Conference on 2nd Annual Clinical Trials in India and China
To be held at 7th - 9th October 2009, BSG Conference Centre, London, UK
Key Speakers
Dr Harvinder Popli, Director and Head In-Licensing, Ranbaxy Labs
Arun Mishra, Associate Director, Worldwide Regulatory Strategy - Emerging Market, Pfi zer
Paul Quinn, Senior Clinical Programs Director, Shire Pharmaceuticals
Francis P. Crawley, Executive Director, Good Clinical Practice Alliance (GCPA)
Paul Travis, Global Clinical Development Director, Huntingdon Life Sciences
Mark Wren, Director, International eServices & Support, Phase Forward
Dr Rajesh Jain, Head – Advanced Development & Clinical Supplies, Reliance Clinical Research Services
Dr Raghib Ali, Clinical Lecturer in Clinical Pharmacology and General Medicine, University of Oxford
Jit Solanki, Medical Director EMEA, Global Medical Affairs, Wyeth
Dr Josemund Menezes, Clinical Project Leader & Medical Advisor, Sanofi -Aventis
Dr Yazhong Deng, General Manager (China) & Senior Manager Biometrics (Regional), GleneaglesCRC
Paul Travis, Global Clinical Development Director, Huntingdon Life Sciences
Sanjiv Kanwar, Managing Director, Polaris Biopharma Consulting
Target Audience
• Pharmaceutical and Biotechnological Companies
• Contract Research Organisations (CROs)
• Contract Manufacturing Organisations (CMOs)
• Drug Regulators, Intellectual Property/Law Firms
• Academia, Government Bodies, Regulatory Affairs
• Clinical Research Scientists
Who should attend?
Clinical trials manager, Clinical development manager, Clinical process
manager, Medical advisor, International/
Quality control/assurance manager, Clinical research manager, Scientifi c
affairs manager, GCP manager, QC associate drug safety manager,
Clinical operations manager, Clinical project leader, Pharmacovigilance
statistician, Biostatistician, Data manager, Clinical pharmacologist, Drug
evaluation manager, Medical director, Global outsourcing manager,
Patient recruitment advisor, Intellectual property associate
Counsels, Analysts, Consultants of:
• Clinical trial operations
• Regulatory affairs
• Risk assessment
• Intellectual property
Day 1
2nd Annual Clinical Trials in India and China
Thursday 8th October 2009
09:30 Registration and refreshments
10:00 Opening address from the chair
10:10 Current & emerging trends in clinical trials
• Identifying the market potential and prospects of the global
clinical trials business
• Assess the changing dynamics of research and development processes
Jit Solanki
Medical Director EMEA, Global Medical Affairs
Wyeth
10:50 Outsourcing clinical trials to India and China,
the steps in the decision process
• Background on pharma trials conducted in India and China
• Shire’s experience to date of India and China
• Drivers for conducting trials in India and China
• How to prepare for a decision on outsourcing/
India and China
Paul Quinn
Senior Clinical Programs Director
Shire Pharmaceuticals
11:30 Morning refreshments
11:50 Managing ethical review and informed consent procedures in India and China
• The principle ethical concerns for clinical trials in the region
• The foremost national and international guidelines for research
ethics in the region
• The structure of ethical review committees and procedures in
India and China
• Differentiating informed consent procedures according to countries
and populations
• The impact of the 2008 revised ‘Declaration of Helsinki’ on the
ethics of clinical trials in the region
Francis P. Crawley
Executive Director
Good Clinical Practice Alliance – Europe (GCPA)
12.30 Looking ahead at India & China
• How lucrative are India & China for conducting clinical trials?
• Evaluating the cost efficiency of R&D and clinical development in
these markets to boost your business
• Implementing strategies and techniques to establish effective
outsourcing model in these markets
Lammert Albers
Head of Business Development, Europe & Asia
MDS Pharma Services
13:10 Networking lunch
14:30 Leveraging clinical trials for strategic alliance: Case Studies in India
• Mapping the current scenario of the clinical trials market in India
• Forecasting the growth prospects in India
• Leveraging clinical trial strength for strategic alliance
Dr Harvinder Popli
Director and Head In-Licensing
Ranbaxy Labs
15:10 China – A success story in clinical trials
• The current scenario of the market in China
• Navigating the environment in China: regulatory, site, ethics,
language, culture
• Optimize the strategies for clinical trials in China
• Is China the next superpower in clinical trials business?
Dr Yazhong Deng
General Manager (China), Senior Manager Biometrics (Regional)
GleneaglesCRC
15:50 Afternoon refreshments
16:10 Liberating monitoring from project management
• Site monitor or a site manager - the conflict of interest
• Restoring core functions of monitoring in emerging countries
• Case for good monitoring practices
Dr Rajesh Jain
Head – Advanced Development & Clinical Supplies
Reliance Clinical Research Services
16:50 Asia-Pacific:
• Review of the growth of clinical trial activity outside of the North American and European regions, and the broad benefits of including Asia Pacific within global drug development programmes
• Demonstrate the prevalence of EDC technology throughout the Asia Pacific region to date
• Demonstrate through practical examples how a global EDC solution with multilingual capabilities can bring drugs to market in multiple regions of the world at a significantly faster pace than previously experienced
• Explain how clinical trial managers can review data in one language that was collected in multiple languages
Mark Wren
Director, International eServices & Support
Phase Forward
17:30 Closing remarks from the chair
17:35 Networking Drinks Reception
Take your discussions further and build new relationships
in a relaxed and informal setting.
Day 2
2nd Annual Clinical Trials in India and China
Friday 9th October 2009
09:30 Registration and refreshments
10:00 Opening address from the chair
10:10 Patient recruitment & retention – any problem?
• Discuss strategies to overcome challenges and future trends in global patient enrollment with a focus on India
• Patient dynamics, medical and cultural backdrop
• Multi-regional trials - one size fit all?
• Strategies for selecting the right types of sites for success
• Regional and investigational sites growing pains
• What’s changing - sponsor, regulatory authority and investigational site focus
Sanjiv Kanwar
Managing Director
Polaris Biopharma Consulting
10:50 Investigate the pros and cons of contract research services in India & China
• Complexity of patient recruitment process
• Intellectual property rights
• Collaborations and negotiations
• Prospects & cost competitiveness
Dr Josemund Menezes
Clinical Project Leader & Medical Advisor
Sanofi-Aventis
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