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NEXT CRA Course: Sept. 17-18, 2020 NEXT GCP Training: Sept. 29, 2020

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CRA Training for Advanced Level
11 SEP 2020
CRA Training for Advanced Level

We announce our Clinical Research Associate (CRA) Training for Advanced on September 17-18, 2020! This is the second module of the Training Program for CRA which is organized by AVANTYO Institute of Clinical Research for monitors. The participants who have already attended the CRA Training for Entry Level (module 1) organized by AVANTYO, will benefit from a 15% discount to the CRA Trai...

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Enrollment in a clinical trial: informing potential patients | Article in Viata Medicala
01 SEP 2020
Enrollment in a clinical trial: informing potential patients | Article in Viata Medicala

The clinical trials are part of medical research and, theoretically, any person can participate in a clinical trial, as a healthy volunteer or in a project focused on a specific pathology or therapeutically indication. Anyone could receive information about a certain clinical trial or about an option of therapy or a molecule under research. But what the Romanian Law says about informing the pat...

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Interactive GCP Virtual Training | August 25 / September 29, 2020
13 AUG 2020
Interactive GCP Virtual Training | August 25 / September 29, 2020

The course offers a refresh on GCP knowledge, to understand better the implications for the quality management system of the sponsor and its suitability for sites in practical terms! This one-day online training is the right choice for members of investigators team or site management professionals. The attendants might be professionals from clinical study teams or referrals,(i.e. clinician, ...

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GDPR for everyone. Applicability in clinical trials – an AVANTYO article in Viata Medicala magazine
04 AUG 2020
GDPR for everyone. Applicability in clinical trials – an AVANTYO article in Viata Medicala magazine

In 2018, the General Data Protection Regulation (GDPR) 2016/679, became applicable and brought new rules to companies to adopt. Due to the large volume of personal data, the compliance with GDPR is important for sponsors, CROs, investigators and sites. What is the GDPR and the personal data, which are the five simple rules for complying with the GDPR, what is the European Code of Conduct in Cli...

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Regular meeting with the competent authorities about clinical trials development in Romania | August 7, 2020
23 JUL 2020
Regular meeting with the competent authorities about clinical trials development in Romania | August 7, 2020

The clinical trials development in Romania is still affected by the COVID-19 outbreak and by the backlog that has to be solved with new solutions to accelerate the studies approval. During the online roundtable organized by AVANTYO on the 7th of August, 2020, at 13:00, the competent authorities will disclose new information on this matter. With the series of regular meetings with the regulatory...

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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
29 JUN 2020
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 ...

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Minute of the roundtable “Development of clinical trials in Romania during the COVID-19 pandemic period’’
03 JUN 2020
Minute of the roundtable “Development of clinical trials in Romania during the COVID-19 pandemic period’’

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, innovat...

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The medical investigator and his team, an interview in Viata Medicala Magazine
26 MAY 2020
The medical investigator and his team, an interview in Viata Medicala Magazine

Dr. Cristina Florescu Moraid is interviewing Dr. Andreea Cristina Dumitriu, Country Lead at Premiere Research Romania, about the importance of the clinical research investigator and his team, pointing on the crucial roles in developing a drug of this clinician who knows very well the criteria for enrolling a certain type of patient and who rigorously selects the right people for a clinical researc...

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Dr. Eugen Bujor Almasan is the new interim president of Competent Authority (NAMMDR)
22 MAY 2020
Dr. Eugen Bujor Almasan is the new interim president of Competent Authority (NAMMDR)

The new interim president of NAMMDR was appointed by the Ministry of Health on 20th of May 2020, after being a vice-president for a few months and personal adviser to a health secretary of state in 2019. Dr. Almasan has also occupied top positions in the industry of clinical research, as IQVIA director and first president of the Romanian CROs’ Association (ACCSCR). In 2020, the president ...

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Announcement of the online roundtable ``Development of clinical trials in Romania during the COVID 19 pandemic period``
11 MAY 2020
Announcement of the online roundtable ``Development of clinical trials in Romania during the COVID 19 pandemic period``

The newest information regarding conducting the research studies during the COVID-19 pandemic that affects the deployment of clinical trials in Romania will be shared by Romanian competent authorities to pharma companies and CROs during the online roundtable organized by Avantyo on Friday, May 15, 2020, at 12:00 P.M. The outbreak of COVID‑19 has affected tremendously the clinical trials indus...

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AVANTYO moves online!
08 MAY 2020
AVANTYO moves online!

AVANTYO Institute of Clinical Research will be starting soon online training, conferencing, and events as a response to the COVID-19 outbreak. The COVID-19 pandemic has rapidly evolved worldwide with major impacts on social life, healthcare systems, and the economy. As a response to this challenge and to keep our subscribers, participants and trainees connected and informed about the latest ...

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The Clinical Trials Monitor, an ``orchestrator`` –  article in Viata Medicala Magazine
04 MAY 2020
The Clinical Trials Monitor, an ``orchestrator`` – article in Viata Medicala Magazine

Dr Cristina Florescu Moraid - AVANTYO CEO, talks about the complexity of knowledge and responsibilities that make the monitor look like an orchestrator who puts the actors of the clinical trial to “sing” for the best “music”. She also points out that this speciality is almost “unknown” to medical science graduates even if clinical trials and monitoring are very ...

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The Good Clinical Practice (GCP) and the responsibilities of  pharma sponsors  - Avantyo article in Viata Medicala magazine
06 APR 2020
The Good Clinical Practice (GCP) and the responsibilities of pharma sponsors - Avantyo article in Viata Medicala magazine

In our fifth article, Dr Cristina Florescu Moraid presents the history of GCP - the code for clinical trials, which are the pharma sponsors’ responsibilities according to these guidelines and the latest guidance to conduct clinical trials during the COVID 19 pandemic issued by EMA and FDA, the regulatory authorities in the US and Europe. After the medical world has been shaken by tragic e...

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Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic
23 MAR 2020
Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic

Update 30.03.2020 | The European Commission, the European Medicines Agency (EMA) and national Heads of Medicines Agencies (HMA) have published new recommendations on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic. The impact of the pandemic on European health systems and more broadly on society will make it necessary for sponsors to ...

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First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development
19 MAR 2020
First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development

The meeting was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), co-chairs the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). The goal of the meeting was to encourage the exchange of information about global efforts to find and develop new vaccines against COVID-19. On March 18, 2020, the first global regulat...

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“Patient Centric Approach, the effective partnership” - Avantyo article in Viata Medicala magazine
06 MAR 2020
“Patient Centric Approach, the effective partnership” - Avantyo article in Viata Medicala magazine

About patient involvement in drug development, the new “direct to patient” DTP model improving patients' recruitment and retention, about “Trials@Home Consortium”, the INNOVATIVE MEDICINES INITIATIVE platform (IMI) dedicated to accelerate the access of patient to novel medication and many other interesting subjects in our last article from Viata Medicala Magazine. Th...

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About the actors of a clinical trial - Avantyo article in Viata Medicala Magazine
13 FEB 2020
About the actors of a clinical trial - Avantyo article in Viata Medicala Magazine

In the third issue of the "Clinical Study Pill" / “Pastila de Studii Clinice” section from Viata Medicala Magazine, we wrote about the clinical trials professionals who perform their entire activity during the research project around the patient to ensure that any newly invented medicine is safe for the patient and works for his benefit to improve the quality of life. Thes...

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Open registrations for Clinical Research Associate (CRA) Training for Entry Level!
08 FEB 2020
Open registrations for Clinical Research Associate (CRA) Training for Entry Level!

We proudly announce our first training on the clinical research education scene. We have started our series of courses with a training for those who are at the core of the study research projects, the people monitoring the activities in terms of compliance with protocols & regulations, and who are also the liaison between many of actors such as sponsor, investigating doctors and other vendo...

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“The clinical trial, from A to Z”, an article in Viata Medicala magazine at the beginning of 2020
24 JAN 2020
“The clinical trial, from A to Z”, an article in Viata Medicala magazine at the beginning of 2020

As previously promised, we continue to "administer" clinical trial pills, by bringing to the attention of Viata Medicala magazine's readers, valuable information about the clinical trial phases. The process of developing a new medicine goes through all the four phases along several years, sometimes the development of a medicine lasting more than ten years. Find more in our arti...

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EUCROF 5th International Conference on Clinical Research
17 JAN 2020
EUCROF 5th International Conference on Clinical Research

On 10 & 11 February 2020, in Amsterdam, the European Contract Research Organizations Federation – EUCROF organizes its conference and proposes the participants to discuss and scrutinize “Science, Technology and Regulations Coming Together for Better Patients’ Health”. “The primary objective of the Conference is to ensure that all attendees are brought fully up ...

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Elections at  UMF
16 JAN 2020
Elections at UMF

Professors Doctors Adrian Streinu-Cercel, Cătălina Poiană and Viorel Jinga are the candidates for the position of rector at Bucharest "Carol Davila" University of Medicine and Pharmacy - UMFCD. The first round of elections will take place on February 10th and the second on February 17 2020. Dr Adrian Streinu – Cercel, PhD, is an infectious diseases senior physician, manag...

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New Interim President of National Agency for Medicines and Medical Devices (ANMDM)
14 JAN 2020
New Interim President of National Agency for Medicines and Medical Devices (ANMDM)

On January 14, 2020, Roxana Stroe was appointed as interim president of the ANMDM by Victor Costache, Minister of Health. Dr Roxana Stroe is a senior physician specialized in Clinical Pharmacology and works at ANMDM since the end of 2010. Dr Stroe is currently the coordinator of the Pharmacovigilance and Risk Management Directorate of the institution. Since 2014, Dr Stroe has been a member of t...

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Interim president of ANMDMR dismissed
09 JAN 2020
Interim president of ANMDMR dismissed

Official news: the Ministry of Health has confirmed that the dismissal order for Marius Daniel Șișu was signed today by Victor Costache, the Minister of Health. Marius Daniel Șișu was appointed in February 2019 by the former Government as interim president of the Romanian National Agency of Drugs and Medical Devices - ANMDMR, although he dropped admission to the Faculty of Pharmacy in July 201...

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We started a series of articles on clinical trials fundamentals & information in Viata Medicala magazine
31 DEC 2019
We started a series of articles on clinical trials fundamentals & information in Viata Medicala magazine

As a preamble to our information activity in 2020, at the end of this year, we have started a series of articles in Viata Medicala magazine, dedicated to physicians, especially those who have not yet come in contact with clinical trials. The first of these articles appeared in the 2019 last issue of the magazine, no. 52, on page 14 and was written by Dr Cristina Florescu Moraid, Avantyo CEO. We...

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About new geographical distribution of clinical trials at the 9th Regular Conference of CRA ACADEMY
15 DEC 2019
About new geographical distribution of clinical trials at the 9th Regular Conference of CRA ACADEMY

Dr. Cristina Florescu Moraid, CEO of AVANTYO Institute of Clinical Research has been invited to open the works of the 9th Regular Conference “Partnership in Clinical Trials”, held in Belgrade, on December 13, 2019 with the presentation "Clinical Trials - Perpetually shifting geographical footprints". The event was organized by CRA Academy from Belgrade. The geographica...

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First Avantyo roundtable has gathered the executives of the ACCSCR members
03 DEC 2019
First Avantyo roundtable has gathered the executives of the ACCSCR members

On November 29, 2019, we have organized our first roundtable hosted by Avantyo's CEO, Dr Cristina Florescu Moraid. The event has focused 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 t...

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Two new DIA conferences, held this December in Amsterdam
21 NOV 2019
Two new DIA conferences, held this December in Amsterdam

The Drug Information Association chose Amsterdam for its two European conferences regarding implementing the new EU clinical trials regulation and complying with global disclosure and transparency requirements for medicinal products and medical devices. Both events are held this December at the Mercure Hotel Amsterdam City. Clinical Trial Regulation Conference The conference will focus on ...

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2019 SCRS Central & Eastern European Ambassador Symposium held in Warsaw, Poland
18 NOV 2019
2019 SCRS Central & Eastern European Ambassador Symposium held in Warsaw, Poland

Poland, wherein 2019 the government invested 100 million PLN to set up the Polish Medical Research Agency dedicated to increase the level of education within the medical corps on the development of clinical trials and to create a network of specialized centres, has been chosen as a host for the 2019 SCRS CEE Ambassador Symposium. ” The Polish Medical Research Agency is not the same i...

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The leading positions in the Romanian National Drug Agency (ANMDMR) blocked by the Ministry of Health
14 NOV 2019
The leading positions in the Romanian National Drug Agency (ANMDMR) blocked by the Ministry of Health

The competition to recruit the president and vice president of the Romanian National Drug Agency (ANMDMR) scheduled for November 6, 2019 has been postponed for subsequent dates. The information is available from an announcement of the Ministry of Health General Directorate of Legal and Human Resources, document consulted by 360medical.ro. The contest scheduled on November 6th at 11:00 am, wa...

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DIA organizes the Clinical Trial Regulation Information Day for CEE Countries, in Bucharest
14 OCT 2019
DIA organizes the Clinical Trial Regulation Information Day for CEE Countries, in Bucharest

Are Central and Eastern European Union member states ready to implement the new EU Clinical Trial Regulation (536/2014)? This information day provides a platform for discussion about the status of the implementation and further compliance with the new Regulation, as well as the associated legislation in the region. The event is organized by the Drug Information Association (DIA) and is held on ...

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Clinical Trials Symposium 2019
11 OCT 2019
Clinical Trials Symposium 2019

Welcome to the Clinical Trials Symposium! We are pleased to announce that our 2019 edition has started, under the patronage of the European CRO Federation and Romanian Association of CROs. We have highlighted so far the importance of developing clinical trials in the medical community, an overview of the real benefit for patients and physicians and the busy activity of the European CRO Federati...

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