Safety Observer 211
CIOMS has published a new draft report on Severe Cutaneous Adverse Reactions (SCARs).
Report 211 — Highlights
CIOMS: SCARs
CIOMS has published a new draft report on Severe Cutaneous Adverse Reactions (SCARs), which covers various aspects including diagnosis and causality assessment.
EMA: New RWE guidance
The EMA has published a couple of guidance documents regarding the use of RWE, which includes a draft reflection paper on the use of RWD in non-interventional studies to generate RWE.
EMA: Reproduction and Lactation
The EMA has published a new concept paper on a proposal to revise the 2008 Guideline on “Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling”.
MHRA & E2B(R3)
The MHRA has published new information on the submission of ICSRs, which describes the plans for the implementation of the ICH E2B(R3) standard in the MHRA database and its impact.
Swissmedic & E2B(R3)
Swissmedic has also published a note to inform MAHs about the plans for the migration of their ICSR submission systems to the E2B(R3) format.
