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Virtual

Dec 09, 2022 1:30 PM - Dec 09, 2022 5:30 PM

(Central Europe Standard Time)

EMA Risk Management Virtual Information Day

Registered participants find access to the virtual conference in their DIA account. This virtual information day provides an update of ongoing Agency’s activities on medicines’ risk management.

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

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

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