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Virtual Event

2024年11月18日 (月) 午後 1:00 - 2024年11月21日 (木) 午後 5:00

(Central Europe Standard Time)

4051 Basel, Switzerland

Signal Management in Pharmacovigilance

This virtual live training course covers essential concepts of signal detection and signal management and provides guidance on how to apply these concepts at participants' function and their organisation, including the data mining techniques for large volume ADR data analysis.

Early-Bird rate for DIA Industry Members Available!

DAYS

HOURS

MINUTES

SECONDS

学部

Margarida  Guimaraes

Margarida Guimaraes

Scientific Administrator, European Medicines Agency, Netherlands

Expert in Pharmacovigilance and Drug Safety. European Medicines Agency (EMA) scientific administrator responsible for performing signal management activities for centrally and nationally authorized products, providing support to (Co)- Rapporteurs and Scientific Committees and contributing to scientific projects in the area of pharmacovigilance and signal management. EMA Emerging Safety Issues (ESIs) coordinator and responsible for the EU-NTC PhV Training Curriculum design, implementation and its maintenance.

Calin A. Lungu, MD

Calin A. Lungu, MD

CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg

Dr. Lungu has over 30 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted more than 160 Pharmacovigilance quality system audits in more than 40 countries around the globe. Apart of audits, he is a dedicated trainer of the official EMA EudraVigilance and XEVMPD training programmes and led over 300 offerings since 2004.

Jose Alberto Ayala  Ortiz, MPharm, MSc

Jose Alberto Ayala Ortiz, MPharm, MSc

QPPV, PVpharm, Spain

José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2004, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.

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