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Considerations for Successful Risk-Minimisation Strategies in the EU

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Abstract

Determining the appropriate risk-minimisation strategies for a product requires careful consideration. An EU market authorisation provides authorisation for a product to be marketed in all EU member states. However, many factors, including healthcare practice and organisation, culture and local regulations, vary among member states, presenting challenges in determining which and how risk-minimisation activities can be implemented across the EU. This article sets out some points for consideration when implementing risk-minimisation activities in the EU.

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References

  1. European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP)—Module V—risk management systems (Rev 1). 2014. EMA/838713/2011 Rev 1. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf. Accessed 22 July 2016.

  2. European Medicines Agency (EMA). Guideline on good pharmacovigilance practices (GVP)—Module XVI—risk minimisation measures: selection of tools and effectiveness indicators (Rev 1). 2014. EMA/204715/2012 Rev 1. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162051.pdf. Accessed 22 July 2016.

  3. European Federation of Pharmaceutical Industries and Associations (EFPIA). EFPIA code of practice on relationships between the pharmaceutical industry and patient organisations. 2011. http://transparency.efpia.eu/uploads/Modules/Documents/code_po2011.pdf. Accessed 24 Aug 2016.

  4. Prescription Medicines Code of Practice Authority (PMCPA). The ABPI code of practice for the pharmaceutical industry. http://www.pmcpa.org.uk/thecode/Pages/default.aspx. Accessed 24 Aug 2016.

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Authors and Affiliations

  1. European Risk Management, UBC, 16 Chemin des Coquelicots, Vernier, 1214, Geneva, Switzerland

    Janine Collins & Dafna Bonneh-Barkay

Authors
  1. Janine Collins
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  2. Dafna Bonneh-Barkay
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Corresponding author

Correspondence to Janine Collins.

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Funding

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

Conflict of interest

Janine Collins and Dafna Bonneh-Barkay are employed by United BioSource Corporation, a subsidiary of Express Scripts.

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Collins, J., Bonneh-Barkay, D. Considerations for Successful Risk-Minimisation Strategies in the EU. Pharm Med 30, 257–261 (2016). https://doi.org/10.1007/s40290-016-0161-7

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  • DOI: https://doi.org/10.1007/s40290-016-0161-7

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