Full program description
The Georgia Clinical & Translational Science Alliance- Georgia CTSA andSC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or other drug related issues. To accurately assess the risk of potential harms, the FDA and other regulatory agencies developed broad sets of regulations and procedures that govern how researchers and the biomedical industry must gather, analyze, and report adverse events. This program will provide an in-depth understanding of adverse event regulatory definitions, processes, requirements, and analysis and investigation techniques to minimize risk in clinical research.
This six (6)-course symposium explores the fundamentals of pharmacovigilance for drugs, medical devices and biologics including adverse event reporting and regulatory requirements, risks management, and case studies demonstrating practical approaches to adverse event reporting.
Program Outcome: At the end of this program, participants will understand terminologies and definitions of adverse events and their reporting procedures and requirements.Participants will gain knowledge of how relationship and causality between medical products and adverse events are determined, and the value of pharmacovigilance in clinical trials.
- Session 1: Regulatory Requirements
- Session 2: Safety Reporting in Investigator-Initiated Trials
- Session 3: Safety Reporting from Other Sources
- Session 4: Safety Reporting in Industry-Sponsored Trials and Case Studies – Part 1
- Session 5: Safety Reporting in Industry-Sponsored Trials and Case Studies – Part 2
- Session 6: Adverse Event Reporting
Learner Level: Beginner, Intermediate
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