Clinical Trials Symposium, 2023

Clinical Trials Symposium, 2023

Organised by Camina Medical Experts with Avantyo Institute of Clinical Research

The Annual Clinical Trials Symposium, organised by Organised by Camina Medical Experts and Avantyo Institute of Clinical Research under the patronage of the European CRO Federation (EUCROF), the Romanian Association of Companies Performing Clinical Research (ACCSCR), and the Romanian Association of International Medicine Manufacturers (ARPIM), was held on 17th November in a hybrid format. Participants joined either in person at the Capital Plaza Hotel in Bucharest or virtually, creating a dynamic and inclusive environment for knowledge exchange.

Over the last fifteen years, the Clinical Trial Symposium has established itself as a unique multidisciplinary platform where representatives from academia, the pharmaceutical industry, regulatory agencies, investigation sites, and clinical research entities come together to discuss visionary advancements in clinical research. This year's theme, "Navigating Visionary Advancements in Clinical Research," encapsulated the forward-looking tone of the discussions.

The agenda featured key topics such as innovative study designs and emerging technologies to improve clinical trial performance, strategies to enhance patient recruitment and retention, challenges encountered during the implementation of EU Regulation 536/2014, feasibility and site selection considerations, and insights into the future of monitoring and auditing. Real-life case studies and presentations provided an invaluable basis for discussions while fostering in-person networking opportunities with decision-makers across the sector.

Dr Cristina Florescu Moraid, the organiser, and President of the Clinical Trials Symposium, set the stage with a welcoming address, alongside remarks from Assoc. Prof. Dr Diana Paun, Presidential Counsellor of the Romanian Administration, and Dr Martine Dehlinger Kremer, President of the European CRO Federation (EUCROF). Mr Mircea Geoana, Deputy Secretary-General of NATO, delivered a special message, emphasising Romania's potential to attract investments in medicine and technology due to its skilled workforce and strategic geopolitical position as a member of NATO and the EU.

The opening session, "Developing Clinical Trials in Romania: Challenges and Opportunities," featured distinguished panellists, including Prof. Dr George Burcea from the National Agency for Medicines and Medical Devices of Romania (NAMMDR), Dr Prada Speranta Petria from the Bioethics Commission of Medicines and Medical Devices, Assoc. Prof. Dr Michael Schenker, President of the Oncology Commission of the Ministry of Health, and Univ. Assist. Dr Teodor Cristian Blidaru, Project Manager of the Health Innovation Hub. Discussions underscored the importance of fostering collaboration and innovation in clinical trials within Romania. Efforts such as the establishment of the Health Innovation Hub earlier this year and workshops aimed at improving Romania’s competitive capacity for clinical studies highlighted the progress being made.

Following a networking break, Dr Goran Vesov from Crest Consulting LLC presented on the "Future of Monitoring and Auditing," offering innovative perspectives tailored to the post-pandemic reality. Theodora Savlovschi-Wicks, Vice President of Global Client Services at Proclinical Group, explored strategies for connecting candidates with employers in the clinical research market, providing actionable insights for professionals.

After lunch, a compelling session titled "Call to Action: Decoding the Challenges of Clinical Trials in Academic Hospitals" featured experts such as Prof. Dr Bogdan Ionel Tamba and Prof. Dr Costin Teodor Streba. The session emphasised the need for greater openness among hospital managers and attending physicians to embrace both public and private clinical trials, while also focusing on optimising financial returns from these studies.

Later panels addressed novel tools for improving patient recruitment and retention, with contributions from Gerard Barron of MAC United Kingdom, and explored the rise of remote clinicians and home visits in clinical research, as detailed by Kaylene Phua from IQVIA Research Nursing in the UK. Mrs Elena Petre provided insights into European regulatory requirements for genetically modified organisms (GMOs) in trials. Long-standing supporters of the symposium, including Rozalina Lapadatu and Alina Comanescu, highlighted the pivotal role of patient associations in enriching clinical research.

The day concluded on a high note with a performance titled "OPERAPOPROCK," featuring tenor Sorin Lupu alongside composer Bela Andrasi and singer Camelia Florescu. This artistic addition brought a celebratory close to an event that continues to shape the future of clinical trials through collaboration, innovation, and inclusivity.