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EMA Clinical Trials Information System - Sponsor user training programme

Demonstrations and explanations of the system functionalities including initial application, RFIs, submitting a modification, search and download options etc.


Faculty

  • Calin A. Lungu, MD

    Calin A. Lungu, MD

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

    Dr. Lungu has more than 15 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted almost 150 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 training programme and led more than 300 offerings since 2004.

  • Jose Alberto Ayala  Ortiz

    Jose Alberto Ayala Ortiz

    • 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.

  • Ruediger  Pankow, DrSc

    Ruediger Pankow, DrSc

    • Principal Consultant, Regulatory Affairs
    • Parexel International, Germany

    Ruediger Pankow is currently Principal Consultant Regulatory Affairs at Parexel, where he has 15 years CRO experience in global management of clinical trial applications and regulatory consulting with specific expertise on the EU Clinical Trials Regulation. Representing ACRO for the EU Scientific and Regulatory Committee he has been continuously involved since 2016 in various European Medicines Agency (EMA) stakeholder activities for the EU Clinical Trial Information System (CTIS) development, since 2019 as sponsor product owner for the EMA CTIS delivery model and as expert for CTIS training modules.

  • Fatima  Pimentel

    Fatima Pimentel

    • Associate Director, SSU & Regulatory
    • Syneos Health, Spain

    Fatima Pimentel joined Syneos Health in 2021 as an Associate Director, Site Start-Up & Regulatory and is also responsible for the training and development of the new CTIS Portal Team. She worked as a Regulator in the Portuguese Agency INFARMED, I.P, between 2005-2021 in the Clinical Trial Unit, as a senior CT coordinator. Fatima was part of several EMA CT groups as well as CTFG. Fátima studied Industrial Pharmacy and obtained a POS-degree in Clinical trials Monitoring. Joining the EMA-CTIS project almost from start as a MS Product Owner and master trainer. Currently she is a trainer in the EMA/DIA CTIS sponsor trainings.

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+41 61 225 51 51


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+41 61 225 51 51