How to conduct a Clinical Trial in accordance with FDA regulations and how to avoid the common deficiencies observed during FDA clinical audits
Instructor:
Elizabeth Bergan
Product ID: 701054
- Duration: 90 Min
Areas Covered in the seminar:
- How to conduct a clinical trial, Phase I-IV studies including principles of working in a regulated environment; discuss 21 CFR part 11, 50, 54, 56, 312 and 812, Good Clinical Practice (GCP)/ICH guidance (specifically ICH E6), and the IND/IDE process.
- Ethics of clinical trials including historical background, current issues and current Regulatory observations.
- How to survive an FDA clinical audit and the common findings that have been cited on FDA 483s and Warning Letters.
- How to collect and organize essential study documents that are required before a clinical trial initiation, during trial conduct and once the study is completed.
Who will benefit:
This webinar will provide valuable assistance to all personal in:
- Pharmaceutical
- Biotechnology
- CROs
- Research facilities conducting clinical trials
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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