2nd Annual

Clinical Trials Asia Summit 2011

13th May 2011, ITC Maratha, Mumbai, India

“A critical guide for successfully conducting clinical trials”

Key Speakers Include: Chirag Trivedi, Head - Medical Affaris Clinical

Arun Bhatt, President, Clininvent Research
Bhaswat S. Chakraborty, Senior Vice President,
Research and Development, Cadila
Girish S. Gudi, Vice President, Drug Metabolism and
Pharmacokinetics, Glenmark Pharmaceuticals
Zinobia Madan, Founder & Managing Director,
ClinOma Healthcare
Operations, Sanofi-Aventis
Milind Antani, Head-Pharma LifeSciences group,
Nishith Desai Associates
Farzana Lakdavala, Medical Advisor, Project Manager
Clinical Research, Wockhardt
Murtuza S. Bughediwala, General Manager, Clinical
Operations & Business Development, Clininvent
Research

Ammar Raza, Associate Director- Medical Affairs, Poonam Sule, Senior Manager - Clinical Research
AstraZeneca (International), Wockhardt

Viraj Rajadhyaksha, Associate Director - Medical Ashish Gawde, Senior Manager- Clinical Research,
Liaison, Sanofi-Aventis BAYER

Arani Chatterjee, Vice President, Clinical Research, Jeroze Dalal, General Manager Clinical Operations,
Panacea Biotec GlaxoSmithKline

Rohit Arora, Deputy Director, Sanofi Pasteur And many more.....

Parminder Kaur, Managing Director, RegPak

BioPharma Consulting (Netherlands)

Prashant Bodhe, Head Regulatory Affairs & Vice

President Operations, DMRI

Associate Partner

Supported By Organized By
 2nd Annual Clinical Trials Asia Summit 2011
13th May 2011, ITC Maratha, Mumbai, India.

Conference Intro:

India has billion plus population and a home for various life threatening diseases. However, these disadvantages provide an opportunity for global medical
practitioners and healthcare providers to look India as an effective destination for research and clinical studies. India has registered fast growth in the number of
clinical trials over the past few years, reflecting that the country has become one of the most attractive destinations for medical research. India represents a fast
growing market for clinical research and studies. The country has managed to position itself as one of the leading destinations for clinical trials over the past few
years. The number of clinical trials has increased, which has provided a boost to the country's reputation as a leading destination for these types of studies. The
availability of world-class healthcare infrastructure, skilled medical professionals, and low cost for patients and volunteers are some of the main factors driving
growth in this industry. The market is expected to perform well in future also and will reach US$ 768 Million by 2013, registering a CAGR of 29% since 2009.

2nd Annual Clinical Trials Asia Summit 2011 will examine the current issues faced in clinical trials operations, addressing the risks, timeline and budget stipulations, while
effectively tackling key challenges in overcoming trials agreement and site contract arbitration problems. This summit will discuss the operational element of trial site
management, strategic partnership with CROs and SMOs, patient, talent & investigators management in order to improve & optimise the overall drug development
effectiveness and ROI. Discover on how to implement and benefit from electronic data management & monitoring cost effectively. This conference will be shared by leading
industrial practitioners across the region to promote practical discussions; especially on the know-how to manage needs, variability of different countries and institutions to
enhance clinical operational excellence and vigilance.

Attendees will have the chance to learn, network and benchmark against the global top pharmas and local industry leaders on the best practices in talent, site, budget and
performance management in clinical trials. The conference aims to provide a detailed analysis of what it takes to conduct clinical trials from a biopharmaceuticals and
vaccines perspective in India and China and also addressing risk/benefit balance, anecdotal experiences of the multinational pharmaceutical industry in India and China,
selection and role of CROs, logistics of operations, clinical trials management, government policies and pharmacovigilance.

2nd Annual Clinical Trials Asia Summit 2011 will provide you with the data that you need to recognize this complex and rapidly-expanding sector. Knowing the future
market, and what impact will that have on future business opportunities? This is your opportunity to stay ahead by learning the latest trends and networking with the trend
setters.It gives us immense pleasure in welcoming you to the Clinical Trials Asia Summit '2011.

Key themes discussed at this Summit

• Where does India stand in the current global clinical trials market and how to take advantage of the same? How can you take advantage of the global market
for clinical trials?
• Discovering technologies and strategies for successful clinical trial management
• Strategies in conducting successful interventional oncology trials in India
• Setting up clinical trial research hub & techniques for applying risk management principles.
• Discovering global opportunities in clinical trial and selecting the right partners to penetrate successfully into the Indian market
• Identifying ideal clinical sites and strategizing patient recruitment and clinical sites management in India to develop appropriate clinical studies
• Avoiding potential pitfalls of trials agreement
• Regulatory review at the Drugs Controller General of India (DCGI) and Central Drugs Standard Control Organization (CDSCO): science, quality, and speed
• Effectively incorporating GCP & GCPs – Knowing what TO-DO and what NOT TO-DO
• Effectively managing cold chain and logistics in clinical trials
• Optimising clinical trials operation effectiveness and ROI through strategic site, patient, data and risk management in the regulated markets
• What are the issues with off-shoring trials to countries such as India & South Asia? – Solutions?
• Motivating and managing clinical project teams to improve timeline and progress
• Exploring the efficacy and safety of new interventions in clinical trials
• Drawing and retaining clinical talent pool to minimise turnover in clinical studies
• Next generation of clinical trials – How big will the market be?

Who Should Attend ?

Vice Presidents, Directors Heads & Managers of:

Clinical Research & Development, Clinical Research Services, Clinical Operations, Clinical Data Management, Clinical IT, Clinical Trials, Medical Affairs, Regulatory
Affairs, Compliance, Quality control / Assurance/GCP, Clinical Study Design, Safety Surveillance, Subject Recruitment, E-Clinical Systems

Target Audience: Industry

Pharmaceutical Organisations, Generic pharmaceutical companies, Contract Research Organisations, Patient Recruitment Companies, Government- Department of
Health, Non-profit organisations/ Association, Academics, Consultants

Why should you attend:

2nd Annual Clinical Trials Asia Summit 2011 - “A critical guide for successfully conducting clinical trials”

Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated
networking drinks time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your
knowledge of the latest business models and strategies in the high-level conference.

Sponsorship & Exhibition Opportunities:

Delegate Registration:
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To register and to book your seats at the conference - please
then exhibit is perfect for you.
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· Providing branded bags, pens, gifts, etc.
· Hosting a networking drinks reception
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· Taking an exhibition space at the conference
ideas
· Target your marketing campaign

Any questions on Sponsorships or Exhibition – Email your queries to sponsor@virtueinsight.com

 2nd Annual Clinical Trials Asia Summit 2011
13th May 2011, ITC Maratha, Mumbai, India
08:30 – Coffee and registration
09:30 – Chairperson opening remarks
Bhaswat S. Chakraborty, Senior Vice President, Research and
Development, Cadila
09:40 – Morning Keynote Address: - Evaluating Clinical Trials
in India - New drug discovery & Development
• Where does India stand in the current global
clinical trials market and how to take advantage of the
same?
• To enhance global clinical trial management.
• Identifying successful techniques of risk reduced cost
management practice.
10:20 – New findings in clinical trial design.
• New skills in clinical trial design and
discovering global opportunities in clinical trial
• New strategies and best practices to do better
trials.
• Highlighting clinical trial design and sharing
new scientific findings.
• Addressing the ethical issues in design &
implementation of clinical trials
• What are the new features introduced in the
clinical trial.
10:50 – Morning coffee & Discussion
11:10 – Panel Discussion: Growing challenges &
opportunities of clinical trial in India
• What are the current challenges faced in today’s market
and discover on how to successfully overcome them in this
highly competitive market.
• Analyzing the opportunity for clinical research organizations
to invest in early stage drug discovery.
• Trial intelligence in Indian clinical trials - Reducing the
duration of trials?
• Determining latest economic opportunities to retain
business wealth and why is India a fitting place for clinical
trial in Asia
• Key challenges to overcome: unethical trials, approval
delay, clinical data sharing, and certified investigator
shortage
Moderator:
Bhaswat S. Chakraborty, Senior Vice President, Research and
Development, Cadila
Panellists:
Jeroze Dalal, General Manager Clinical Operations,
GlaxoSmithKline (http://in.linkedin.com/pub/jeroze-dalal/8/309/a49)
Viraj Rajadhyaksha, Associate Director - Medical Liaison,
Sanofi-Aventis
(http://in.linkedin.com/pub/viraj-rajadhyaksha/13/358/ab2)
Farzana Lakdavala, Medical Advisor, Project Manager Clinical
Research, Wockhardt
Ashish Gawde, Senior Manager- Clinical Research, BAYER
(http://in.linkedin.com/pub/ashish-gawde/18/625/6aa)
11:40 – Design of Clinical Drug-Drug Interaction Studies
• Drug-drug interactions are a common problem during drug
treatment and can have implications in safety and efficacy
of medication.
• The aim of drug interaction studies performed on new drug
candidates under development is to gain knowledge on how
the new drug candidate affects other medicinal products
and vice versa.
• The drug-interaction potential should be taken into account
in the risk-benefit evaluation of the drug and has
implications in labelling and marketability.
• Considerations in the design of clinical drug-drug
interaction studies will be discussed in this talk.
Girish S. Gudi, Vice President, Drug Metabolism and
Pharmacokinetics, Glenmark Pharmaceuticals
(http://in.linkedin.com/pub/girish-gudi/9/743/34a)
12:10 - Managing risks and improve efficiency when managing
clinical supply chain in India
• Formulating strategies to target identified risks and
challenges when outsourcing clinical supply chains
• Assessing the readiness of the infrastructure of Local depot
network for clinical supplies to achieve optimal operation
and cost - efficiency
• Implement systematic demand forecast techniques to
ensure punctual clinical supply
• Establishing successful risk mitigation strategies to
transform resilient supply chains into a competitive edge
12:40 – Quality assurance and controversies arising out of
Clinical Trials.
• Discussing the effective communication methods in clinical
trial.
• Significance of quality assurance when outsourcing clinical
trial to India
• Integrate various clinical trial systems to improve data
quality
Arun Bhatt, President, Clininvent Research
(http://in.linkedin.com/pub/arun-bhatt/5/431/958)
13:10 - Networking luncheon - Take your discussions
further & build new relationships in a relaxed
& informal setting...
 2nd Annual Clinical Trials Asia Summit 2011
13th May 2011, ITC Maratha, Mumbai, India.
Afternoon Chairperson :
Zinobia Madan, Founder & Managing Director, ClinOma
Healthcare (http://in.linkedin.com/pub/zinobia-madan/28/890/12)
14:10 - Effectively managing cold chain and logistics in clinical
trials
· Overcoming challenges in clinical trial logistics and ensuring
data security during the packaging and distribution process
· Managing the gap efficiently and successfully between cold
chain storage, clinical packaging, distribution and logistics
· Identifying risks and forecasting potential risks in the clinical
supply chain
· Combining technology and skilled workforce in mitigating
risks and the threat to the clinical data
14:40 – Panel Discussion: Update yourself towards
guidelines and regulations in the Indian clinical trial market.
• Regulatory review at the Drugs Controller General of India
(DCGI) and Central Drugs Standard Control Organization
(CDSCO): science, quality, and speed
• Assessing the regulatory environment, infrastructure built
up and talent availability in India to determine your clinical
trial strategies
• Challenges in regulatory for the global expansion in clinical
trial.
• In the clinical trial environment implementation –
Implementing right global strategies at the right time?
Moderator:
Milind Antani, Head-Pharma LifeSciences group, Nishith
Desai Associates
(http://in.linkedin.com/pub/dr-milind-antani/3/792/22b)
Panellists:
Rohit Arora, Deputy Director, Sanofi Pasteur
(http://in.linkedin.com/in/drrohitarora)
Arani Chatterjee, Vice President, Clinical Research, Panacea
Biotec (http://in.linkedin.com/in/aranichatterjee)
Parminder Kaur, Managing Director, RegPak BioPharma
Consulting (Netherlands) (http://nl.linkedin.com/pub/parminder-
kaur/3/6b2/5b4)
Prashant Bodhe, Head Regulatory Affairs & Vice President 17:10 - Chairperson's closing remarks
Operations, DMRI
Zinobia Madan, Founder & Managing Director, ClinOma
Healthcare (http://in.linkedin.com/pub/zinobia-madan/28/890/12)
15:20 – Afternoon Coffee & Discussion
15:40 – New EU pharmacovigilance directive and its impact on
clinical trials conducted in India
Parminder Kaur, Managing Director, RegPak BioPharma
Consulting (Netherlands) (http://nl.linkedin.com/pub/parminder-
kaur/3/6b2/5b4)
16:10 – Margin of safety: Identifying ideal clinical sites and
strategizing patient recruitment and clinical sites management in
India to develop appropriate clinical studies
• To implement correct safety and healthy measures.
• Ensuring security of clinical data and non-disclosure.
• Avoid striving to find suitable patients and to obtain their
consent
• Importance Of site selection & patient recruitment strategies
in India
• Drug safety and its pivotal role in clinical development in
India current and future
Ammar Raza, Associate Director - Medical Affairs, AstraZeneca
(http://in.linkedin.com/pub/dr-ammar-raza/7/4a2/887)
16:40 – Panel Discussion: Discovering global opportunities in
clinical trial and selecting the right partners to penetrate
successfully into the Indian market
• Understanding sponsors principle for selecting the local
clinical research organization
• Anticipating trends in clinical trials towards 2012
• Efficient partnering and managing the outsourced clinical
trial process
• Understanding India’s offering in large scale global trials:
cost, resources, patient pool.
• Effectively incorporating GCP & GCPs – Knowing what TO-
DO and what NOT TO-DO
Moderator:
Panellists:
Murtuza S. Bughediwala, General Manager, Clinical
Operations & Business Development, Clininvent Research
(http://in.linkedin.com/pub/dr-murtuza-bughediwala/6/8b1/a85)
Subashri Shivkumar, Hub Unit Director-Regional Clinical
Operations, Bristol-Myers Squibb
(http://in.linkedin.com/in/subashrishivkumar)
Chirag Trivedi, Head - Medical Affaris Clinical Operations,
Sanofi-Aventis (http://in.linkedin.com/pub/dr-chirag-trivedi/21/b0/344)
Poonam Sule, Senior Manager - Clinical Research
(International), Wockhardt
(http://in.linkedin.com/pub/dr-poonam-sule/7/169/3a6)
17:20 - Networking Drinks - Take your discussions
further & build new relationships in a relaxed
& informal setting...
Patrial list of attendees from our previous Clinical Trials Asia Summit 2010
Accenture, Alkem laboratories, Apotex Research, Astellas Pharma, AstraZeneca, Atharva Lifesciences Consulting, Bentham Science
Bristol-Myers Squibb, ByteMindz, Cadila, Cambridge Research and Instrumentation, Clinical Research Services,
Clinigene International Limited, Clininvent Research, ClinOma Healthcare, Clintrials Research Pvt. Ltd, Cognizant Technology Solutions, CSC,
Cygnus Business Consulting & Research Pvt Ltd, Dr. Reddys, Eli Lilly, Fresenius-Kabi Oncology, G7 Synergon, Genericlicensing,
Global Health, GlaxoSmithKline, HCL Technologies, IACR (Indian Academy of Clinical Research), Johnson and Johnson,
MMSH Clinical Research Pvt. Ltd, MS Clinical Research, Nextvel Consulting, Nishith Desai Associates, Novartis,
OmniActive Health Technologies, P.D. Hinduja National Hospital & MRC, Patient Safety and Pharmacovigilance, PercipEnz Technologies,
Pfizer, Pharmacast, PharmaLeaf, Pharmavioce, Pharm-Olam (UK), Piramal Life Sciences, PRIME Hospital, Profil Institute - Clinical Research,
Provenance Research, Quartesian Clinical Research, RegPak BioPharma Consulting, Ruby Hall Clinic, Semler Research Center Pvt Ltd,
Serum Institute of India, SiroClinpharm, Sristek Consulting, St.John's Medical college, Stempetuics Research, Tech – Observer,
Techsol Systems, TechTree IT Systems, Unilever, Unithink Soft Solutions, Until Roi, VAC3 Clinical Services, Vibha Pathlabs & Hormone Centre,
Voisin Consulting Life Science, WHO, Wockhardt, YCLIN

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 2nd Annual Clinical Trials Asia Summit 2011
13th May 2011, ITC Maratha, Mumbai, India.

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