Medical Writing Observational Studies EMA releases the revised Good Pharmacovigilance Practices Module V – updated guidance on risk management plans

Volume 26, Issue 3 - Observational Studies

EMA releases the revised Good Pharmacovigilance Practices Module V – updated guidance on risk management plans

Abstract

Recently, the EMA released the revised Module V – Risk Management Systems (Rev 2) of Good Pharmacovigilance Practices (GVP) accompanied by a revised version of the guidance on the format of the risk management plan (RMP) in the EU – in integrated format. The revision will result in concise, scientifically focussed and riskproportionate documents and is applicable to all sections of the RMP, especially sections that have become overly lengthy over time and often duplicate information presented elsewhere in the dossier or in other documents, such as the periodic safety update report.
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References

  1. Good pharmacovigilance practices. European Medicines Agency. [cited 2017 Jun 12]. Available from: Available from: http://www.ema.europa.eu/ema/index.jsp? curl=pages/regulation/document_listing/document_listing_000345.jsp
  2. Guidelines on good pharmacovigilance practices (GVP). Introductory cover note, last updated with draft revision 2 of module V on risk management system for public consultation. EMA/136477/2016. 2016 Feb 29 [cited 2017 Jun 12]. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_ procedural_guideline/2017/03/WC500224566.pdf
  3. European Medicines Agency’s interaction with industry stakeholders. Annual Report 2015. EMA/774549/2015. 2016 Jun 16 [cited 2017 Jun 12]. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2016/06/WC500208988.pdf
  4. Guideline on good pharmacovigilance practices (GVP). Module V – Risk management systems (Rev 2) – draft for public consultation. European Medicines Agency and Heads of Medicines Agencies. 2016 Feb 24 [cited 2017 Jun 12]. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2016/02/WC500202424.pdf
  5. Draft guidance on format of the risk management plan (RMP) in the EU – in integrated format. EMA/PRAC/613102/ 2015 Rev.2 accompanying GVP Module V Rev.2. European Medicines Agency. 2016 Feb 29 [cited 2017 Jun 12]. Available from: Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500202373&mid=WC0b01ac058009a3dc
  6. GVP Module V–Risk management systems, EMA/838713/2011 Rev 2. European Medicines Agency and Heads of Medicines Agencies. 2017 Mar 28 [cited 2017 Jun 12]. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf
  7. Guidance on format of the risk management plan (RMP) in the EU – in integrated format. European Medicines Agency and Heads of Medicines Agencies. 2017 Mar 30 [cited 2017 Aug 18]. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/03/WC500224770.docx
  8. Guideline on good pharmacovigilance practices (GVP). Module V – Risk management systems (Rev 1). European Medicines Agency and Heads of Medicines Agencies. 2014 Apr 15 [cited 2017 June 12]. Available from: Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific _guideline/2012/06/WC500129134.pdf

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