AE (Adverse Event) and SAE (Serious Adverse Event) Reporting and Processing Procedures for Clinical Trials

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:

• What is Clinical Safety reporting and processing
• Responsibilities, functions, and management of SAE reporting and medical safety for a clinical trial
• How to develop Clinical Trial Safety Management Plan
• How to Set-up of SAE Tracking System
• What important variables should be Recorded in AE and SAE report as per ICH and FDA guidelines
• How to do narrative writing

Who Will Benefit:

This webinar will benefit

• Staff working in medical affairs, medical safety, clinical operations, and clinical trial project management.
• Senior management staff in biotech, pharmaceutical, and medical device companies.
• Persons interested in pursuing a career in medical safety.

Shide Badri
Vice President, Amarex Clinical Research, LLC

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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