Posted on 20 Oct 2021

First PV SIG Meet&Share on 13 December 2021

DSUR requirements other than ICH E2F – Be aware! (Impact of EU-CTR and other local requirements on DSURs)”

  • MHRA requirements for DSURs
  • EU-CTR requirements and DSURs
  • Discussion: ICH E2F vs. EU-CTR; best practices and experience sharing
  • Other requirements (e.g., Japan, China)
  • Experience sharing on Health Authority's questions about SUSARs for biosimilars - dialogue of clinical safety & PV department

Meeting details: 13 December 2021 at 2 PM CET. EMWA members can email info@emwa.org for a Zoom invite.