AGENDA

14th of November, 2025 – 1 day hybrid event Bucharest Onsite & Online Hotel Marshal Garden, Panoramic Hall

"Navigating the Labyrinth: Overcoming Complexity in Clinical Trials to Boost Site and Patient Involvement.""



  • Registration and welcome coffee
    09:30 10:00
  • Welcome Speeches
    Dr. Cristina Florescu Moraid, Organizer, President of Clinical Trials Symposium (Romania); CEO Avantyo Institute of Clinical Research
    George Regio Tanaseanu, President of the Romanian Association of CROs (ACCSCR) Romania; Country Manager PSI CRO AG Romania
    10:00 10:30
  • Panel 1: From Complexity to Clarity: Designing Trials That Actually Work
    Monique Denise Maria Al, Special Advisor at the Central Committee on Research Involving Human Subjects (CCMO), The Netherlands, Vice Chair CTCG, Co-Chair MedEthics EU

    Topics:
    • Multi-country regulatory burden or how to raise the attractiveness of a country for clinical trials development

    Moderators:
    Laurentiu Dasca, Country Manager Arensia Exploratory Medicine, Romania
    Teodor Cristian Blidaru, Project Manager of the Romanian Health Innovation Hub

    Panelists:
    Razvan Mihai Prisada, President of the National Agency for Medicines and Medical Devices of Romania
    Doina Draganescu, President of the National Bioethics Commission of Medicines and Medical Devices, Dean Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Romania
    Karolina Maria Nowak, Director of Innovation and Biotechnology Development Department, Medical Research Agency, Warsaw, Poland
    Lina Gudima, Past President National Drug Agency, Republic of Moldova
    Alexandru Rafila, President of Health Commission, Deputy Chamber of Romanian Parliament, Romania
    10:30 11:30
  • Coffee Break
    11:30 12:00
  • Panel 2: Sites on the Edge: What They Really Need to Stay in the Game?

    Topics:
    • Site feedback loops: Are sponsors listening?
    • Tools that help (or hurt) site engagement

    Moderator:
    George Regio Tanaseanu, President of the Romanian Association of CROs (ACCSCR) Romania; Country Manager PSI CRO AG Romania

    Panelists:
    Anca Streinu Cercel, Prof. Dr. Matei Bals ”National Institute of Infectious Diseases“, «Carol Davila» Medicine and Pharmacy University, Bucharest, Romania
    Laurentia Nicoleta Gales, Head of Oncology department II, “Prof. Dr. Alexandru Trestioreanu” Institute, Bucharest
    Michael Schenker, President of Oncology Commission, Ministry of Health, General Manager of “Saint Nectarie” Oncology Center, Romania
    Anca Colita, General Manager “Fundeni” Clinical Institute, Bucharest, Romania
    12:00 12:45
  • Panel 3: The Patient’s Voice Matters: From Barriers to Breakthroughs in Clinical Trials

    Topics:
    • Overcoming obstacles to participating in CTs
    • Creating transparency and clarity in trial communication
    • Empowering patients and sites through collaboration

    Moderators:
    Ileana Stoicescu, Head of Arensia Research Clinic, “Prof.Dr.Alexandru Testioreanu” Institute of Oncology Bucharest
    Cristina Pentiuc, Health & Value Lead, Pfizer Romania- Updates about development of Clinical Trials Portal for patients, Romania

    Panelists:
    Darina Hrdlickova, Consultant and Investigator, President of Association of CROs (ACRO-CZ), Country Coordinator Camina Medical Experts, Czech Republic
    Rozalina Lapadatu, President of Autoimmune Disease Patients Association, Romania
    Alina Comanescu, Founder of Community Health Association, Romania
    Radu Ganescu, President of the Coalition of Organizations of Patients with Chronic Diseases (COPAC) Romania
    Cezar Irimia, President of Oncologic Patients Federation, Romania (FABC)
    Camelia Soceanu, President of S.O.S. Mielom Association
    12:45 13:30
  • Lunch
    13:30 14:30
  • Panel 4: The Strategic Role of Study Coordinator-Enhancing Study Conduct and Data Quality
    Moderator:
    Tiberiu-Gabriel Simionescu, Lead Project Manager, Arensia Exploratory Medicine, Romania

    Panelists:
    George Regio Tanaseanu, Country Manager PSI CRO AG Romania
    Darina Hrdlickova, Executiv Director of Association of CROs (ACRO-CZ), Country Coordinator Camina Medical Experts, Czech Republic
    Sorin Visan, Director Corporate Trial Operations, Arensia Exploratory Medicine
    Oana Clevet, Study Coordinator at OncoHelp Timișoara
    Anca Brasoveanu, Senior Manager Clinical Operations, Novotech
    14:15 15:00
  • ICH-GCP R 3- what is new?
    Catalina Sarbu, Director Operational Excellence Arensia Exploratory Medicine, Secretary of the Romanian Association of CROs (ACCSCR) Romania
    15:00 15:15
  • Panel 5: The Patient Lens-Making Patient-Centricity Real

    Topics:
    • Balancing complexity with empathy
    • Informed consent in the digital era
    • Decentralised trials: patient empowerment or burden?


    Panelists:
    Florin M. Petrutiu, CIO/CISOCIO/CISO, CNS Healthcare, USA
    Rebeca Gonzalez Vicedo, Director Decentralized Client Solutions, Future Meds, Germany
    15:15 15:45
  • Coffee Break
    15:45 16:15
  • Panel 6: Sponsor–Site–Patient Triangle: Bridging the Gap

    Topics:
    • Building trust between stakeholders
    • Feedback loops and shared KPIs
    • Is co-designing trials with sites and patients the future?

    Moderator:
    Alina Codrescu, Director, Head of Cluster, Clinical Operation Balkan Cluster

    Panelists:
    Leontina Voicea, Senior Clinical Research Manager, Novo Nordisk, Romania
    Viorel Vacaru, Patient Access Lead, UCB Romania
    Ana Stoikovic, General Manager Svarog Research, Croatia, Chair of Event & Training WG, EUCROF
    Lia Chislari, Republican Hospital, Chisinau, Republic of Moldova
    Marinela Debu, President of Hepatic Disease Patient Association, Romania
    16:15 17:00
  • Conclusions
    Cristina Florescu Moraid, Organizer, President of Clinical Trials Symposium (Romania) ; CEO Avantyo Institute of Clinical Research
    17:00 17:15
  • Networking & Tombola Event
    17:15 17:30


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SPEAKERS

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exhibitors, or media, please contact our Marketing and Communication Department
at diana.lupu@avantyo.com or +40 (0) 726 840 456

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The Bucharest International Clinical Trials Symposium is an event organized by Avantyo Institute of Clinical Research - www.avantyo.com