Last updated – 11 October 2021
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
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
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
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
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?