2024-2026 Work Plan of the Good Clinical Practice Inspectors Working Group (GCP IWG)
2024-2026 Work Plan of the Good Clinical Practice Inspectors Working Group (GCP IWG)
2024-2026 Work Plan of the Good Clinical Practice Inspectors Working Group (GCP IWG)
EMEA-003300-PIP01-22
EMEA-002951-PIP02-21
Opinion/decision on a Paediatric investigation plan (PIP): Vabysmo, Faricimab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Eye disorders, PIP number: P/0006/2024
Opinion/decision on a Paediatric investigation plan (PIP): Jakavi, Ruxolitinib (phosphate), decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: P/0034/2024
Methylphenidate product-specific bioequivelance guidance
EMEA-002582-PIP03-23
Opinion/decision on a Paediatric investigation plan (PIP): Aspaveli, Pegcetacoplan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Renal and urinary disorders, PIP number: P/0030/2024
EMEA-002582-PIP03-23
Finding clinical trials with the ACT EU Trial Map, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 7 March 2025, 13:30 (CET) to 7 March 2025, 14:30 (CET)