The competent authorities have shared the newest information regarding conducting the research studies during the COVID-19 pandemic that affects the deployment of clinical trials in Romania, in front of over 60 participants from 35 CROs and pharmaceutical companies during the online roundtable organized by AVANTYO on May 15, 2020.
The event has brought the opportunity to discuss rules, innovative solutions and concepts and has brought many helpful answers about:
• Source Data Verification (SDV)
• E-consent / the electronic signature of the informed consent in clinical trials
• The documentation to be submitted for emergency notifications
• Clinical trials approval with VHP procedure (Voluntary Harmonisation Procedure)
• Backlog
• Electronic submissions of documents to the National Drug Agency and the Bioethics Commission
• The National Drug Agency reorganization strategy
Please find here the minute of the roundtable.
The roundtable “Development of clinical trials in Romania during the COVID 19 pandemic period" is the first online event organized by AVANTYO Institute of Clinical Research with the purpose to bring all together around one table the representatives of the competent authorities and the pharmaceutical companies & contract research organizations.
The roundtable has been host by Dr. Cristina Florescu Moraid, CEO of Avantyo Institute of Clinical Research and it has had as special guests:
Dr. Roxana Stroe - President of the National Agency for Drugs and Medical Devices Romania (ANMDMR) at that moment
Dr. Bujor Eugen Almasan – Vice-President of the National Agency for Drugs and Medical Devices Romania (ANMDMR) at that moment, now President of the agency
Dr. Mirela Vita – Lead of Clinical Trials Department, the Romanian National Agency for Drugs and Medical Devices Romania (ANMDMR)
Dr. Adina Pirvu - GCP Inspector at Romanian National Agency for Drugs and Medical Devices Romania (ANMDMR)
Prof. Dr Constantin Mircioiu – Secretary of the National Commission for Bioethics of Medicines and Medical Devices
Over 60 representatives from the clinical trials industry have attended: CROs and Pharma companies, the Romanian CRO Association (ACCSCR) and the Romanian Association of International Medicines Manufacturers (ARPIM). We might mention above attendants: Abbott, AbbVie, Amgen, Antibiotice, Arensia, AstraZeneca, Bristol Myers Squibb, Clintec International, Covance, Eli Lilly, Icon, IQVIA, Johnson & Johnson, Medone Research, Merck, Parexel, Premier Research Romania, PSI CRO, Roche and many other.
The event might be considered as a fruitful one. For the first time in the last years, we had the opportunity to see at the same table the entire leadership of the local regulatory authorities of clinical trials, ANMDMR and CNCMDM, answering all questions with a natural, positive, transparent and open attitude in front of the clinical trials industry.
As it has been agreed during the roundtable, another similar event regarding the deployment of the clinical trials in Romania will be organized by AVANTYO in three months.
