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Conclusions of the roundtable “Development of clinical trials in Romania during the COVID-19 pandemic period’’ published in Viata Medicala magazine

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Conclusions of the roundtable “Development of clinical trials in Romania during the COVID-19 pandemic period’’ published in Viata Medicala magazine

Dr Cristina Florescu Moraid has written a brief overview of the discussions from the roundtable that she hosted on May 15, 2020. The event has focused on the changes and solutions to be taken into consideration to improve the clinical trials deployment in Romania, activity severely affected by the COVID-19 outbreak.

On the spot, there are the hot concerns that brought into discussion topics of high interest for the clinical trial industry, as the activity has decreased as a consequence of COVID-19 pandemic. The Romanian competent authorities - the National Agency for Drugs and Medical Devices Romania (NADMDR /ANMDMR) and the National Commission for Bioethics of Medicines and Medical Devices (NCBMMD/CNCMDM) - have shared the newest information also answering to questions regarding data verification, e-consent, emergency notifications, the VHP procedure (Voluntary Harmonization Procedure), Backlog, electronic submissions, the reorganization strategy of the National Agency for Drugs and Medical Devices Romania (NADMDR /ANMDMR).

The article emphasises that for the first time in the last years, we had the opportunity to have at the same table the entire leadership of the local regulatory authorities in clinical trials. Both NADMDR  and NCBMMD have answered to all the questions with a natural, positive, transparent attitude in front of the 60 participants from 35 CROs and pharmaceutical companies, representatives of the Romanian CROs Association (ACCSCR) and the Romanian Association of International Medicines Manufacturers (ARPIM).

We are pleased with the authorities’ promise to repeat this online event every three months, and AVANTYO Institute of Clinical Research will moderate the meeting as a neutral partner, always eager to help.

Please here the article from Viata Medicala Magazine in Romanian, and here the detailed 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 article has been published on 26th of June 2020, in Viata Medicala magazine no. 25, on pages 4-5, in the “Clinical Trials Pill / Pastila de studii Clinice” which is presented by AVANTYO Institute of Clinical Research and its invitees. See here the article in Romanian.

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The series of articles about clinical trials in Viata Medicala magazine in the section “Pastila de … studii clinice” / “The clinical trials … pill,” are part of our education and information activity in 2020. The articles are dedicated to physicians, especially those who have not yet come in contact with clinical trials.

Please check the News Section of our site to find the rest of the articles.

  1. We started a series of articles on clinical trials fundamentals & information in Viata Medicala magazine
  2. “The clinical trial, from A to Z”, an article in Viata Medicala magazine at the beginning of 2020
  3. About the actors of a clinical trial - Avantyo article in Viata Medicala Magazine
  4. “Patient-Centric Approach, the effective partnership” - Avantyo article in Viata Medicala magazine
  5. The Good Practice (GCP) and the responsibilities of pharma sponsors - Avantyo article in Viata Medicala magazine
  6. The Clinical Trials Monitor, an "orchestrator" – article in Viata Medicala Magazine
  7. The medical investigator and his team, an interview in Viata Medicala Magazine

You might also find them posted on our social media pages, on Facebook and Linkedin.

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Posted on: 29 June 2020