Glenda Guest BS, CCRA, RQAP-GCP, TIACR, FACRP, has an extensive background in the clinical research industry having worked as a monitor, project manager, data management coordinator, database programmer, quality assurance auditor and senior trainer since joining the clinical research profession with Norwich Clinical Research Associates (NCRA) within 1997. With 20+ years of regulated research experience and her extensive background in a clinical CRO environment, she has developed a unique perspective, not only of the regulatory requirements for pharmaceutical and device development and market approval but also the insights from collaboration with multiple sponsor companies’ varying approaches in meeting those requirements. Ms. Guest is a published writer, certified clinical research associate, registered quality assurance professional (GCP) and a certified clinical research trainer. An invited speaker at local and global professional meetings and has been honored with the ACRP 2015 Global Conference Top Speaker Award, the MAGI Outstanding Speaker Award 2018 and SQA Distinguished Speaker 2017 and 2018.
July 23 2019
01 : 00 PM EST
The passage of the 21st Century Cures Act and the recent release of draft guidance from FDA signal changes ahead for the Humanitarian Use Device and Humanitarian Device Exemption Programs in the US.Whether you work strictly with medical devices, or with device combination products you will not want to miss the opportunities afforded by these changes. The requirements for qualifying for Humanitarian Use Devi..