Medical Writing Observational Studies Reporting non-interventional post-authorisation safety studies (NI-PASS)

Volume 26, Issue 3 - Observational Studies

Reporting non-interventional post-authorisation safety studies (NI-PASS)

Abstract

Post-authorisation safety studies (PASS), whether interventional or, more commonly, non-interventional (NI), can be used by entities such as the European Medicine Agency´s Pharmacovigilance and Risk Assess ment Committee to oblige drug companies to collect data on approved products. NI PASS study reports should be drafted according to a particular mandated format, which may not be intuitive for writers more familiar with clinical study reports for interventional trials. This article addresses the structure of NI-PASS reports, comparing and contrasting with the clinical study reports of interventional trials.
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References

  1. Guideline on good pharmacovigilance practices (GVP): Module VIII – Postauthorisation safety studies (Rev 1). 19 April 2013. EMA/813938/2011 Rev 1. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129137.pdf
  2. 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. Official Journal of the European Communities L 311/67. 28.11.2001. Available from: Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:311:0067:0128:en:PDF
  3. EU PAS Register Guide. European Medicines Agency. 28 July 2014, EMA/613603/2012. Available from: Available from: http://www.encepp.eu/publications/documents/EUPASRegisterGuide.pdf
  4. Guidance for the format and content of the final study report of non-interventional post-authorisation safety studies. 30 July 2013. EMA/48663/2013. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2013/01/WC500137939.pdf
  5. Guidance for the format and content of the protocol of non-interventional postauthorisation safety studies. 26 September 2012. EMA/623947/2012. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2012/10/WC500133174.pdf

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