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EMA Clinical Trial Information System (CTIS) Information Day

The focus of this live virtual CTIS information day is to share practical advice and best practices with regard to transitioning clinical trials, timelines in CTIS, system metrics, insights of clinical trial assessments as well as user management.


Faculty

  • Marianne  Lunzer, DrMed

    Marianne Lunzer, DrMed

    • Assessor, Dept of Clinical Trials, Federal Office for Safety in Health Care
    • AGES, Austria

    Marianne is a medical doctor by training and joined AGES in 2008 as a pharmacovigilance assessor. She was an alternate PRAC member between 2015 and 2017. In 2017, she joined the clinical trial unit at AGES as a safety assessor and has since been part of the Clinical Trials Facilitation and Coordination Group (CTFG) group. Since 2022 she is chairing the group now called Clinical trials coordination group (CTCG). Marianne contributed to the CTFG best practice guidelines for safety assessors for clinical trials and is a member of the drafting team for the Commission implementing regulation for the cooperation in safety assessment of clinical trials.

  • Noemie  Manent, PharmD

    Noemie Manent, PharmD

    • TDA-TCS Operations Workstream Lead
    • European Medicines Agency, Netherlands

    Noémie Manent joined the European Medicines Agency EMA in March 2011 as a Principal Scientific Administrator in the Compliance and Inspection Sector. She is involved in the coordination of EMA Good Clinical Practice (GCP) and pharmacovigilance inspections. She also has a major role in the update of the European Clinical Trial Database (EudraCT) to integrate clinical trial results data to the already established protocol related data and allow for sponsors to publish clinical trial results on the European Clinical Trial Register (www.euclinicaltrialsregister.eu). Currently, she is involved with the implementation of the clinical trial Regulation No. 536/2014 and particularly with the EU portal and database.

  • Pieter  Vankeerberghen

    Pieter Vankeerberghen

    • Head of Clinical Trials
    • European Medicines Agency, Netherlands

    Pieter Vankeerberghen studied Industrial Pharmacy, obtained a Ph.D. in Pharmaceutical sciences and holds a master degree in informatics. After working for 4 years in R&D, first in Clinical Data Management and later as project manager in human pharmacology, he joined the Belgian authorities in 2000 leading various projects. From 2016 he led their R&D department for clinical trials and unmet medical need. In this role he was a Member State Product Owner for the CTIS project. Since August 2020, he is head of EMA clinical workstream and CTIS programme manager.

  • Laura  Pioppo

    Laura Pioppo

    • Scientific Administrator, CTIS expert
    • European Medicines Agency, Netherlands

    Laura qualified as pharmacist before joining the EMA in 2009 in the Compliance and Inspection Department where she was responsible for the coordination and follow up of GCP and Pharmacovigilance inspections requested by CHMP. Since 2017 she has been working on the development of the Clinical Trial Information system (CTIS), defining and testing the system functionalities in collaboration with the MS and sponsors product owners and the European Commission.

  • Monique  Al

    Monique Al

    • Team Coordinator National Clinical Trial Office
    • Central Committee on Research Involving Human Subjects (CCMO), Netherlands

    Monique Al obtained her degree in Human Nutrition at Wageningen University & Research, The Netherlands. Subsequently she received a PhD in Human Biology in September 1994 at the Maastricht University. After that she worked for several nutritional and pharmaceutical companies in the field of clinical research. In 2001 she started as a scientific staff member at the Central Committee on Research Involving Human Subjects (CCMO) in The Netherlands. Currently she is an coordinating advisor specialized in clinical trials and clinical investigations at the CCMO.

  • Marianne  Andersson

    Marianne Andersson

    • Director Regulatory Processes, Clinical Trials
    • Astrazeneca, Sweden

    Marianne is a qualified pharmacist that have been working with regulatory affairs in clinical research within AstraZeneca for more than 20 years. She has led regulatory submissions for new medicines in different phases in development. Currently, she is leading the work with ensuring internal procedures are compliant with external requirements globally, which includes the implementation of the new Clinical Trial Regulation within the company. Marianne is also a CTIS sponsor product owner working with EMA testing the different functionalities of the system.

  • Gabriella  Di Matteo

    Gabriella Di Matteo

    • Director CTRO Team Manager
    • Pfizer, Belgium

    Working in Early Clinical Research for more than 25 years, and leading the implementation of the CT Directive and Belgian law on Clinical Trials for the Pfizer Clinical Research Unit (Brussels) as Regulatory Manager. Member of Pfizer internal workstreams on EU CTR and active tester of the portal since UAT 1 in early 2016. Currently Global Clinical Trial Application Submission Manager in Pfizer Global Regulatory Operations, managing submissions in various European countries as well as outside Europe. Strong advocate of the EU CTR and its portal.

  • Maria  Elgaard Sørensen

    Maria Elgaard Sørensen

    • Special advisor
    • Danish Medicines Agency, Denmark

    Maria Elgaard is a special adviser and project manager at the Danish Medicines Agency and currently in an interim position as team manager in the CT unit. Educational background is M.SC.Pharm and she has been working as an assessor of clinical trials application for several years. As of 2016 she has been increasingly engaged in the CTIS project currently as MSPO and master trainer. Nationally she has been appointed business specialist in both the European and the Danish IT solutions for handling clinical trials and other national systems with interaction to the clinical trials area.

  • Outi  Konttinen

    Outi Konttinen

    • General Secretary
    • National Committee on Medical Research Ethics (TUKIJA), Finland

    Outi Konttinen has served as an executive secretary of the national committee since 2001. She is Master of Social Sciences, political science and public health as her main subjects. Outi has been appointed to represent Finland and/or Finnish RECs in the following EU institutions and other EU-level bodies: European Commissions Clinical Trials Expert Group; European Network on Research Ethics Committees (EUREC); EMA CTIS expert group and Union database meeting with Member States, EMA.

  • Roxana-Mirela  Spulber

    Roxana-Mirela Spulber

    • Change Management Officer
    • European Medicines Agency, Netherlands

    Roxana-Mirela Spulber joined the European Medicines Agency in November 2021 as a Change Management Officer in the TDA-CTS team. Roxana has extensive marketing experience, having worked for Oracle and IBM for 14 years. Today, she is a member of the operation workstream for the Clinical Trial Information System (CTIS), Data Analytics and Methods Task Force, focusing on training and events.

  • Peter Richard Arlett, MD, FFPM, FRCP

    Peter Richard Arlett, MD, FFPM, FRCP

    • Head Data Analytics and Methods Task Force
    • European Medicines Agency, Netherlands

    Dr Peter Arlett - Head, Data Analytics and Methods Task Force, European Medicines Agency. Education: Medical Degree, University College London 1991; Member, Royal College of Physicians (MRCP) of London 1994; Fellow of the Faculty of Pharmaceutical Medicine (FFPM) of the Royal College of Physicians of London 2007; Fellow of the Royal College of Physicians of Edinburg 2017; Honorary Professor, London School of Hygiene and Tropic Medicine (2020). Career to date: Head of Pharmacovigilance and Epidemiology Department, EMA 2008 – 2020; Principal Administrator, Pharmaceuticals Unit, European Commission 2003-2008; UK MHRA 1996-2003; Hospital Physician, Oxford and London, UK NHS 1991-1996.

  • Maria  Spillane

    Maria Spillane

    • Senior Trial Capabilities Associate – Austria, Germany & Switzerland
    • Eli Lilly Cork Ltd. – Global Business Solutions Cork, Ireland

    Maria has been working in Clinical Research for over 10 years as a Study Coordinator, CRA and Study Manager. She has been with Eli Lilly for almost 3 years, initially as a Sr. Trial Capabilities Associate and more recently as a Sr. Manager for Trial Capabilities. Maria is the Eli Lilly Master Trainer for CTIS and has been involved in the rollout of the CTR within Lilly, as well as the preparation for the initial clinical trials submitted through the CTIS portal.

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