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Management of Drug Safety Concern Through a Pharmacovigilance Steering Committee

Management of Drug Safety Concern Through a Pharmacovigilance Steering Committee


The understanding of all drugs being potential poisons should not be alien to anyone in the pharmaceutical industry. Even at therapeutic doses, some medications are not selective enough in their pharmacology and often interfere with surrounding organs and systems. Pharmacovigilance is that construct that allows for the monitoring of a new pharmaceutical substance or device once it has been released into the market and its purpose is heavy towards safety.ย  When properly implemented, it should reveal adverse reactions and provide information over a timeline that helps prescribers make better decisions concerning the use of the given agent. This course exposes students to the origin of pharmacovigilance and the key players at the global and local levels.


In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.







Lesson 1: Historical Perspectives of WHO Drug Safety Management


  • Objectives of Pharmacovigilance
  • Responsibilities of Pharmacovigilance


Lesson 2: Current Practices of Pharmacovigilance


  • Spontaneous Reporting
  • Other Methods of Collecting Safety Data
  • National Pharmacovigilance Centers
  • WHO Program for International Drug Monitoring
  • Good Pharmacovigilance Practice


Lesson 3: Partners in Pharmacovigilance


  • The Quality Assurance and Safety
  • The Uppsala Monitoring Centre (UMC)
  • The National Pharmacovigilance Centers
  • Hospitals and Academia
  • Health Professionals
  • Patients


Lesson 4: Drug Regulation Under Pharmacovigilance


  • Clinical Trial Regulation
  • Post Marketing Drug Safety Monitoring
  • Pharmacovigilance in National Drug Policy
  • Pharmacovigilance in Disease Control Public Health Programs


Lesson 5: Pharmacovigilance and International Health


  • Drug Utilization
  • The ERICE Declaration
  • Challenges for the ERICE Declaration
  • Global Response to Drug Safety Issues


Lesson 6: Future Challenges and Drug Safety Considerations


  • Globalization
  • Web-based Sales and Information
  • Broader Safety Concerns
  • Public Health Versus Pharmaceutical Industry Economic Growth
  • Monitoring of Established Products
  • Attitudes and Perceptions to Benefit and Harm
  • Outcomes and Impact










Management of Drug Safety Concern Through a Pharmacovigilance Steering Committee
Dr. Masaab Bashir
Dr. Massab Bashir holds a Ph.D. in Microbiology and Immunology. Dr. Bashir leads a medical and research writing team of qualified doctors. Massab and his team have over five years of research writing experience in the medical, biotech, and pharmaceutical fields. To date, Dr. Bashir and his team have successfully completed more than 500 projects

$150 $150

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Safety is one of the core desirable qualities of a novel remedy: pharmaceutical substance or device. Members of our team who did not have a clear understanding of safety and the role of pharmacovigilance in ensuring it, have been brought up to speed thanks to Dokeos!

Regina C


Training Director

$150 $150

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