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Pharmacovigilance- Risk management
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1. Introduction
2. Adverse Event (AE) versus Adverse Reaction (adverse drug reaction ADR) – the distinction
Additional resources
1. Post-Authorisation Safety Studies (PASS)
2. Post-Authorisation Efficacy Studies (PAES)
3. Public hearings
4. EudraVigilance
Additional resources (websites to check)
1. Introduction
2. Principles of risk management
3. The Risk Management Plan (RMP)
4. Specific regulations in Europe
References & Additional Resources
1. What is ‘safety communication’?
2. Safety communication - content
3. Safety communication channels
4. Patients’ role and contribution to safety communication
5. Further reading
6. Direct healthcare professional communication. Communicating medicines safety information directly to healthcare professionals: an introduction to DHPC
References
Assessment
1. Introduction ►