Loyola University Chicago

Executive and Professional Education Center

Housed in the Loyola Business Leadership Hub

Pharmacovigilance: A Practical Approach

The focus of the course is to train students to understand and have basic competence in the area of Pharmacovigilance. Pharmacovigilance is 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 course is based upon the textbook Pharmacovigilance: A Practical Approach written by two of our Affiliate Faculty, Drs. Doan and Lievano, who are world-class experts. The Bureau of Labor Statistics reports that jobs in this sector are growing at an above average rate. Pharmacovigilance is a fast-growing area in industry, health sciences, and in regulatory agencies and trained personnel are needed in an environment with few Pharmacovigilance programs.

  • 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 Session
ONLINE: January 11 - May 27, 2022
Registration closes January 5, 2022

Live sessions (30-90 mins.)
Tuesdays and Thursdays at 7:00 p.m. CT

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