The 2nd Annual VibPharma Clinical Trials Conference in Emerging Markets will take place in Prague on March 1-2, 2010, focusing on maximizing opportunities for global clinical development. Attendees will hear from distinguished speakers on various topics including site selection, patient recruitment, and regulatory challenges specific to emerging markets like India and Eastern Europe. The event aims to foster networking and provide insights into navigating the complexities of conducting clinical trials in these regions.

1. 2nd Annual
VIBpharma
Clinical Trials in
Emerging Markets
Maximising the opportunities for
global clinical development
Monday 1 – Tuesday 2 March 2010, Prague, Czech Republic
DISTINGUISHED SPEAKERS INCLUDE:
Anish Desai, Eric Hurden,
Head R&D and Medical Director, Associate Director, Global Clinical
BAyER HEALTHCARE INDIA Operations, BIOGEN IDEC
Ramil Abdrachitov, Josemund Menezes,
Clinical Research Manager, Clinical Clinical Project Leader and Medical
Research Region Central and Eastern Advisor CRU – India,
Europe – Russian Department, SANOFI AVENTIS
ASTRAzENECA
Eva Lapkova,
Pavel Farkas, Clinical Monitoring Manager for Czech
Senior Director, Biopharmaceutics, Republic, Slovakia and Hungary,
PLIVA CROATIA MERCK
Jörg Möller, Cem Ozesen,
Senior Vice-President Head, Global Clinical Research Manager,
Clinical Development, MERCK
BAyER SCHERING PHARMA
WHy yOU SHOULD ATTEND?:
Attend
to netw
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• Improve your long-term clinical development over 50 rk with
strategies by understanding how to maximise
pharma leading
opportunities in emerging markets an
compan d biotech
• Identify challenges with site selection and ies fro
patient recruitment and discover e ective
methods to overcome them
around m
the wor
• Discover channels where you can improve ld
your o -shoring strategy and make the most
of opportunities for conducting trials in
emerging countries
• Uncover the pros and cons of importing and Sliver sponsor:
exporting drugs and biological samples in
order to save money on your operations
REGISTER NOW:
■ Online: www.clinicaltrialsevents.com/emerging-markets/register ■ Tel: +44 (0)20 7753 4268
■ Email: book@arena-international.com ■ Fax: +44 (0)20 7915 9773

2. Programme day one Monday 1 March 2010
8:30 Registration ● Upgrading ethics committees to govern all local trial sites
Site management organisation and maximising
9:00 Opening remarks from the Chair ●
patient recruitment
Eric Hurden, Associate Director, Global Clinical Operations,
● Retaining talent in an increasingly competitive
BIOGEN IDEC
trial environment
PROJECT AND SITE MANAGEMENT SOLUTIONS ● Capacity building at the clinical sites and reducing
FOR OFFSHORE TRIALS patient drop-out rates
● Overcoming infrastructure restrictions and identifying
9:10 Getting the site selection right to achieve the best strategy for advancing clinical trials
optimal study outcomes Josemund Menezes, Clinical Project Leader and Medical
● Ensuring that sponsors understand the pros and cons Advisor CRU – India, SANOFI AVENTIS
of each site location
● Determining ways to access to patient population and 12:10 Infrastructure challenges in conducting trials in India
make the recruitment process easier ● Dealing with the lack of processes and systems in regards to
● Understanding the regulatory approval processes communication and conducting clinical trials abroad
● Establishing a relationship with local authorities ● Finding adequate clinical facilities and trained clinical
● Understanding the benefits of chosen sites for long term investigators
trial sustainability and patient retention ● Overcoming regulatory barriers to entry in site selection
Ramil Abdrachitov, Clinical Research Manager, ● Ensuring adequate record keeping on paper and available
Clinical Research Region Central and Eastern Europe – electronic databases
Russian Department, ASTRAzENECA Viraj Rajadhyaksha, Senior Manager, Operations, Planning
and Management Clinical Research, PFIzER INDIA
9:40 Non-invasive monitoring and management
of global trials 12:40 Lunch
● Giving CROs flexibility whilst ensuring the best use of
resources are met and there are minimal delays PRACTICAL AND ETHICAL CHALLENGES IN
Maintaining ongoing communication to identify
EMERGING MARKETS
●
problems early
● Ensuring key deliverables and timelines are met 14:00 Feasibility studies for informed decision making
● Understand the practicalities of vendor management in when conducting clinical trials in emerging regions
offshore trial sites ● Adequate country selection and patient
● Making the decision for keeping project management recruitment projections
in-house or outsource to a service provider ● Facilitating the decision making process through a
Olav Flaten, Medical Director, GSK analysis of options
Start up challenges and avoiding delays to study progress
10:10 Panel Discussion: Setting up metrics for
●
Evaluating the benefits of emerging markets compared
trials in emerging countries
●
to developed countries
● Developing performance metrics that are appropriate to the
● The benefits of taking a non survey approach to feasibility
circumstances and meet the challenges of the trial
● Cost benefit analysis to reveal the full extent of the pros
● Adapting existing measures once trial sites are chosen
and cons
● Determining all variables that can affect a trial to assist with
Eric Hurden, Associate Director, Global Clinical Operations,
minimising risk
BIOGEN IDEC
● Variations in metrics for different trial sites
10:40 Morning Refreshments 14:30 When and how to conduct a successful clinical
trial in an emerging clinical research country
Key decision drivers supporting the conduct of
MAXIMISING OPPORTUNITIES AND OVERCOMING ●
your trial abroad
CHALLENGES IN INDIA AND ASIA-PACIFIC ● Managing cultural differences and minimising
11:10 Keynote presentation: Clinical development in risks of errors
emerging markets: the case of the Asia-Pacific ● Ensuring that every site complies with both local
region and global ethics board
● Understanding current regulatory and legal aspects ● Choosing trial partners through analysis of ethical
of the region and GCP compliance
● Developing your strategy for complying regulations ● Patient recruitment considerations for building a
and communicating with regulatory bodies sustainable trial environment
● Successfully navigating the approval process ● Sustaining local access to treatments found to be
● Determining the restrictions on importing and exporting safe and effective
of drugs and biological samples Cem Ozesen, Clinical Research Manager, MERCK
● Dealing with ethics committees
Jörg Möller, Senior Vice-President Head, Global Clinical 15:00 Panel Discussion: Choosing the right trial
Development, BAyER SCHERING PHARMA partner through an efficient and thorough
selection process
11:40 Maximising the benefits of the growing ● Setting a selection criteria to find the right quality partner
market for trials in India ● Information gathering processes to determine partners
● The benefits of high quality medical staff and an increasingly capabilities and strengths
professional regulatory framework ● Understanding competencies and track records in
● Development in regulations and reviewing the benefits of chosen trial sites
setting up clinical trials in India ● Agreeing to robust contracts that cover all study areas

3. Programme day Two
● Minimising the time taken for partner selection to reduce 8:30 Registration
overall cost of clinical trials
● Establishing a relationship of trust to get the trial off to the 9:00 Opening remarks from the Chair
best start Pavel Farkas, Senior Director, Biopharmaceutics,
PLIVA CROATIA
15:30 Afternoon refreshments
09:10 Delegates will be able to attend three one-hour
CASE STUDIES FROM CENTRAL AND roundtable discussion groups from a selection of key
EASTERN EUROPE topics. Each session will be chaired by an industry
expert who will facilitate an exchange of opinions,
16:00 Making the most of clinical trial hubs in the Czech essential experiences and learning related to a
Republic, Slovakia and Hungary current aspect of data management
● Strategic issues and consequences for key trial decisions
● Developing awareness of different regulations, licensing Roundtable 1
environments, patient populations and expectations Ethical considerations of conducting trials
● Building the expertise amongst clinical investigators to
in emerging markets
successfully set up and run trials
● Understanding local regulations and operating within
● Considerations for sponsors with limited experience in
guidelines to ensure compliance ethical codes of conduct
Central and Eastern Europe for setting up clinical trials
Cem Ozesen, Clinical Research Manager, MERCK
Eva Lapkova, Clinical Monitoring Manager for Czech
Republic, Slovakia and Hungary, MERCK
Roundtable 2
16:30 Overcoming cultural and communication barriers Advantages and challenges of conducting trials
when conducting trials in Eastern Europe in Eastern Europe
● Tailoring project management and communication ● Navigating obstacles in trial set up and project management
processes for offshore trials in core trial sites
● Matching patient expectations with recruitment Ramil Abdrachitov, Clinical Research Manager, Clinical
processes for different sites Research Region Central and Eastern Europe – Russian
● The challenge of working with different bureaucratic Department, ASTRAzENECA
bodies and regulatory processes
● Communication techniques to secure co-operation from Roundtable 3
authorities without delaying trial set up processes Maximising the benefits of clinical trials in Asia
● Agreeing clear and measurable outcomes, timelines, ● Identifying suitable locations and working with local
costs and expectations with local trial partners and authorities to facilitate trial conduct
recruiting adequately skilled staff Lesley Mathews, Strategic Sourcing Manager,
Mikhail Putilovskiy, Clinical Operations Manager, BAyER HEALTHCARE
ELI LILLy RUSSIA
Roundtable 4
17:00 Closing remarks from the Chair and close of Day One
Identifying opportunities in the Asia-Pacific region
for cost effective clinical development
● Making the most of available resources and expertise
in the region
Jörg Möller, Senior Vice-President Head, Global Clinical
Development, BAyER SCHERING PHARMA
Roundtable 5
Developing and maintaining successful a relationship
between trial sponsors and service providers
● Building trust and agreeing measureable outcomes for trials
in unfamiliar territories
Pavel Farkas, Senior Director, Biopharmaceutics,
PLIVA CROATIA
Roundtable 6
Managing patient expectations and implementing a
successful patient recruitment and retention strategy
● Maximising the opportunity for patient recruitment and
maintaining the long term viability and success of the trial
Olav Flaten, Medical Director Norway, GSK
12:40 Lunch
Register online now at: www.clinicaltrialsevents.com/emerging-markets/register

4. PosT-conference workshoP
Tuesday 2 March 2010
Successful CRO selection
14:00 The challenges and benefits of conducting trials
in the Czech Republic and monitoring processes
●
●
Reviewing the challenges of setting up trials
Designing trial structures to take account of local when conducting trials in
●
infrastructure and site constraints
Understanding the regulatory issues emerging markets
● Making the most of patient recruitment opportunities
wednesday 3 March 2010
● Maximising drug development in the Czech Republic
Petr Cypro, Medical Director, BRISTOL MEyERS SqUIBB led by: roger Joby, Managing director, 1to1to1
About the workshop:
LONG TERM STRATEGIES FOR CLINICAL Choosing the right trial partner is a crucial step towards building a
DEVELOPMENT successful clinical trial model but trial sponsors must have a clear vision
of trial aims and communicate this effectively to partners throughout
14:30 Panel discussion: The sustainability of global
the selection process and the conduct of the clinical trial. Knowing your
studies in emerging markets goals makes it easier to make decisions on selection criteria and carry
● Determining the long term value of conducting out assessments of the strengths and capabilities of potential partners.
trials in emerging countries
● Assessing outsourcing decisions on the basis of Having made the decision on your trial partner, the importance of
quality, cost and measurable outcomes contract negotiation and subsequent project monitoring is paramount
in order to achieve the goals of the trial on time and on budget. This
● Anticipating cost increases in a rapidly
workshop provides a practical and interactive environment in which
professionalising and competitive trial arena
to engage with the challenges of CRO selection and monitoring. It
● Robust quality assurance frameworks to determine is intended to enable delegates to share experiences of selection
value for money strategies, contract planning and trial monitoring.
● Ascertaining the long term effectiveness of
offshoring strategies
Workshop agenda:
15:30 Afternoon refreshments 9:00 Registration and coffee
9:30 Effective planning for making optimal
INDIA: COMPETING IN A GROWING MARKET
selection decisions
FOR CLINICAL DEVELOPMENT ● Knowing your goals – balancing decisions on quality,
15:30 Recruiting trained CRAs and investigators in a timelines and trial costs
competitive Indian market ● The impact of site selection on selection processes –
● Finding the most qualified professionals as the local expertise and availability of resources
number of trials increase ● Developing study metrics and key deliverables of a trial
● Setting the criteria for staff recruitment to ensure
appropriate levels of experience and expertise 10:15 The process of selection
● Working with clinical trial training institutes to supply ● Understanding candidates partners capabilities
qualified professionals and strengths
● Staff retention in the face of intense competition ● Requests for information and requests for proposals
between trial sponsors ● Due diligence and analysis of proposals
● Making the most of the professionalisation in the ● Matching trials to appropriate CROs
industry to reduce trial errors
11:00 Refreshments
● The long term clinical trial strategy for emerging countries
Anish Desai, Head Research and Development and 11:30 Contract negotiation and agreement
Medical Director, BAyER HEALTHCARE INDIA ● Matching contracts to desired trial outcomes
● Choosing a fixed, fixed unit priced or variable contract
16:00 Conducting clinical studies for generic ● Protecting your trial against cost and time overruns
pharmaceuticals in India: a global sponsor's view
● Dealing with the lack of processes and systems for 12:15 Project monitoring and evaluation
communication and conducting clinical trials ● Planning the project management functions to ensure
● Finding adequate clinical facilities and trained clinical adequate oversight functions
investigators ● Developing performance metrics for measuring conduct
● Overcoming regulatory barriers to entry in site selection and outcomes of the trial
● Ensuring adequate record keeping on paper and ● Earned value analysis
available electronic databases
Pavel Farkas, Senior Director, Biopharmaceutics, 13:00 Close of workshop
PLIVA CROATIA
About your workshop leaders:
17:00 Closing remarks from the Chair and close of Roger Joby B.Sc. MAPM is the Managing Director of 1to1to1. Roger has
conference been involved in the pharmaceutical industry for over 30 years working for
both CROs and pharmaceutical companies and now as an independent
consultant. Roger’s experience includes project management, proposal
generation, sub-contractor contacts and project finance.
1to1to1 is part of R. & N.R. Consulting specialising in project management
consultancy in clinical research. The company was formed in March
2000 and has a range of clients that include large and medium sized
pharmaceutical companies, bio-techs and CROs

5. Silver sponsor: About the Conference
DOKUMEDS CRO VIBpharma is proud to announce the launch of our second
Eastern Europe based Full annual Clinical Trials in Emerging Markets conference
Service CRO operating since taking place in Prague on 1-2 March 2010.
1995 in Latvia, Lithuania, Estonia, Russia and Ukraine. Phase
II-IV clinical R&D services including Project Management, In the current economic climate reducing costs and
Regulatory Services, Contract and Finance Management, Data increasing efficiency during the clinical trial process is
Management and Medical Consultancy. Member of CROs crucial to sustaining the long term development of new
alliance (Acrossalliance) operating in East-Central and South treatments. There exists challenges, in setting up and
Europe; ISO certified in International Project Management.
www.dokumeds.lv
running a clinical trial that must be overcome. A key
factor in determining the effectiveness of your trial is
Media Partners: recruiting the right types of patients at the right time. It is a
complex and intricate area, requiring knowledge of human
Pharmaceutical Technology is behaviour, marketing and management expertise, together
used daily as a means of creating with scientific knowledge.
partnerships and as a point of
reference by professionals within the pharmaceutical industry. As more pharma and biotech companies look to emerging
This comprehensive resource supplies the latest news releases, regions to conduct their studies the need for information,
detailed information on industry projects, white papers, expertise, guidance and advice on managing the pitfalls of
event information and a thorough breakdown of products and
services. www.pharmaceutical-technology.com operating in new and unfamiliar countries becomes greater
than ever. Emerging regions such as Eastern Europe and
Biocompare is the most comprehensive, in-depth, and Asia, where large patient populations are available pose,
objective website for life science product information.
opportunities but also risks. Key challenges encountered
Thousands of scientists use Biocompare daily to quickly find
the right product for their experiments rather than looking by sponsors include:
through multiple print catalogs. Visit www.biocompare. ● Obtaining regulatory approval in trial sites and
com to find the products you need, stay informed of new working with national regulators in an ever changing
technologies, read product reviews, watch product videos,
bureaucratic landscape
and keep up-to-date on life science news.
● Import licences and overcoming supply chain issues
GlobalData GlobalData's Report Store
features thousands of high ● Infrastructure and communications challenges in
quality research reports across a broad range of industries. developing countries
The reports draw on in-depth primary and secondary research,
databases of proprietary in house data and high quality ● Choosing trials partners and outsourcing to local
analysis from our expert teams. Data and analysis at the or global CROs - ensuring that the partnership is
company, country and industry level includes competitors, effectively managed is paramount
valuations, trends, forecasts and analytics.
www.global-market-research-data.com ● Recruiting adequately trained clinical investigators
VIBpharma’s Clinical Trials in Emerging Markets conference
Join our Linked-in group online. will bring together pharma and biotech companies to
Name: Clinical Trials Arena share solutions to strategic and operational challenges
in setting up and conducting studies in new territories.
Attendees will hear from experienced professionals who
Who should attend? will share their knowledge on making the most of the
The audience will be made up of Vice Presidents, opportunities and benefits of conducting trials in emerging
Directors and Managers within pharmaceutical and markets. Attend this practical, insightful and solution led
biotech companies from the following areas: event to generate new cost and time saving ideas
• Outsourcing
• Clinical Operations
• Procurement
• External Alliances
• Clinical Trials
• Clinical Research
• R&D
• Project Management
Do you wish to exhibit your products
• Contracts and services at this exclusive event?
• Legal
If you want to be a part of this leading industry event,
• Counsel please contact Jaz Sidhu in our sponsorship team.
jazsidhu@arena-international.com
Tel: +44 (0) 20 7753 4259

6. Booking Form
Clinical Trials in Emerging Markets, Monday 1 – Tuesday 2 March 2010, Prague, Czech Republic
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