SPEAKERS 2022

Martha Reyes

Minister of Health of Nicaragua

Martha Reyes

Minister of Health of Nicaragua

PARTICIPATES

Plenary session 10:30

International cooperation on good practices under the current geopolitical conditions
Время: 10:30 — 11:50
Questions and topics for discussion
• Formation of new international alliances of countries not involved in sanctions wars
• International professional industry societies and associations as a GMP rules harmonisation tool
• Experience of international cooperation on regulatory matters
• Support mechanisms for evolving regulatory systems

Hireche Amel

Deputy Director of control and expertise at the National Agency for Pharmaceuticals of Algeria

Hireche Amel

Deputy Director of control and expertise at the National Agency for Pharmaceuticals of Algeria

PARTICIPATES

Plenary session 10:30

International cooperation on good practices under the current geopolitical conditions
Время: 10:30 — 11:50
Questions and topics for discussion
• Formation of new international alliances of countries not involved in sanctions wars
• International professional industry societies and associations as a GMP rules harmonisation tool
• Experience of international cooperation on regulatory matters
• Support mechanisms for evolving regulatory systems

Pravin Jagtap

Assistant Drugs Controller, Central Drugs Standard Control Organisation (CDSCO) of India

Pravin Jagtap

Assistant Drugs Controller, Central Drugs Standard Control Organisation (CDSCO) of India

PARTICIPATES

Plenary session 10:30

International cooperation on good practices under the current geopolitical conditions
Время: 10:30 — 11:50
Questions and topics for discussion
• Formation of new international alliances of countries not involved in sanctions wars
• International professional industry societies and associations as a GMP rules harmonisation tool
• Experience of international cooperation on regulatory matters
• Support mechanisms for evolving regulatory systems

Hamidreza Inanloo

Director, International Affairs Department, Iranian Food and Drug Administration

Hamidreza Inanloo

Director, International Affairs Department, Iranian Food and Drug Administration

PARTICIPATES

Plenary session 10:30

International cooperation on good practices under the current geopolitical conditions
Время: 10:30 — 11:50
Questions and topics for discussion
• Formation of new international alliances of countries not involved in sanctions wars
• International professional industry societies and associations as a GMP rules harmonisation tool
• Experience of international cooperation on regulatory matters
• Support mechanisms for evolving regulatory systems

Ashraf Hossain

Director, Directorate General of Drug Administration (DGDA), Bangladesh

Ashraf Hossain

Director, Directorate General of Drug Administration (DGDA), Bangladesh

PARTICIPATES

Plenary session 10:30

International cooperation on good practices under the current geopolitical conditions
Время: 10:30 — 11:50
Questions and topics for discussion
• Formation of new international alliances of countries not involved in sanctions wars
• International professional industry societies and associations as a GMP rules harmonisation tool
• Experience of international cooperation on regulatory matters
• Support mechanisms for evolving regulatory systems

Tania Zenaida Oviedo Latorre

Lead GMP Inspector, Directorate General of Medicines, Supplies and Drugs (DIGEMID) of Peru

Tania Zenaida Oviedo Latorre

Lead GMP Inspector, Directorate General of Medicines, Supplies and Drugs (DIGEMID) of Peru

PARTICIPATES

Plenary session 10:30

International cooperation on good practices under the current geopolitical conditions
Время: 10:30 — 11:50
Questions and topics for discussion
• Formation of new international alliances of countries not involved in sanctions wars
• International professional industry societies and associations as a GMP rules harmonisation tool
• Experience of international cooperation on regulatory matters
• Support mechanisms for evolving regulatory systems

Nani Handayani

Lead GMP Inspector, Indonesian Food and Drug Authority, Indonesia

Nani Handayani

Lead GMP Inspector, Indonesian Food and Drug Authority, Indonesia

PARTICIPATES

Plenary session 10:30

International cooperation on good practices under the current geopolitical conditions
Время: 10:30 — 11:50
Questions and topics for discussion
• Formation of new international alliances of countries not involved in sanctions wars
• International professional industry societies and associations as a GMP rules harmonisation tool
• Experience of international cooperation on regulatory matters
• Support mechanisms for evolving regulatory systems

Natalia Malykh

Vice President for Business Development, the Pharmasyntez Group of Companies

Natalia Malykh

Vice President for Business Development, the Pharmasyntez Group of Companies

PARTICIPATES

Plenary session 10:30

International cooperation on good practices under the current geopolitical conditions
Время: 10:30 — 11:50
Questions and topics for discussion
• Formation of new international alliances of countries not involved in sanctions wars
• International professional industry societies and associations as a GMP rules harmonisation tool
• Experience of international cooperation on regulatory matters
• Support mechanisms for evolving regulatory systems

Vladislav Shestakov

Director of the FSI «State Institute of Drugs and Good Practices», Russian Ministry of Industry and Trade

Vladislav Shestakov

Director of the FSI «State Institute of Drugs and Good Practices», Russian Ministry of Industry and Trade

Vladislav Shestakov (DOB: November 27, 1969, place of birth: Salekhard, Yamalo-Nenets Autonomous District, USSR) – Director of the FSI ‘State Institute of Drugs and God Practices’. Before the current appointment, Director Shestakov chaired the Pharmaceutical and Biotechnology Department of All-Russia Public Organization ‘Business Russia’. Honorary Chemist, certified GMP inspector and auditor, Director Shestakov is also Deputy Head of the State GMP Inspectorate and Head of Good Practices Committee for professional qualification of the National Pharmaceutical Chamber. Director Shestakov has been actively engaged in the public healthcare and pharmaceutical industry since 1997.

Biographic information

Mr. Shestakov was born in Salekhard on November 27, 1969. In 1987 he entered the Tyumen State Medical Institute, and continued education in 1989 in the Smolensk State Medical Academy. In 2005 he graduated from the State University of Management majoring in “State and municipal management”. Graduated from the Academy of Labor and Social Relations in 2008, majoring in “Business management”. In 2016 he received a diploma of advanced professional training at the Moscow Institute of Physics and Technology (MIPT) majoring in «Current good manufacturing practices of pharmaceutical production and quality control — theory and practice of GMP inspections / audit.» In early 2000 Mr. Shestakov was Deputy Director General of the Irbitsky Chemical Plant. In 2001 – as Vice President of the Russian Medical Production Association ‘RosMedProm’ – he initiated activities aimed at the low price pharmaceutical production and offered manufacturers a whole number of cost effective recommendations for their product portfolios. In 2002 he headed Sales Department of German company ChemoPharm’s office in Moscow. Worked as Deputy Director General in Makiz-Pharma Ltd. in 2004, and became Director General of the Skopin Pharmaceutical Plant in 2005. In 2007 held the position of Director for Government and Public Relations in NGO ‘Alliance of professional pharmaceutical organizations’. In 2008 he was offered the post of President at EpidBioMed corporation. In 2009 Mr. Shestakov managed Business Development Department in ‘BinnoPharm’ company. After he left the Usolye-Sibirskoye Chemical and Pharmaceutical Plant where he was Director General’s Adviser in 2011-2012, Mr. Shestakov took the position of NanoLek company’s first deputy Director General from 2012 through 2013. As of November 27, 2013 Mr. Shestakov was appointed as Director of the FSI ‘State Institute of Blood Substitutes and Medical Preparations’ (later renamed as State Institute of Drugs and Good Practices). As of 2003, he is a regular lecturer of professional development programs on managing commercial and government organizations, as well as specialized programs in pharmacy and pharmaceutical production. He is a certified a certified international GMP inspector of the World Health Organization.

Awards
  • Honorary Chemist of the Russian Federation
  • Letter of Appreciation ‘For Professional Excellence’ signed by the Russian Minister of Industry and Trade
  • Letter of Appreciation signed by the Deputy Health Minister of the Syrian Arab Republic «For Meritorious Contribution to Cooperation between Russia and Syria»

PARTICIPATES

Plenary session 10:30

International cooperation on good practices under the current geopolitical conditions
Время: 10:30 — 11:50
Questions and topics for discussion
• Formation of new international alliances of countries not involved in sanctions wars
• International professional industry societies and associations as a GMP rules harmonisation tool
• Experience of international cooperation on regulatory matters
• Support mechanisms for evolving regulatory systems

Irina Spichak

Executive Director, Eurasian Academy of Good Practices

Irina Spichak

Executive Director, Eurasian Academy of Good Practices

PARTICIPATES

An Open Mic on good practices

International alliances for good practices: Education, Regulation, Production
Время: 12:00 — 13:00

Natalia Chadova

Head of department for inspection of medicines and expertise, FSI «SID&GP» of the Ministry of Industry and Trade of Russia

Natalia Chadova

Head of department for inspection of medicines and expertise, FSI «SID&GP» of the Ministry of Industry and Trade of Russia

PARTICIPATES

An Open Mic on good practices

International alliances for good practices: Education, Regulation, Production
Время: 12:00 — 13:00

Madina Sottaeva

Deputy Head of department for inspection of medicines and expertise, FSI «SID&GP» of the Ministry of Industry and Trade of Russia

Madina Sottaeva

Deputy Head of department for inspection of medicines and expertise, FSI «SID&GP» of the Ministry of Industry and Trade of Russia

PARTICIPATES

An Open Mic on good practices

International alliances for good practices: Education, Regulation, Production
Время: 12:00 — 13:00

MORE

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Yelena Lavnik

Head of the Pharmaceutical Inspection Division, Head Office for Quality Control of Medical Care, Medical Expertise, Appeals of Citizens and Legal Entities, Ministry of Health, Belarus

Yelena Lavnik

Head of the Pharmaceutical Inspection Division, Head Office for Quality Control of Medical Care, Medical Expertise, Appeals of Citizens and Legal Entities, Ministry of Health, Belarus

PARTICIPATES

An Open Mic on good practices

International alliances for good practices: Education, Regulation, Production
Время: 12:00 — 13:00

MORE

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Lilia Titova

Executive Director of the Union of Professional Pharmaceutical Organisations

Lilia Titova

Executive Director of the Union of Professional Pharmaceutical Organisations

PARTICIPATES

An Open Mic on good practices

International alliances for good practices: Education, Regulation, Production
Время: 12:00 — 13:00

 

Panel session 15:30

A unifying role of the GxP in the conditions of the changing reality. Part 1
Время: 15:30 — 16:50
Questions and topics for discussion
• Drug safety for the nation Drug quality assurance in the light of new legislative measures and initiatives
• Good distribution practice New logistics chains, supply chains and sales channels
• Compliance with the good pharmacy practice: what is the future of the target market?
• Good pharmacovigilance practiceThe Session Partner: PRO.MED.CS Praha a.s.

Tatiana Vyazmina

Director of Quality, R-Pharm Group of Companies

Tatiana Vyazmina

Director of Quality, R-Pharm Group of Companies

PARTICIPATES

An Open Mic on good practices

International alliances for good practices: Education, Regulation, Production
Время: 12:00 — 13:00

Valery Aristov

Corporate Quality Director, Pharmasyntez Group of Companies

Valery Aristov

Corporate Quality Director, Pharmasyntez Group of Companies

PARTICIPATES

An Open Mic on good practices

International alliances for good practices: Education, Regulation, Production
Время: 12:00 — 13:00

Chinara Mambetalieva

Deputy Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission

Chinara Mambetalieva

Deputy Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission

PARTICIPATES

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Dmitry Rozhdestvensky

Head of the Department of Coordination of the Movement of Medicines and Medical Devices of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission

Dmitry Rozhdestvensky

Head of the Department of Coordination of the Movement of Medicines and Medical Devices of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission

Education and professional activities:
  • In 1998 he graduated from the «Vitebsk state medical Institute».< / li>
  • 1999-2002 – post-Graduate studies, then clinical studies in Vitebsk state medical University on a speciality «Clinical pharmacology».
  • 2002-2004-Department of General and clinical pharmacology of Vitebsk state medical University (Republic of Belarus).
  • 2004-2014-Republican clinical and pharmacological laboratory of up «Center of examinations and tests in health care» (Republic of Belarus).
  • 2014-present Eurasian economic Commission, Department of technical regulation and accreditation (Russian Federation).
Area of practical interest:

Clinical studies of drugs, biological statistics, clinical pharmacology.

Research:

The planning, implementation and quality assurance of more than 140 studies reproduced (generic) drugs in the Republic of Belarus, 30 clinical trials of medicines (Allergy, cardiology, neurology, ophthalmology) I and III phases.

PARTICIPATES

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Zhanar Ordabekova

Head of the Pharmaceutical Inspectorate and Integration, Committee on Medical and Pharmaceutical Surveillance, Ministry of Health, Kazakhstan

Zhanar Ordabekova

Head of the Pharmaceutical Inspectorate and Integration, Committee on Medical and Pharmaceutical Surveillance, Ministry of Health, Kazakhstan

PARTICIPATES

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Mkrtich Shakaryan

Head of the Good Pharmaceutical Practice Department, Emil Gabriyelyan Scientific Center of Drug and Medical Technologies Expertise, Armenia

Mkrtich Shakaryan

Head of the Good Pharmaceutical Practice Department, Emil Gabriyelyan Scientific Center of Drug and Medical Technologies Expertise, Armenia

PARTICIPATES

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Tatiana Tumelya

Head of the Republican Control and Analytical laboratory of RUE «Center for Examinations and Tests in Health Service», Ministry of Health of Belarus

Tatiana Tumelya

Head of the Republican Control and Analytical laboratory of RUE «Center for Examinations and Tests in Health Service», Ministry of Health of Belarus

PARTICIPATES

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Martkul Musaeva

Head of the Single-window System Division, Drugs and Medical Devices Department, Ministry of Health, Kyrgyzstan

Martkul Musaeva

Head of the Single-window System Division, Drugs and Medical Devices Department, Ministry of Health, Kyrgyzstan

PARTICIPATES

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Nazi Abdyrasulova

Head of the Good Practices Division, Pharmaceuticals and Medical Devices Department, Ministry of Health, Kyrgyzstan

Nazi Abdyrasulova

Head of the Good Practices Division, Pharmaceuticals and Medical Devices Department, Ministry of Health, Kyrgyzstan

PARTICIPATES

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Natalia Volovich

Deputy Director — Head of the Registration Department, Representative office of Gedeon Richter in Russia

Natalia Volovich

Deputy Director — Head of the Registration Department, Representative office of Gedeon Richter in Russia

Education

Tyumen State Medical Academy, pharmacy specialty, pharmacist qualification.

Career path

Began her work in the pharmaceutical industry in 1997 as a pharmacist. In 2006 continued her professional path in the Moscow representative office of Gedeon Richter as a certification manager.

In 2011 took over the leadership of the Registration Department, was appointed at the position of Deputy Director of the Representative Office of Gedeon Richter (Hungary), Moscow.

Scope of ​​professional interests: 

  • business activities of Gedeon Richter in Russia and CIS countries;
  • pricing and legislation on the regulation of the drug market in Russia, the CIS countries and the EAEU;
  • launches of new medicines;
  • clinical trials;
  • development of company’s product portfolio;
  • company’s participation in the drug labeling project;
  • legislative and industry initiatives

PARTICIPATES

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Hasmik Abrahamyan

Director of the Quality Department, Geropharm Group of Companies

Hasmik Abrahamyan

Director of the Quality Department, Geropharm Group of Companies

PARTICIPATES

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Tatiana Sitko

Adviser of the Pharmaceutical Inspection Department, Head Office for Quality Control of Medical Care, Medical Expertise, Appeals of Citizens and Legal Entities, Ministry of Health of Belarus

Tatiana Sitko

Adviser of the Pharmaceutical Inspection Department, Head Office for Quality Control of Medical Care, Medical Expertise, Appeals of Citizens and Legal Entities, Ministry of Health of Belarus

PARTICIPATES

Panel session 15:30

A unifying role of the GxP in the conditions of the changing reality. Part 1
Время: 15:30 — 16:50
Questions and topics for discussion
• Drug safety for the nation Drug quality assurance in the light of new legislative measures and initiatives
• Good distribution practice New logistics chains, supply chains and sales channels
• Compliance with the good pharmacy practice: what is the future of the target market?
• Good pharmacovigilance practiceThe Session Partner: PRO.MED.CS Praha a.s.

Viktoria Presnyakova

Chairperson of the board of the Independent Pharmacies Association

Viktoria Presnyakova

Chairperson of the board of the Independent Pharmacies Association

PARTICIPATES

Panel session 15:30

A unifying role of the GxP in the conditions of the changing reality. Part 1
Время: 15:30 — 16:50
Questions and topics for discussion
• Drug safety for the nation Drug quality assurance in the light of new legislative measures and initiatives
• Good distribution practice New logistics chains, supply chains and sales channels
• Compliance with the good pharmacy practice: what is the future of the target market?
• Good pharmacovigilance practiceThe Session Partner: PRO.MED.CS Praha a.s.

Maria Ponomaryova

Adviser of the Pharmaceutical Inspection Department, Head Office for Quality Control of Medical Care, Medical Expertise, Appeals of Citizens and Legal Entities, Ministry of Health of Belarus

Maria Ponomaryova

Adviser of the Pharmaceutical Inspection Department, Head Office for Quality Control of Medical Care, Medical Expertise, Appeals of Citizens and Legal Entities, Ministry of Health of Belarus

PARTICIPATES

Panel session 15:30

A unifying role of the GxP in the conditions of the changing reality. Part 1
Время: 15:30 — 16:50
Questions and topics for discussion
• Drug safety for the nation Drug quality assurance in the light of new legislative measures and initiatives
• Good distribution practice New logistics chains, supply chains and sales channels
• Compliance with the good pharmacy practice: what is the future of the target market?
• Good pharmacovigilance practiceThe Session Partner: PRO.MED.CS Praha a.s.

Judith Tibisay Delgado

Executive Secretary of the Review Board of Pharmaceutical Products, National Institute of Hygiene “Rafael Rangel”, Venezuela

Judith Tibisay Delgado

Executive Secretary of the Review Board of Pharmaceutical Products, National Institute of Hygiene “Rafael Rangel”, Venezuela

PARTICIPATES

Panel session 15:30

A unifying role of the GxP in the conditions of the changing reality. Part 1
Время: 15:30 — 16:50
Questions and topics for discussion
• Drug safety for the nation Drug quality assurance in the light of new legislative measures and initiatives
• Good distribution practice New logistics chains, supply chains and sales channels
• Compliance with the good pharmacy practice: what is the future of the target market?
• Good pharmacovigilance practiceThe Session Partner: PRO.MED.CS Praha a.s.

Fleurdelis E. Mendiola

Pharmacist IV, Food and Drug Administration, Philippines

Fleurdelis E. Mendiola

Pharmacist IV, Food and Drug Administration, Philippines

PARTICIPATES

Panel session 15:30

A unifying role of the GxP in the conditions of the changing reality. Part 1
Время: 15:30 — 16:50
Questions and topics for discussion
• Drug safety for the nation Drug quality assurance in the light of new legislative measures and initiatives
• Good distribution practice New logistics chains, supply chains and sales channels
• Compliance with the good pharmacy practice: what is the future of the target market?
• Good pharmacovigilance practiceThe Session Partner: PRO.MED.CS Praha a.s.

Filiz Ozul

Head of Medicines Inspection Department, Turkish Medicines and Medical Devices Agency, Turkey

Filiz Ozul

Head of Medicines Inspection Department, Turkish Medicines and Medical Devices Agency, Turkey

PARTICIPATES

Panel session 15:30

A unifying role of the GxP in the conditions of the changing reality. Part 1
Время: 15:30 — 16:50
Questions and topics for discussion
• Drug safety for the nation Drug quality assurance in the light of new legislative measures and initiatives
• Good distribution practice New logistics chains, supply chains and sales channels
• Compliance with the good pharmacy practice: what is the future of the target market?
• Good pharmacovigilance practiceThe Session Partner: PRO.MED.CS Praha a.s.

Anatoly Krasheninnikov

Director General, National Pharmacovigilance Research Centre

Anatoly Krasheninnikov

Director General, National Pharmacovigilance Research Centre

He graduated from Kazan state medical University, has additional higher financial and economic education, MBA in innovation and project management. Member of the presidential program of management training. Author of 16 scientific works, 1 monograph.

PARTICIPATES

Panel session 15:30

A unifying role of the GxP in the conditions of the changing reality. Part 1
Время: 15:30 — 16:50
Questions and topics for discussion
• Drug safety for the nation Drug quality assurance in the light of new legislative measures and initiatives
• Good distribution practice New logistics chains, supply chains and sales channels
• Compliance with the good pharmacy practice: what is the future of the target market?
• Good pharmacovigilance practiceThe Session Partner: PRO.MED.CS Praha a.s.

Dmitry Voloshin

Founder of the proGMP.ru web portal

Dmitry Voloshin

Founder of the proGMP.ru web portal

PARTICIPATES

Panel session 15:30

A unifying role of the GxP in the conditions of the changing reality. Part 1
Время: 15:30 — 16:50
Questions and topics for discussion
• Drug safety for the nation Drug quality assurance in the light of new legislative measures and initiatives
• Good distribution practice New logistics chains, supply chains and sales channels
• Compliance with the good pharmacy practice: what is the future of the target market?
• Good pharmacovigilance practiceThe Session Partner: PRO.MED.CS Praha a.s.

Olga Lidia Jacobo Casanueva

Director, Center for the State Control of Medicines, Equipment and Medical Devices (CECMED)

Olga Lidia Jacobo Casanueva

Director, Center for the State Control of Medicines, Equipment and Medical Devices (CECMED)

PARTICIPATES

Panel session 15:30

A unifying role of the GxP in the conditions of the changing reality. Part 1
Время: 15:30 — 16:50
Questions and topics for discussion
• Drug safety for the nation Drug quality assurance in the light of new legislative measures and initiatives
• Good distribution practice New logistics chains, supply chains and sales channels
• Compliance with the good pharmacy practice: what is the future of the target market?
• Good pharmacovigilance practiceThe Session Partner: PRO.MED.CS Praha a.s.

Miloš Luburić

GMP inspector, Institute for Medicines and Medical Devices (CInMED), Montenegro

Miloš Luburić

GMP inspector, Institute for Medicines and Medical Devices (CInMED), Montenegro

PARTICIPATES

Panel session 17:00

A unifying role of the GxP in the conditions of the changing reality. Part 2
Время: 17:00 — 18:20
Questions and topics for discussion
• Special aspects of circulation of reference standards
• Crucial issues of good preclinical and good clinical practices
• From generics to innovations. Regulation and production of innovative and high-tech medicines
• The laboratory phase of pharmaceutical development as a fundamental pillar for quality and efficacy of a medicinal product
• Special aspects of batch release testingThe Session Partner: Akhrikhin

Valery Makarov

Director for Science, RMC «Home of Pharmacy»

Valery Makarov

Director for Science, RMC «Home of Pharmacy»

PARTICIPATES

Panel session 17:00

A unifying role of the GxP in the conditions of the changing reality. Part 2
Время: 17:00 — 18:20
Questions and topics for discussion
• Special aspects of circulation of reference standards
• Crucial issues of good preclinical and good clinical practices
• From generics to innovations. Regulation and production of innovative and high-tech medicines
• The laboratory phase of pharmaceutical development as a fundamental pillar for quality and efficacy of a medicinal product
• Special aspects of batch release testingThe Session Partner: Akhrikhin

Mahmoud Fawaz Al-Qawasmeh

Head of the Drug Control and Inspection Department, Jordan Food and Drug Administration (JFDA), Jordan

Mahmoud Fawaz Al-Qawasmeh

Head of the Drug Control and Inspection Department, Jordan Food and Drug Administration (JFDA), Jordan

PARTICIPATES

Panel session 17:00

A unifying role of the GxP in the conditions of the changing reality. Part 2
Время: 17:00 — 18:20
Questions and topics for discussion
• Special aspects of circulation of reference standards
• Crucial issues of good preclinical and good clinical practices
• From generics to innovations. Regulation and production of innovative and high-tech medicines
• The laboratory phase of pharmaceutical development as a fundamental pillar for quality and efficacy of a medicinal product
• Special aspects of batch release testingThe Session Partner: Akhrikhin

Pavel Burenkov

Deputy Head of the Inspection Authority of the FSI “State Institute of Drugs and Good Practices”, Russian Ministry of Industry and Trade

Pavel Burenkov

Deputy Head of the Inspection Authority of the FSI “State Institute of Drugs and Good Practices”, Russian Ministry of Industry and Trade

PARTICIPATES

Panel session 17:00

A unifying role of the GxP in the conditions of the changing reality. Part 2
Время: 17:00 — 18:20
Questions and topics for discussion
• Special aspects of circulation of reference standards
• Crucial issues of good preclinical and good clinical practices
• From generics to innovations. Regulation and production of innovative and high-tech medicines
• The laboratory phase of pharmaceutical development as a fundamental pillar for quality and efficacy of a medicinal product
• Special aspects of batch release testingThe Session Partner: Akhrikhin

Du Jing

GMP Inspector, Centre for Food and Drug Inspection (CFDI), China

Du Jing

GMP Inspector, Centre for Food and Drug Inspection (CFDI), China

PARTICIPATES

Panel session 17:00

A unifying role of the GxP in the conditions of the changing reality. Part 2
Время: 17:00 — 18:20
Questions and topics for discussion
• Special aspects of circulation of reference standards
• Crucial issues of good preclinical and good clinical practices
• From generics to innovations. Regulation and production of innovative and high-tech medicines
• The laboratory phase of pharmaceutical development as a fundamental pillar for quality and efficacy of a medicinal product
• Special aspects of batch release testingThe Session Partner: Akhrikhin

Dmitry Somov

Acting Director General of the Information Center for Expertise, Accounting and Analysis of Circulation of Medical Products, Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Dmitry Somov

Acting Director General of the Information Center for Expertise, Accounting and Analysis of Circulation of Medical Products, Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor)

PARTICIPATES

Panel session 17:00

A unifying role of the GxP in the conditions of the changing reality. Part 2
Время: 17:00 — 18:20
Questions and topics for discussion
• Special aspects of circulation of reference standards
• Crucial issues of good preclinical and good clinical practices
• From generics to innovations. Regulation and production of innovative and high-tech medicines
• The laboratory phase of pharmaceutical development as a fundamental pillar for quality and efficacy of a medicinal product
• Special aspects of batch release testingThe Session Partner: Akhrikhin

Naala Grivapsh

Corporate Quality Director, Binnopharm Group of Companies

Naala Grivapsh

Corporate Quality Director, Binnopharm Group of Companies

PARTICIPATES

Panel session 17:00

A unifying role of the GxP in the conditions of the changing reality. Part 2
Время: 17:00 — 18:20
Questions and topics for discussion
• Special aspects of circulation of reference standards
• Crucial issues of good preclinical and good clinical practices
• From generics to innovations. Regulation and production of innovative and high-tech medicines
• The laboratory phase of pharmaceutical development as a fundamental pillar for quality and efficacy of a medicinal product
• Special aspects of batch release testingThe Session Partner: Akhrikhin

Vladimir Gegechkori

Deputy Director General (Production and Strategic Development), National Centre for Reference Standards

Vladimir Gegechkori

Deputy Director General (Production and Strategic Development), National Centre for Reference Standards

PARTICIPATES

Panel session 17:00

A unifying role of the GxP in the conditions of the changing reality. Part 2
Время: 17:00 — 18:20
Questions and topics for discussion
• Special aspects of circulation of reference standards
• Crucial issues of good preclinical and good clinical practices
• From generics to innovations. Regulation and production of innovative and high-tech medicines
• The laboratory phase of pharmaceutical development as a fundamental pillar for quality and efficacy of a medicinal product
• Special aspects of batch release testingThe Session Partner: Akhrikhin

Deon Poovan

Senior Manager: Inspectorate and Regulatory Compliance, South African Health Products Regulatory Authority (SAHPRA), South Africa

Deon Poovan

Senior Manager: Inspectorate and Regulatory Compliance, South African Health Products Regulatory Authority (SAHPRA), South Africa

PARTICIPATES

Panel session 17:00

A unifying role of the GxP in the conditions of the changing reality. Part 2
Время: 17:00 — 18:20
Questions and topics for discussion
• Special aspects of circulation of reference standards
• Crucial issues of good preclinical and good clinical practices
• From generics to innovations. Regulation and production of innovative and high-tech medicines
• The laboratory phase of pharmaceutical development as a fundamental pillar for quality and efficacy of a medicinal product
• Special aspects of batch release testingThe Session Partner: Akhrikhin

Leila Gargoubi

GMP Inspector at Direction of Inspection Department, Ministry of Health, Tunisia

Leila Gargoubi

GMP Inspector at Direction of Inspection Department, Ministry of Health, Tunisia

PARTICIPATES

Panel session 17:00

A unifying role of the GxP in the conditions of the changing reality. Part 2
Время: 17:00 — 18:20
Questions and topics for discussion
• Special aspects of circulation of reference standards
• Crucial issues of good preclinical and good clinical practices
• From generics to innovations. Regulation and production of innovative and high-tech medicines
• The laboratory phase of pharmaceutical development as a fundamental pillar for quality and efficacy of a medicinal product
• Special aspects of batch release testingThe Session Partner: Akhrikhin

Vladimir Subbotin

Deputy Director of the Department for Sanitary, Phytosanitary and Veterinary Measures, Eurasian Economic Commission

Vladimir Subbotin

Deputy Director of the Department for Sanitary, Phytosanitary and Veterinary Measures, Eurasian Economic Commission

PARTICIPATES

Association of Veterinary Pharmaceutical Manufacturers Panel Discussion

GMP for Animal Health Industry: Trends and Prospects
Время: 16:20 — 18:00

Pre-registration is required to attend the session!

Questions and topics for discussion:
•Inspection mechanism: legal innovations
•Status and prospects of inspections: the perspective of the EAEU, inspection authorities, and business community
•International experience: current approaches to GMP and avenues for further cooperation
•Technical aspects of GMP inspections: explanations and recommendations by national inspection authorities

The Session Partner: AVPHARM

Yuri Yeryomin

Head of the Inspection Authority, Federal State Institution “The Russian State Centre for Animal Feed and Drug Standartisation and Quality”

Yuri Yeryomin

Head of the Inspection Authority, Federal State Institution “The Russian State Centre for Animal Feed and Drug Standartisation and Quality”

PARTICIPATES

Association of Veterinary Pharmaceutical Manufacturers Panel Discussion

GMP for Animal Health Industry: Trends and Prospects
Время: 16:20 — 18:00

Pre-registration is required to attend the session!

Questions and topics for discussion:
•Inspection mechanism: legal innovations
•Status and prospects of inspections: the perspective of the EAEU, inspection authorities, and business community
•International experience: current approaches to GMP and avenues for further cooperation
•Technical aspects of GMP inspections: explanations and recommendations by national inspection authorities

The Session Partner: AVPHARM

Vadim Shut

Deputy Director, Head of Veterinary Pharmaceutical Inspectorate of Belarusian State Veterinary Centre, Head of Veterinary Pharmaceutical Inspectorate

Vadim Shut

Deputy Director, Head of Veterinary Pharmaceutical Inspectorate of Belarusian State Veterinary Centre, Head of Veterinary Pharmaceutical Inspectorate

PARTICIPATES

Association of Veterinary Pharmaceutical Manufacturers Panel Discussion

GMP for Animal Health Industry: Trends and Prospects
Время: 16:20 — 18:00

Pre-registration is required to attend the session!

Questions and topics for discussion:
•Inspection mechanism: legal innovations
•Status and prospects of inspections: the perspective of the EAEU, inspection authorities, and business community
•International experience: current approaches to GMP and avenues for further cooperation
•Technical aspects of GMP inspections: explanations and recommendations by national inspection authorities

The Session Partner: AVPHARM

Natalia Popova

Head of the Department of Medicines Manufacturing Inspection of the FSI “SID and GP”

Natalia Popova

Head of the Department of Medicines Manufacturing Inspection of the FSI “SID and GP”

PARTICIPATES

Association of Veterinary Pharmaceutical Manufacturers Panel Discussion

GMP for Animal Health Industry: Trends and Prospects
Время: 16:20 — 18:00

Pre-registration is required to attend the session!

Questions and topics for discussion:
•Inspection mechanism: legal innovations
•Status and prospects of inspections: the perspective of the EAEU, inspection authorities, and business community
•International experience: current approaches to GMP and avenues for further cooperation
•Technical aspects of GMP inspections: explanations and recommendations by national inspection authorities

The Session Partner: AVPHARM

Emmanuelle Motte

GMP expert for veterinary pharmaceutical manufacturers, HealthforAnimals

Emmanuelle Motte

GMP expert for veterinary pharmaceutical manufacturers, HealthforAnimals

PARTICIPATES

Association of Veterinary Pharmaceutical Manufacturers Panel Discussion

GMP for Animal Health Industry: Trends and Prospects
Время: 16:20 — 18:00

Pre-registration is required to attend the session!

Questions and topics for discussion:
•Inspection mechanism: legal innovations
•Status and prospects of inspections: the perspective of the EAEU, inspection authorities, and business community
•International experience: current approaches to GMP and avenues for further cooperation
•Technical aspects of GMP inspections: explanations and recommendations by national inspection authorities

The Session Partner: AVPHARM

Semyon Zhavoronkov

Managing Director, Association of Veterinary Pharmaceutical Manufacturers (AVPHARM)

Semyon Zhavoronkov

Managing Director, Association of Veterinary Pharmaceutical Manufacturers (AVPHARM)

PARTICIPATES

Association of Veterinary Pharmaceutical Manufacturers Panel Discussion

GMP for Animal Health Industry: Trends and Prospects
Время: 16:20 — 18:00

Pre-registration is required to attend the session!

Questions and topics for discussion:
•Inspection mechanism: legal innovations
•Status and prospects of inspections: the perspective of the EAEU, inspection authorities, and business community
•International experience: current approaches to GMP and avenues for further cooperation
•Technical aspects of GMP inspections: explanations and recommendations by national inspection authorities

The Session Partner: AVPHARM

Timur Chibilyaev

Executive Director, Association for Assistance to the Veterinary Affairs Promotion “National Veterinary Association”

Timur Chibilyaev

Executive Director, Association for Assistance to the Veterinary Affairs Promotion “National Veterinary Association”

PARTICIPATES

Association of Veterinary Pharmaceutical Manufacturers Panel Discussion

GMP for Animal Health Industry: Trends and Prospects
Время: 16:20 — 18:00

Pre-registration is required to attend the session!

Questions and topics for discussion:
•Inspection mechanism: legal innovations
•Status and prospects of inspections: the perspective of the EAEU, inspection authorities, and business community
•International experience: current approaches to GMP and avenues for further cooperation
•Technical aspects of GMP inspections: explanations and recommendations by national inspection authorities

The Session Partner: AVPHARM

Vasily Nikitin

Head of the Division of Pharmaceutical Inspectorate Training and Development, FSI “State Institute of Drugs and Good Practices”

Vasily Nikitin

Head of the Division of Pharmaceutical Inspectorate Training and Development, FSI “State Institute of Drugs and Good Practices”

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Jesus Herrera

Director of Drugs, Medicines and Cosmetics, Autonomous Service of Sanitary Comptrollership, Venezuela

Jesus Herrera

Director of Drugs, Medicines and Cosmetics, Autonomous Service of Sanitary Comptrollership, Venezuela

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Sladjana Marsenic

GMP Inspector, Inspectorate, Institute for Medicines and Medical Devices (CInMED), Montenegro

Sladjana Marsenic

GMP Inspector, Inspectorate, Institute for Medicines and Medical Devices (CInMED), Montenegro

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Isac Quiñones Maya

Center for the State Control of Medicines, Equipment and Medical Devices (CECMED), Cuba

Isac Quiñones Maya

Center for the State Control of Medicines, Equipment and Medical Devices (CECMED), Cuba

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Ibraheem Yahya Khbrani

Inspection Expert of Products & Facilities, Saudi Food and Drug Authority (SFDA), Saudi Arabia

Ibraheem Yahya Khbrani

Inspection Expert of Products & Facilities, Saudi Food and Drug Authority (SFDA), Saudi Arabia

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

B.M. Rao

Corporate Director of Quality Assurance, Dr. Reddy’s Laboratories

B.M. Rao

Corporate Director of Quality Assurance, Dr. Reddy’s Laboratories

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Dmitry Gursky

General Director, Makiz Pharma

Dmitry Gursky

General Director, Makiz Pharma

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Olga Maklakova

Corporate Quality Director for Eurasian economic zone, Akrikhin

Olga Maklakova

Corporate Quality Director for Eurasian economic zone, Akrikhin

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Alla Mikhailova

Director of Quality, Microgen

Alla Mikhailova

Director of Quality, Microgen

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Irina Polyakova

Deputy Director of Quality, St. Petersburg Research Institute of Vaccines and Serums, Russia

Irina Polyakova

Deputy Director of Quality, St. Petersburg Research Institute of Vaccines and Serums, Russia

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Yelena Kuzmina

Head of Quality Assurance Division, Polysan

Yelena Kuzmina

Head of Quality Assurance Division, Polysan

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Olga Laskina

Deputy Director of Quality, Gedeon Richter-Rus

Olga Laskina

Deputy Director of Quality, Gedeon Richter-Rus

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Yevgenia Nelyapina

Deputy Director of Quality for Project Activity, Pharmaceutical company Sotex

Yevgenia Nelyapina

Deputy Director of Quality for Project Activity, Pharmaceutical company Sotex

PARTICIPATES

Workshop. Part 1

Workshop. Part 1
Время: 11:00 — 13:30

The Session Partner: Sun Pharma

Yelena Denisova

Deputy Director of the Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation

Yelena Denisova

Deputy Director of the Department of Pharmaceutical and Medical Industry Development, Ministry of Industry and Trade of the Russian Federation

Elena Denisova has the experience and knowledge in the areas of registration and reregistration of foreign and domestic medicines, and inspecting of medicines manufacturers on compliance with GMP requirements. She has a certificate of GMP Inspector, issued by WHO. From January 2014 Elena Vladimirovna had been in charge of Division for medicines manufacturing licensing of the Department for pharmaceutical and medical industry development. In May 2017 she was appointed the Deputy Director of the Department for pharmaceutical and medical industry development of Minpromtorg of Russia. Almost 9 years Elena Denisova was working in Roszdravnadzor, where, as well, she was in charge of medicines registration area. Her general experience in pharmaceutical field is 20 years, including employment in major companies, manufacturing medicines – 5 years.

PARTICIPATES

Plenary session 10:30

International cooperation on good practices under the current geopolitical conditions
Время: 10:30 — 11:50
Questions and topics for discussion
• Formation of new international alliances of countries not involved in sanctions wars
• International professional industry societies and associations as a GMP rules harmonisation tool
• Experience of international cooperation on regulatory matters
• Support mechanisms for evolving regulatory systems

Irina Novikova

Director General, GxP News

Irina Novikova

Director General, GxP News

PARTICIPATES

An Open Mic on good practices

International alliances for good practices: Education, Regulation, Production
Время: 12:00 — 13:00

Alexei Kedrin

Chairman of the board of Association of EAEU Pharmaceutical Manufacturers

Alexei Kedrin

Chairman of the board of Association of EAEU Pharmaceutical Manufacturers

PARTICIPATES

Panel session 13:10

Eurasian integration in the field of good practices under current geopolitical conditions
Время: 13:10 — 14:30
Questions and topics for discussion
• Growth of the common EAEU market under the «Strategy 2025» and development roadmaps
• Review of approved key measures and decisions of the Eurasian Economic Commission in 2020-2022
• Identifying common expert approaches for conducting GMP inspections according to the EAEU rules
• Transition to the supranational regulation. Experience of the EAEU member states
• Further issues of integration and harmonisation. Experience of pharmaceutical companiesThe Session Partner: PharmEco Group of Companies

Roman Drai

R&D Director, Geropharm group of companies

Roman Drai

R&D Director, Geropharm group of companies

PARTICIPATES

Panel session 17:00

A unifying role of the GxP in the conditions of the changing reality. Part 2
Время: 17:00 — 18:20
Questions and topics for discussion
• Special aspects of circulation of reference standards
• Crucial issues of good preclinical and good clinical practices
• From generics to innovations. Regulation and production of innovative and high-tech medicines
• The laboratory phase of pharmaceutical development as a fundamental pillar for quality and efficacy of a medicinal product
• Special aspects of batch release testingThe Session Partner: Akhrikhin

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