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  • Ethics Commission

Ethics Commission

Руководители

Апрышкина Анна Владимировна
Апрышкина Анна Владимировна
руководитель отдела
отдел организационно-методического сопровождения научно-исследовательских программ
Дзивицкий Олег Алексеевич
врач-хирург
поликлиника "звёздная"
Лидирующие позиции по клиническим исследованиям в Северо-Западном регионе
56 постоянных <br>спонсоров
56 постоянных
спонсоров
Лидирующие позиции по клиническим исследованиям в Северо-Западном регионе
12 врачей - <br>лидеров мнения
12 врачей -
лидеров мнения
Профессиональный уровень исследователей и опыт работы в клинических исследованиях более 10 лет
12 главных <br>исследователей
12 главных
исследователей
«Клиника передовых научных исследований», Журнал «Город 812», 2017 год
«Клиника передовых научных исследований»
«Клиника передовых научных исследований»

The Ethics Commission was created at the R&D Center "Eco-Security" to consider ethical aspects to conduct bio-medical clinical (pre-clinical) trials (investigations) of medicinal drugs, technologies, materials and medical products, to review clinical study programs and mechanisms to protect human rights and security, as well as protection of rights and interests of investigators.

The Ethics Commission addresses issues as follow: 

  • independent expertize of investigation documents as per Standard Operating Procedures; independent and unbiased safety assessment of investigation and compliance with ethical norms, rights and health of study subjects both on the design stage and the stage to conduct clinical trials of non-authorized medicinal products (Phase I and bio-equivalence) and post-authorization studies (Phases II – IV); 
  • evaluation of compliance of study management (design, randomization, etc.), qualification of investigators and technology of Eco-Security R&D Center LLC with the Good Clinical Practice (GCP);
  • Monitoring of compliance with international and national ethic norms for study management.

The Ethics Commission assesses all biomedical researches involving humans as subjects.

The Ethics Commission is a public and autonomous body, not affiliated with the investigator or customer. It is responsible to ensure compliance with standards of ethics and interests of subjects involved in clinical trials and researches of medicinal drugs and diagnostic methods at the Eco-Security R&D Center LLC. To run its functions and succeed, the Ethics Commission communicates with the Council of Ethics at the Ministry of Health. The Ethics Commission acts in compliance with the Regulation on the Ethics Commission, applicable legislation of RF and International Law.

The Ethics Commission is remunerated for its services as per the price list specifying the cost of measures to consider submittal (the package of documents) and to assess Phase I-IV clinical studies, bio-equivalence studies as well as biomedical researches and thesis researches where the decision of the Ethics Commission taken upon the submittal consideration is not affected by the payment for services.

The Ethics Commission is a public body. The information about its members, business hours, decisions taken relating to the Ethics Commission is not confidential.

Chairman: Dzivitskiy Oleg

Secretary: Apryshkina Anna 

E-mail: lec@ecоsafety.ru,
Tel. (812) 500-52-03, ext. 5035

 

 

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