Summit Agenda

Regulatory Affairs

Regulatory strategy for Eurasian countries: what challenges will influence the development of markets in the near future and how to ensure a competitive advantage?

Overview presentation “The regulatory landscape of pharmaceutical markets in Eurasia: risks and potential”

Mandatory registration of medicinal products under the EAEU rules in action

Prospects for the creation of a single organisation for medicines registration across the EAEU

Experience gained in Russia after a full transition to medicines registration according to the rules of the EAEU

How is registration by the rules of the EAEU proceeding in different countries of the Union and what difficulties do regulators see?

Mandatory registration of medicines according to the rules of the EAEU in action: how is the process of registration of medicines in different countries of the Union going and what difficulties do regulators see?

Frequent requests from regulators to pharmaceutical companies: how to avoid mistakes and reduce risks?

Requirements to GMP inspections as part of the preparation of documents for registration of medicines according to the EAEU rules. Extension of the validity period for national GMP certificates for registration of medicines by the EAEU rules

Feedback from pharmaceutical companies: experience of preparing documents according to the rules of the EAEU. Successes, Challenges Facing Pharmaceutical Companies, and lessons learned

Mutual recognition of registered medical products by the Member States of the Union: challenges and solutions

Requirements for conducting bioequivalence studies in accordance with the EAEU rules. Specifics of preparing a registration dossier for generic medicines

Accelerated access to medicines in Eurasian markets: current situation, risks and opportunities

Programs for accelerated drug market access: necessity, benefits and risks. World experience and the current situation in Eurasia

The practice of accelerated registration of vaccines and drugs which treat COVID-19 in Eurasia and the prospects for expanding the practice of early access to innovative drugs for the treatment of other diseases (for example, orphan and oncological diseases)

Implementation of an accelerated drug registration procedure within the EAEU common market: regulatory framework, accumulated experience and inhibiting factors

Opportunities for mutual recognition: which countries’ registrations are recognised in Eurasia to accelerate drug access to the market?

Digitalisation and prospects of transition to electronic submission of documents for registration of medicines

Digitalisation: electronic platforms / portals / infrastructure / eCTD. Electronic laws and electronic signatures. Electronic documents. Electronic Certificate of Pharmaceutical Product (e-CPP). Virtual meetings and communication

Challenges of integration of digital tools by regulatory authorities in Eurasia and the benefits of their use

How can you increase confidence in the use of electronic documents and signatures?

How to build communication between regulators and pharmaceutical companies and raise awareness of the best electronic document management practices?

“Regulator’s reception” – roundtables with regulators

You will have an opportunity to ask regulators your questions in one-on-one meetings or as part of a small group via voice call and\or chat, and get prompt answers. We are currently inviting representatives of regulatory authorities from the countries of Central Asia (Kazakhstan, Uzbekistan, Kyrgyzstan, Turkmenistan, Tajikistan), the Caucasus (Azerbaijan, Armenia, Georgia), Eastern Europe (Ukraine, Belarus, Moldova), as well as Mongolia to take part in this event.

Suggested topics for discussion:

Registration of medical products

Organisation of the pharmacovigilance system

Approaches to drug pricing

Approaches to the formation of lists of essential medicines

Requirements to applications for participation in public procurement tenders

Anti-monopoly regulation of pharmaceutical markets in Eurasian countries

Implementation of the labeling system in Eurasian countries: Russian experience, preparation and challenges in other countries

Russian experience in the implementation of the labeling system: the results of the implementation of the system, the stability of its operation in the current period, the availability of data, interaction with the industry - change management, prospects for the development of the system

What difficulties do market players face when working in the system and what are the ways to resolve them? Position of pharmaceutical manufacturers, distributors and pharmacy chains

Preparations for the implementation of the labeling system in Kazakhstan and Uzbekistan in 2022: which path has been chosen? Pilot projects for the transition to work in the marking system. Selected system operators. Challenges and risks. Preparation for the implementation of the labeling system by regulators, pharmaceutical manufacturers, distributors and pharmacy chains

Labeling within the EAEU single market: what challenges does the implementation of the drug labeling system in Russia entail for other countries of the Union? Is synchronisation of national systems possible? What problems may arise for the movement of medicines within the EAEU single pharmaceutical market?

What lessons can pharmaceutical market players in the EAEU countries learn from the experience of implementing the labeling system in Russia?

Parallel imports in Eurasia: risks for sustainable development of pharmaceutical markets and for patients

The problem of parallel imports in Eurasian pharmaceutical markets: what are the risks for the development of pharmaceutical markets and for the health of patients?

The practice of parallel import in Eurasia: Which countries permit it and where is it illegal? Reasons parallel imports in selected countries

What solutions can be applied at the level of regulators and market participants to reduce parallel imports in Eurasian countries?

How to organise control over the import of products in individual countries to deal with the problem of re-export and counterfeiting effectively?

Observance of intellectual property rights as a guarantee of the availability of innovative medicines in the Eurasian markets

Necessary conditions under which the creators of original medicines will be interested in bringing their products to the markets of Eurasian countries

Work to improve legislation in the field of intellectual property rights protection. Experience in developing lists of registered medicinal products in the EAEU and Russia

Regulation of protection of intellectual property rights as part of the shared pharmaceutical market of the EAEU and in individual Eurasian countries

Risks of using compulsory licensing in case of emergencies such as the global COVID-19 pandemic

Patent disputes in the countries of the Eurasia region and proven judicial practice

Market Access

Regulation of prices for medicines: approaches to reference pricing and price control in the retail sector

Approaches to medicine pricing in Eurasian countries

Methods of reference pricing used in Eurasian countries

Price registration and re-registration rules in Eurasian countries

Risks of medicine shortage in Eurasian countries and possible solutions

Options provided by legislation to raise registered prices and practice

Opportunities to raise registered prices

Medicine pricing in public procurement in Eurasian countries

Approaches to medicine pricing in EAEU single pharmaceutical market

Pricing in the retail sector: to regulate or not? International experience and approaches in Eurasian countries. Risks of price regulation in the retail segment for OTC drugs in Kazakhstan

Ensuring access to innovative medicines in the markets of Eurasian countries

Challenges of introduction of new innovative drugs to the Eurasian markets

Development of universal drug supply and public procurement as guarantee, which ensures patient access to innovative drugs in Eurasian countries

Approaches to building public procurement and defining tender requirements in Eurasian countries

Patient-oriented approaches to pharmacy and their development in Eurasian countries

Innovative models of drug supply. Risk & cost sharing contracts: what experience has been accumulated at the international level? Under what conditions will innovative contracts be developed in Eurasian countries?

Ensuring access to innovative drugs for the treatment of cancer and cardiac diseases, diabetes

Creation of orphan disease lists and approaches to providing patients with the necessary medicines

The market for generics and biosimilars: how to ensure the availability of high-quality generics in the markets of Eurasia?

Quality of generics and their value: how is the quality of generics determined? “Made in” – does the quality of generics really depend on the country of origin or is it just a matter of reputation?

Инвестиционная привлекательность рынков стран Евразии для международных производителей дженериков: какие тенденции влияют на бизнес-климат в регионе?

Investment attractiveness in Eurasian countries' markets for international generic manufacturers: what trends affect the business climate in the region?

How the generics market will develop in the countries of Eurasia: forecasts of the leading players in the countries of Eurasia

Common pharmaceutical market of the EAEU for generics: risks and opportunities

Launching new generic drugs to the markets of Eurasia: what factors hinder the emergence of new drugs?

Regulation of generics’ pricing: what risks do pharmaceutical market players see in the markets of Eurasia and what changes could help increase the availability of quality generics for patients?

Approaches to determining the terms of tenders in Eurasia: how to find a balance between the availability of medicines in terms of price and quality for patients?

Prospects for the development of the biosimilar market in the countries of the Eurasia region

Patient-centric approaches to health care: prospects for development in Eurasia

Patient-centric approaches to healthcare: concept, international practice and application in Eurasia

Integration of patient-centric approaches to healthcare into the public procurement system: challenges and opportunities

Opportunities to improve interaction between pharmaceutical market players to increase patient access to innovative drugs and technologies in Eurasian countries

Patient organisations as a driving force for the development of patient-centered approaches to healthcare. Patient organisations as a link between regulators, pharmaceutical companies and patients in need of expensive therapy

Development of patient organisations in Eurasian countries: accumulated experience and constraints

Sales

Commercial sector of the pharmaceutical markets in Eurasia

As part of the summit, we will hold sessions on trends in the development of the commercial sector of the pharmaceutical markets in Central Asia (Kazakhstan, Uzbekistan, Kyrgyzstan, Turkmenistan, Tajikistan), the Caucasus (Azerbaijan, Armenia, Georgia), Eastern Europe (Ukraine, Belarus, Moldova), as well as Mongolia.

Sales of medicines in Eurasia over the course of 9 months of 2021: results and predictions. Growth drivers and outsiders

Changes in consumer behavior: how have sales of medicines and medical devices changed due to the ongoing coronavirus pandemic?

What adaptive commercial strategies have been adopted by pharmaceutical manufacturers in response to the changing market situation in Eurasia?

Patterns of drug consumption – how is the demand for drugs of various price categories changing? What is the ratio between the demand for imported and domestic goods / prescription and over-the-counter medicines / original and generic medicines in context of the global coronavirus pandemic?

Trends in development of the wholesale and retail sectors of Eurasian pharmaceutical markets

Pharmacy chains today and tomorrow: international trends and the situation in Eurasian countries. What changes will help make the sector more predictable and will improve pharmaceutical manufacturers’ investment profitability in the sector

Models of interaction between pharmaceutical manufacturers, distributors and pharmacy chains: how to make cooperation more efficient?

New trade channels in Eurasian pharmaceutical markets: e-commerce development rates and predictions, prospects to sell medicines in supermarkets

Ensuring sales transparency in Eurasian markets: how to achieve greater transparency on the part of distributors and pharmacy chains? Difficulties in the development of sales analytics in Eurasia and solutions

Nutritional supplements market: global trends in the sector's development and constraining factors in Eurasian countries

Development trends of the OTC segment in Eurasian countries: how to develop a culture of responsible consumption of OTC drugs?

Trends in the development of the OTC segment in Eurasian countries. Under what conditions can we expect an increase in the consumption of OTC drugs in the region?

Development of consumption of OTC drugs. Benefits and risks for patients and government systems

The concept of responsible self-medication as a way to minimize risks when consuming OTC drugs

Conditions for expanding the availability of vitamins and dietary supplements in Eurasian countries

Marketing

Interaction with the medical community in a new reality: how to build effective progress in an era of a pandemic?

How has the way pharmaceutical companies’ interact with the medical community changed during the pandemic? What changes will remain in the future, and what can we expect to return to the past?

Offline vs online visits of medical representatives: what will be the balance in the future?

Medical Representative Today and Tomorrow: What skills need to be developed today to stay competitive in the future?

Use of digital technologies when working with the medical community: development of portals, ecosystems. Improvement of the content of materials for the medical audience

How to improve the effectiveness of remote visits to develop contacts with doctors?

Compliance and ethical promotion of medicines in Eurasia: regulation and practice

State regulation in the promotion of drugs: differences in the requirements of different countries

Ethical issues of pharmaceutical promotion: international approaches and сode of ethics in the countries of Eurasia

The difference between the approaches of international and local companies: how to achieve equal competitive conditions for all market participants when promoting drugs in the medical community?

Promotion of drugs through digital channels: regulation and practice

Marketing strategies: what technologies are effective for promoting products in Eurasian countries?

Marketing in the current reality: what set of tools allows you to most effectively reach your customers and bring the biggest return on investment?

How to effectively distribute the marketing budget in the new reality? What channels and formats of promotion should you choose?

Traditional media promotion and use of digital tools in Eurasian countries: what trends and changes are highlighted by the pharmaceutical market professionals?

COVID-19 pandemic and consumer behavior: how to quickly adjust promotion strategies?

Digital tools in drug promotion: phone calls, webinars, social media, individual digital visits to doctors. Key KPIs and ways to improve the efficiency of using digital tools

Content and genres of marketing materials: how to attract the attention of consumers in the era of information oversaturation?

Videos, banners, storytelling, etc. – how to use genre diversity to interest your target audience?

Promotion of drugs in social media: challenges and successful examples of drug promotion in social media. Working with professional communities and influencers. Top performing formats on social media

Human Resources Development

Development of human resources for companies in the pharmaceutical market in Eurasia: challenges and solutions

Issues of training qualified personnel for pharmaceutical companies: what steps are required on the part of governments, market players and educational institutions in order to meet the growing demand for specialists for the pharmaceutical industry?

State programs, joint programs of pharmaceutical companies and universities as an opportunity to train specialists for the pharmaceutical industry

The new reality requires new competencies – what skills should the personnel of pharmaceutical companies develop? How to develop managerial staff for the pharmaceutical industry and keep staff within companies long term?