Summary about ZHA | ARC-Traicoa

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MW5 - Medical Writing Course about Risk Management

Introduction to risk management systems in pharmacovigilance

Summary about this course

Decision Making Tools

Introduction
Your active part
Your quiz
Summary about ZHA (13:24)
Summary about FMEA (14:15)
Summary about Decision Making Tools (12:10)

Risk Management in Pharmacovigilance - REMS (US)

Introduction
Your active part
Your quiz
Walk-through US template_incl REMS template (14:39)
Walk-through US medication guides_incl FDA pages (3:42)
Walk-through guidance for medication guide_incl. FDA guidance (7:30)

Risk Management in Pharmacovigilance - RMP (EU) Principles

Introduction
Your active part
Your quiz
Summary of EU RMP principles (12:31)
Summary of structure and connections of EU RMP (15:12)
Summary of risks and safety concerns of EU RMP (14:12)

Risk Management in Pharmacovigilance - RMP (EU) - Example of new innovative

Introduction
Your active part
Walk-through EU RMP Part 1 and 2 (19:07)
Walk-through EU RMP Part 3 and 4 (9:51)
Walk-through EU RMP Part 5 to annexes and finalisation (12:29)

Risk Management in Pharmacovigilance - RMP (EU) - Example of generic

Introduction
Your active part
Walk-through EU RMP Part 1 and 2 (12:46)
Walk-through EU RMP Part 3 and 4 (8:38)
Walk-through EU RMP Part 5 to annexes and finalisation (8:41)

Risk Management in Pharmacovigilance - RMP (EU) - RMP Life-cycle

Introduction
Your active part
Your quiz
EU RMP - Sending the document, incl. correct versioning (17:36)
EU RMP - Receiving feedback (12:44)
EU RMP - PASS/PAES/Consortium (11:04)

Risk Management in Pharmacovigilance - Risk Communication &R Risk Minimisation Measures (EU)

Introduction
Your active part
Your quiz
Risk Minimisation Measures & Educational Tools (13:00)
Safety Communication & DHCP (14:28)
Effectiveness checks, including appropriate tracking within the company (12:06)

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Summary of course

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Summary about ZHA

5.1.3 Summary about ZHA.pdf

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