FORUM AGENDA
PRE-FORUM DAY, February 28
19:00
19:00
WELCOME RECEPTION AND BUSINESS OPPORTUNITIES
Welcome reception will be held in the National Kazakh Abay Restaurant. It is located on the mountain Kok Tobe, in one of the most beautiful places of the city of Almaty at an altitude of 1100 meters.
Address: Almaty, 050010, Dostyk pr. 104B.
A shuttle service from Rixos Almaty to the venue and back will be arranged for participants.
08:30
08:30
REGISTRATION OF DELEGATES, MORNING COFFEE, MEETING WITH COLLEAGUES.
09:25
09:25
START OF THE CONFERENCE. WELCOME SPEECH OF ORGANIZERS
09:30
09:30
STRATEGIC DISCUSSION: THE EURASIAN PHARMACEUTICAL MARKET THROUGH THE EYES OF TOP MANAGERS. GOALS, OBJECTIVES, PROSPECTS
Moderator: VYACHESLAV LOKSHIN, President, Association of International Pharmaceutical Manufacturers in the Republic of Kazakhstan
  • Current development strategies of pharmaceutical companies. Specifics of work in different markets of the region, considering peculiarities of pricing regulation, registration requirements, introduction of labelling procedures, transport and logistics infrastructures
  • Drivers of growth of the pharmaceutical market in the Eurasian region
  • Areas of regulatory support to address the challenge of uninterrupted drug supply
  • What plans do international pharmaceutical companies have to localize and deepen production?
  • Effective cross-national co-operation between pharmaceutical manufacturers in the Eurasian region

Speakers:
ARTHUR VALIEV, CEO of Sun Pharma in Russia
YERHAT ISKALYEV, Chairman of the Board, «SK-Pharmacia».
AZIZ KASIMKHOJAEV, Managing Partner, Pharma Choice
ADILET NAZARBAYEV, head, Johnson & Johnson Kazakhstan.
MARIA SHIPULEVA, director of the AstraZeneca office in Kazakhstan
SVETLANA CEBAN, partner of EY, Tax and Legal Services Department, Kazakhstan and Central Asia
To be confirmed:
PETR RODIONOV, CEO, Gerofarm
10:30
10:30
PLENARY DISCUSSION: IMPROVEMENT OF THE INTEGRATION PROCESS IN THE SPHERE OF REGULATION OF TREATMENT OF MEDICINES IN THE EAEU: MAIN CHANGES, BARRIERS, PROSPECTS
Moderator: VYACHESLAV LOKSHIN, President, Association of International Pharmaceutical Manufacturers in the Republic of Kazakhstan

  • Review of key changes regarding the regulation of pharmaceutical activities in the common economic space
  • Optimization of the procedure for bringing previously registered medicinal products into compliance with Union law
  • Ongoing work to simplify re-authorization and dossier matching procedures
  • Conditions for accelerated expert examination in the course of registration of medicinal products
  • Prospects for addressing issues of integration interaction between Member States in mutual recognition of registration procedures
  • The strategy of the common market of medicines of the EAEU - the vision of the regulators in the future. Concept for the further development of a common market for medicines within the Union - what steps should be taken first?
  • Collaboration on information exchange between country regulators and drug manufacturers

Speakers:
YERKIN DAUTBAYEV, General Director - Chairman of the Board of RGP for PCB «National Center for Examination of Medicines and Medical Products» of the Medical and Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan.
TATIANA DENISIK, Deputy Directorate of Drug Organization of the Ministry of Health of the Republic of Belarus
TATEVIK ERICYAN, coordinator on the issues of treatment of medicines and medical products within the EAEU, «Scientific center of examination of medicines and medical technologies. Academician Emil Gabrielian»
To be confirmed:
NURLAN ISKAKOV, Chairman, Medical and Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan
Representative of the Ministry of Health of the Kyrgyz Republic
Representative of the Eurasian Economic Commission
12:00
12:00
COFFEE BREAK AND BUSINESS COMMUNICATION
12:30
12:30
PLENARY DISCUSSION: STATE REGULATION OF MEDICINE PRODUCT PRICES – OVERVIEW OF APPROACHES AND RELEVANCE OF METHODS
Moderator: MARINA DURMANOVA, President, Association for Support and Development of Pharmaceutical Activity of the Republic of Kazakhstan

  • Practical application of pricing mechanisms and approaches to price regulation in the countries of the Eurasian region
  • Differences in methods of price regulation as a factor in the development of market imbalances
  • The problem of sharing the information needed to fulfil the price comparison mechanism
  • Evolution of deregulation: the experience of phased deregulation of over-the-counter drug prices in the Republic of Kazakhstan

Speakers
MARAT OMAROV, Chairman, Agency for the Protection and Development of Competition of the Republic of Kazakhstan
YERZHAN ZHUNISOV, Deputy General Director, RGP for PCB «National Center for Examination of Medicines and Medical Products» of the Medical and Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan
AGZAM NARTAYEV, Director, «Pharmaceutical Safety Center» of the Ministry of Health of the Republic of Uzbekistan
OLEG KASPAROV, CIS Cluster Leader, Bayer
ALEXEY CEDRIN, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the EAEU
ZAFAR VAHIDOV, partner, Vakhidov & Partners
To be confirmed:
SAULE ERZHANOVA, Director of the Department of Drug Policy, Ministry of Health of the Republic of Kazakhstan
Representative of the Department of Medicines and Medical Equipment, Ministry of Health of the Kyrgyz Republic
Representative of the Department of Antimonopoly Regulation, Eurasian Economic Commission
13:45
13:45
LUNCH
13:45
13:45
FOCUS REPORT: «SYSTEMIC RISKS OF THE LEGAL ENVIRONMENT WITHIN EAEU AND NATIONAL KAZAKHSTAN LEGISLATION, AFFECTING THE TREATMENT AND AVAILABILITY OF MEDICINES IN THE KAZAKHSTAN MARKET»
Speaker:
 LARISA EMELYANOVA, senior lawyer, law firm AEQUITAS.
15:00
15:00
DISCUSSION: INCREASING THE AVAILABILITY OF INNOVATIVE DRUGS IS THE MOST IMPORTANT FACTOR FOR HEALTH SYSTEM MATURITY AND SUSTAINABILITY
  • The need to reduce the time and increase the volume of patient access to innovative drugs
  • Key challenges in bringing an innovative drug to emerging markets and possible solutions
  • Development of innovative drug supply – an investment in the future of a sustainable healthcare system

Speakers:
ANNA DRELICH, Head of Pricing, Market Access and Tender Channel, Bayer Kazakhstan

Johnson & Johnson Kazakhstan (speaker specified)
AstraZeneca in Kazakhstan (speaker specified)

To be confirmed:
SAULE ERZHANOVA, Director of the Department of Drug Policy, Ministry of Health of the Republic of Kazakhstan Representatives of Legal Consulting

16:00
16:00
INTELLECTUAL PROPERTY PROTECTION IS A KEY ELEMENT OF SUCCESSFUL INNOVATION DEVELOPMENT AND A GUARANTEE OF INVESTMENT SECURITY
  • Development of the Eurasian patent system. Eurasian Patent Pharmaceutical Register
  • Can “patent linkage” serve as a tool to provide transparency regarding patent-protected inventions and legal certainty in the registration process of reproduced medicinal products and biosimilars?
  • Approaches to creating and protecting a patent portfolio in the countries of the Eurasia region
  • Challenges of entering the market after patent expiration (Day One Launch Doctrine)

Speakers: The Eurasian Patent Organization, representatives of regulatory authorities, consulting, industry associations, pharmaceutical manufacturers
16:45
16:45
COFFEE BREAK AND BUSINESS COMMUNICATION
17:00
17:00
ASSESSMENT OF HEALTH CARE TECHNOLOGIES AS A TOOL TO IMPROVE THE EFFICIENCY OF ORGANIZATION, FINANCING, QUALITY AND ACCESSIBILITY OF MEDICAL CARE
Moderator: ALEXANDER BYKOV, Director of Health Economics, «R-Farm»

During the session, we will discuss the recognition of a medicinal product of particular importance for public health. Prospects for establishing uniform approaches to the practice of drug selection in the EAEU member states. What benefits will this status bring in the future, apart from accelerated registration - inclusion in lists and programs of preferential medicine provision, pricing, special conditions for participation in tendering?

Speakers:
GULNARA KULKAEVA, Chairman of the Board, RGP on PCB «Salidat Kairbekova National Scientific Center for Health Development»
VITALY OMELIANOVSKY, General Director of FSBU «Center of Expertise and Quality Control of Medical Care» of the Ministry of Health of the Russian Federation
VADIM KUKAVA, Executive Director, Association of Pharmaceutical Companies «Pharmaceutical Innovations» («Infrara»)
ALEXANDER MARTYNENKO, Director of Industrial Policy, Association of International Pharmaceutical Manufacturers
To be confirmed:
VITALY OMELIANOVSKY, General Director of FSBU «Center of Expertise and Quality Control of Medical Care» of the Ministry of Health of the Russian Federation
AstraZeneca (speaker specified)
18:00
18:00
«ETHICAL CODE OF ASSOCIATION OF INTERNATIONAL PHARMACEUTICAL PRODUCERS IN THE REPUBLIC OF KAZAKHSTAN. NEW EDITION»
Speakers:.
 GALYMZHAN KOZHAKANOV, Head of Representative Office «SANDOZ PHARMACEUTICALS D.D» in the Republic of Kazakhstan - Chairman of the Ethical Committee, Association of International Pharmaceutical Producers in the Republic of Kazakhstan
 VYACHESLAV LOKSHIN, President, Association of International Pharmaceutical Manufacturers in the Republic of Kazakhstan
18:20
18:20
END OF DAY 1. OFFICIAL RECEPTION FOR FORUM PARTICIPANTS
09:00
09:00
MORNING COFFEE
09:30
09:30
EXPERT AND ANALYTICAL REVIEW OF PHARMACEUTICAL MARKETS: 2023 RESULTS, TRENDS AND FORECASTS
During the session, we will analyze the dynamics of the pharmaceutical markets in the Eurasian region as a whole and in various segments, identify growth drivers, assess investment attractiveness and make forecasts for future development.

Speakers: representatives of leading analytical agencies IQVIA, Proxima Research, Sirius Group
VALENTINA MARCHENKOVA, founder, Group of companies «Sirius»
ANNA KIM, Commercial Director, Pharma Choice
10:30
10:30
DEVELOPMENT OF THE PUBLIC PROCUREMENT SYSTEM AS AN ELEMENT OF STABILITY IN BUSINESS AND A REAL TOOL FOR ENSURING DRUG SAFETY
  • Trends in the legislative system of public procurement
  • Development of a system of long-term contracts
  • Innovative model of drug provision in modern conditions
  • Centralization of procurement in various therapeutic areas

Speakers:
TATIANA DENISIK, Deputy Head of the Drug Supply Organization of the Ministry of Health of the Republic of Belarus
YERHAT ISKALYEV, Chairman of the Board, «SK-Pharmacia»
ZAFAR VAHIDOV, partner, Vakhidov & Partners
ALEXANDER NESTERENKO, Head of Export Department, Gerofarm
BATYRBEK MASHKEEV, CEO, «Viva-Farm»
TATIANA TRUHAN, Secretary of the Commission for Priority Procurement of the Ministry of Health of the Republic of Belarus, Head of the Group of Competitive Tenders and Procurement of the Marketing, Foreign Economic Activity and Tender Procurement Department of RUP «Belfaration»
To be confirmed:
ABDULLAH AZIZOV, Director, Pharmaceutical Industry Development Agency, Ministry of Health of the Republic of Uzbekistan
NATALIA VASILEVSKAYA, Deputy Minister, Ministry of Antimonopoly Regulation and Trade of the Republic of Belarus
SAULE ERZHANOVA, Director of the Department of Drug Policy, Ministry of Health of the Republic of Kazakhstan
YERHAT ISKALYEV, Chairman of the Board, «SK-Pharmacia»
OTABEK CHORIYEV, Head of Department of Pharmaceutical Regulation, Determination of Drug Demand
Ministry of Health of the Republic of Uzbekistan
ZAFAR VAHIDOV, partner, Vakhidov & Partners
11:30
11:30
COFFEE BREAK
12:00
Hall 1
12:00
Hall 1
OPPORTUNITIES FOR LOCALIZATION AND DEEPENING OF PRODUCTION FOR GLOBAL COMPANIES. DEVELOPING AND IMPROVING THE EFFICIENCY OF IN-HOUSE PRODUCTION
  • How do states encourage localization and how do business representatives view investment attractiveness?
  • What is the feasibility of localization for pharmaceutical companies? Analysis of issues ranging from preferential access to government procurement to the export of drugs to EAEU countries.
  • Approaches to localization: creation of own site or joint investment in existing facilities of local companies
  • Improving the company's efficiency by introducing advanced practices and production technologies

Speakers:
LILIA TITOVA, Executive Director of the Union of Professional Pharmaceutical Organizations
ABDULLAH AZIZOV, Pharmaceutical Industry Development Agency of the Ministry of Health of the Republic of Uzbekistan
PAVEL HEGAI, CEO, Gedeon Richter Kazakhstan and CIS Regional Business Development Director, Gedeon Richter
SK-Pharmacy (speaker specified)
AstraZeneca (speaker specified)
12:00
Hall 2
12:00
Hall 2
CLINICAL TRIALS IN THE EAEU AND CIS – CURRENT SITUATION, OPPORTUNITIES AND BARRIERS
  • Current state of the clinical trials market in the Eurasian region
  • Regulatory framework for the development of clinical trials
  • Possibility of inspecting EAEU clinical sites
  • Prospects for mutual recognition of clinical trial results within the framework of the integration process
  • Field inspection methodology for clinical trials within the EAEU

Speakers:
NADEZHDA TIKHONOVA, Senior Director of Clinical Research, AstraZeneka Russia and Eurasia
MARGARITA GRAF, Head of Clinical Research Development Center, RGP on PCB «Salidat Kairbekova National Scientific Center for Health Development»
13:15
Hall 1
13:15
Hall 1
GOOD PHARMACEUTICAL PRACTICES: FEATURES, REQUIREMENTS, INNOVATIONS
Moderator: FARIDA MAKEEVA, Head of Inspection Department, RGP for PCB «National Center for Examination of Medicines and Medical Products» of the Medical and Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan

  • Current readiness of pharmaceutical manufacturers in the EAEU member states to implement GMP standards
  • Inspection of drug manufacturing for compliance with the EAEU rules – work to harmonize approaches
  • Current approaches and opportunities for cooperation
  • Mutual recognition issues

Speakers:
AZIZ DUSMATOV, Director of «Center of Good Practices» Pharmaceutical Industry Development Agency under the Ministry of Health of the Republic of Uzbekistan
FARIDA MAKEEVA, Head of Inspection Department, RGP for PCB «National Center for Examination of Medicines and Medical Products» of the Medical and Pharmaceutical Control Committee of the Ministry of Health of the Republic of Kazakhstan
MADINA SOTTAEVA, Head of the Inspection Department of Manufacturers of Medicines FBU «GILS and NP» of the Ministry of Industry and Trade of the Russian Federation
MKRTICH SHAKARYAN, Head of the Department of Good Pharmaceutical Practice, «Scientific Center of Examination of Drugs and Medical Technologies named after Academician Emil Gabrielyan»
EKATERINA YAKOVLEVA, Head of Quality Group, AstraZenek Russia and Eurasia
ELENA POPOVA, Senior Director of Regulatory and Health Policy, International Pharmaceutical Manufacturers Association
13:15
Hall 2
13:15
Hall 2
RWD/RWE – PROSPECTS FOR USING REAL CLINICAL PRACTICE DATA
  • Current consideration and prospects for the adoption of the Concept of Development of Approaches to Collection, Analysis and Use of Real Clinical Practice Data in the Circulation of Medicines in the EAEU member states
  • Opportunities to use RWD/RWE for the registration of new medicines and to speed up the launch of innovative and orphan medicines, as well as in the post-marketing period.
  • Global experience in using data from real clinical practice and the ability to implement best practices

Speaker:
ALEXEY KOLBIN, Head of the Department of Clinical Pharmacology and Evidence Medicine of the First St.-Petersburg State Medical University. Akad. I.P. Pavlova, Ph.D.
ALEXANDER MALODOVNIKOV, Director of Quality Management, Statandocs
VADIM KUKAVA, Executive Director, Association of Pharmaceutical Companies «Pharmaceutical Innovations» («Infrara»)
14:15
Hall 1
14:15
Hall 1
TRENDS IN DIGITALIZATION OF THE HEALTHCARE SYSTEM
  • Current status and main directions of digitalization in healthcare
  • The role of the pharmaceutical industry in the development of digitalization trends, particularly in terms of the use of AI and the collection of big data.
  • What areas of interaction/partnership with the pharmaceutical industry exist now and may exist in the future?

Speaker:
SVETLANA NIKINEN, Director of Registration, AstraZeneka Russia and Eurasia
TATIANA DENISIK, Deputy Head of the Drug Supply Organization of the Ministry of Health of the Republic of Belarus
14:15
Hall 2
14:15
Hall 2
FOCUS REPORT: PHARMACOVIGILANCE SYSTEM DOCUMENTS AS PART OF THE REGISTRATION DOSSIER
  • Risk Management Plan (RMP) – when it's needed, when it needs to be updated
  • Summary of the risk management plan as a document publicly available in the Union’s information systems

Speaker:
EKATERINA SOROKINA, Director, Statandocs
15:00
15:00
LUNCH BREAK
16:00
16:00
FOCUS SESSION: IMPLEMENTATION OF LABELING AND TRACEABILITY SYSTEM FOR MEDICINES IN KAZAKHSTAN, UZBEKISTAN AND KYRGYZSTAN
  • Current status of the labeling implementation process in the countries of the region
  • Key challenges facing the industry and ways to overcome them
  • Unification of approaches to labeling on the territory of the EAEU
  • Measures to ensure traceability and transparency of cross-border trade

Speakers:
MARINA DURMANOVA, President, Association for Support and Development of Pharmaceutical Activity of the Republic of Kazakhstan
ALEXEY KOSAREV, Project Manager of the «Pharma» Advanced Technologies Development Center (CPCP) - Operator of the state labeling system «Honest Sign»
BICESH KURMANGALIYEVA, General Director of the Project Office of the Single Operator of Marking and Traceability of Goods in the Republic of Kazakhstan
NARGIZ SULEIMENOVA, Senior Attorney EY, Tax and Legal Services Department, Kazakhstan and Central Asia
ALEXANDER CHERNICHENKO, CEO of «Meuse Media»
17:00
17:00
SERVICE BREAK
17:10
17:10
PARALLEL THEMATIC ROUND TABLES WITH REGULATORS AND BUSINESS REPRESENTATIVES OF THE EURASIAN REGION COUNTRIES (KAZAKHSTAN, BELARUS, UZBEKISTAN)
18:30
18:30
SUMMARY AND CONCLUSION OF THE FORUM. COCKTAIL RECEPTION.
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