Management of the Data Safety Management Committee for Clinical Trials

Join this webinar to receive instructions on the uses of, need for, setup of, and management of a Data Safety Management Committee for an FDA regulated clinical trial.

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Last Recorded Date: Sep-2019

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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
Instructor Profile:
Yashar Salek 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.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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