Agenda - Workshop on the use of Bayesian statistics in clinical development

EMEA-002724-PIP01-19-M03

Annex to 16-19 June 2025 CHMP Agenda

Agenda of the CHMP meeting 16-19 June 2025

HMA-EMA joint Network Data Steering Group meeting - 30 April 2025

Opinion/decision on a Paediatric investigation plan (PIP): Zynlonta, Loncastuximab tesirine, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Blood and lymphatic system disorders, PIP number: P/0152/2024

EMEA-002474-PIP02-18-M02

Opinion/decision on a Paediatric investigation plan (PIP): Orladeyo, Berotralstat, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Congenital, familial and genetic disorders, PIP number: P/0151/2024

Opinion/decision on a Paediatric investigation plan (PIP): Flucelvax Tetra, influenza vaccine (surface antigen, inactivated, prepared in cell cultures) [QIVc], decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infections and infestations, PIP number: P/0168/2024

Opinion/decision on a Paediatric investigation plan (PIP): Trimbow, beclometasone dipropionate,formoterol fumarate dihydrate,glycopyrronium bromide, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Respiratory, thoracic and mediastinal disorders, PIP number: P/0167/2024