This presentation will provide a detailed review of the FDA regulations for Clinical Trials Process. After attending this session, participants will have an understanding of FDA regulations pertaining to the implementation of clinical trials and concepts of Good Clinical Practice (GCP) and Bioethics.
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Elizabeth Bergan, joined PQC Consulting, Inc., as a Senior Consultant. She has over 10 years of clinical research experience in the pharmaceutical and medical device industry. She recently held the position of Managing Partner for Eye Trials, a contract research organization overseeing a number of multi-center clinical trials. Prior to that, she had held various management positions at STAAR Surgical including Manager of Clinical Affairs. Her clinical studies experience includes protocol design, trial site initiation, study close-out, final data collection and submission of Pre-Market Application (PMA). At STAAR Surgical, Elizabeth managed several large multi-center clinical trials and was instrumental in preparing clinical trial data for an FDA Advisory Panel meeting. Consequently, her team was successful in obtaining FDA approval for STAAR Surgical Visian ICL™.
She has extensive experience preparing for and participating in FDA Bioresearch Monitoring audits. Through her various positions, Elizabeth has been involved with the development of policies and procedures for clinical protocol and case report form design, clinical monitoring, adverse event reporting, and clinical data management. She has trained a number of employees on applicable FDA Guidelines and Good Clinical Practices (GCPs) as well as ICH Guidelines.
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