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Minute of the Regular meeting with the authorities about clinical trials development in Romania - August 7, 2020

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Minute of the Regular meeting with the authorities about clinical trials development in Romania - August 7, 2020

The second AVANTYO online meeting with 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 (NCBMMD), was held on August 7, 2020, and gathered over 95 virtual attendees from the clinical trials industry and patients representatives.

The “Regular meeting with the competent authorities about clinical trials development in Romania – August 7, 2020” was organized by AVANTYO Institute of Clinical Research with the purpose to facilitate new clarifications regarding a better development of the clinical trials in Romania.

The clinical trials development in Romania is still affected by the COVID-19 outbreak and by the backlog that has to be solved by finding new solutions to accelerate the studies approval.

Therefore, this event has brought together around the same roundtable representatives of the authorities and pharmaceutical companies & contract research organizations to find new ways of improvement and move forward.

Dr Cristina Florescu Moraid, CEO and Co-founder of AVANTYO Institute of Clinical Research has been moderating the meeting and put questions collected from the industry representatives, while the special guests have been invited to answer: on behalf NAMDMR: Dr Bujor Eugen Almasan – President, Dr Mirela Vita - Lead of Clinical Trials Department, Dr Adina Pirvu - GCP Inspector, and the NCBMMD has been represented by Prof Dr Constantin Mircioiu – Secretary. Prof. Dr Viorel Jinga, the rector of the University of Medicine and Pharmacy “Carol Davila” - Bucharest and Mrs Marinela Debu from the patient Association with Hepatics Diseases have been invited to add their perspective.

Topics of the meeting:

  • Remote Source Data Verification (SDV)
  • The Investigator’s brochure
  • Authorizing the amendments to the clinical trial application
  • Electronic submissions of documents to the National Drug Agency and the Bioethics Commission
  • Implementation of Clinical trials - Regulation EU No 536/2014
  • Methods for recruitment of patients in clinical trials
  • Accelerated approval of CT in Romania
  • The National Drug Agency reorganization status
  • Backlog status

These hot issues have been discussed in front of over 95 professionals and actors from the clinical trials industry: competent authorities, clinical research and regulatory affairs managers for clinical trials from CRO and Pharma companies, medical investigators, the Romanian CRO Association (ACCSCR), the Romanian Association of International Medicines Manufacturers (ARPIM).

We might mention above attendees from the industry: 3S Pharma, Accovion, AbbVie, Advance Clinical, Amgen, Arensia, AstraZeneca, Byer, Bristol Myers Squibb, Camina Medical, CIDP Biotechnology, Clintec International, Comac, Craiova Cardiology Center, CTG, Easthorn, Eli Lilly, Filip & Company, HT Research, Icon, IQVIA, Janssen / Johnson & Johnson, Linical, MDX Research, Medone Research, Merck, MSD. Novartis, Novo Nordisk, Opera CRO, Parexel, Pharm-Olam, PPDI, PRA, Precision for Medicine, Premier Research Romania, PSI CRO, Roche, Sanofi, Servier Pharma, Sinteract, Terapia, and other.

Please find here the Minute of the Meeting and the page of the event: https://www.avantyo.com/roundtables/regular-meeting-with-authorities-aug2020]

Posted on: 30 September 2020