With support:
Ministry of Industry and Trade Eurasian Economic Union FSI «SID & GP» SKOPINFARM LTD.

RU EN
Main Expert activity Composition of the Expert Council


Composition of the Expert Council





Composition of the Expert Council


ABOUT THE WORK GROUPS

ABOUT THE WORK GROUPS



The working (thematic) group of the Expert Council of the Academy is a consultative group, which is created to solve individual tasks within the competence of the Expert Council.

The working (thematic) group shall be guided by the law of the Eurasian Economic Union (hereinafter referred to as the Union), the national legislation of the Union member states, as well as the Charter of the Academy.


The main functions of the working (thematic) group:


1
Analysis of international experience and experience in the application of regulation in the field of circulation of medicines of the states-members of the Union with regard to the topic under discussion
2
Consideration and preparation of proposals to improve approaches to the topic under discussion in the field of drug circulation
3
Review and preparation of draft recommendations on thematic issues in the field of drug circulation
4
Submission of proposals to the authorized bodies in the field of drug circulation of the member states of the Union in the form of draft recommendations corresponding to the goals and objectives of the thematic working groups
5
Consideration and preparation of proposals, development of measures to solve individual tasks set by the Expert Council of the Academy







WORKING GROUP ON THE TOPIC

WORKING GROUP ON THE TOPIC




Draft Annex No. 1 "Requirements for the production of sterile drugs



Target:


Prepare the Russian-language text of the new Annex 1 of the GMP (Annex 1 Manufacture of Sterile Medicinal Products) for further discussion with regulators of EEU countries

Objectives:


1
Adapt the text translation to the current EEU legislation and the conceptual apparatus used in the EEU countries
2
Identify and outline necessary changes in current legislation and/or documents that need to be developed to ensure compliance with the new Annex 1
3
Formulate questions to be discussed with the regulators of the EAEU countries in the subsequent discussion of the new draft Annex 1

Manager:





Nadezhda Valentinovna Arkhipova

Team:


Qualified experts with extensive knowledge and experience




WORKING GROUP ON THE TOPIC

WORKING GROUP ON THE TOPIC




"Scientific toxicological evaluation data to confirm the feasibility of combining products on the same production line"



Target:


Determination of approaches to the use of scientific data from toxicological assessment when deciding whether products can be combined on the same production line

Objectives:


1
Development of Methodological Guidelines for combining the production of drugs in common production facilities.

Areas of application of toxicological assessment:
🔹The relationship between the scientific data of toxicological assessment and cross-contamination risk assessment (significance of physical and chemical properties);
🔹Differences in approaches to toxicological assessment for drugs of different groups (chemical synthesis drugs, biotechnology drugs, organ preparations, blood products, vaccines, etc.)
2
Development of Annexes to methodological guidelines defining approaches to toxicological assessment for special cases of combined production
3
Developing a strategy for training industry professionals in "toxicology for good manufacturing practices"

Managers:





Tatyana Mikhailovna Vyazmina



Lyudmila Sergeyevna Guzevatykh

Team:


Qualified experts with extensive knowledge and experience




WORKING GROUP ON THE TOPIC

WORKING GROUP ON THE TOPIC




"Scientific and methodological approaches to quality control issues (microbiology)"



Target:


Promoting the development of the pharmaceutical industry of the EAEU countries by developing industry-specific guidance documents and ensuring a unified approach to good microbiological control practices in topical issues that require development of solutions

Objectives:


1
Analysis of international experience and experience of the pharmaceutical industry of the EAEU countries
2
Preparation and analysis of proposals on issues listed in the Work Plan of the Working Group
3
Preparation of draft scientific and methodological recommendations

Manager:





Asya Anatolievna Chernyavskaya

Team:


Qualified experts with extensive knowledge and experience




WORKING GROUP ON THE TOPIC

WORKING GROUP ON THE TOPIC




"Pharmaceutical Engineering"



Target:


Recovery of pharmaceutical engineering market and increasing the level of engineering services

Objectives:


1
Discussion and definition of transparent criteria for selecting companies - suppliers of engineering services
2
Preparation of draft documents in the field of pharmaceutical engineering based on global experience

Manager:





Igor Vsevolodovich Falkovsky

Team:


Qualified experts with extensive knowledge and experience




WORKING GROUP ON THE TOPIC

WORKING GROUP ON THE TOPIC




"Authorized Persons"



Target:


Increase the role of the Ombudsman, promote the professional development of Ombudsmen, strengthen communication in the field of OHR work between EAEU member states

Objectives:


Organization of a discussion club for AP, exchange of knowledge, experience, creation of a unified digital information platform for AP EAEU, implementation of best practices

Manager:





Olga Valentinovna Maklakova

The team:


Qualified experts with extensive knowledge and experience




WORKING GROUP ON THE TOPIC

WORKING GROUP ON THE TOPIC




"Rules for pharmaceutical inspections of the EAEU"



Target:


Assistance in the formation of a common market for medicines within the Eurasian Economic Union in terms of pharmaceutical inspections for compliance with the Good Manufacturing Practice Rules

Objectives:


1
Conducting a coordinated policy between the Member States of the Union in the field of drug circulation in terms of pharmaceutical inspections for compliance with the Good Manufacturing Practice Rules, taking into account the mutual interest in ensuring the safety, efficacy and quality of medicines for life and health of people
2
Holding thematic meetings and roundtables, exchange of knowledge and experience within the EAEU. Discussion of topical issues in the framework of these topics

Managers:





Elena Borisovna Lavnik



Madina Magometovna Sottaeva

Team:


Qualified experts with extensive knowledge and experience




WORKING GROUP ON THE TOPIC

WORKING GROUP ON THE TOPIC




Project of Part IV "Requirements for Production of High-Technology Drugs



Target:


Prepare the Russian-language text of the new Part IV GMP (Part IV GMP requirements for Advanced Therapy Medicinal Products) for further discussion with regulators of the EAEU countries

Objectives:


1
Adapt the text translation to the current EAEU legislation and the conceptual apparatus used in EA countries
2
Identify and outline the necessary changes in current law and/or documents that need to be developed to ensure compliance with the new Part IV
3
Formulate questions to be discussed with the regulators of the EAEU countries in the subsequent discussion of the draft of the new Part IV

Manager:





Natalya Vladimirovna Burlakina

Team:


Qualified experts with extensive knowledge and experience