Loyola University Chicago

Executive and Professional Education Center

A Member of the Loyola Business Leadership Hub

Pharmacovigilance: A Practical Approach

Detect. Assess. Analyze.

This course trains students to understand and have basic competence in the area of Pharmacovigilance: the science of the collection, detection, assessment, monitoring, and prevention of adverse effects of approved therapeutics. Pharmacovigilance incorporates big data approaches and results in sophisticated analyses more quickly than traditional Safety Pharmacology approaches.

The area of Pharmacovigilance is fast-growing in industry, health sciences, and regulatory agencies. According to the Bureau of Labor Statistics, jobs in the sector are increasing at an above average rate and trained personnel are needed in an environment with few Pharmacovigilance programs.

This course is based upon the textbook Pharmacovigilance: A Practical Approach written by world-class experts and affiliate faculty, Drs. Doan and Lievano.

Additional Info

  • Personnel and staff in industries connected to development and marketing of pharmaceuticals and medical devices, especially those who wish to receive additional training to advance or switch careers.
  • Graduate, medical, and post-baccalaureate students who want to seek employment in this new growing sector and medical personnel who may be impacted by the growth of this science.
  • Individuals who currently work in epidemiology, biotech, life science, and pharmaceutical industries.
  • Medical staff (residents, interns, nurses) who wish to pursue an alternative career related to pharmaceutics

By the time participants complete the course, they should be able to:

  • Describe the methods and strategies used to identify and develop drugs
  • Describe the regulatory environment as it pertains to pharmacovigilance and pharmacoepidemiology
  • Define the steps of the clinical trial process
  • Define the elements of patient safety and concepts of benefit-risk, signal management, product safety vaccine and post-marketing drug safety
  • Articulate the elements of pharmacovigilance based on FDA good pharmacovigilance practices
  • Apply the concepts in Pharmacovigilance to address specific challenges presented by special populations

The Regulatory Environment

  • Does Regulation Drive Science or Does Science Drive Regulation?

Safety Data and Real World Evidence

  • Product Safety Monitoring in Clinical Trials
  • Signal Management and Methods of Signal Detection
  • Safety Governance
  • Causality Assessments - Liver, Renal, Skin and Major Adverse Cardiac Events 

Epidemiology Real World Evidence

  • Role of Epidemiology in the Pharmaceutical Industry
  • Real World Epidemiological Studies 

Special Topics

  • Pharmacovigilance in Pregnancy
  • Pharmacovigilance in Pediatrics
  • Pharmacovigilance in Elderly

Special Populations

  • Monitoring Safety of Vaccines
  • Medical Devices Vigilance and Post Market Surveillance
  • Applications of Human Factors and Health Literacy in Pharmacovigilance

The Next Frontier

  • Risk Management
  • Benefit-Risk
  • Information Technology in Pharmacovigilance: Current State and Future Direction
  • The Future of Safety Science is Happening Now
Fabio Lievano, M.D.
Course Director, Affiliate Associate Professor
Stritch School of Medicine
Thao Doan, M.D.
Course Co-Director, Affiliate Assistant Professor
Stritch School of Medicine
Keith Jones, Ph.D. 
Program Director, Course Co-Director, Professor
Stritch School of Medicine
Jawed Fareed, Ph.D.
Stritch School of Medicine
Simon Kaja, Ph.D.
Assistant Professor
Stritch School of Medicine
Rocco Gogliotti, Ph.D.
Assistant Professor
Stritch School of Medicine
George Battaglia, Ph.D.
Professor Emeritus
Stritch School of Medicine
Peter Bacher, M.D. Ph.D.
Affiliate Asssistant Professor
Stritch School of Medicine

Upcoming Sessions

Dates: Jan. 9 - May 23, 2024
Class meets Tuesdays and Thursdays at 7:00 p.m. CT (30-90 mins.)

Asynchronous recorded lectures (90 minutes) will be provided between sessions


Contact us

Office Phone: 312.915.6780
Office Email: executive-ed@luc.edu

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