Global Pharmacovigilance Awareness

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Duration :

10

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course : 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

Pharmacovigilance is the process of monitoring the efficacy and safety profile of novel medications throughout their use in the healthcare system. The use of these medications in the heterogeneous population and uncontrolled environment will provide information concerning the side effects, adverse reactions, and interactions that could not have been unearthed during the clinical trials. This course includes an introduction to the concept’ detailing its history and importance. It also emphasizes the need for global pharmacovigilance.

 

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.

 

 

Curriculum

 

 

Introduction

 

Lesson 1: What is Pharmacovigilance?

 

  • Origin of Pharmacovigilance
  • Scope of Pharmacovigilance

 

Lesson 2: Purpose of Pharmacovigilance

 

Lesson 3: Pharmacovigilance Systems

 

  • Methods of Pharmacovigilance Systems
  • Spontaneous Reporting
  • Cohort Event Monitoring
  • Targeted Clinical Investigations
  • Comparison of Pharmacovigilance Methods

 

Lesson 4: Pharmacovigilance Case Processing

 

  • Data Management
  • Relationship Assessment Between Drug and Adverse Reaction
  • Reporting to Appropriate Bodies

 

Lesson 5: Achieving Global Pharmacovigilance Awareness

 

  • National Pharmacovigilance Centers
  • Health Professionals
  • Pharmaceutical Companies
  • Patients and General Public
  • WHO Monitoring Programs
  • Challenges to Achieving Global Pharmacovigilance Awareness

 

Glossary

 

Conclusion

 

Quiz

 

Author:

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Ellena J. Jefferson
Ellena is a CAPA Manager at Janssen Pharmaceuticals where she serves as a Training and Quality Advisor with ICON plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Ellena is a fixer who continuously strives for excellence as a way of life; not just as a job.

Reviews:

5/5
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