Pharmacovigilance and therapeutic risk management across the medicine lifecycle

CPD
By
Chloe Hava
-

References

  1. World Health Organization. Regulation and prequalification: what is pharmacovigilance? 2026. At: www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance
  2. Council for International Organizations of Medical Sciences. Practical aspects of signal detection in pharmacovigilance: report of CIOMS working group VIII. Geneva: CIOMS. 2010.
  3. Council for International Organizations of Medical Sciences. Benefit-risk balance for medicinal products: report of CIOMS working group XII. Geneva: CIOMS. 2025.
  4. Therapeutic Goods Administration. Product regulation according to risk. 2015. At: www.tga.gov.au/products/regulations-all-products/regulation-essentials/regulation-basics/product-regulation-according-risk
  5. UK Government. Guideline III adverse event reporting. 2026. At: www.gov.uk/government/publications/pharmacovigilance-of-veterinary-medicines-in-great-britain/adverse-event-reporting
  6. Therapeutic Goods Administration. Adverse event reporting. At: https://aems.tga.gov.au
  7. Therapeutic Goods Administration. Database of adverse event notifications (DAEN). At: www.tga.gov.au/safety/adverse-events/database-adverse-event-notifications-daen
  8. Therapeutic Goods Administration. Therapeutic product vigilance: version 1.4. Woden: TGA. 2017.
  9. Therapeutic Goods Administration. Our regulatory framework. 2020. At: www.tga.gov.au/products/regulations-all-products/regulation-essentials/regulation-basics/our-regulatory-framework
  10. Greenbaum D, Cheung S, Turner C, et al. Pharmacovigilance in Australia: how do adverse event reports from clinicians contribute to medicine and vaccine safety? Aust Prescr 2024;47(6):186–91.
  11. Uppsala Monitoring Centre. Pharmacovigilance training your way. At: https://who-umc.org/education-and-training/self-paced-online-courses/
  12. Therapeutic Goods Administration. Product and consumer medicine information. At: www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/PICMI
  13. Aizpurua-Arruti X, Goyenechea E, Isla A, et al. Impact of additional monitoring on pharmacovigilance and pharmacists’ role: a scoping review. Pharmacoepidemiol Drug Saf 2025;34(9):e70201.
  14. Therapeutic Goods Administration. Therapeutic Goods Administration performance report 2023–24. Woden: TGA. 2025.
  15. Li R, Curtain C, Bereznicki L, et al. Community pharmacists’ knowledge and perspectives of reporting adverse drug reactions in Australia: a cross-sectional survey. Int J Clin Pharm 2018;40(4):878–89.
  16. Pharmaceutical Society of Australia. Medicine safety: take care. 2019.
  17. Medicines and Healthcare products Regulatory Agency. Guidance on adverse drug reactions. At: https://assets.publishing.service.gov.uk/media/5feefb4c8fa8f53b7a0fbe36/Guidance_on_adverse_drug_reactions.pdf
  18. Therapeutic Goods Administration. Reporting adverse events for health professionals. 2025. At: www.tga.gov.au/safety/report-problem/report-adverse-event-or-safety-problem/reporting-adverse-events-health-professionals
  19. Therapeutic Goods Administration. Blue card adverse reaction reporting form. 2026. At: www.tga.gov.au/resources/resources/forms/blue-card-adverse-reaction-reporting-form
  20. Therapeutic Goods Administration. National adverse events following immunisation (AEFI). 2026. At: www.tga.gov.au/resources/resources/forms/national-adverse-events-following-immunisation-aefi
  21. Australian Government Department of Health and Ageing. National medicines policy. Canberra: Australian Government Department of Health and Ageing. 2000.
  22. Medicines and Healthcare products Regulatory Agency. Pharmacovigilance: the inside track. At: www.sps.nhs.uk/wp-content/uploads/2021/09/2021-10-13-circulation-MUS-Webinar-Pharmacovigilance-The-inside-track.pdf
  23. Algarvio RC, Conceição J, Rodrigues PP, et al. Artificial intelligence in pharmacovigilance: a narrative review and practical experience with an expert-defined Bayesian network tool. Int J Clin Pharm 2025;47(4):932–44.
  24. Aslam A, Majid HA, Muhammad Boota N, et al. Strengthening pharmacovigilance through patient reporting: a scoping review of awareness, barriers, and facilitators. J Pharm Policy Pract 2026;19(1):2651405.
  25. Gebreyohannes EA, Thornton C, Thiessen M, et al. Views on the development and use of a new digital adverse drug event reporting platform in Australia: a qualitative study. Drug Saf 2024;48(2):179–90.
  26. van Hunsel F, de Waal S, Härmark L. The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015. Pharmacoepidemiol Drug Saf 2017;26(8):977–83.
  27. Watson S, Chandler RE, Taavola H, et al. Safety concerns reported by patients identified in a collaborative signal detection workshop using VigiBase: results and reflections from Lareb and Uppsala Monitoring Centre. Drug Saf 2018;41(2):203–12.
  28. van Hoof M, Chinchilla K, Härmark L, et al. Factors contributing to best practices for patient involvement in pharmacovigilance in Europe: a stakeholder analysis. Drug Saf 2022;45(10):1083–98.
  29. Härmark L, Weits G, Meijer R, et al. Communicating adverse drug reaction insights through patient organizations: experiences from a pilot study in the Netherlands. Drug Saf 2020;43(8):745–9.
  30. Beckmann J, Hagemann U, Bahri P, et al. Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum. Drug Saf 2014;37(10):743–59.
  31. Uppsala Monitoring Centre. #MedSafetyWeek. At: https://who-umc.org/medsafetyweek/
  32. Therapeutic Goods Administration. Safety updates. At: www.tga.gov.au/news/safety-updates
  33. Therapeutic Goods Administration. Australian public assessment reports. At: www.tga.gov.au/resources/auspar
  34. Therapeutic Goods Administration. Database of recalls, product alerts and product corrections. At: https://apps.tga.gov.au/PROD/DRAC/arn-entry.aspx
  35. Australian Commission on Safety and Quality in Health Care. Safety through adverse event reporting. 2026. At: https://learn.safetyandquality.gov.au/mod/page/view.php?id=5551
  36. National Centre for Immunisation Research and Surveillance. National and international resources. 2026. At: https://ncirs.org.au/health-professionals/national-and-international-resources
  37. World Health Organization. Tools and innovations in pharmacovigilance. 2026. At: www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/guidance/operations/tools-innovations
  38. World Health Organization. The WHO’s vaccine safety virtual learning ecosystem. At: https://gvsi-aefi-tools.org/e-learning/
  39. Radecka A, Loughlin L, Foy M, et al. Enhancing pharmacovigilance capabilities in the EU regulatory network: the SCOPE joint action. Drug Saf 2018;41(12):1285–302.
  40. UK Government. New SCOPE ADR e-learning module receives European-wide CME/CPD accreditation. At: www.gov.uk/government/news/new-scope-adr-e-learning-module-receives-european-wide-cmecpd-accreditation