Doctor working with laptop computer and writing on paperwork. Hospital background.

M3 Safety Medical Writing, Quality and Compliance

Current Status

Not Enrolled

Price

Closed

Get Started

This module is part of the learning path to be Qualified Professional in Pharmacovigilance and Drug Safety (QPDS)

What is Module 3?

Once the pharmacovigilance trainee understands drug safety regulation and is able to handle PV activities on a daily basis, this module, allow him/her to lead projects on redacting Aggregate Reports and Risk Management Plans, identifying new potential risks and developing risk minimization measures, ensuring Quality and Compliance and contributing in Audits and Inspections.

Course Content

Module 03: Pharmacovigilance Projects
Signal Management 1 Quiz
Lesson Content
Aggregate reporting (PSUR, PEBRER, ASR, PADER, DSUR, ACO) 1 Quiz
Lesson Content
Risk Management System 1 Quiz
Pharmacovigilance Systems and their Quality Management 1 Quiz
Audits and Inspections 1 Quiz
Lesson Content