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Drug Safety and Pharmacovigilance

An elective course in the Certificate Program Regulatory Affairs and Compliance.

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.

  • Details
  • $735
  • January 10, 2022 to March 20, 2022
  • Delivery Mode: Online
  • Reg#: 00163
  • ID/Units: PHRMSCI X493  (2.00)
    ( Section 1 )
  • Quarter: WINTER 2022


Dr. Albert Rego, Ph.D., M.B.A., is a scientific consultant to the regulated industries, with over thirty years of experience in the pharmaceutical and medical device industries. Areas of specialization are in the national and international regulatory aspects of the scientific testing requirements for chemical, biological, and sterilization technologies. He has experience in performing, directing, designing, and evaluating clinical and non-clinical studies for pharmaceuticals and medical devices. Selective expertise includes chemical stability testing, medical device evaluations, statistical design and interpretation, regulatory submissions, chemical hygiene plans, analytical chemistry methodologies, and sterilization validation.

Textbook Information

Textbooks for your course may be purchased from any vendor or bookseller of your choice.

No textbooks are required for this course.

Meeting Schedule

EventDateDayStart TimeEnd TimeLocationRoom
START01/10/2022Monday------Online (Access Begins)---
END03/20/2022Sunday------Online (Access Ends)---