Module 6

03/10/2024

Why do we collect post marketing safety case reports?

Patient

Complains

Data sheet change

Doctor

Advises

Reported ADRs

Assessed and debated

Spontaneous Reports

Collated and investigated

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Signal detection and evaluation

• EMA and MAH to monitor EudraVigilance at least monthly (more frequently for some products) ➢ Expectations of MAH regarding EudraVigilance are unclear www.adrreports.eu refreshed monthly - review on update • Web reports available via interactive PDF

• Key information and explanatory text on home page

• Disclaimer is presented on entering the search tool • Agreement to the disclaimer remains valid for 7 days • Search functionality also provided: A to Z for substance list

Berlin, C, Blanch, C, Lewis, DJ, et al. Are all quantitative post-marketing signal detection methods equal? Pharmacoepidemiology & Drug Safety 2012; 21: 622-630.

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