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    Eliminate the Confusion - New Requirements for Clinical Laboratories to Meet GCP

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    Website https://www.complianceonline.com/requirements-for-clinical-laboratories-gcp-compliance-webinar-train | Want to Edit it Edit Freely

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    Deadline: February 26, 2019 | Date: February 26, 2019

    Venue/Country: U.S.A

    Updated: 2019-02-07 02:18:31 (GMT+9)

    Call For Papers - CFP

    As a result of the FDA and EU Clinical Trials Directive 200/20/EC and subsequent promulgation of laws, EMA inspection and reflection paper in clinical laboratories in the EU covering the conduct of clinical trials in accordance with Good Clinical Practice (GCP), there is the need for laboratories undertaking analysis of samples from clinical trials to comply with GCP regulations and guidance. The standard to be followed by such laboratories is not well defined in FDA and ICH GCP and hence the development of new EMA standards (finalized in 2012) which provides guidance on the standards which will set the gold standard in the EU, US and potentially internationally.

    This session will review the key requirement for compliance for the analysis of samples collected from subjects participating in clinical trials and forms a key part of the clinical trials process. It is essential that sample analysis and evaluation is performed to an acceptable standard which will ensure patient safety is not compromised and that data is reliable and accurately reported.

    This presentation will explain the new standards required by laboratories analyzing clinical trial samples. The session is aimed at both sponsors using clinical laboratories and those at laboratories who wish to demonstrate to sponsors of clinical trials and government agencies worldwide that the clinical laboratory operates to a standard that assures the reliability, quality and integrity of the work and results generated.


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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