This forum is the only international event dedicated to discussing regulatory, ethical and operational aspects of running clinical trials in Russia

8 - 10 November 2016

40+ speakers in 2016:

Vladimir Bulatov, Medical Director, AstraZeneca Russia
Vladimir Bulatov

Medical Director

AstraZeneca Russia

Dmitry Vlasov, Dmitry Vlasov, BayerCountry Medical Director Russia & Head Medical Cluster CIS
Dmitry Vlasov

Dmitry Vlasov

BayerCountry Medical Director Russia & Head Medical Cluster CIS

Victoria Kosmacheva, Clinical Research Manager, GlaxoSmithKline
Victoria Kosmacheva

Clinical Research Manager

GlaxoSmithKline

Dmitry Rozhdestvensky, Deputy Head of Department for Coordination of Formation of Common Market for Drugs and Medical Devices, Department for Technical Regulation and Accreditation, Eurasian Economic Commission
Dmitry Rozhdestvensky

Deputy Head of Department for Coordination of Formation of Common Market for Drugs and Medical Devices, Department for Technical Regulation and Accreditation

Eurasian Economic Commission

Evgeniy Rogov, Independent Auditor,
Evgeniy Rogov

Independent Auditor

Olga Melnik, Head of Clinical Operations, Novartis Pharma
Olga Melnik

Head of Clinical Operations

Novartis Pharma

Daria Tolkacheva, Health Economics Manager, Biocad
Daria Tolkacheva

Health Economics Manager

Biocad

Marina Debryanskaya, Head of Clinical Trials Management, Russian Innovation Centre, Takeda Pharmaceuticals
Marina Debryanskaya

Head of Clinical Trials Management, Russian Innovation Centre

Takeda Pharmaceuticals

Elena Volskaya, Vice-Rector for Science, Moscow State University of Medicine and Dentistry, Chairman, Interuniversity Ethic Commission
Elena Volskaya

Vice-Rector for Science

Moscow State University of Medicine and Dentistry, Chairman, Interuniversity Ethic Commission

Julia Trakhtenberg, Medical director, IPHARMA
Julia Trakhtenberg

Medical director

IPHARMA

Natalia Vostokova, Chief Operating Officer, IPHARMA
Natalia Vostokova

Chief Operating Officer

IPHARMA

Evgeny Kulikov, Head of Scientific Department, Associate Professor, Division of General Medical Practice,  Siberian State Medical University
Evgeny Kulikov

Head of Scientific Department, Associate Professor, Division of General Medical Practice

Siberian State Medical University

Mehmet Yıldız, Owner, MEDEX SMO
Mehmet Yıldız

Owner

MEDEX SMO

Elena Malyshko, Senior Clinical Operation Manager Russia, CIS and Baltic Countries, Abbvie
Elena Malyshko

Senior Clinical Operation Manager Russia, CIS and Baltic Countries

Abbvie

Vladimir Kovalev, Clinical Research Manager, Medical Department, Abbott Laboratories
Vladimir Kovalev

Clinical Research Manager, Medical Department

Abbott Laboratories

Anatoly Krasheninnikov, Head of Clinical Trials Centre, Kazan Medical University
Anatoly Krasheninnikov

Head of Clinical Trials Centre

Kazan Medical University

Maxim Bunimovich, Senior Quality Management Specialist, Clinical Site Monitoring, Quintiles Russia
Maxim Bunimovich

Senior Quality Management Specialist, Clinical Site Monitoring

Quintiles Russia

Marina Guryleva, Chairman of the Ethic Committee,  Kazan Medical University
Marina Guryleva

Chairman of the Ethic Committee

Kazan Medical University

Vladimir Popov, Head of Department of Professional Clinical Pharmacodynamics, NGHCI
Vladimir Popov

Head of Department of Professional Clinical Pharmacodynamics

NGHCI "Scientific Clinical Centre", Russian Railways

Natalia Semenova, Chairman of the Independent Ethic Committee, St. Petersburg Psychoneurological Research Institute n.a. V.M. Bekhterev
Natalia Semenova

Chairman of the Independent Ethic Committee

St. Petersburg Psychoneurological Research Institute n.a. V.M. Bekhterev

Yuri Zaretskiy, Managing Director, ZM Company Inc
Yuri Zaretskiy

Managing Director

ZM Company Inc

Olga Zvonareva,  Research Fellow, Department of Health, Ethics and Society (HES), School for Public Health and Primary Care (CAPHRI), Maastricht University
Olga Zvonareva

Research Fellow

Department of Health, Ethics and Society (HES), School for Public Health and Primary Care (CAPHRI), Maastricht University

Tatiana Zwereva, CEO & Owner, Lege Artis Clinical Research Group
Tatiana Zwereva

CEO & Owner

Lege Artis Clinical Research Group

Audrius Sveikata, Managing Director, Biomapas
Audrius Sveikata

Managing Director

Biomapas

Irina Shumikhina, Director Business and Development,,  Investigator Sites Network
Irina Shumikhina

Director Business and Development,

Investigator Sites Network "Clinical Research Partner", Principal Investigator, Internal Medicine and Clinical Pharmacology

Alexander Obukhov, Head of Medical Department, Pharmstandart
Alexander Obukhov

Head of Medical Department

Pharmstandart

Alexander Solodovnikov, Senior Clinical Operations Team Lead, Clinical Operations Site Management, WORLDWIDE CLINICAL TRIALS
Alexander Solodovnikov

Senior Clinical Operations Team Lead, Clinical Operations Site Management

WORLDWIDE CLINICAL TRIALS

Ravil Niyazov, Adviser on Medicinal Products Development and Authorization,
Ravil Niyazov

Adviser on Medicinal Products Development and Authorization

Olga Stepanova, Clinical Operations Department Manager, Les Laboratoires Servier
Olga Stepanova

Clinical Operations Department Manager

Les Laboratoires Servier

Lorna M. Graham, Associate Director Project Management, WORLDWIDE CLINICAL TRIALS
Lorna M. Graham

Associate Director Project Management

WORLDWIDE CLINICAL TRIALS

Anna McDonald, Partner, Head of Russian Life Sciences Practice, Dentons
Anna McDonald

Partner, Head of Russian Life Sciences Practice

Dentons

Anna Shutkevich, Research Project Manager, Pfizer
Anna Shutkevich

Research Project Manager

Pfizer

Oleksii Gaidamak,  MD Regional Country Director, Ukraine, Russia, Belarus, Georgia, Synevo
Oleksii Gaidamak

MD Regional Country Director

Ukraine, Russia, Belarus, Georgia, Synevo

150+ Attendees

Over 150 delegates from Russia and beyond annually attend the event. The Clinical Trials. Russia is recognised as a unique and valuable opportunity to meet with peers and discuss common challenges.

40+ Experts

AstraZeneca Russia, Novartis Pharma, R-Pharm, GSK, Roszdravnadzor, Quintiles, Pfizer H.C.P. Corporation, Les Laboratories Servier Representative Office, NovaMedica, Pharmstandart and many others

3-Day Programme

Topical and compact programme filled with interactive formats, panel discussions and debates, showcasing original viewpoints and innovative case studies

Forum’s structure in 2016:

 • TWO days of Main Forum

PRE-CONFERENCE Seminars (Tuesday, 8th November):

Seminar 1:    Pharmacovigilance: regulatory and medical aspects of clinical trials (pre- and post-registration).

Seminar 2:    What is Medical Writing in clinical trials?

FLEXIBLE registration

HIGHLIGHTS: Clinical Trials. Russia
The only strategic meeting place for the sector's professionals from Russia and beyond

FORMAT: 3 days, 40+ speakers, Case studies and dynamic panel discussions, reflecting the clinical trials sector’s very latest trends and issues

SPEAKERS & DELEGATES:
Among speakers and delegates were clinical trials professionals from Abbott Laboratories, IPHARMA, Accell Clinical Research, Takeda Pharmaceuticals, Pfizer H.C.P., Quintiles and many more.

View 2015 EVENT Photo-gallery >>

Watch 2015 EVENT Video >>


Sponsors

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IPHARMA
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BIOMAPAS
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Worldwide Clinical Trials
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Clinical Research Partner
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Dentons
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Bio Eq
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Smooth Drug Development
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Vita Aeterna
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Synevo
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Centre of Clinical Trials

Supporting organisations

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http://inpharma.info
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www.spfo.ru
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www.arfp.ru

Media Partners

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http://riaami.ru
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www.ria-stk.ru
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Научный Журнал
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vrachivmeste.ru
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http://www.rusvrach.ru/
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http://www.farmsouz.ru
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http://promoboz.com/ru
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http://con-med.ru/
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http://mediapro.msk.ru
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" Pharmaceutical Herald Weekly"
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Media Sphera
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Medsovet.info
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Promportal.su
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INPHARM

PHARMA, the accredited Common Use Center (CUC) "Biomedical Services" of Technopark "Skolkovo" a contract research organization of ChemRar/ChemDiv group, focusing on conducting clinical trials of investigational drugs developed by Russian and International pharmaceutical and biotech companies in Russia and EAEU.
Our pipeline consists of over 40 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 and #10 for 2014, #12 for 2015).

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Biomapas – Full Service CRO, we are specializing in complex clinical research, marketing authorization and post-authorization support. Biomapas is providing fully integrated services (one-stop-shop) to biopharmaceutical and medical device industry for more than 15 years. Our team of professionals experienced in Clinical Trials, Regulatory Affairs, Pharmacovigilance and Medical Writing services supporting companies in various regions, such as European Union, Eastern Europe, Russia & CIS. We have solid experience in numerous therapeutic fields such as, but not limited to Psychiatry, CNS, cardiovascular diseases, oncology, neurology, rheumatology, pulmonology, metabolic disorders. ISO 9001:2015 certified CRO, Member of AICROS Association. We keep our promises. Always.

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Worldwide Clinical Trials employs more than 1,400 professionals around the world, with offices in North and South America, Eastern and Western Europe, CIS countries including Russia, Ukraine, Armenia, Georgia; and Asia. One of the world’s leading, full-service contract research organizations (CROs), we partner with sponsors in the pharmaceutical and biotechnology industries to deliver fully integrated clinical development and bioanalytical services, extending from first-in-human through phase IV studies. Grounded in medicine and science, we help sponsors move from medical discovery into clinical development and commercialization, helping bring innovative solutions to market that deliver enhanced value and improve patient lives. Our employees are among the best in their fields – clinicians, scientists, operational and regulatory specialists who offer expertise across a range of therapeutic areas, including neuroscience, cardiovascular diseases, immune-mediated inflammatory disorders (IMID), and rare diseases. For more information, visit our website at www.worldwide.com.

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The "Clinical Research Partner" company was established by clinical research professionals in 2015. Our mission is to develop clinical trials infrastructure in Russia and provide a range of unique services:

1. Site Management Organization:
The company in cooperation with few medical institutions established a network of dedicated investigator sites conducting phase I-IV clinical trials under the "Clinical Research Partner" quality standards.
The key advantages of working with our network are good data and documents quality, quick subjects' enrollment and commitment to timeliness.
The network includes dedicated fully equipped and managed by "Clinical Research Partner" sites located in different districts of St.-Petersburg, Russia with access to diverse patients' population:
- Investigator site #1 PMI "Euromedservice" - private accredited medical institution located in St.-Petersburg historical suborn Pushkin and covering city south area.
- investigator site #2 Modern German Medical Center "AMEDAKLINIK" located in the center of the city.
- Investigator site #3 "Baltmed" with phase 1 unit located in the north part of the city.
- Investigator site #4 "7 doctors" located in the center of the city.

Each network site has all required staff, equipment and facilities to conduct a study. "Baltmed" medical center has own local laboratory and radiology facilities as well as dedicated phase 1 unit. All investigator sites work according to unified quality standards (SMO Quality Management system) any by close oversight of internal quality manager.
The sites could conduct a trials in different therapeutic areas: pulmonology, oncology, rheumatology, gastroenterology, psychiatry, neurology, cardiology and etc.

2. Network Independent Ethic Committee provides ethic coverage for all sites. IEC could also provide ethic coverage for other sites which don't have own LEC.
3. Educational program on the base of clinical trial training center which provides a set of different training (Pharmacoviligance, GCP, coordinator and etc) and Quality Management services.

For more details please contact:
- info@crptrials.com
- www.crptrials.com

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Dentons is one of the largest international law firms and has been advising on client projects in Russia and the CIS for more than 25 years. The firm has offices in Almaty, Astana, Baku, Kyiv, Moscow, St. Petersburg, and Tashkent, with more than 240 lawyers. The firm also works closely with law firms in Armenia, Belarus, Georgia, Kyrgyzstan, Moldova, and Turkmenistan. Dentons provides a full spectrum of services to international and Russian corporations, banks, and other financial institutions, direct investment funds, start-ups, state enterprises, private individuals, and non-commercial organizations. Dentons combines 7,300 lawyers in 140 offices across 58 countries worldwide

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BioEq is the first privately held dedicated clinical pharmacology research unit for phase I-IV studies in Russia.

BioEq was established in 2014 with the investment support of Russian Venture Company BioFund, and it occupies the territory of 2,000 sq.m.in the city center of St. Petersburg. The unit conducts phase I and bioequivalence studies in healthy volunteers, phase I in patients, phase I-IV in different therapeutic indications
Within 2.5 years of operation, 124 clinical trials (both local and multinational) were approved by the Ministry of Healthcare of the Russian Federation for conduct at BioEq site.
Three divisions operate at BioEq:

  • phase I and bioequivalence studies
  • oncology studies
  • studies in therapeutic areas (pulmonology, rheumatology, cardiology, CNS, and other areas)

The unit has 60 beds, modern equipment, in-patient and out-patient departments, rooms for medicinal procedures, independent emergency care department (which is also required for complex phase I studies), clinical diagnostic laboratory, pharmacy, archive and other operational facilities.
Subject recruitment department enrols healthy volunteers from the database, and patients from the database and referring doctors.
Medical staff includes doctors-investigators, among which there are several key opinion leaders nurses, emergency physicians, pharmacists, coordinators, and other specialists focused on research activities.
BioEq has developed Quality Management System, which has been implemented at all organisational and operational levels.

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Smooth Drug Development is the leader in clinical research in Russia and CIS. Smooth offer to Pharmaceutical and Biotech Companies “one-stop-shop” services (including site management in Russia, CIS and Baltic States) aiming to achieve their regulatory and clinical milestones quickly and cost-effectively: from registration strategy development to marketing authorization.
The company has completed over 170 clinical trials. We perform first-in-human studies, phase I-III studies, post-registration programmes (observational programmes, Risk management plan, Patient registries, Patient support programmes, pharmacovigilance).
Smooth has been maintaining the quality management system, which is being implemented at all organizational and operational levels. The system has been confirmed and approved by the international ISO 9001:2008 certificate.
Smooth has been maintaining Business Continuity Management System conforming to the standard BS 25999:2006 "Business continuity management".
The experienced team of 60+ professionals, established network of sites and principal investigators, non-trivial approaches to project progress, and an adequate ratio between price and quality attract both local and overseas middle and big-size pharmaceutical companies. 

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Vita Aeterna - the dynamically developing Russian CRO with the central office in Moscow that provides full range of services for Russian and foreign clients in multicenter GCP/EMA/ FDA phase 1-4 clinical studies, bioequivalence studies, registration of medicinal products and medical devices, BAAs, veterinary medicinal products, pharmaceutical substances, pharmacovigilance in Russia, Czech Republic, Ukraine, Belarus, Kazakhstan, Kyrgyzstan, Mongolia and Baltic countries. Vita Aeterna also has an extensive experience of postmarketing (observational) and epidemiological programs involving more than 10 000 patients and consults, and develops medical documents.
Our motto – optimum decision for all inquiries of our client.
Moscow, Nauchny proezd, 19
+7 (495) 228-37-03
info@vitaaeternarps.com
www.vitaaeterna-cro.com

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Synevo Central Labs is the largest wholly-owned, fully-harmonized and GCLP accredited network of central laboratories in Europe dedicated exclusively to support clinical trials. Our facilities in Poland, Romania, Ukraine, Germany, Belarus, Bulgaria, Serbia, Moldova, Georgia, Turkey and in Russia operate with the same analytical platforms, materials and reagents and under identical procedures. We offer a comprehensive organization of a clinical trial laboratory part, starting from study-specific kits preparation and investigator site personnel training through sample logistics management and specimen analyse to lab results reporting and final database transfer. We provide our clients with 24/7 access to a real-time data through our web-based, secured and user-friendly application, known as LabOne.

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«Centre of Clinical Trials» Company Limited was founded in January 2009. The company's main goal is to provide clinical trials services of medicinal products for pharmaceutical companies on the territory of the Russian Federation according to Russian legislation and international regulations. Additionally, CCT Co. Ltd. provides consulting services, audit services and offers educational programs for professionals involved in clinical trials.

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The Association of Pharmaceutical Companies «Innovative Pharma» (InPharma) brings together major pharmaceutical companies that actively invest in research and development and are counted among the top 20 global pharmaceutical producers. Members of the Association have research facilities all over the world and also work with Russian R&D centers to conduct clinical trials, cooperating with more than 250 R&D facilities across Russia. Members of the Association carry out research and development in the key fields of medicine, such as cardiology, endocrinology, psychiatry, neurology, oncology, urology, gastroenterology and diabetology. With a view towards developing partnership for innovative pharmaceutical R&D, members of the Association enter into partnership agreements with the Russian development institutions – the Skolkovo Innovation Centre and the Russian Venture Capital Company, as well as develop projects to modernize the biomedicine and biopharmaceutical sectors in Russia, and invest in the construction of manufacturing facilities and research laboratories.

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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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The Advertising Informational Agency “Standards and Quality”


Publication and distribution of the magazines: «Standards and Quality», «Business Excellence», «Methods of Quality Management», «Production Quality Control», «The Quality in Construction» and «The World of Measurement»; books including educational and training editions, CD-versions of products on standardization, metrology, certification, quality control, technical regulation, and ecology.

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"VrachiVmeste.ru (Doctors United) is an educational social network for doctors. The web portal editors have prepared over 1000 exclusive educational videos for different medical specialists. The video archive includes recorded conference reports on vital topics, video-lectures by Russian and foreign PhDs in medicine, documentaries and interviews on relevant medical issues. Our web portal regularly holds webinars which provides you with a unique opportunity to ask questions on-line. VrachiVmeste.ru encourages knowledge exchange, professional communication, and forming new occupational contacts. Feel free to join us!"

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PHARMACEUTICAL INDUSTRY REVIEW - 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.

Publication is a partner and participant of leading global exhibitions in pharmaceutical and related areas  ACHEMA, CPhI, Interpack, P-MEC, Powtech, Pharmintech, Analitika Expo, Pharmtech, Adam Smith conferences on pharma.

Online catalog of the equipment: www.cphem.com. Main models of equipment for every stage of technological process for solid, liquid, semisolid and gaseous dosage forms.

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 " Pharmaceutical Herald Weekly" 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.

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Medsovet.info - federal medical informational Internet-portal takes the 9-th position among Russian medical sites.
More than 2 million people come to the portal each month in search of information in the following divisions:
• Division for doctors
• Division for patients
• Hospitals & clinics
• Medicines
Medsovet.info provides its visitors with:
• The full database of medicines with INN search engine
• The information of medical institutions of Russia with rating
• Forum for patients and doctors’ dialogues
• Medical Internet shop Medsovet Market
• Buying medicines through the online pharmacies

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iVrach is a professional online community for Russian-speaking HCPs. It is a place where doctors can exchange their observations and questions about clinical issues, as well as participate in various educational activities.

iVrach members use their real identities. This enables each member verification and creates an atmosphere of trust necessary for effective professional collaboration.

By applying emerging web trends and technologies iVrach not only enhances physician to physician interactions but also facilitates effective dialogue between HCP community and the industry.

http://IVRACH.COM

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PromPortal.su industrial informational portal

PromPortal.su industrial informational portal was launched in 2006
At our site you can find all the required industrial-related information you need: industrial companies, industrial goods and services, exhibitions, news and announcements. You can buy and sell any goods and provide any services related to manufacturing, construction; producing equipment, hardware and building materials.
Promportal.su does not sell, deliver or produce any goods, but provide access for the information on companies and their goods for various industries.

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Universal Medical Portal (uMEDp.ru) has been created with the participation of leading experts in various spheres of medicine that had been collaborating with the publishing house "Medforum" for many years. Scientific content and medical publishing materials are the starting point in the development of a network resource in the concept of continuing medical education.

At the moment, uMEDp.ru provides free convenient access to healthcare information for 19 major medical specializations.

The web-portal publishes professional authentic content; in particular, it has collected more than 2000 articles and publications from medical periodicals, as well as a number of interactive tasks. The portal is also being used as a platform for the online webinars and broadcast events. Besides, e-mailing and electronic distribution to our own database of doctors is practiced, that is permanently updated via registration at offline activities and Internet subscription that helps to provide regular contact with the large audience of uMEDp.ru.

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