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Pre-analytics- A Challenge Less Heeded | 7487
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Pre-analytics- a challenge less heeded

2nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

Aparna Jha Ahuja

Accepted Abstracts: Pharmaceut Reg Affairs

DOI: 10.4172/2167-7689.S1.008

Pre-analytical phase is the most vulnerable part of the total testing process in any clinical trial. The pre-analytical variables include specimen collection, handling, processing, physiological influences and/or interference factors. Pre-analytics is considered to be among the greatest challenges to the laboratory fraternity. However, pre-analytical activities, management of unsuitable specimens and reporting policies are not fully standardized worldwide. There are no internationally accepted guidelines and recommendations as well as related quality measures available for pre-analytical phase. There is large heterogeneity in the criteria for sample rejection, the different strategies by which unacceptable samples are managed, processed and test results reported worldwide. Good practices and compliance with the new strategies for error prevention can lead to a substantial reduction in pre-analytical errors.
Aparna Jha Ahuja is Lab Director of Clinical Reference Lab, SRL Diagnostics, Gurgaon and also heads Clinical Trials Lab, Biochemistry & specialized Chemistry. She is a member of core SRL Leadership Teams and has more than 2 decades experience. She completed MBBS (with distinction), MD (Medical Biochemistry) and PG certificate in hospital management from prestigious Institutes in New Delhi. She is an auditor with NABL (India) and CAP (US). She has publications in reputed international journals and is Life Member of scientific societies like Indian Medical Association, DMA, AMBI & ACBI. She has been invited as panelist/chairperson/speaker by media and in several National/International fora like Arab Health Congress, Indo-US summit and WHO summit. She has organized several CMEs/training sessions/workshops, the recent one being the workshop co-organized with CAP.