The Annual Clinical Trials Symposium, organized by 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), took place this year on November 17th in a hybrid format, both person at Capital Plaza Hotel in Bucharest and online.

For the latest 15 years, The Clinical Trial Symposium is that unique multidisciplinary platform for the clinical trials community where meet representatives from academia, the pharmaceutical industry, regulatory agencies, investigation sites, and clinical research entities to confer on visionary advancements in clinical research.

The agenda for this year addressed topics related to:

• innovative study designs and new technologies supporting clinical trial performance

• novel tools and strategies to enhance patient recruitment & retention

• feasibilities and site selection strategies

• challenges and lesson learned after implementation of EU Regulation 536/2014

• future of monitoring and auditing

and other relevant aspects that play a key role in the safe and efficient conduct of clinical trials.

The symposium facilitated in-person networking opportunities with decision-makers while focusing on real-life case studies and insightful presentations.

This year's theme, "Navigating Visionary Advancements in Clinical Research," set the tone for the event. The program commenced with welcoming addresses delivered by Dr. Cristina Florescu Moraid, the organizer and President of the Clinical Trials Symposium (Romania), Assoc. Prof. Dr. Diana Paun, Presidential Counsellor of the Romanian Administration, Dr. Martine Dehlinger Kremer, President of the European CRO Federation (EUCROF), and included a message from Mr. Mircea Geoana, Deputy Secretary-General of NATO, who emphasized Romania's potential to attract new investments. With a talented workforce and a strategically advantageous geo-political location, Romania, as a member of the EU and NATO, is primed to evolve into a hub for groundbreaking developments in medicine and technology.

The symposium featured a diverse array of sessions, with the inaugural one focusing on "Developing Clinical Trials in Romania: Challenges and Opportunities." Our special guests at this panel were Prof. Dr. George Burcea from the National Agency for Medicines and Medical Devices of Romania (NAMMDR) Department of Clinical Studies, Dr. Pharm. Prada Speranta Petria from the Bioethics Commission of Medicines and Devices Medical, Attorney Ioana Popescu Bucharest Physicians College (CMMB), Bucharest, Assoc. Prof. Dr. Michael Schenker, President of Oncology Commission, Ministry of Health, The founder and manager of the "Saint Nectarie" Oncology Center and Univ. Assist. Dr. Teodor Cristian Blidaru, Project Manager of the Health Innovation Hub, provided valuable insights.

All panel participants emphasize the importance of collaborating on clinical studies' advancement in Romania. This commitment led to the establishment of the Health Innovation Hub earlier this year. To address this need, the Health Innovation Hub was established this year. Mr. Teodor Cristian Blidaru, the project manager, collaborated with the Ministry of Health, the National Agency for Medicines and Medical Devices of Romania (NAMMDR), G6UMF, and LAWG to organize the inaugural workshop titled "Romania: The Development of a Competitive Model for Clinical Studies." The overarching objective of this workshop was to enhance Romania's capacity for conducting clinical trials. This involved setting measurable performance and impact indicators within a comprehensive country dashboard or scorecard with annual and multi-annual targets, commencing with a baseline measurement in 2023.

In summary, the current scenario showcases commendable timelines for study approvals, effective collaboration among regulatory authorities, and a growing engagement of academia in clinical trials. The ultimate aim of the competent authorities is to re-establish Romania's prominence in the realm of clinical studies.

After the networking coffee break, the event continued with a session on the "Future of Monitoring and Auditing" delivered by Dr. Goran Vesov, MD, representing Crest Consulting LLC in North Macedonia. The presentation underscored innovative monitoring and audit models specifically tailored to the current post-pandemic reality. The segment included a presentation titled "Connecting Candidates and Employers in the Present Clinical Research Market" by Theodora Savlovschi-Wicks, Vice President of Global Client Services for CROs at Proclinical Group. Mrs. Theodora Savlovschi-Wicks discussed strategies for candidates in clinical trials to capture the interest of employers, offering insights on dos and don'ts to secure success and employment in CRO/sponsor organizations.

Post-lunch, the program continued with a session titled "Call to Action: Decoding the Challenges of Clinical Trials in Academic Hospitals." The distinguished guests on this panel were MD Bitel Brandusa Permanent Representative of the UMF" Carol Davila" to the EU Brussels, Prof. Dr. Bogdan Ionel Tamba, MD, PhD, Head of department CEMEX, “Gr.T Popa” University of Medicine and Pharmacy from Iasi, Prof. Dr. Costin Teodor Streba, ProDean University of Medicine and Pharmacy, from Craiova, Prof. Dr. Oancea Cristian, Professor of Pulmonology, Vice-Rector for Scientific Research University of Medicine and Pharmacy ”Victor Babes” from Timisoara, Prof. Dr. Aysel Simin Florescu, General Manager “Victor Babes” University Hospital from Bucharest, Dr. Adrian Gabriel Marinescu, MD, Medical Director “Matei Bals” Institute of Infectious Disease, from Bucharest and Prof. Dr. Anca Colita, General Manager “Fundeni Clinical Institute”, from Bucharest.

The panel deliberated on the participation of academia in clinical trials, the evident enthusiasm among hospital managers to engage in such trials, and the imperative for greater openness among both management and attending physicians. This openness extends to approving the execution of clinical trials in both public and private hospitals, with a simultaneous emphasis on enhancing the financial returns derived from clinical studies within each institution.

At the Annual Clinical Trials Symposium event held on November 17, Prof. Dr. Robert Ancuceanu addressed the challenges and opportunities in pediatric clinical trials. In the panel on novel tools and strategies to improve patient recruitment and retention, Gerard Barron, Interim Head of Clinical Operations at MAC United Kingdom, discussed Stakeholder Engagement in Clinical Trials. Additionally, Kaylene Phua, Associate Director at IQVIA Research Nursing and Phlebotomy Solutions, United Kingdom, explored The Rise of Remote Clinicians & Home Visits in Clinical Research.

Mrs. Elena Petre, Head of the Department at the National Agency for Environmental Protection, Romania, presented insights into European regulatory requirements concerning genetically modified organisms (GMOs) in clinical trials. Additionally, the significance of patients' voices in clinical research was highlighted through perspectives shared by long-time supporters of the symposium: Mrs. Rozalina Lapadatu, President of the Autoimmune Disease Patients Association, Romania; Mrs. Alina Comanescu, Founder of the Community Health Association, Romania; and Mrs. Marinela Debu, President of the Hepatic Disease Patient Association, Romania. These annual contributors emphasized the vital role patient associations play in supporting and enriching the field of clinical research.

Last but not least, this edition of Clinical Trials Symposium, reached its crescendo with a captivating artistic performance titled "OPERAPOPROCK." Special guests for this memorable moment included tenor Sorin Lupu, along with composer Bela Andrasi and singer Camelia Florescu, adding a sublime touch to the conclusion of this landmark event.