Good Pharmacovigilance Practices (GVP): Legal Framework of the Global Pharmacovigilance Program

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Description:

This course will help you understand the fundamental components of the many global pharmacovigilance guidelines, regulations, and reporting programs, with a special emphasis on European Union (or E.U.) Good Pharmacovigilance Practices (or G.V.P.) Guidelines and U.S. Food and Drug Administration (or U.S. F.D.A.) guidance.

Pharmacovigilance contributes to the protection of patients and public health in an essential way. For this reason, it is highly important for pharmaceutical manufacturers to follow Good Pharmacovigilance Practices with programs in place that focus on risk assessment and management.

Curriculum for this course:

Course Introduction

Course Overview	32 secs
What You'll Learn	25 secs

Legal Framework: Global Pharmacovigilance Program

European Union	1 min 11 secs
GVP and the EU Pharmacovigilance System	33 secs
Key Elements of The EU Pharmacovigilance System	10 secs
GVP Guidelines & Guidance Documents	1 min 16 secs
Modules Covering Major Pharmacovigilance Processes	26 secs
Product-Or-Population-Specific Considerations	10 secs
Risk Management and Pharmacovigilance	16 secs
The Risk Management Plan	58 secs
EU GVP Quick Knowledge Check	30 secs
Terms Related to Pharmacovigilance in the EU	8 min
R+EU Pharmacovigilance Terms Quick Knowledge Check	30 secs
United States	1 min 27 secs
US Pre-Marketing Risk Management	1 min 1 secs
US Post-Marketing Pharmacovigilance Assessments	21 secs
Risk Management Plan	1 min
Health Canada	48 secs
WHO	53 secs
ICH	31 secs
CIOMS	48 secs
CDSCO	41 secs