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

30 November - 1 December 2021

Moscow, Russia, Intercontinental Hotel

Sponsors

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IPHARMA
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Roche
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Statandocs
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Sciencefiles

Supporting organisations 2021:

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SPFO
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ARFP

Media Partners 2021:

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GxP News
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http://www.rusvrach.ru/
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MediaMedika
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Pharmvestnik
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Remedium
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Interfax
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Pharma RF
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Medvestnik
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PharmMedProm

IPHARMA is a contract research organization focusing on conducting clinical trials and the registration of investigational drugs and medical devices 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 150 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 an optimal timeline for your drug development. IPHARMA is a reliable partner and an ideal platform for the clinical development of new medicinal products and medical devices. According to the information-analytical bulletin issued by the Association of Clinical Trial Organizations (ACTO), IPHARMA topped the list of CROs by the number of local trials and bioequivalence trials conducted in 2020.

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FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors and is for prescription use only. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Foundation Medicine is your dedicated partner to support your therapeutic development from discovery through to commercialization. Our innovations include proven comprehensive genomic profiling tests, genomic data solutions, clinical trial solutions, and companion diagnostic development/commercialization.

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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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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 more than 12 years, has been supporting the 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 portfolio includes support of more than 500 clinical trials, including rare specialities and dosage forms.

Our high-quality services are trusted by 114 global and local pharma companies and CROs, including 4 Top 10 pharma companies. 

Take a look at our partners’ reviews at:   http://www.sciencefiles.ru/

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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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Союз профессиональных фармацевтических организаций

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Association of Russian Pharmaceutical Manufacturers

the integrated Russian of leaders of the pharmaceutical enterprises to which the action is more than 80% of drugs which are released in the country, of about 45% of export, is more than 75% of internal drugs in falling of the ONLS program.

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https://www.aipm.kz

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

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https://pharmvestnik.ru/

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http://strategyjournal.ru/

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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.

Bakuninskaya st. 71, bld. 10, 105082, Moscow, Russia
t: (495) 780-34-25; f: (495) 780-34-26;
e-mail: remedium@remedium.ru
www.remedium.ru, www.rosapteki.ru

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Research and production reviewed journal "Drug Development & Registration" is actual free applied edition for the pharmaceutical experts.

Companies and their employees from production, development, research, quality control and registration departments; staff of the laboratories, contract research organizations, scientific and educational centers and universities are our target audience. Now the journal has more than 16 000 subscribers. Publications are distributed at all key pharmaceutical, chemical and technological actions (seminars, conferences and exhibitions). The journal is read and discussed in all cities of Russia. There are residents in Russia, CIS and Europe among subscribers of journal.

Four main subject parts of the journal "Drug Development & Registration" include drug development cycle from its synthesis till getting drug registration certificate. The first part is devoted to pharmaceutical technology and surveys the scientific and practical issues from extraction and production of  pharmaceutical substances, technologies and equipment to standard medical products manufacture; the subject of the second part is the study of  analytical procedure of quality control; the third examines approaches to the drug quality and safety evaluation and the fourth part describes questions regarding validation of methods, preparing registration data and drug life cycle in GxP environment.

For placing your advertising information, please, e-mail us or contact by phone: info@pharmjournal.ru; +7 (495) 720 42 20

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Interfax is the biggest information group in the CIS and the recognized leader in the B2B segment of Russia’s information market.

Interfax is the most frequently cited source for information on Russia and the CIS in the foreign press.

Interfax develops professional information solutions that help companies operate in the financial and commodity markets, enabling them to reach investment decisions, manage risk, organize external communications and fulfill regulatory requirements.

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https://medvestnik.ru/

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http://pharmmedprom.ru

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