The leading event for all parties involved in the clinical trials market in CEE

17 - 18 April 2018

SPONSORS

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Synevo
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SanaClis
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CTA Focus
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IQVIA
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Clinerion
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Synektik Group
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MTZ

Media Partners

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Applied Clinical Trials
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Clinical Informatics News
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Biotechnologia.pl
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CEbiotech
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GMP News

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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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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CTA Focus is an international contracting organization specialized in clinical trial contract and budget negotiations with offices in Bucharest - Romania and Malaga - Spain. Our company guarantees significant experience in negotiating in over 57 countries throughout the world (EMEA, Middle East, North and Latin America and Asia Pacific), has an international team of 21 permanent specialists and 25 languages are spoken by the team. CTA Focus provides local language negotiation and country level budget knowledge. CTA Focus has a full template library for each country and/or region and its own build in online negotiations tracking system. www.ctafocus.com

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IQVIA (NYSE:IQV) is a leading global provider of information, innovative technology solutions and contract research services focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward. IQVIA enables companies to rethink approaches to clinical development and commercialization, innovate with confidence as well as accelerate meaningful healthcare outcomes. IQVIA has approximately 55,000 employees in more than 100 countries, all committed to making the potential of human data science a reality. IQVIA’s approach to human data science is powered by the IQVIA CORE™, driving unique actionable insights at the intersection of big data, advanced technology and analytics with extensive industry knowledge.
IQVIA is a global leader in protecting individual patient privacy. The company uses a wide variety of privacy-enhancing technologies and safeguards to protect individual privacy while generating and analyzing the information that helps their customers drive human health outcomes forward. IQVIA’s insights and execution capabilities help biotech, medical device, and pharmaceutical companies, medical researchers, government agencies, payers and other healthcare stakeholders tap into a deeper understanding of diseases, human behaviors and scientific advances, in an effort to advance their path toward cures. To learn more, visit www.IQVIA.com.

 

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Clinerion enables early patient access to innovative treatments through solutions for clinical trial patient recruitment, real-world evidence, and market access. Clinerion's Patient Recruitment System accelerates clinical research by radically improving the efficiency and effectiveness of trial recruitment. Key tools for Clinerion’s patient data services include data-assisted protocol optimization, site feasibility evaluation and patient identification. Clinerion’s solutions allow member hospitals to participate in leading-edge, industry-sponsored trials and save time in patient recruitment. They enable pharmaceutical companies to gain time and cost savings by streamlining operations and gaining strategic intelligence. Clinerion’s proprietary Big Data analytics technologies leverage real-time data from electronic health records which remain under the full control of participating hospitals. Clinerion is a global data technology company headquartered in Switzerland. Clinerion's solutions follow international patient privacy and data security standards.

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Synektik Group is a leading supplier of innovative products, services and IT solutions for diagnostic imaging and nuclear medicine. We sell medical devices and IT solutions used in radiology and operate a research laboratory for diagnostic imaging systems and a service center for medical equipment. The company is the first and largest commercial manufacturer of radiopharmaceuticals used in diagnostics (PET) for oncology and other fields in Poland.
Synektik Group operates three radiopharmaceutical manufacturing plants: one at Świętokrzyskie Oncology Centre in Kielce, the second in Warsaw at the Military Institute of Medicine where the R&D facility and personnel are based and the third at Mszczonów. At the R&D center Synektik operates its own Research and Development program working on radioactive tracers for oncology, cardiology and neurology, providing dose delivery services for clinical trials.

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MTZ Clinical Research Sp. z o.o. (MTZ) is a FDA inspected Clinical Research Site; focused on early clinical research development and biosimilar in healthy.

Since 2002 European and American pharmaceutical companies and Contract Research Organizations (CROs) have availed themselves of the services of MTZ Clinical Research (MTZ) a leading Polish company specializing in early phase clinical trials, bioequivalence and bioavailability studies.

Most studies are conducted at Company’s clinical research site which accommodates up to 30 subjects. It is also used as a specialized site for Phase III studies. MTZ also conducts single and multicentre trials (Phase II) at specialized clinics across Poland. Since August 2009 Company holds ISO 9001:2008 Certificate from DAS CERTIFICATION Ltd. accredited by UKAS.
MTZ conducts the following type of studies:
- Phase I/II healthy & patients, various indications
- Biosimilars healthy & patients
- Special populations
- Proof-of-Concept
- Bioequivalence and Bioavailability
- PK/PD, Food effect studies
- Therapeutic equivalence
- Tobacco risk evaluation & smoking-cessation studies.

MTZ has conducted over 220 research projects with over 6000 participating healthy subjects and patients who are recruited mainly from Company’s own registered database of volunteers.

mtz-clinical.pl

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https://www.gcppl.org.pl/

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http://www.nia.org.pl/

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LifeScience Klaster Krakow (LSK) is the network of institutions from Krakow and Małopolska Region (Poland) which agreed to collaborate in order to develop and deliver to the market innovations in the field of life sciences.

These organizations represent six areas of interests: biotechnology and life science business, research & development, science and education, healthcare, business support and local government actively guiding and facilitating the cooperation at the regional level.

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Polfarmed is a voluntary and self-governing organization of enterprises operating in the fields of production of medicinal products, medical devices as well as introducing medicaments and medical devices on the territory of the Republic of Poland and operating in the fields of manufacturing raw materials, appliances to their production and servicing of medical devices.

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The Association of Pharmaceutical Research and Development (APRaD) has been formed by 16 world leading pharmaceutical companies active in the research and development of new medicines that improve health and quality of life, with a presence in Ukraine.

The pharmaceutical industry, represented by APRaD, is committed to the research and development, quality manufacturing and distribution of innovative medicines that save lives, reduce overall health care costs and improve the quality of life of people. As a non-for-profit and non-governmental organization, APRaD gives much emphasis to co-operation with Ukrainian authorities, and other international organizations concerned with health and pharmaceutical industry-related issues.

The Association’s objectives are: to become a recognized voice of the research-based pharmaceutical industry operating in Ukraine, to promote value of innovations, to conduct effective advocacy for public policies that improve access to quality medicines in Ukraine, and to be effective strategic partner to the Government of Ukraine.

APRAD is a Member of the European Federation of Pharmaceutical Industries and Associations – EFPIA.

Our Strategic priorities:

The Association focuses on four major areas: access to medicines and reimbursement, ethical promotion, improved regulatory environment for pharmaceuticals and intellectual property rights’s protection. Specifically, APRaD:

  • Builds awareness about the R&D Pharmaceutical industry and original medicines;
  • Strives to resolve Intellectual Property Rights and Data Protection issues;
  • Is the advocate for a better access to quality medicines and establishment of reimbursement system;
  • Promotes and encourage ethical business principles and practices among its members and the pharmaceutical industry in general;
  • Develops effective partnership with Government stakeholders as well as represent the interests of the pharmaceutical industry before all relevant authorities;
  • Establishes appropriate links with international pharmaceutical associations

The activities of the Association are not intended to generate profits. The Association has no intention whatsoever to create or promote cartels or gentlemen’s agreements and will put in place active measures to ensure such arrangements do not arise. The Association does not engage in trade, commercial transactions or political activities.

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http://www.czechbio.org/

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Bulgarian Association of Clinical Research (BACR) was registered in 2003 as an independent nongovernmental /not-for-profit/ organization. Up to date the members of BACR are more than 135 persons and legal entities, representatives of such companies as Amgen, Appletree Clinical Investigations, AstraZeneca Bulgaria, August Research, Balkan Trials, Bayer Bulgaria, Biovantix, Clinical Trials Group, Covance, GlaxoSmithKline, INC Research, Institut d'Expertise Clinique - Bulgarie, Janssen, Milray, Novartis Pharma Services, Novo Nordisk Pharma, Patient Recruitment Solutions, PPD Bulgaria, Premier Research, PSI Pharma Support, Quintiles Bulgaria, R&D Services, Resbiomed, Roche Bulgaria, Sanofi-Aventis, Sopharma, Sopharma Trading, Tokuda, World Courier Bulgaria, lawyers, journalists.

 

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http://www.motesz.hu/

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http://arpim.ro/

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http://inovia.rs/

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Hungarian Clinical Trial Management Society (CTMS) is a non-governmental organization of clinical study specialists including most of the hundreds of colleagues working at study sites, pharmaceutical companies, contract research organizations (CROs), academic or regulatory institutions, or private practices.

CTMS was founded in 2001 with the purpose of providing a forum for specialist involved in clinical trials.

By using and sharing the experience accumulated over a decade, it contributes to the professional and ethical standards of clinical studies conducted in Hungary, the legal environment, and human resources to reach a level that globally and regionally increases the competitiveness of Hungary and to live up to the trust of patients who play the most important role in clinical studies.

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Hungarian Society for Pharmaceutical Sciences was founded in 1924. We have Industrial Pharmacy, Community Pharmacy and Hospital Pharmacy professional groups. Besides their work, the scientific activity is performed in the sections: Drug Analysis, Pharmaceutical Technology, Pharmacognosy, Drug Research, Drug Affairs and Organization, Drug Therapy and Pharmaceutical Care. The Society has about 2500 members.

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http://www.ascdr.ro/

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http://ifpa.lt

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http://www.polcro.pl/

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http://btminnovations.pl/

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http://www.appliedclinicaltrialsonline.com/

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Part of Cambridge Healthtech Publishing, Clinical Informatics News reports on innovative technologies from clinical trials to medical informatics. Technology continues to permeate all aspects of clinical trials and the patient experience, and the tools to support these efforts are maturing rapidly. ClinicalInformaticsNews.com, the Clinical Informatics News Newsletter and News Bulletins provide authoritative news, views and insights on the vast landscape of innovation between clinical trial management and delivery of care.

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http://biotechnologia.pl

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Central European Biotechnology Portal http://cebiotech.com/

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https://gmpnews.net/

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