Pharmacovigilance: A Practical Approach

Quinlan School of Business

How long?

  • 5 months
  • online

Quinlan School of Business

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Who should attend

  • 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

About the course

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.

Key Benefits

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

Program Topics

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

Experts

Fabio Lievano

FABIO LIEVANO‚ MD‚ is the Senior Director‚ Clinical Risk Management and Safety Surveillance‚ at Merck & Co.‚ Inc. Dr. Lievano is a physician and epidemiologist with experience on a variety of clinical‚ epidemiological‚ drug safety‚ pharmacovigilance‚ risk management‚ risk minimization and pub...

Thao Doan

Thao T. Doan, MD Senior Medical Director, Medical Safety Evaluation, Pharmacovigilance and Patient Safety, AbbVie SELECTED PUBLICATIONS Doan T. Patterson R, Greenberger PA. Cough Variant Asthma: Usefulness of a Diagnostic-Therapeutic Trial with Prednisone. Annals of Allergy, 1992: 69:505-9. ...

Keith Jones

Molecular Cardiovascular and Innate Immunity/Inflammatory signaling in the heart and heart disease. Ischemia/reperfusion injury, cardioprotection (ischemic and remote), and heart failure. We have a recent interest in the interaction between the cardiovascular system and the nervous system, and ex...

Jawed Fareed

Jawed Fareed is a Professor of Pathology and Pharmacology and Director of the Hemostasis and Thrombosis Research Laboratories at Loyola University Medical Center, Chicago, IL. Dr. Fareed’s main research interest is the development of novel anticoagulant and antithrombotic drugs. He is recognized ...

Simon Kaja

Accomplished neuroscientist with 16+ year's experience in the academic, biotech/pharma and CRO setting with strong expertise in ophthalmology, neuroscience, neurology and neuroinflammation. Ph.D. in Medicine/Neuroscience, B.Sc. Molecular Biology and Biochemistry significant expertise in HTS/HCS...

Rocco Gogliotti

I am currently an Assistant Professor in the Department of Molecular Pharmacology and Neuroscience at Loyola University Chicago. My training has spanned both industry and academia, which has provided me with a broad scientific background that I utilize to address hypotheses with diverse and innov...

Pharmacovigilance: A Practical Approach at Quinlan School of Business

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