Medical Writing Vaccines and Immunotherapies Pharmacovigilance for vaccines and immunotherapies

Volume 27, Issue 1 - Vaccines and Immunotherapies

Pharmacovigilance for vaccines and immunotherapies


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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  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:
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Vaccines and immunotherapies
President's Column
A history of EMWA
An introduction to vaccines and immunotherapies
Immuno-oncology: Harnessing our immune system to fight cancer
Changing methods to assess targeted therapies in oncology
HIV vaccine clinical trials: An overview
Allergen immunotherapy in the European regulatory environment
Pharmacovigilance for vaccines and immunotherapies
Addressing vaccine hesitancy in writing
Results of the 2017 EMWA salary survey
Lay writing: Strategies for improving assent forms
The perils of the unknown: Missing data in clinical studies
Medical writing in China: Trends and opportunities
PhD student: A medical writer in the making!
News from the EMA
Medical Communications
Journal Watch
In the Bookstores
The Webscout
Teaching Medical Writing
Good Writing Practice
Medical Devices
Getting Your Foot in the Door
Entering medical communications as a non-native English speaker
Out on Our Own
Lingua Franca and Beyond


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