EU Investigational Medicinal Product Dossier (IMPD) — Summary — GLPI-103
| Field | Value |
|---|---|
| Document ID | IMPD-EU |
| Version | 1.0 |
| Region | EMA / EU (CTR 536/2014) |
| Standard | EU Clinical Trial Regulation; IMPD guideline |
| Confidentiality | Confidential — portfolio use |
Supports EU clinical-trial authorization (CTA) via CTIS under Regulation (EU) 536/2014.
[MOCK]administrative identifiers.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Regulatory (EU) | Initial IMPD summary |
Contents
- Quality (S/P): drug substance and drug product quality data — per Module 3 (M3).
- Nonclinical: pharmacology, PK, toxicology summaries supporting the proposed clinical doses (M2.4/M2.6; M4).
- Clinical: previous clinical experience and rationale (IB-001; CSR-101/102/201 for later phases).
- Overall risk–benefit: supports the proposed trial (e.g., PROT-301) — see M2.5.6.
CTA / Submission
Submitted via CTIS; aligned EU assessment; safety reporting (SUSARs, DSUR) per CTR 536/2014 and the Safety Management Plan (TMF-SMP). EU-RMP: RMP-EU.