EMA Risk Management Virtual Information Day

The focus of this Information Day will be an update of the Agency’s ongoing activities on medicines’ risk management, with the opportunity for an interactive platform to exchange experiences between Regulators and Industry, specifically looking at the safety of medicines and COVID-19 vaccines in women of child-bearing potential (WCBP), during pregnancy and breastfeeding, with special attention on challenges and lessons learned in different settings, such as when developing guidance documents, planning strategies for optimising data collection, measuring the effectiveness of risk minimisation measures (RMMs).

GVP module XVI – Addendum III – Pregnancy Prevention Programme (PPP) and other pregnancy-specific risk minimisation measures (RMMs)

GVP module product – or population-specific considerations III: pregnant and breastfeeding women

Due to the current situation related to COVID-19, the specific topics of this information day may be adjusted.

• Individuals experienced in risk management, risk minimisation development and evaluation at small to medium enterprises (SMEs)
• MAAs/MAHs for generic products
• MAAs/MAHs for innovator products
• Contract Research Organisations (CROs)
• Assessors at National Competent Authorities (NCAs)
• Risk communication experts
• Patients and Healthcare Professional (HCP) group representatives
• Qualified persons responsible for Pharmacovigilance (QPPVs)