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.
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.
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
Speaker
Yashar SalekCourse Provider
Yashar Salek,
