Faculty
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
CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg
Dr. Lungu has over 30 years of experience in pharmacovigilance and regulatory compliance. He has conducted 180+ PV audits for pharmaceutical companies and EU authorities, advised on PV system improvement, and supported EU inspections. Since 2004, he has been an official EMA EudraVigilance trainer, delivering 300+ global courses, and has served as EMA master trainer for the Clinical Trials Information System since 2021. He continues to train and support EVDAS use for MAHs. Dr. Lungu earned his MD from the Free University of Brussels in 1992.
Jose Alberto Ayala Ortiz, MPharm, MSc
CEO, 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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