Volume 23, Issue 4 - Post-Approval Regulatory Writing

Strategic medical writing in the post-authorisation phase

Author: Sarah J. Richardson

Abstract

Download the full article

References

1. Thalidomide Society. Extract from a lecture given at the 1992 UNITH Congress. Available from: http://www.thalidomidesociety.org/
2. Florence LA. Is thalidomide to blame? BMJ 1960;2(5217):1954.
3. Royal Pharmaceutical Society. The evolution of pharmacy. Available from: http://www.rpharms.com/learning-resources/the-evolution-of-pharmacy.asp
4. Her Majesty's Stationary Office (HMSO). Medicines Act 1968. Available from: http://www.legislation.gov.uk/ukpga/1968/67
5. Franks ME, Macpherson GR, Figg WD. Thalidomide. Lancet 2004;363(9423):1802–11.
6. Forjanic Klapproth J. Strategic benefits. ICT November 2011:72–5.
7. Forjanic Klapproth J, Drees B. The new documentation paradigm. International Clinical Trials May 2010:26–9.
8. Essential Drugs.org. ISDB assess EMEA transparency performance. Available from: http://www.essentialdrugs.org/edrug/archive/200011/msg00037.php
9. Abbasi K, Herxheimer A. The European Medicines Evaluation Agency: open to criticism. Transparency must be coupled with greater rigour. BMJ 1998;317(7163):898–900.
10. Arlett P. Pharmacovigilance: visions for the future. Opportunities for public health from the new EU pharmacovigilance legislation. Slides at ICDRA, Tallinn 26 October 2012. Available from: http://www.icdra.ee/attachments/article/17/1-Peter-Arlett.pdf
11. European Medicines Agency. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community Code Relating to Medicinal Products for Human Use. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004481.pdf
12. European Commission. Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004. Laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF
13. European Commission. Commission implementing regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:159:0005:0025:EN:PDF
14. European Commission. Regulations: Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF
15. Borg JJ, Aislaitner G, Pirozynski M, Mifsud S. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation of pharmacovigilance. Drug Saf 2011;34(3):187–97.
16. European Medicines Agency. Transparency: questions and answers for marketing-authorisation holders (MAH). Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/q_and_a/q_and_a_detail_000046.jsp&mid=WC0b01ac0580023e81
17. Permandand G, Mossialos E, McKee M. Regulating medicine in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance. Clin Med 2006;6(1):87–90.
18. European Medicines Agency. PRAC: overview.
19. Spooner A, De Lisa R, Benstetter M, Burgos G, Raine J. Establishing the pharmacovigilance risk assessment committee – major advances in transparency for EU pharmacovigilance activities. Regulatory Rapporteur 2014;11(4):8–9.
20. Begg C, Cho M, Eastwood S, Horton R. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996;276(8):637–9.
21. Lang T. Medical writing: where it's been, where it's going. AMWA J 2000;15(2):9–12.
22. Limaye N. Outsourcing medical writing: the evolution of a niche domain. Pharma Times 2010;42(8):30–2.
23. European Medicines Agency. Volume 9A of the rules governing medicinal products in the European Union. Available from: http://www.ema.europa.eu/ema/index
24. European Medicines Agency. Pharmacovigilance: regulatory and procedural guidance. Available from: http://www.ema.europa.eu/ema/index
25. Medicines and Healthcare products Agency. Risk minimisation, Risk Management Plans and post authorisation studies Q&A. Available from: http://www.mhra.gov.uk/
26. European Medicines Agency. Requirements for Risk Management Systems. Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 1). Available from: http://www.ema.europa.eu/
27. Goedecke T. Overview of GVP modules V (risk management systems), VIII (post authorisation safety studies and ENCePP). EU 28: Science, medicines, health – a regulatory system fit for the future, 6–8 May 2013, Dubrovnik slides.
28. European Medicines Agency. Questions and answers on the Risk Management Plan (RMP) summary 05 May 2014. Available from: http://www.ema.europa.eu/
29. Chamberlain James L, Creuwels LAJM, Davies M. Risk management plans – new challenges for a new era. Regulatory Rapporteur 2014;11(6):4–7.
30. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic Safety Update Report (Rev 1). Available from: http://www.ema.europa.eu/
31. European Commission: Guidelines on pharmacovigilance for medicinal products for human use. Available from: http://ec.europa.eu/
32. European Medicines Agency: Chapter 7 Periodic Safety Update Reports Article 34. Available from: http://www.ema.europa.eu/
33. European Medicines Agency. European Union Reference Dated and Submission of Periodic Safety Update Reports. Available from: http://www.ema.europa.eu/
34. Ladd G. Are you ready for the new EU pharmacovigilance legislation changes Part 1. Available from: http://www.pharmaphorum.com/
35. European Medicines Agency. ICH Guideline E2C (R2). Available from: http://www.ema.europa.ema/
36. European Medicines Agency. ICH guideline E2C (R2) Periodic Benefit-Risk Evaluation Report (PBRER). Available from: http://www.ema.europa.eu/
37. European Medicines Agency. ICH guideline E2C (R2) Periodic Benefit-Risk Evaluation Report: questions and answers [31 March 2014]. Available from: http://www.ema.europa.eu/
38. European Commission. Volume 10 of the rules governing medicinal products in the European Union. Available from: http://www.ec.europa.eu/health/documents/eurdralex/vol-10
39. European Medicines Agency. Guideline of good pharmacovigilance practices (GVP) Module VIII – post-authorisation studies. Available from: http://www.ema.europa.eu/
40. Hamilton S. Effective authoring of clinical study reports: a companion guide. Med Writing 2014;23(2)86–92.