Module 12 Presentations

What is xEVMPD & Art. 57 used for

• The information will be used to

➢ Support regulatory business activities (e.g., PSUR submission)

➢ Process and evaluate Individual Case Safety Reports

➢ Support PV signal management activities

➢ Perform data analysis and business analysis at EMA

➢ Calculate PV Fees payable by MAH

➢ Strengthen transparency and communication with EMA • With the developments on PLM eAF: xEVMPD data will be used as a baseline for PMS (together with SIAMED) as it contains CP and non-CP product data

The Organisation for Professionals in Regulatory Affairs