Medical Writing Vaccines and Immunotherapies Pharmacovigilance for vaccines and immunotherapies
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Volume 27, Issue 1 - Vaccines and Immunotherapies

Pharmacovigilance for vaccines and immunotherapies

Abstract

Although the content of EU Periodic Benefit- Risk Evaluation Reports (PBRERs) for vaccines is governed by the same regulatory framework as applies to other medicinal products, the complex nature of vaccines presents vaccine-specific challenges that need to be considered when preparing safety documents. Notably, the complex multicomponent nature of vaccines necessitates inclusion of additional data elements in vaccine PBRERs, to allow assessment of the resultant impact on the safety profile. In addition, analysis of safety data in vaccine PBRERs requires stratification of data to elucidate the impact of issues such as the effects of patient age and vaccine batch variability on the safety profile.

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References

  1. Guideline on good pharmacovigilance practices (GVP) Product- or Population- Specific Considerations I: Vaccines for prophylaxis against infectious diseases. European Medicines Agency. 2013 [cited 2017 Dec 21]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/12/WC500157839.pdf
  2. Guidelines on good pharmacovigilance practices (GVP). European Medicines Agency. 2017 [cited 2017 Dec 21]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/10/WC500236404.pdf
  3. Definition and application of terms of vaccine pharmacovigilance (report of CIOMS/WHO Working Group on Vaccine Pharmacovigilance). Council for International Organizations of Medical Sciences (CIOMS). 2012 [cited 2017 Dec 21]. Available from: http://www.who.int/vaccine_safety/initiative/tools/CIOMS_report_WG_vaccine.pdf
  4. Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1). European Medicines Agency. 2013 [cited 2017 Dec 21]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142468.pdf
  5. ICH guideline E2C (R2) on periodic benefit-risk evaluation report (PBRER). 2013 [cited 2017 Dec 21]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/12/WC500136402.pdf
  6. E2C(R2) Implementation Working Group ICH E2C(R2) Guideline: Periodic Benefit- Risk Evaluation Report Questions & Answers. 2014 [cited 2017 Dec 21]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2C/E2C_R2_QAs_Step4.pdf

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