Roundtables
Better informed with fresh ideas
The concept of Roundtables shall offer a platform for specialists at executive level from the various segments of clinical research arena to meet and vividly network over a concentrated session of 3 to 4 hours, across lunch or dinner, to informally and openly share their challenges and solutions in the given segment. Only one topic shall be addressed during the Roundtable, under the moderation of one senior expert in the given area.
The participants shall leave the event better informed and with fresh ideas to implement for their organization/specific needs. The participation at Roundtables is by invitation only and free of charge.
The Roundtables shall address hot topics in the clinical research field (e.g. regulatory, operational and logistics aspects, patient enrollment and patient-centricity etc.), as well as „on-demand“ educational topics (e.g. increasing awareness re-implementation of new legislative aspects at national/international level, new technologies applicable to clinical research etc.), sponsored by the various players in the industry.
International Clinical Trials Day
Next date: 19.05.2023
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Legislative status and clarifications regarding the submission dossier as well as the duration of the approval of clinical trials in Romania in 2022, considering the transition from the European Directive to the new Clinical Trials regulation EU No. 536/2014
Last date: May 10th, 2022
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European Regulation Day
Last date: 20th May 2021
Harmonized Clinical Trials authorisation by EU member states. Status Quo Romania and CEE countries.
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Regular meeting with the competent authorities about clinical trials development in Romania
Register for free to the regular online roundtable held on August 5, 2020, and find out directly from the competent Romanian authorities, the National Agency for Medicines and Medical Devices in Romania (NADMDR) and the National Commission for Bioethics of Medicines and Medical Devices the newest information on the latest regulatory issues regarding conducting the clinical trials in Romania during this period.
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Meeting with the competent authorities about clinical trials development in Romania
Last date: 25 February 2021
Register for free to the online roundtable held on Friday, February 25, 2021, and find out directly from the competent Romanian authorities, the National Agency for Medicines and Medical Devices in Romania (NADMDR) and the National Commission for Bioethics of Medicines and Medical Devices the newest information on the latest regulatory issues regarding conducting the clinical trials in Romania during this period.
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Online roundtable ``Development of clinical trials in Romania during the COVID 19 pandemic period``
Last date: May 15, 2020
Register for free to the online roundtable held on Friday, May 15, 2020, and find out directly from the competent Romanian authorities, the National Agency for Medicines and Medical Devices in Romania (ANMDMR) and the National Commission for Bioethics of Medicines and Medical Devices the newest information regarding conducting the research studies during the COVID-19 pandemic that affects the deployment of clinical trials in Romania.
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What are the educational needs for clinical trial professionals in order to better respond to 2020 challenges?
Last date:
The roundtable will focus on educational needs of clinical research professionals in 2020, in the context of the expected changes in the process of submission & approval of clinical trials, due to the new Clinical Trial Regulation (EU 536/2014) and of the new organizing rules of the Romanian National Agency for Drugs and Medical Devices – ANMDMR based on the 134/2019 law.
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