Pharmacovigilance - Risk management

Topic outline

• Select section General

  General

  Collapse all Expand all

  After completing this 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

   

  EUPATI Open Classroom content is free for all learners.
  At the end of each course you can test your knowledge and earn a certificate for a 10-euro administrative fee. If interested, click the button below:

  Enrol & Access the assessment
• Select section Lesson 1: Background and general principles of Pharmacovigilance and its legislative framework (focus EU)

  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

  • Select activity What is pharmacovigilance (PhV)?

    

    What is pharmacovigilance (PhV)? Book

    Completion

    Learners must

    

    View
  • Select activity 2. Adverse Event (AE) versus Adverse Reaction (adverse drug reaction ADR) – the distinction

    

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

    Completion

    Learners must

    

    View
  • Select activity Additional resources

    

    Additional resources Page

    Completion

    Learners must

    

    View
• Select section Lesson 2: Pharmacovigilance Measures and the European EudraVigilance

  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

  
  
  

  • Select activity 1. Post-Authorisation Safety Studies (PASS)

    

    1. Post-Authorisation Safety Studies (PASS) Book

    Completion

    Learners must

    

    View
  • Select activity 2. Post-Authorisation Efficacy Studies (PAES)

    

    2. Post-Authorisation Efficacy Studies (PAES) Book

    Completion

    Learners must

    

    View
  • Select activity 3. Public hearings

    

    3. Public hearings Book

    Completion

    Learners must

    

    View
  • Select activity 4. EudraVigilance

    

    4. EudraVigilance Book

    Completion

    Learners must

    

    View
  • Select activity Additional resources (websites to check)

    

    Additional resources (websites to check) Page

    Completion

    Learners must

    

    View
• Select section Lesson 3: Principles of risk management in the European Union

  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

  • Select activity 1. Introduction

    

    1. Introduction Page

    Completion

    Learners must

    

    View
  • Select activity 2. Principles of risk management

    

    2. Principles of risk management Page

    Completion

    Learners must

    

    View
  • Select activity 3. The Risk Management Plan (RMP)

    

    3. The Risk Management Plan (RMP) Book

    Completion

    Learners must

    

    View
  • Select activity 4. Specific regulations in Europe

    

    4. Specific regulations in Europe Book

    Completion

    Learners must

    

    View
  • Select activity References & Additional Resources

    

    References & Additional Resources Page

    Completion

    Learners must

    

    View
• Select section Lesson 4: Safety Communication including Direct Health Care Professional Communication (DHPC)

  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

  • Select activity 1. What is ‘safety communication’?

    

    1. What is ‘safety communication’? Page

    Completion

    Learners must

    

    View
  • Select activity 2. Safety communication - content

    

    2. Safety communication - content Page

    Completion

    Learners must

    

    View
  • Select activity 3. Safety communication channels

    

    3. Safety communication channels Page

    Completion

    Learners must

    

    View
  • Select activity 4. Patients’ role and contribution to safety communication

    

    4. Patients’ role and contribution to safety communication Page

    Completion

    Learners must

    

    View
  • Select activity 5. Further reading

    

    5. Further reading Page

    Completion

    Learners must

    

    View
  • Select activity 6. Direct healthcare professional communication. Communicating medicines safety information directly to healthcare professionals: an introduction to DHPC

    

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

    Completion

    Learners must

    

    View
  • Select activity References

    

    References Page

    Completion

    Learners must

    

    View
• Select section Assessment

  Assessment

  • Select activity Assessment

    

    Assessment Quiz

    Completion

    Learners must

    

    Receive a grade

    

    Receive a passing grade