The Bucharest International Clinical Trials Symposium
Navigating the Labyrinth: Overcoming Complexity in Clinical Trials to Boost Site and Patient Involvement - 2025 - HYBRID EVENT

AGENDA

8th of November, 2024 – 1 day hybrid event Bucharest Onsite & Online Novotel Bucharest City Center

Stay Ahead of the Game: Transformation in Clinical Trials in the Age of Artificial Intelligence.



  • 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
    Dr. George Regio Tanaseanu, President of the Romanian Association of CROs (ACCSCR) Romania; Country Manager PSI CRO AG Romania
    Message from European CRO Federation
    Dr. Martine Dehlinger Kremer - President of European CRO Federation (EUCROF), VP Scientific Affairs, Pediatric SME, ICON Plc
    10:00 10:30
  • Romania and Europe's Strategic Role in Shaping Global Clinical Trials: Navigating Regulations and Opportunities
    Claudia Hesselmann, PhD - Founder and CEO ARENSIA Exploratory Medicine GmbH
    10:30 10:45
  • Status Quo and Future Prospects: National Strategy for Developing Clinical Trials in Romania
    Chair:
    Dr. George Regio Tanaseanu, President of the Romanian Association of CROs (ACCSCR) Romania; Country Manager PSI CRO AG Romania
    Speakers:
    Dr. Pharm. Razvan Mihai Prisada, President of the National Agency for Medicines and Medical Devices of Romania (NAMMDR)
    Prof. Dr. Doina Draganescu, President of the Ethics Commission, National Bioethics Commission of Medicines and Medical Devices, Romania, Dean Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Romania
    Assoc. Prof. Dr. Michael Schenker, President of Oncology Comission, Ministry of Health, The founder and manager of “Saint Nectarie” Oncology Center, Romania
    Dr. Frank Loeffler, Strategic Council of the Health Innovation Hub and Local Vice-president of the American Working Group (LAWG), Country Manager Roche Romania
    Univ. Assist. Dr. Teodor Cristian Blidaru, Project Manager of the Health Innovation Hub
    Prof. Dr. Constantin Volovat, “Grigore T Popa” University of Medicine and Pharmacy Iasi, Romania

    And other representatives of Romanian competent authorities.

    10:45 11:30
  • Coffee Break
    11:30 12:00
  • Pioneering the Future of Cancer Treatment: Breakthrough Insights and Innovations from CART Oncology Trials
    Prof. Dr. Ciprian Tomuleasa, PhD-Medfuture for Research Center for Advance Medicine, Cluj, Romania
    12:00 12:20
  • Unlocking the Potential of CART Trials in Romania: Overcoming Challenges and Seizing Growth Opportunities
    Alina Georgiana Axinte, Senior Manager Clinical Operations, Regional Clinical Operations (RCO) Division Bristol Myers Squibb
    12:20 12:40
  • EU Regulation CTR 536/2014 - Challenges faced at the end of the transition period (30 January 2025)
    Pierre Frederic Omnes, Executive Director at TransPerfect Life Sciences
    12:40 13:00
  • Lunch
    13:00 14:00
  • Building Bridges: Investigator's Insights on Successful Collaborations with Sponsors, CROs, Hospital Environment, Regulatory Bodies, and Patients
    Prof. Dr. Anca Streinu Cercel, Prof. Dr. Matei Bals ”National Institute of Infectious Diseases“, «Carol Davila» Medicine and Pharmacy University, Bucharest, Romania
    14:00 14:20
  • Decentralized Clinical Trials: Overcoming Challenges and Embracing Opportunities in Supporting Investigators and Patients
    Dr.Cristina Florescu Moraid, CEO Camina Medical Experts
    14:20 14:40
  • Initial learnings on patient centricity from RADIAL, a pan-European, decentralised and hybrid proof-of-concept trial
    Assistant Prof.Bart Lagerwaard, University Medical Center Utrecht
    14:40 15:00
  • Coffee Break
    15:00 15:30
  • How are digital technologies integrated into clinical trials platforms?
    Florin Petrutiu, CIO/CISOCIO/CISO, CNS Healthcare, USA
    15:30 16:00
  • Revolutionizing Drug Development: AI - a Game Changer in Clinical Research for Contract Research Organization
    Alexandre Malouvier, PhD, Senior Director Scientific Affairs & Digital Innovation, Clinical Development & Commercial Solutions, ICON Commercialisation & Outcomes Services, France
    16:00 16:30
  • AI in Medical Writing: Enhancing Quality and Reducing Time
    Octav Andronic, Assistant Professor - General Surgery, Coordinator BigData Analysis Department – CieH Carol Davila University of Medicine and Pharmacy, Bucharest
    16:30 17:00
  • Patient-Centric Approaches: Enhancing Engagement and Retention
    Chair:
    Rozalina Lapadatu, President of Autoimmune Disease Patients Association, Romania
    Speakers:
    Alina Comanescu, Founder of Community Health Association, Romania
    Marinela Debu, President of Hepatic Disease Patient Association, Romania
    Radu Ganescu, President of the Coalition of Organizations of Patients with Chronic Diseases (COPAC) Romania
    17:00 17:30
  • Conclusions
    Dr. Cristina Florescu Moraid, Organizer, President of Clinical Trials Symposium (Romania) ; CEO Avantyo Institute of Clinical Research
    Dr. George Regio Tanaseanu, President of the Romanian Association of CROs (ACCSCR) Romania; Country Manager PSI CRO AG Romania
    17:30 17:45
  • 17:45 18:30


Register now

SPEAKERS

Dr. Martine Dehlinger Kremer Dr. Martine Dehlinger Kremer President of European CRO Federation (EUCROF);
VP Scientific Affairs, Pediatric SME, ICON Plc
Dr. Claudia Hesselmann, PhD Dr. Claudia Hesselmann, PhD Founder & CEO | ARENSIA Exploratory Medicine GmbH
Dr. George Regio Tanaseanu Dr. George Regio Tanaseanu President of the Romanian Association of CROs (ACCSCR) Romania
Country Manager PSI CRO AG Romania
Dr. Pharm. Razvan Mihai Prisada Dr. Pharm. Razvan Mihai Prisada President of the National Agency for Medicines and Medical Devices of Romania (NAMMDR)
Univ. Assist. Dr. Teodor Cristian Blidaru Univ. Assist. Dr. Teodor Cristian Blidaru Project Manager of the Health Innovation Hub
Prof. Dr. Constantin Volovat Prof. Dr. Constantin Volovat “Grigore T Popa” University of Medicine and Pharmacy Iasi, Romania
Florin M. Petrutiu, MIT, CISSP Florin M. Petrutiu, MIT, CISSP CIO/CISOCIO/CISO, CNS Healthcare, USA
Prof. Ciprian Tomuleasa, MD, PhD Prof. Ciprian Tomuleasa, MD, PhD Research Professor at the Medfuture Research Center for Advanced Medicine
Alina Georgiana Axinte Alina Georgiana Axinte Senior Manager Clinical Operations, Regional Clinical Operations (RCO) Division Bristol Myers Squibb
Pierre-Frédéric Omnes Pierre-Frédéric Omnes Executive Director at TransPerfect Life Sciences
Prof. Dr. Anca Streinu-Cercel, MD PhD Prof. Dr. Anca Streinu-Cercel, MD PhD Professor Infectious Diseases
Bart Lagerwaard, PhD Bart Lagerwaard, PhD University Medical Center Utrecht
Dr. Frank Loeffler Dr. Frank Loeffler Strategic Council of the Health Innovation Hub and Vice-president of the Local American Working Group (LAWG), Country Manager Roche Romania
Dr. Cristina Florescu Moraid, MSc, EuSpLM Dr. Cristina Florescu Moraid, MSc, EuSpLM President of Clinical Trials Symposium
CEO AVANTYO Institute of Clinical Research
Alexandre Malouvier, PhD Alexandre Malouvier, PhD Senior Director Scientific Affairs & Digital Innovation, Clinical Development & Commercial Solutions, ICON Commercialisation & Outcomes Services, France
Octav Andronic Octav Andronic Assistant Professor - General Surgery, Coordinator BigData Analysis Department – CieH Carol Davila University of Medicine and Pharmacy, Bucharest
Prof. Dr. Doina Draganescu Prof. Dr. Doina Draganescu President of the Ethics Commission, National Bioethics Commission of Medicines and Medical Devices, Romania, Dean Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Romania
Emmanuel Walckenaer Emmanuel Walckenaer CEO Yseop
Rozalina Lapadatu Rozalina Lapadatu President of Autoimmune Disease Patients Association, Romania
Radu Ganescu Radu Ganescu The president of the Coalition of Organizations of Patients with Chronic Diseases (COPAC), Romania
Alina Comanescu Alina Comanescu Founder of Community Health Association, Romania
Assoc. Prof. Dr. Michael Schenker  Assoc. Prof. Dr. Michael Schenker  President of Oncology Comission, Ministry of Health, The founder and manager of “Saint Nectarie” Oncology Center, Romania
Marinela Debu Marinela Debu President of Hepatic Disease Patient Association, Romania
The á cappella quintet ANATOLY The á cappella quintet ANATOLY Opera House BRASOV

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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