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Opening to accelerate the clinical trials approval

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Opening to accelerate the clinical trials approval

Viata Medicala magazine publishes an analysis of the panel discussion “Strategies to Speed-Up the Review Timelines by the National Agency For Drugs and Medical Devices in Romania (NADMDR)”, the first session of the Annual Clinical Trials Symposium held online on the 20th of November 2020.

This topic of high interest takes part of the event Agenda as a consequence of the fact that since 2008, our country participates in fewer and fewer clinical trials as a result of the long periods of approval from the competent authority, the National Agency for Medicines and Medical Devices of Romania (NAMMDR).

One of the principal causes of these delays is the chronic lack of staff within the Agency and lately the fact that it functions without applying the law 134 / August 2019 that rules its organization, the management of the authority changes very often, the communication and transparency with the industry and patients are in deficit. The agency representative has mentioned their effort to reduce the approval period for the COVID-19 clinical trials.

The industry expects NAMMDR to show readiness to accelerate the approval of clinical trials.

The author, Dr Mariana Minea, reviews of the statements made by the panellists - representatives of the NAMDMR, of the pharmacological companies and CROs, academia and a journalist. See the list of speakers and moderators on https://www.clinicaltrialsymposium.com/agenda.

We invite you to read the article in Romanian.

"Viata Medicala" magazine, has published the article in the 48th edition, page 12, under the section Medical Events, the 4th of December 2020.

Posted on: 04 December 2020