The only international event dedicated to discussing regulatory, ethical and operational aspects of running clinical trials in Russia

1 - 2 December 2020

Online

Sponsors

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IPHARMA
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Sciencefiles
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InfoDialog
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Statandocs

Supporting organisations 2020:

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SPFO
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SojuzPharma

Media Partners 2020:

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Pharmvestnik
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Remedium
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MediaMedika
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GMP News
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Pharmaceutical Industry Review,
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Научный Журнал
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National Pharmaceutical Journal
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http://www.farmsouz.ru

IPHARMA is a contract research organization focusing on conducting clinical trials of investigational drugs developed by Russian and International pharmaceutical and biotech companies in Russia and EAEU. IPHARMA is a member of ChemRar High-Tech Center group of companies and an accredited partner of Skolkovo Innovation Center.

Our pipeline consists of over 120 clinical trials in oncology, virology, endocrinology, pulmonology, neurology, transplantology, etc. We provide agile clinical services in both early-phase and registration trials, as well as medical, regulatory, and PV expertise to ensure optimal timeline for your drug development. According to Association of Clinical Trials Organizations, IPHARMA has been ranked as a market leader of Russian innovative drugs. (ACTO Analytical report #8 for 2013, #10 for 2014, #12 for 2015, #14 for 2016, #16 for 2017 and #18 for 2018).

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Medicover Integrated Clinical Services (MICS) formerly Synevo Central Labs is a specialised business unit within the Diagnostic Services division with the overarching objective to help bring innovative therapies and diagnostics to the market. MICS has been providing bespoke services to our clients and their patients for over 20 years, making strategic use of Medicover assets, including laboratories with state-of-the-art diagnostic equipment, medical clinics and hospitals, as well as the vast expertise and enthusiasm of a workforce that has grown to more than 20,000 professionals.

MICS’ services include and are organised along discrete lines of activity, including: Central Lab Services, Biospecimen Management, Patient Recruitment, and Precision Medicine. Tightly integrated in all Medicover geographies and beyond, MICS employs a dedicated team of highly specialised staff, including clinical and diagnostics specialists, contract research professionals, account managers, project managers, logistics experts, analysts, and more.

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Sciencefiles for over 11 years supports development and registration of both pharmaceutical products and medical devices. We prepare key documentation, together with data-management and biostatistics for any trial phase (I through IV) and in all therapeutic areas.
Our company provides support for more than 460 clinical trials, including rare specialities and dosage forms.
There are 103 clients from global and local pharma and CRO that trust our high-quality service.
Take a look at our partners’ reviews via http://www.sciencefiles.ru/

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The company specializes in the development of software products in the field of medicines monitoring, medical devices and medical services. The company has developed and supports the development of 10 large information systems (more than 5,000 objects and over 100,000 users) that solve urgent problems in the healthcare sector. Our solutions operate at the federal level (national registry of medicinal product), regional level (health departments of the constituent entities of the Russian Federation), warehouses, pharmacy chains, local health insurance funds and pharmaceutical manufacturers.

One of the latest solutions is specialized software “Electron” focused on the preparation and maintenance of a dossier (eCTD) for a drug throughout the life cycle, with the possibility of centralized management and monitoring of processes from anywhere in the world, in order to obtain a registration certificate in accordance with EEC rules.

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Statandocs today is a multi-profile, dynamically developing company that offers a wide range services that are of high demand within the pharmaceutical industry. For clinical and observational studies (including RWE) we prepare complete essential documents package, support submission process, develop and maintain eCRF and IWRS, conduct validation and statistical analysis of data with preparation of interim and final study report. For registration dossiers (national, EAEU) we prepare all CTD modules, including CTD overview (module 2), assist in submissions, develop and conduct user testing for patient information leaflets, provide cloud service for eCTD XML EAEU for dossier preparation and life-cycle maintenance. We perform pharmacovigilance activities during clinical trials and after market authorization, including development of SOPs, master-file, RMP, conduct literature monitoring and prepare PSURs and DSURs. Statandocs offers various trainings and educational programs both in online format and as face-to-face sessions. Moreover, we actively work in the area of scientific medical writing, preparing materials for physicians and patients, articles (including systematic review and meta-analyses), posters and presentations. Our staff includes over 65 employees, including the highest medical writer head count in the region. We conducted over 1100 various projects for 94 clients in Russia, EAEU and CIS, including big international, regional and local pharmaceutic companies and CROs. Documents and services offered by us are well accepted by regulatory bodies in Armenia, Belarus, Vietnam, Georgia, Kazakhstan, Moldova, Russian Federation, Tadzhikistan, Uzbekistan, Ukraine, and USA. Statandocs is a reliable partner, we evolve rapidly, do not fear the most complex challenges and are at all times ready for productive cooperation.

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Established in 1994. The Association comprises 60 international pharmaceutical companies that provide over 80% of the world’s pharmaceutical products and over 60% of medicines imported to the Russian Federation.

AIPM Mission

To promote economic and legal policies that focus on the development of organized and open pharmaceutical market, improving of medical services quality and expansion of the range of modern medicines for the benefit of Russian people.

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http://www.arfp.ru

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http://www.spfo.ru

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http://sojuzpharma.ru/

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”Pharmvestnik” (Pharmaceutical Bulletin) is the leading specialized weekly newspaper covering the Russian pharmaceutical industry with a certified circulation of 16 200 copies. The 20 year-long first-hand pharma market experience has made it a reliable source of professional information for all types of market players – manufacturers, distributors, pharmacies, regulators – as well as the pharmaceutical and medical communities at large.
”Pharmvestnik” carries opinions of market leaders, leading experts, authorities, and public organizations.
It covers the Russian pharma market analysis by sector, regulatory activities as well as offers practical advice valuable in the pharmacist’s and HR manager’s perspective. Equal coverage is also given to all Russia’s federal districts as ”Pharmvestnik” has regional representatives in all largest cities and towns.
Since 2013, the “PhV-Analytics” series has been published under ”Pharmvestnik” umbrella brand. It includes a digital quarterly collection of analytical reports on all aspects of the pharma market functioning and a hard-copy annual report.

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Remedium group of Companies renders the whole range of services for specialists in the field of medicine and pharmaceutics. For years the principle directions of activity of “Remedium” Group of Companies are publication of particularized periodicals, assignment of electronic databases, arrangement and implementation of measures, rent-a-rep service, organization of advertisement and PR support.

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http://www.con-med.ru/

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https://gmpnews.net/

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Pharmaceutical Industry Review

WILL GET YOUR MESSAGE TO THE PEOPLE THAT MATTER MOST

The leading Russian language magazine on/for pharmaceutical industry.

We cover: major trends and events in pharma industry; analytical information on technologies, manufacturing & equipment, research & development; sector and legal news, opinions of market participants; case studies; companies’ profiles; interviews, market insights, history, quality control, etc…

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National Pharmaceutical Journal

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