18th of November, 2022 – 1 day hybrid event

“Reshaping the clinical research landscape as consequence of latest geopolitical challenges”
Wide opportunities for CEE to boost presence in international clinical trials

  • (7:45-8:00 Central Eastern Time CET)
    Welcome word
    08:45 09:00
  • (8:00-8:45 Central Eastern Time CET)
    Implementation of the new EU legislation for clinical trials (No 536/2014) in Romania: status quo and open actions
    09:00 09:45
  • (8:45-9:30 Central Eastern Time CET)
    The impact of the war in Ukraine on Clinical trials worldwide and in the CEE region
    09:45 10:30
  • (9:30-10:00 Central Eastern Time CET)
    Case study: strategies and mitigation in late phase clinical trials after pausing activities in Russia
    10:30 11:00
  • (10:00-10:30 Central Eastern Time CET)
    Case study: regulatory challenges and practical insight into the performance of an investigational site in Ukraine during war situation
    11:00 11:30
  • (10:30-10:45 CET)
    Coffee Break
    11:30 11:45
  • (10:45-11:15 Central Eastern Time CET)
    Panel Discussions: opportunities and challenges for Romania and its neighbors to boost contribution to international clinical trials in context of local geopolitics
    11:45 12:15
  • (11:15-11:30 Central Eastern Time CET)
    Decentralized and Hybrid Clinical Trials in EU: Regulatory environment and readiness among healthcare professionals and sponsors to implement these
    12:15 12:30
  • (11:30-12:30 CET)
    12:30 13:30
  • (12:30-13:00 Central Eastern Time CET)
    Digitization of clinical research in Romania: status-quo and case studies from real life experiences
    13:30 14:00
  • (13:00-14:00 Central Eastern Time CET)
    Innovative Trial Designs in early phase clinical development: operational challenges and best practices
    14:00 15:00
  • (14:00-14:20 CET)
    Coffee Break
    15:00 15:20
  • (14:20-13:00 Central Eastern Time CET)
    Learning and takes aways after 2 years of clinical research in pandemic environment: patient enrolment and retention, site performance and monitoring of late phase clinical trials in Romania
    15:20 16:00
  • (15:00-16:00 Central Eastern Time CET)
    Importance of patient´s voice in clinical research: view from patient associations
    16:00 17:00

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Clinical Trials Symposium is an event organized by Avantyo Institute of Clinical Research -