SOPs.…”
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Un homme qui crie = A screaming man

Table of Contents: “…Rebel forces are attacking the government and the authorities demand the people contribute to the "war effort" with money or volunteers old enough to fight. …”

Medical communications principles and best practice /

Table of Contents: “…Contents: Overview: what is "medical communications" -- Understanding your audience (scientific community, regulatory authorities, payers, doctors, nurses, patients and PAGs, pharmaceutical companies) -- Finding out what there is to know and where the information is coming from -- Possible channels to provide the information to our audience -- Why we do what we do.…”
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Procedural assessments of SOPs to ensure SOPs are logical and meet GXP requirements

Table of Contents: “…Contents: Procedural assessment cycle and tools of SOPs -- Working instruction template -- The SOP title -- The scope of content -- When scope covers multiple tasks or is a part of a larger process -- Filling the scope, procedure & checklist in our template -- Authors, general requirements and further elements of content -- Importance of up-to-date information -- Proper writing & revising of the content -- Preparing a checklist -- Regulatory requirements -- Sources of information -- Documentation -- Format and language -- Points to remember -- Added value -- Feasibility.…”
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Antiretroviral therapy 2007, new concepts and lessons learned

Table of Contents: “…Contents: Data from recent past about AIDS -- HIV life cycle and mechanisms of action of antiretroviral agents -- Nucleoside-nucleotide reverse transcriptase inhibitors (NRTIs/NtRTIs): potency, pharmacokinetics and adverse effects -- Non-nucleoside reverse transcriptase inhibitors (NNRTIs) -- Protease inhibitors (PIs) -- Cell entry inhibitors -- Initiation of antiretroviral therapy in the naive patient -- Health authorities' guidelines for initial therapy -- Key factors for improved durability -- Cell cycle and effect of antiviral agents -- Risks of early treatment -- New directions in antiretroviral therapy.…”
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Chocolat / by Harris, Joanne

The Qur'an or the Bible? : Which is God's word? / by Shorrosh Anis

Why OECD GLP and not ISO / IEC 17025?

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OECD guidance for national compliance monitoring programmes carrying out study audits /

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