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Drug Safety and Pharmacovigilance
An elective course in the Certificate Program Regulatory Affairs and Compliance.
Course closed to new registrations: Call ( 949 ) 824-5414 for more information or sign up below to be notified when this course becomes available.
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Course Description
With increasing public and regulator focus on product and patient safety, regulatory requirements in this area have become more demanding. Regulatory Affairs professionals work closely with the pharmacovigilance team to comply with regulatory authority requirements and ensure product safety. Learn the essential elements of pharmacovigilance and managing risks/benefits of drugs and biologics throughout the product lifecycle. With focus on US and EU requirements and international harmonization guidelines, explore topics that include pre-marketing and postmarketing adverse event surveillance and reporting, individual case safety reports, aggregate safety reports, safety operational units, MedDRA coding, quality systems, good pharmacovigilance practices, safety inspections, electronic records, safety labeling, signal detection, risk management (REMS, RMPs), and pharmacoepidemiology.
Prerequisite: BIOSCI X450 Fundamentals of Clinical Trials, or equivalent experience.
Instructor
Textbook Information
Textbooks for your course may be purchased from any vendor or bookseller of your choice.
Optional Textbook(s):
Cobert's Manual Of Drug Safety And Pharmacovigilance 9780763791599
Meeting Schedule
Event Date Day Start Time End Time Location Room
START 01/09/2023 Monday --- --- Online (Access Begins) ---
END 03/19/2023 Sunday --- --- Online (Access Ends) ---