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1. Introduction
2. Part 2: describing the landscape
3. Pharmaceutics and pharmaceutical sciences
4. Manufacturing and quality assurance
5. Distrubution and legal status
6. Counterfeiting
7. Epidemiology and statistics
8. Relative vs. absolute risk
9. Number needed to harm/...to treat
10. Sources of information
11. Understanding 'risk' and 'benefit'
12. Pharmacotherapy vs non-pharmacological approaches
13. Unachievable, but nice to read
14. Living with uncertainty
15. Risk, uncertainty, ambiguity and ignorance
16. Law and legislation
17. Legislation in confederations and practicable national medicines acts
18. Liability, or risk of liability
19. National and international guidelines
20. Prepared for crisis?
21. Management in pharmacovigilance
22. How to develop and establish a pharmacovigilance system
23. Causality assessment, risk assessment, and benefit-to-harm assessment
24. Decision-making processes
25. Reporting to other authorities and international organisations
26. Relevant stakeholders and partners
27. Communication
28. International co-operation
29. In the background and influential
30. Economic factors
31. That's pharmacovigilance!
32. You can find and read more at
33. In summary
34. Thank you for listening

Topics Covered

• Pharmacovigilance
• Production of medicinal products
• Epidemiology and statistics
• Understanding ‘risk’ and ‘benefit’
• Measuring risk
• Law and legislation
• Management of pharmacovigilance
• Stakeholders and partners
• Media and patient communication

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Categories:

• Methods
• Pharmaceutical Sciences

Talk Citation

Publication History

• Published on June 29, 2023

Financial Disclosures

• Dr. Ulrich Hagemann has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.