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Module II- Pharmacovigilance system master file
47
Transcript
Module II- Pharmacovigilance system master file
Ph. Jaber .M Jaber. MSc. Pharmacology. Head of Pv Section/RDU department/JFDA
Content
Timeline
II.A. Introduction
II.B.1. Objectives
II.B.2. Registration and maintenance
II.B.3. The representation of PV systems
II.B.6. PV system master file presentation
II.B.4. Information to be contained in the PSMF
II.B.5 Change control, logbook, versions and archiving
II.A. Introduction
Goal
The PV system master file definition is a detailed description of the PV system used by the marketing authorisation holder with respect to one or more authorised medicinal products
Detail
Detail
Marketing
Marketing
Strategy
Strategy
SWOT Analysis
SWOT Analysis
Objective
Objective
Action
Action
Advertising
Advertising
Social
Social
Videos
Videos
Other Promotions
Other Promotions
Assessment
Assessment
Measurement 1
Measurement 1
Measurement 2
Measurement 2
Sales
Sales
Strategy
Strategy
Projections
Projections
Objective
Objective
Distribution
Distribution
Targets
Targets
Tactics
Tactics
Assessment
Assessment
Tracking Results
Tracking Results
Measurement
Measurement
Design
Design
Strategy
Strategy
Posters
Posters
Approach
Approach
Packaging
Packaging
Approach
Approach
Distribution
Distribution
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