Vitaliy Koikov

7 Questions 5 Answers 0 Followers

Questions related from Vitaliy Koikov

How necessary and effective are single window mechanisms for authorizing clinical trials?

To issue a permit for clinical trials, it is necessary to obtain approval from a number of expert bodies - the Commission on Bioethics, the National Medicines Regulator ... often the applicant has...

10 August 2021 1,487 3 View

Is it possible to conduct clinical trials of a combination of unregistered drugs (clinical trials of the third phase)?

It is known that after drug registration, it is possible to conduct a clinical study of the combination of this drug with another registered drug (4th phase of an interventional clinical study)....

01 March 2020 9,798 4 View

Is it necessary to create a separate specialized expert organization for the expertise of the advanced therapy medicinal products?

In each country, usually approval for a clinical trial of a drug is issued by the national expert organization in the field of drug circulation (FDA, EMA, etc.) and the National Bioethics...

01 March 2020 1,448 0 View

How to interest and (or) force sponsors (pharmaceutical companies, etc.) to invest in conducting clinical trials in the country?

In our country, the volume of clinical trials is quite low. Despite the favorable conditions (shortening the time for obtaining approval and bureaucratic barriers), the sponsors (represented by...

25 February 2020 2,500 3 View

Is approval of a national expert organization (analogous to the FDA, EMA) required to obtain permission for clinical trial of a combination of drugs?

In our country, approval for a clinical trial of a drug is issued by the national expert organization in the field of drug circulation (which is an analogue of the FDA, EMA and issues approval for...

24 February 2020 1,615 7 View

Is it possible to implement master and doctoral programs in organizations that are not affiliated with the university, for example, in RC and RI?

Is it possible to implement master and doctoral programs for training research personnel in organizations that are not affiliated with the university, for example, in research centers and research...

23 February 2020 5,013 7 View

How correct is it to introduce at the national level a complete ban on participation in clinical trials of certain vulnerable research subjects?

How correct is it to introduce at the national level a complete ban on participation in clinical trials of certain categories of vulnerable research subjects? For which categories of vulnerable...

23 February 2020 2,097 3 View