Why Should You Attend:
This webinar instructs on the varied responsibilities and functions among the Drug Company, CRO, and Clinical Site for Medical Safety Management for different types of clinical trials as defined by US FDA and global regulatory guidelines.
The procedures for SAE reporting should be contained in company SOPS and well organized with regard to staff assignments and responsibilities before a trial begins to assure all responsibilities are covered.
Areas Covered in the Webinar:
Who Will Benefit:
This webinar provide valuable assistance to personnel in biotech, pharmaceutical, and medical device companies. Employees who will significantly benefit by attending this training include:
Dr. Shide Badri, VP of Safety and Pharmacovigilance, Amarex Clinical Research - has more than 15 years of experience in medical practice and clinical research. Dr. Badri leads global drug and device safety activities of the Safety and Pharmacovigilance (PV) division, including collecting and evaluating of serious adverse events and adverse reactions, supervises the activities and development of Safety personnel, directs the identification and assessment of potential safety signals, oversees the analysis of clinical data and ensures organizational, financial and strategic goals are attained with respect to Clinical Safety and PV and Risk Management activities.
During her career, Dr. Badri has managed Clinical Safety, Pharmacovigilance, Coding and Medical Monitoring projects, and been involved in writing clinical protocols, clinical study reports (CSRs), annual and period safety reports and Case Report Forms (CFRs) for clinical trials across a broad range of therapeutic indications including Cardiovascular, Dermatology, Endocrinology, Gastroenterology, Hematology, Infectious Disease (Sepsis and Septic shock), Nephrology, Neurology, Oncology, Ophthalmology, Pediatrics, Psychiatry, Pulmonology, Urology, Gene Therapy, Pain Management, Critical Care Medicine, Wound Healing (e.g. Diabetic Foot Ulcers and Venous Leg Ulcers), Vaccines, and Rare Diseases.
Dr. Badri earned her MD degree in 2002 and before joining Amarex worked as a physician in rural and urban health centers with a focused on preventative.
Serious Adverse Event (SAE) reporting is a critically important function for all clinical trials. It is part of the medical safety responsibilities for a trial. The primary importance is to protect the safety of subjects in a trial. Secondarily it is to monitor if the product being tested is having any harmful side effects on trial participants.
Clinical trial medical safety is equivalent to pharmacovigilance, but for a single clinical trial. It is a required function for a GCP compliant clinical trial. It is required by US FDA and ICH guidelines.
SAE reporting is typical managed by a physician assigned to the clinical trial team.
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