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Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulators.

Alexandra C PacurariuKelly PlueschkeCarla Alonso OlmoXavier Kurz
Published in: Pharmacoepidemiology and drug safety (2018)
Overall, the rate of recruitment and timely finalization were improved after 2 years of additional follow-up but show that further work is needed to facilitate use of registry data for regulatory purposes, a work that has started via the EMA registry initiative.
Keyphrases
  • transcription factor
  • public health
  • quality improvement
  • drug administration