Pharmacovigilance - Risk management

After completing the course, you will be able to:

Outline the principles of pharmacovigilance
Explain the major steps in pharmacovigilance signal management
List the key stakeholders in pharmacovigilance and their roles
Compare Post Authorisation Safety Studies (PASS) and Post Authorisation Efficacy Studies (PAES)
Outline the organisation of public hearings
Explain the concept and structure of EudraVigilance
Outline the principles of risk management for medicinal products in the European Union (EU) including the risk management plan
Explain the EU specific measures for additional monitoring
Outline the concept of safety communication
Relate the ‘Direct to health care professionals communication’ to the overall principles of safety communication

8 hours

EUR 8.00

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Topic outline

General

Lesson 1: Background and general principles of Pharmacovigilance and its legislative framework (focus EU)

Learning outcomes of this lesson:
	Outline the principles of pharmacovigilance Explain the major steps in pharmacovigilance signal management List the key stakeholders in pharmacovigilance and their roles

Book

1. Introduction Book

Book

2. Adverse Event (AE) versus Adverse Reaction (adverse drug reaction ADR) – the distinction Book

Page

Additional resources Page

Lesson 2: Pharmacovigilance Measures and the European EudraVigilance

Learning outcomes of this lesson:
	Compare Post Authorisation Safety Studies (PASS) and Post Authorisation Efficacy Studies (PAES Outline the organisation of public hearings Explain the concept and structure of EudraVigilance

Book

1. Post-Authorisation Safety Studies (PASS) Book

Book

2. Post-Authorisation Efficacy Studies (PAES) Book

Book

3. Public hearings Book

Book

4. EudraVigilance Book

Page

Additional resources (websites to check) Page

Lesson 3: Principles of risk management in the European Union

Learning outcomes of this lesson:
	Outline the principles of risk management for medicinal products in the European Union (EU) including the risk management plan Explain the EU specific measures for additional monitoring

Page

1. Introduction Page

Page

2. Principles of risk management Page

Book

3. The Risk Management Plan (RMP) Book

Book

4. Specific regulations in Europe Book

Page

References & Additional Resources Page

Lesson 4: Safety Communication including Direct Health Care Professional Communication (DHPC)

Learning outcomes of this lesson:
	Outline the concept of safety communication Relate the ‘Direct to health care professionals communication’ to the overall principles of safety communication

Page

1. What is ‘safety communication’? Page

Page

2. Safety communication - content Page

Page

3. Safety communication channels Page

Page

4. Patients’ role and contribution to safety communication Page

Page

5. Further reading Page

Book

6. Direct healthcare professional communication. Communicating medicines safety information directly to healthcare professionals: an introduction to DHPC Book

Page

References Page

Assessment

Quiz

Assessment Quiz

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