Books by Tamra Sami — EbookNetworking.net

17 books found

Canada aims for 7-day approval for Phase I trials; rules redefine sponsors.(Canada): An article from: Bioresearch Monitoring Alert

Canada aims for 7-day approval for Phase I trials; rules re…

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AAI lacked validation data, evades 483.(Human drugs): An article from: Validation Times

AAI lacked validation data, evades 483.(Human drugs): An ar…

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Batelle receives 483 for inadequate maintenance of facility, procedural issues in GLP inspection. (Sponsor-monitors/GLP).(Batelle Memorial Institute, ... An article from: Bioresearch Monitoring Alert

Batelle receives 483 for inadequate maintenance of facility…

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Documentation issues follow Florida investigator from NIH. (Sponsor-monitors/GLP).(National Institutes of Health, University of Florida; assays for drug): An article from: Bioresearch Monitoring Alert

Documentation issues follow Florida investigator from NIH. …

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Study coordinator complaint triggers four-month audit, resulting in 12-page 483. (Clinical investigators).: An article from: Bioresearch Monitoring Alert

Study coordinator complaint triggers four-month audit, resu…

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OHRP reviews 100 cases a year, but fewer than eight go anywhere. (IRBs).: An article from: Bioresearch Monitoring Alert

OHRP reviews 100 cases a year, but fewer than eight go anyw…

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IRB kept sloppy records, failed to review critical information.(IRBs)(Huntsville Hospital)(Institutional Review Board ): An article from: Bioresearch Monitoring Alert

IRB kept sloppy records, failed to review critical informat…

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EU GCP directive to go into force in May despite gaps in member states.(International)(good clinical practice)(European Union): An article from: Bioresearch Monitoring Alert

EU GCP directive to go into force in May despite gaps in me…

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IVD exporter caught with 'cat in the bag,' as FDA warns firm about rodent control, QS deficiencies.(Medical devices): An article from: Validation Times

IVD exporter caught with 'cat in the bag,' as FDA…

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GCP inspections to be nation-based; pharma firms advised to 'get it right first time' for Phase I trials.(EU Clinical trials)(Good Clinical Practices): An article from: Bioresearch Monitoring Alert

GCP inspections to be nation-based; pharma firms advised to…

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FDA not eyeing third party audits of raw materials; stressing C of As.(Excipients): An article from: Validation Times

FDA not eyeing third party audits of raw materials; stressi…

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Expecting unexpected AEs can reduce IRB reporting burden; FDA not inclined to expand DMCs to help out.(Adverse events)(Institutional Review ... An article from: Bioresearch Monitoring Alert

Expecting unexpected AEs can reduce IRB reporting burden; F…

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Subpart C on prisoner research should be scrapped, SACHRP told.(United States. Office for Human Research Protections. Secretary's Advisory Committee ... An article from: Bioresearch Monitoring Alert

Subpart C on prisoner research should be scrapped, SACHRP t…

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OTC manufacturer changes product specs following validation.(Human drugs): An article from: Validation Times

OTC manufacturer changes product specs following validation…

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CI/sponsor kept no case report forms or raw data; substitutes study drug without prior approval. (Clinical investigators).: An article from: Bioresearch Monitoring Alert

CI/sponsor kept no case report forms or raw data; substitut…

By: Tamra Sami, urokinas

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FDA can find no objections in CI audit. (Clinical investigators).(Metabolic and Atherosclerosis Research Center, Cincinnati, Ohio; clinical investigator, ... article from: Bioresearch Monitoring Alert

FDA can find no objections in CI audit. (Clinical investiga…

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FDA to pilot dispute resolution, giving 10 days to challenge 483s.: An article from: Inspection Monitor

FDA to pilot dispute resolution, giving 10 days to challeng…

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