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

13-14 November 2018

InterContinental Moscow Tverskaya Hotel

Sponsors

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Worldwide Clinical Trials
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IPHARMA
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QuintilesIMS
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Statandocs
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Vector Logistics
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Synevo
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Centre of Clinical Trials
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SanaClis
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BIOMAPAS

Supporting organisations

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Innovative Pharma

Media Partners

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Pharmvestnik
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MediaMedica
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Pervostolnik
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Remedium
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Vrachi Vmeste
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Pharmaceutical Industry Review
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GMP News
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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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IPHARMA, the accredited Common Use Center (CUC) "Biomedical Services" of Technopark "Skolkovo" is 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 60 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 and #14 for 2016).

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QuintilesIMS (NYSE:Q) is a leading integrated information and technology-enabled healthcare service provider worldwide, dedicated to helping its clients improve their clinical, scientific and commercial results. Formed through the merger of Quintiles Transnational and IMS Health, QuintilesIMS’s approximately 50,000 employees conduct operations in more than 100 countries. Companies seeking to improve real-world patient outcomes through treatment innovations, care provision and access can leverage QuintilesIMS’s broad range of healthcare information, technology and service solutions to drive new insights and approaches. QuintilesIMS provides solutions that span clinical to commercial, bringing customers a unique opportunity to realize the full potential of innovations and advanced healthcare outcomes.

As a global leader in protecting individual patient privacy, QuintilesIMS uses healthcare data to deliver critical, real-world disease and treatment insights. Through a wide variety of privacy-enhancing technologies and safeguards, QuintilesIMS protects individual privacy while managing information to drive healthcare forward. These insights and execution capabilities help biotech, medical device and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders in the development and approval of new therapies, and to identify unmet treatment needs and understand the safety, effectiveness and value of pharmaceutical products in improving overall health outcomes. To learn more, visit www.QuintilesIMS.com

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Statandocs company provides a wide range of services for clinical trials planning and conduction, including medical & scientific writing, data management and biomedical statistics.
Statandocs employees are experienced in clinical trials as investigators, clinical research associates, data managers, project managers and clinical team leaders.
Statandocs statisticians all have a higher medical education that enhances proper interpretation of trial data from both mathematical and clinical points of view.
All this allows Statandocs to develop an optimal clinical study or clinical development program design taking its practical feasibility into account, allowing the study goals to be reached whilst maintaining the patient’s safety and the preferences of clinical study site’s personnel.

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Vector-Logistics provides international Cold Chain Logistics and Customs Brokerage services. Dedicated Turn-Key solutions for the Pharmaceutical and Medical industries. Over 20 years of hands on experience with a full spectrum of clinical, scientific and commercialised shipments.
We understand your important goals and missions and we share responsibility with you. Thus, our mission is to provide the highest QoS in order to bring your logistics chain to excellence. Our regulatory and operational specialists contribute to your success. We align to the best practice standards for your projects, meet your requirements with flexible solutions and assign a dedicated manager for each project.
Vector-Logistics operates as a partner, we deliver your cargo on time, safely, keeping all temperature ranges by every freight means.
Full range of services for:
• Pharmaceuticals expertise and commercial deliveries
• Medical equipment
• Clinical & Pre-Clinical trials
• Scientific Research
• Drug Registration
We do for your:
• Pick & Pack
• Inland/Sea/Air freight
• Customs Brokerage
• Regulatory support
• Obtaining Certification and Registration for Import/Export
• Destruction
• Depot
• Sourcing
• Professional services and consulting

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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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SanaClis was founded in 2000 by seasoned industry experts all of whom have had executive level positions in leading pharma companies and large global CROs. SanaClis is a full-service CRO offering a comprehensive range of services for clinical trials in Central and Eastern Europe.

SanaClis is one of the very few CROs offering customs brokerage, warehousing and distribution of clinical trial materials in Ukraine and Russia in its own premises and by own professional staff, in addition to clinical monitoring and regulatory services. SanaClis facilities/depots and processes meet criteria of the most stringent international standards and local requirements.
In 2012, SanaClis s.r.o. was rated positively by reputable business agency Creditreform and for 2013 and 2014 was awarded and certified with the AA rating by Bisnode rating agency. SanaClis has earned its place on Nice Insight's survey of Top Ten lists of Clinical Research Organizations (CROs) for 2015, based on customer perceptions of quality.

This is the first time a Slovakia-based CRO has finished among the leaders in the CRO industry, reflecting intensive investments and quality assurance measures. In 2015, Sanaclis was awarded with the CRO Leadership Award in the category Reliability.

Core products and services:
- Regulatory
- Clinical Monitoring
- IMP & CTS Management
- Customs clearance & brokerage
- Site Contracting & Payments
- Project Management
- Quality Management
- Central Laboratory Russia - incl. Bioequivalence Studies
- Data management, Statistics & Medical writing

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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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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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https://www.rafm.ru/

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http://inpharma.info

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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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http://con-med.ru/magazines/pervostolnik/

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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.farmsouz.ru/

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http://vrachivmeste.ru/

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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

 

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https://gmpnews.net/

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http://www.rusvrach.ru/

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