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3rd Annual Clinical Development & Outsourcing in Central & Eastern Europe

Event Overview

It is widely agreed that Central & Eastern Europe is one of the most competitive regions globally for running clinical trials. The CEE still offers huge potential to save time , lower cost and to achieve high quality data. As these clinical markets develop and mature, issues such as site selection, outsourcing, fast regulatory approval and even now patient recruitment are increasingly challenging. Both the more established, and sometimes increasingly saturated, EU member states in the region, as well as the developing regions in the former Soviet Union and Balkans still offer great value. Pharma and CROs are exploring these territories now more than ever in search of less saturated sites, untapped, "treatment naive" patient populations, as well as highly motivated and capable investigative teams. Local knowledge is still the essential factor allowing a strong understanding with regulators and ethics committees, motivating investigators and study personnel as well as clinical trial subjects.

This event is the only one which will examine in detail, the key regulatory, clinical, outsourcing and environmental factors which impact the clinical trials landscape in specific locations in CEE. Particular and specific attention will be given to Russia and the Ukraine, The Balkan region, as well as Central European EU member states and even Turkey, via separate, focused, streamed conference sessions being run in parallel.

With the continued rapid growth of clinical trials performed in CEE, combined with the trend towards decentralised outsourcing, partnerships with CROs and other clinical solution providers are becoming increasingly critical to study success.
NextLevel Pharma's "CEE Clinical Development & Outsourcing" event is the only meeting in CEE which provides dedicated, 1 on 1 partnering sessions. This enables trial sponsor companies (Pharma, Biotech, Vaccine, Diagnostic and Medical device manufacturers) to meet with clinical solution providers like CROs, central labs, leading consultants, software to discuss potential partnerships and drive forward clinical programs in an exciting and dynamic region.

Why attend?

  • Hear fresh perspectives from sponsor companies who have run clinical trials in this developing region in partnership with CROs and benefit from their experience.
  • Learn how can CEE stay competitive against other emerging regions.
  • Adapt your tactics to train, motivate and retain the clinical teams and patients in these specific regions.
  • Gain vital local knowledge by hearing updates on challenging clinical regulations.
  • Case study presentations from experts active in the CEE and CIS region, with particular attention given to Russia, Ukraine, Turkey and he Balkan regions.
  • Implement the most efficient partnership model in the clinical development to maximise the performance of your CRO and clinical partners.
  • Partner with the leading clinical solution providers operating in CEE/CIS in our exclusive 1-on-1 partnering sessions.
  • Network and build the contacts & relationships you need at NextLevel Pharma's very popular & entertaining networking dinner – the only one for clinical research professionals in CEE studies.

Who will benefit:

Pharmaceutical & Biotechnology Organisations:
Global / European / Regional / Country Heads of Outsourcing, Business Development, Clinical Operations, Clinical Development, Contract Management, Risk Management, R&D Sourcing, Vendor Relationship and Purchasing, Medical Affairs, Medical Directors.

CROs & Clinical Solution Providers:
CEOs, Business Development Directors, Product Managers, Marketing Managers and Country Managers from the region.

Venue & Dates:

Conference: September 22nd – 23rd, 2008

Post-Event Workshop & Partnering: September 24th, 2008

Venue: Hotel Crowne Plaza, Bratislava, Slovak Republic

Why Bratislava?

Sitting aside the Danube, and the capital of the Slovak Republic, Bratislava is emerging as an ideal venue for conferences. Its attractive, cosmopolitan and historical old town centre is an ideal location for relaxed business occasions.

Located close to Vienna (60km) and Budapest (250km) and easily accessible from the Czech Republic & Poland, Bratislava is proving to be a very convenient location for business in the centre of Europe.

How to fly to Bratislava?

Option 1: Bratislava International Airport
(Airlines: include SkyEurope, Ryanair, Lufthansa, CSA, LOT)

Option 2: Vienna International Airport
(and then just a 45 minute taxi ride!)

Your Prestigious Speaker Panel:

Industry:

Regional Director Clinical Research, CEE
Wyeth

Vice President, Global Clinical Strategic Resourcing
Wyeth, USA

Director, Global Clinical Development
Otsuka, USA

Associate Director, CRO Relationship Manager
Teva, Israel

GCP Committee Chief
Association of Research-based
Pharmaceutical Companies (AIFD), Turkey

Clinical Research Unit Director
Sanofi-Aventis, Turkey

Associate Director, Neurology
Biogen-Idec

Head, Medical Affairs and Research Specialists
Pfizer

CROs & Clinical Solution Providers:

CEO
AbCRO, Inc.

President
AbCRO, Inc.

European Director CRAcademy
DOCS International B.V.

Director of Project Management
SPRI Clinical Trials, LLC

Chief Operating Officer
SPRI Clinical Trials, LLC

Director Clinical Operations
Clinpharm International, Germany

Independent Consultant
and Team Leader of World Bank project
CEESTAHC - CEE
Society of Technology Assessment in Health Care

Director of Business Development
HungaroTrial

Sales Director Life Sciences
Oracle Health Sciences Global Business Unit, EMEA

Clinical Site:

Department of Hematology
Ankara University Medical School, Turkey

Professor of Medicine,
Head of IBD Clinical and Research Centre
Charles University, Prague

Head of the Department of Radiation Psychoneurology,
Institute for Clinical Radiology State Institution
Research Centre for Radiation Medicine of Academy of Medical Sciences of Ukraine

Regulatory & Government Officials:

Deputy Director
US Office for Human Research Protections, DHHS

Head of the Bureau
of Clinical Assessment & Drug Information
State Agency of Medicines, Estonia

Organiser

NextLevel Pharma
Phone: +421 232 662 621
Fax: +421 232 662 622
Email: ceeclinical(at)nextlevelpharma.com

 
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