Why Should You Attend:
SAE reporting is a critically important function for all clinical trials. It is part of the medical safety responsibilities for a trial and is typical managed by a physician assigned to the clinical trial team.
The primary importance of a clinical trial is to protect the safety of subjects. 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.
This webinar will discuss the Definitions for Clinical Safety reporting and processing, development of Clinical Trial Safety Management Plan, Set-up of SAE Tracking System, Record of AE and SAE important variables based on the ICH and FDA guidelines, e.g., causality and severity assessments, SAE reporting and processing; Clinical Site, Sponsor (drug company), and CRO responsibilities.
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.
Areas Covered in the Webinar:
Who Will Benefit:
This webinar will benefit
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.
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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. ComplianceOnline 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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
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