Investigator meeting · Prof. Benedikt Fischer

11 Sept 2026 · In person · Prof. Benedikt Fischer, Charité Berlin · MSL Dr. Anna Becker · Nephrada

ReviewedManualENG-0011Safety

Safety flag

This record contains a potential adverse-event observation. It has been routed to Pharmacovigilance per SOP-PV-014 and is excluded from AI processing.

Location: Charité Berlin
Therapeutic area: Nephrology
Country: Germany
Stakeholder tier: Tier 1
Strategic objective: SO-NPH-02 · Generate long-term eGFR slope evidence to support full approval and HTA submissi…
Initiative: Not linked
MSL: ABDr. Anna BeckerMSL, Nephrology (DACH)
Product: Nephrada (nephradin)

Topics discussed

Steroid-sparing strategies
APRIL pathway mechanism

Scientific content used

PD-L1 testing pathway infographic
VTX core scientific deck v3.2

Questions raised

What is the immunoglobulin monitoring recommendation?

Notes

Investigator meeting. Observation about an OLE patient with recurrent sinopulmonary infections after 14 months; question on IgG monitoring frequency. Safety flag raised and routed per SOP-PV-014.

Insights captured (1)

Capture insight

INS-0058High
Steroid-sparing strategies
Potential safety observation: recurrent infections in OLE patient after 14 months; question on IgG monitoring frequency. Flagged for pharmacovigilance handoff.
Routed

Review workflow

Draft
Submitted
3Reviewed

Review complete. Quality ratings and insights can now be used in aggregates.

Follow-ups

Connect with Clinical Development

0 of 1 complete

Quality ratings

1–5, rated at review

Scientific relevance: 2
Strategic relevance: 5
Depth of exchange: 5
Actionability: 4

Data lineage

Source system: Manual
Sync: Entered manually in Hub
System of record: Hub
Record id: ENG-0011

Audit history (0)

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