Management of the Data Safety Management Committee for Clinical Trials
Instructor:
Yashar Salek
Product ID: 706133
Training Level: Basic
- Duration: 60 Min
Why Should You Attend:
You will gain current, practical knowledge about the responsibilities, functions, and management of medical safety in a clinical trial with a special emphasis on the DSMC. The expert presenter of this webinar, Dr. Yashar Salek, presents to multiple DSMCs each year for multiple FDA regulated clinical trials.
The Data Safety Management Committee (DSMC), or Board (DSMB), is an important and sometimes required element of a clinical trial. The traditional purpose for the DSMC is to assure safety in a clinical trial, but it can also be used to assess efficacy at some interim stage of a trial.
This webinar instructs on the uses of, need for, setup of, and management of a Data Safety Management Committee for an FDA regulated clinical trial.
Who Will Benefit:
- Medical affairs personnel
- Medical Safety Officers
- Clinical statisticians
- Medical researchers product regulators
- Clinical researchers
- Clinical product development consultants and service providers
- Senior management staff in biotech, pharmaceutical, and medical device companies
- Persons interested in a career in medical safety for clinical research or pharmacovigilance
Yashar Salek
Director of Clinical Development, Amarex Clinical Research LLC
Dr. Yashar Salek (MD, MSc.) is a published scientist currently working in the clinical product development industry as Director of Clinical Development at Amarex Clinical Research where he designs and manages clinical trials in a range of clinical indications including: neurology, psychiatry, gastroenterology, pediatrics, wound care, pulmonology, and OB/GYN.
Dr. Salek is also an expert in analyzing and presenting clinical data for Data Safety Management Committees (DSMC), which he does routinely as part of his work at Amarex. Prior to joining Amarex, Dr. Salek worked as a researcher at the Kunin-Lunenfeld Applied Research Unit of University of Toronto where he developed clinical interventions to improve dementia symptoms in elderly population. Dr. Salek received his Medical Doctorate (M.D.) at Tehran University of Medical Sciences, and his Master of Science (MSc.) in Neurosciences at York University, Toronto, Canada, where he was focused on development of novel methodologies for early detection and diagnosis of cognitive impairments.
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