EMA Risk Management Virtual Information Day
Overview
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).
Featured topics
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.
Who should attend?
• 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)
Program Committee
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Martin Huber, MPH, MPharm • Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair
Federal Institute for Drugs and Medical Devices (BfArM), Germany -
Francesca Day • Human Medicines Division, Head of Therapeutic Areas Department (H-TA)
European Medicines Agency , Netherlands -
Evdokia Korakianiti, PhD, MSc • Head of Quality and Safety of Medicines
European Medicines Agency, Netherlands -
Georgy Genov, MD • Head of PHV Office, ad-interim Head of Quality & Safety of Medicines Department
European Medicines Agency, Netherlands -
Heidi Janssen • Head, Endocrinology, Metabolism & Cardiovascular
European Medicines Agency, Netherlands -
Viola Macolic Sarinic, DrSc, MD, MSc • PRAC Scientific Lead
European Medicines Agency, Netherlands -
Maria Giovanna Satta • Scientific Officer in the Office of Therapies for Neurological and Psychiatric D
European Medicines Agency, Netherlands