Global Pharmacovigilance Awareness

5/5
50
global pharmacovigilance online course

Duration :

2

1 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker. They can also be shared on Linkedin.

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 events, 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:

marc
Marc Estrow
Marc Estrow is an Oxford University graduate from the department of pharmacology with over 20 years’ experience in drug safety & pharmacovigilance, who specializes in global safety compliance, business process improvement and signal detection. He has worked with over 50 clients in the US, France and United Kingdom. He is a featured speaker at conferences and webinars on drug safety topics including auditing and reporting.

Reviews:

5/5
50
USD: United States (US) dollar ($) ^

$60

Buy now

More than 25 learners ? Request a quote !

This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

[finale_countdown_timer campaign_id="40465" skip_rules= "yes"]

$60.00 / year

$60.00 / year

We might have this course but it's not displayed online. Please type your email and we will get back to you within 24h

No video yet for this course