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‘In the highly competitive clinical research environment, the key issue for Central & Eastern Europe is how to respond to new challenges and how to stay competitive.’

Discover how you can be at the forefront of the market by overcoming the logistical and cultural hurdles, which are still considered a major concern by potential sponsors at The SMi Group's 5th Annual Conducting Clinical Trials in Europe Conference.

The conference will feature case studies from those conducting trials in emerging markets such as Russia, Poland and the Czech Republic and this two day intensive forum will help you learn more about:

MULTIREGIONAL CLINICAL TRIALS: examine the pros and cons of conducting multiregional trials and learn the value they can bring
eCLINICAL SOLUTIONS AND DATA INTEGRATION: analyse the current trends, tools and strategies for effective clinical data management
SUPPLY CHAIN: outline and challenges and opportunities in clinical trial logistics operations and supply
PATIENT RECRUITMENT: consider suitable patient recruitment and retaining strategies and understand patient motivation in Central Eastern Europe
GOOD CLINICAL PRACTICE: Discuss the current status of ethics committees and ethical review systems in Central & Eastern Europe

Our exceptional speaker line-up includes special presentations by;
  • Dr Heinrich Klech, Senior Area Director, Medical & Regulatory, Europe (EMS), Eli Lilly
  • Dr Ramil Abdrachitov, Clinical Research Manager, Clinical Research Region Central and Eastern Europe – Russian Department AstraZeneca

Exclusive presentations from industry experts:

  • Christa Janko, Head of Operations, Vienna School of Clinical Research
  • Chris Tierney, Business Development Manager, Healthcare EMEA, DHL Exel Supply Chain
  • Tony Hersh, Clinical Research Director, Parexel
  • Ian Thompson, Medical Quality Assurance Advisor, Eli Lilly
  • Nawab Qizilbash, Director, Oxon Clinical Epidemiology Services and Consultant Geriatrician (Formerly, Director of Epidemiology and Evidence-Based Medicine, GSK)
  • Dr Georgi Georgiev, Clinical Research Manager, AstraZeneca CRR CEE Bulgaria
  • Jette Klose Frederiksen, Pharma Consultant, PharmaIT, NN IT
  • Dr Dennis Joseph, Regional Operations Director, Pfizer
  • Francis P. Crawley, Executive Director, Good Clinical Practice Alliance – Europe; & Co-founder & Steering Committee Member, Strategic Initiative for Developing Capacity in Ethical Review (SIDCER)

Who should attend SMi’s Conducting Clinical Trials in Europe Conference?
  • Medical Directors
  • Director of Clinical Operations
  • Outsourcing & Procurement Managers
  • Directors of Clinical Research
  • Senior Clinical Project Managers
  • Head of Regulatory Affairs
  • GCP Auditors

Venue Information


Prague Marriott Hotel

A majestic jewel in one of Europe's most enchanting cities, the Prague Marriott Hotel is steps from Old Town Square and major attractions. Known for first-class service and event facilities, the Prague Marriott Hotel features 1,452 sq meters of event space for intimate gatherings or large events alike.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dr Heinrich Klech

Dr Heinrich Klech, Senior Area Director, Medical & Regulatory, Europe (EMS), Eli Lilly

9:10 KEYNOTE ADDRESS

Dr Heinrich Klech

Dr Heinrich Klech, Senior Area Director, Medical & Regulatory, Europe (EMS), Eli Lilly

  • Examining the pros and cons of multi regional trials
  • Regulatory acceptance
  • Reducing costs
  • Ensuring quality of trials
  • Overcoming challenges
  • 9:50 ADVANTAGES AND DISADVANTAGES OF CLINICAL TRIALS IN RUSSIA AND EASTERN EUROPE

    Paul Loveday

    Paul Loveday, CEO, ClinStar LLC

  • Why has Eastern Europe become so “hot”?
  • Advantages of running clinical trials in Eastern Europe
  • Extraordinary patient recruitment

    Better quality than in the West and

    Better client service

    10:30 Morning Coffee

    10:50 CONDUCTING MULTINATIONAL CLINICAL TRIALS IN RUSSIA

    Dr Ramil Abdrachitov

    Dr Ramil Abdrachitov, Clinical Research Manager, Clinical Research Region Central and Eastern Europe – Russian Department, Astra Zeneca

  • Complying with GCP Standards
  • Local regulations
  • What’s the submission process?
  • Statistics about clinical trials in Russia
  • Optimising performance – key factors to consider
  • 11:30 MANAGING GLOBAL CLINICAL TRIAL LOGISTICS OPERATIONS

    Chris Tierney

    Chris Tierney, Commercial Development Manager, Healthcare EMEA, DHL Exel Supply Chain

  • Outlining the challenges
  • Presenting the opportunities
  • Evaluating the benefits
  • 12:10 Networking Lunch

    13:30 FORECASTING & PLANNING, A STRATEGIC FOCUS

  • Picking the winners ; optimal protocol design
  • Selecting sites in a competitive environment
  • Scenario planning to maximise recruitment rates and reduce time to market
  • Site management to ensure predicted recruitment rates are achieved
  • Cost effective contingency planning and proactive implementation
  • Tony Hersh

    Tony Hersh, Clinical Research Director, PAREXEL International

    Antoni  Jedrzejowski

    Antoni Jedrzejowski , Project Manager, Parexel

    14:10 INSPECTIONS IN EUROPE

    Ian  Thomson

    Ian Thomson, Medical Quality Assurance Advisor, Eli Lilly & Company

  • The challenges at sponosor as well at investigating sites
  • What still needs to be harmonised?
  • 14:50 Afternoon Tea

    15:20 FUNCTIONAL SERVICE PROVIDER ENGAGEMENT – A SOLUTION TO ACHIEVING FLEXIBLE RESOURCING?

    Dr Dennis Joseph

    Dr Dennis Joseph, Regional Operations Director, Pfizer Central Research

  • Why FSP?
  • What’s different about this model?
  • Did it deliver?
  • Would I recommend it to a friend or enemy?
  • What will it look like in years to come?
  • 16:00 COST-EFFICIENT PHASE IV TRIALS FROM MEDICAL DATABASES

    Dr Nawab Qizilbash

    Dr Nawab Qizilbash, Director Oxon Clinical Epidemiology & Honorary Senior Lecturer in Epidemiology, Imperial College, London University; Honorary Consultant Geriatrician, Hospital Cantoblanco, Madrid; Member , Green College, Oxford University

    16:40 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Georgi Georgiev

    Georgi Georgiev, Manager, Clinical Research, AstraZeneca Bulgaria

    9:10 BETTER & FASTER PATIENT RECRUITMENT

    Georgi Georgiev

    Georgi Georgiev, Manager, Clinical Research, AstraZeneca Bulgaria

  • Overcoming difficulties relating to patient recruitment
  • Understanding patient motivation
  • Accessing centralised healthcare systems
  • Understanding the regulatory, ethical and health authority requirements
  • 9:50 ECLINICAL METHODOLOGY AND ENTERPRISE ARCHITECTURE

    Philip Puls

    Philip Puls, Senior Project Manager, NNIT

  • R&D processes and IT systems must be approached by rethinking the entire eClinical landscape (applications and processes)
  • Defining a larger vision and architecture, by developing new and improved processes based on identified gaps, by building business cases for each chosen project area, and then initiating the projects in the best sequence to maximise benefits
  • It is important to move away from silo/stovepipe/legacy systems, towards a modular architecture based on browser/web access across organisational and geographical areas
  • 10:30 Morning Coffee

    10:50 TRAINING AND EDUCATION OF CLINICAL RESEARCH EXPERTS

    Dr Christa Janko

    Dr Christa Janko, Head of Operations, Vienna School Of Clinical Research

  • What expertise and skills are required?
  • Can Europe's "clinical research manpower" compete with other regions?
  • How is training and education of clinical researchers structured in Europe?
  • Where are the major training hubs? - Where are the gaps?
  • Where do we go? - Current initiatives in Europe
  • 11:30 IDENTIFYING AND RESOLVING COMPETING AND CONFLICTING INTERESTS IN CLINICAL TRIALS

    Dr Christa Janko

    Dr Christa Janko, Head of Operations, Vienna School Of Clinical Research

  • Details to be confirmed
  • 12:10 Networking Lunch

    13:30 CASE STUDY

    Joanna Przesmycka

    Joanna Przesmycka, Head Clinical Operations EuEast, Novo Nordisk Pharma

  • Adverse Event Reporting
  • Legal responsibilities
  • Preparing for inspections
  • Opportunities and challenges for clinical trials
  • 14:10 THE FUTURE OF GOOD CLINICAL PRACTICE AND ETHICAL REVIEW IN CENTRAL & EASTERN EUROPE

    Dr Francis Crawley

    Dr Francis Crawley, Director General, European Forum For Good Clinical Practice

  • The impact of the EU GCP Directive, as well as WHO & ICH GCP guidelines and US CFR on current practices in CTs in Central & Eastern Europe
  • The development of national GCP guidelines in Central & Eastern Europe
  • The current status of ethics committees and ethical review systems in Central & Eastern Europe
  • The development of associations for GCP and ethical review across the EU and Central & Eastern Europe
  • The impact of initiatives undertaken by the European Commission, Council of Europe, WHO, NIH, OHRP, and GCPAlliance – Europe in developing a GCP and ethical framework for CTs in Central & Eastern Europe
  • 14:50 Afternoon Tea

    15:20 ***PANEL DEBATE***

    The impact of the EU CTD on clinical research practices in CEE
    Personal experiences adapting to the directive
    Future changes needed to the legislation
    Are trials harmonised yet?
    Dr Francis Crawley

    Dr Francis Crawley, Director General, European Forum For Good Clinical Practice

    Georgi Georgiev

    Georgi Georgiev, Manager, Clinical Research, AstraZeneca Bulgaria

    Sigrid Boehme

    Sigrid Boehme, Study Team Leader, Global Study Management STH, Bayer-Schering Pharma

    Dr Dennis Joseph

    Dr Dennis Joseph, Regional Operations Director, Pfizer Central Research

    16:00 CLOSING KEYNOTE ADDRESS

    Marek Barger

    Marek Barger, Clinical Trials Manager, Pfizer

    16:40 Chairman’s Closing Remarks and Close of Conference

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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