Introduction to Good Pharmacovigilance Practice (GVP)

5/5
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good pharmacovigilance practice

Duration :

2

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 contributes to the protection of patients and public health in an essential way.  It is highly mandatory for life sciences manufacturers to follow GVP with programs in place that focus on risk assessment and management. This course is based on the official GVP guidelines and is a complete training program for all individuals that need a refresher. You will learn about identification and assessment of safety signals for good reporting practice, as well as the features of a good case report. At the end you’ll be able to develop a pharmacovigilance plan.

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:

 

Lesson 1: Identifying Safety Signals

  • Features of a good case report

 

Lesson 2: Signal Investigation through Observational Studies

  • Pharmacoepidemiologic Studies
  • Regisitries
  • Surveys

 

Lesson 3: Interpreting Safety Signals

 

Lesson 4: How to Develop a Pharmacovigilance Plan

 

Glossary

 

Evaluation

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 with the FDA at conferences and webinars on drug safety topics including auditing and reporting.

Reviews:

5/5
119
USD: United States (US) dollar ($)

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