EMA publishes updated VeDDRA terms, proposed new guidance for Phase II ERA and updated eSubmission guidance

18 June, 2015

The EMA has published a number of new and updated guidance documents:

  • Updates to the VeDDRA clinical terms following the annual review (Link)
  • Concept paper on the testing strategy and risk assessment for plants in the Phase II of the ERA for VMPs (Link)
  • Updated guidance on eSubmission (Link)


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Environmental Risk Assessments

Our ecotox services include:

- ERAs to CVMP / VICH standards
- Responses to complex questions for MAAs
- Study design & management
- Phase I and Phase II (Tier A & B)
- Computer modelling (FOCUS)