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Clinical Trials &

Partnering India 2010
Towards global standards and excellence in clinical development
24-25 May 2010 Hyatt Regency Mumbai, India

Featuring latest updates and industry case studies from:

Dr Shailesh Mehta, Vice President,
Clinical R & D, Medical Affairs
Biologicals - South Asia,
Glaxosmithkline Pharmaceuticals
Dr Mohanish Anand, Regional Head
Clinical Operations-Asia, Pfizer Global
Research & Development
Dr Rajinder Kumar Jalali, Director,
Medical Affairs & Clinical Research,
Ranbaxy Laboratories
Dr Siddharth Chachad, Medical &
Safety, Regulatory Affairs, Cipla
Dr Narendra Maharaj,
General Manager, Global Clinical
Operations, Glenmark Research Centre,
Glenmark Pharmaceuticals
Dr Deven Parmar, Vice President -
Clinical Research, Wockhardt
Dr Mubarak Naqvi, CRU Director,
Sanofi-aventis
Dr Partha Gokhale, Head of Clinical
Operations, Wyeth Research
Sundeep Shrivastava, Post Marketing
Clinical Associate, Asia, Abbott
Healthcare
Dr Anil N Shinde, Clinical Operations
Director, Novo Nordisk
Prof Y K Gupta, Head, Dept. of
Pharmacology, All India Institute of
Medical Sciences; & Coordinator,
Pharmacovigilance Programme
Of India

Meet your peers as you: Key themes and issues

• Gather the latest regulatory updates impacting global and
Indian clinical development
• Take advantage of India’s strengths and primary drivers
in this fast-growing trials hub
• Understand critical challenges and essentials to deliver
cost-effective, on-time clinical studies
• Address the key bottlenecks and available solutions to
optimise resources
• Maximise efficiencies and learn from practical examples
and industry case studies
• Explore and evaluate the most appropriate partners and
outsourced services for your needs
• Further your partnerships in clinical research – how to
deepen collaborations
to be discussed include:
• Regulatory Overview & Enforcement
• Developing Robust Trial Design & Efficient Clinical
Trial Management
• Outsourcing and Partnering in Clinical Trials
• Monitoring Clinical Trial Quality & Audits
• Clinical Research Infrastructure & Manpower Needs
S!
PLU
Post-Conference Workshop
Wednesday 26 May 2010
A Practical Guide for Effective Medical
Writing from Pre-to Post-Authorisation

www.ibc-asia.com/cro
Organised by: Bronze Sponsor: Media Partners:

Life Sciences

REGISTER NOW! Customer Service Hotline: (65) 6514 3180

 Clinical Trials & Partnering India 2010
Towards Global Standards and Excellence in Clinical Development

Clinical trials in India in 2002 generated $70 million in revenue and will grow to $200 million
by 2007 and anywhere between $500 million and $1 billion by 2010

Source: Confederation of Indian Industry (CII)

With its clinical trial outsourced market forecast to grow at a CAGR of over 30% from 2010-2012, to around US$ 600 million,
India will cement its position as one of highest growing clinical trial destinations in the world.

The clinical trials market in India can be both lucrative for CROs and sponsors conducting global clinical trials, owing to a huge
patient pool representing both chronic, infectious & degenerative diseases, easy recruitment of patients, and high cost savings.
Recent regulatory reforms, the formation of the Clinical Trials Registry - India (CTRI) and improved IPR protection with changed
rules have provided a further boost along with reduced taxes and duties.

IBC’s 2nd annual Clinical Trials and Partnering India conference is dedicated to providing a business crucial platform to discuss
best practices and strategies for effective clinical development and achieving global standards of excellence. It also provides the
opportunity for sponsors to evaluate and further alliances in outsourcing, from contract research organizations (CROs), to sites,
data management, supply chain and related 3rd party service providers.

Attendees to 2009 Clinical Who Should Attend Clinical Trials and

Partnerships Asia Partnering India 2010
By Industry IT/Data By Job Functions
Finance/
Investment Management
2% 7% Clinical Outsourcing • Project Management • Clinical R&D • Clinical
CRO Legal Operations • Business Development • Legal Affairs • Regulatory Affairs
44% 2%
Media • Quality Assurance • Contracts Administration
7%

By Job Title
Director, Business Development • Director, Strategic Planning • Director,
Consulting Packaging Clinical Research • Head, Clinical Operations • Director, Global Sales •
6% 3%
Pharmaceutical Head, Global Clinical Development • Head, Service Delivery • Head,
Supply Chain 20%
4% Clinical Outsourcing • Director, Strategic Alliances & Communications
Pharma/Medical
Site Services Devices • Director, Data Management • Head, Research Alliances • Director, R&D
4% 1% • Chief Scientific Officer • Head, Global Discovery Alliances • Director,
Drug Discovery
By Geography
Asia
India 16%
77% United Kingdom
5%
Past Participating Organizations Include
ABBOTT HEALTHCARE • ASTRAZENECA • BENNETT COLEMAN •
CHILTERN • CLINIGENE INTERNATIONAL • CLININVENT RESEARCH •
USA CLINSYS • COGNITIVE DRUG RESEARCH LTD (CDR) • COVANCE • CYTEL
2% STATISTICAL SOFTWARE & SERVICES • DAIICHI SANKYO • EISAI
CLINICAL RESEARCH • ELI LILLY AND CO • ELSEVIER • FIL CAPITAL
By Job Title ADVISORS • GLAXOSMITHKLINE PHARMACEUTICALS • GVK
Business Account Management
Development/Strategy 4%
BIOSCIENCES • HCL TECHNOLOGIES • HEMAS CLINICAL RESEARCH
24% Head, Clinical SERVICES • i3 PHARMA RESOURCING • ICON CLINICAL RESEARCH •
MD/
President/CEO Research
19% 20% MAKROCARE • MANIPAL ACUNOVA • MARKEN • NOVARTIS • OCASA
LOGISTICS • OMNICARE PHARMACEUTICALS • ORACLE CORPORATION
• PFIZER • PHARMANET CLINICAL SERVICES • PIRAMAL LIFE SCIENCES
• PT EQUILAB • PT PRODIA DIACRO LABORATORIES • QUINTILES
Pharmacovigilence/ RESEARCH • RANBAXY LABORATORIES • SIRO CLINPHARM • SOFTBOX
Quality
3% SYSTEMS • SOLVAY PHARMACEUTICALS • THOMSON REUTERS •
Head, Sales & Director, Clinical TRIESTA SCIENCES • WOCKHARDT
Data Management Marketing Operations
3% 13% 14%

www.ibc-asia.com/cro
 Clinical Trials & Partnering India 2010
Monday 24 May 2010
08:30 Registration & Morning Coffee / Tea
09:00 Chairperson’s Opening Remarks
09:10 Asia as an Emerging Hub for Clinical Trials in Drug
Development
• Outlook of global drug development in Asia
• Understanding favourable factors for clinical trials in Asian sites
• Identifying market potential, strengths and weaknesses
Dr Mohanish Anand, Regional Head Clinical Operations - Asia,
Pfizer Global Research & Development
Regulatory Overview & Enforcement
09:45 Charting a Course through Shifting Global Regulatory
Tides – How Sponsors Can Plan Today for the Changes
of Tomorrow
• What technological, scientific, ethical and economic changes
are converging on regulatory agencies in India and across
the globe?
• What challenges face regulators in various geographic regions,
and the impact on trial sponsors
• Possible ideas for how regulatory policies may adapt to meet
these challenges and what those changes will mean for sponsors
of global clinical trials
Geoff Fatzinger, Executive Director Global Regulatory Affairs,
INC Research
10:20 Pharmacovigilance, Patient Safety and Current
Challenges Around Safety Reporting
• How does patient safety differ from pharmacovigilance?
• Limitations of addressing patient safety in clinical trials
• Challenges in addressing post-authorisation safety from
regulatory perspective
Dr Siddharth Chachad, Medical & Safety, Regulatory Affairs,
Cipla Ltd
10:55 Morning Refreshments
11:25 Status of Phase I Trials in India and ICH Pre-clinical
Safety Guidelines
• How will this influence the registration and execution of
Phase I trials?
• What are the major components in accelerating Phase I trials
in India?
• Understanding and addressing major risk management and
safety considerations
• Key issues and considerations relating to biologics
Dr Deven Parmar, Vice President - Clinical Research, Wockhardt
12:00 Regulatory Changes: How they Help or Hinder India’s
Global Reputation in Clinical Trials
• How will regulatory changes affect the pace of clinical trials in
India relative to its competitors?
• What are the initiatives by regulators to ensure rigorous, efficient
and more transparent approval processes?
• What measures are in place to ensure that protection of patient
rights and ethical standards are upheld?
• How can CROs and sponsors work with regulators to ensure
that world class scientific and ethical standards are achieved?
PANEL DISCUSSION
Panelists:
Dr Deven Parmar, Vice President - Clinical Research, Wockhardt
Dr Rajinder Kumar Jalali, Director, Medical Affairs & Clinical Research,
Ranbaxy Laboratories Ltd
Prof Y K Gupta, Head, Dept. of Pharmacology, All India Institute
of Medical Sciences; & Coordinator, Pharmacovigilance Programme
Of India
12:35 Networking Lunch
REGISTER TODAY! Tel: (65) 6514 3180 Fax: (65) 6733 5087
CONFERENCE DAY 1
14:00 Emergence of Early Clinical Development in India
• Overview of FIM/ 1b/ 2a studies
• Current level of expertise/ capabilities in India for conducting
phase-1a/ 1b/ 2a studies
• Recent advances in early development/ especially POC studies
• Early clinical development in India: Potential opportunity
Dr Narendra Maharaj, General Manager, Global Clinical Operations,
Glenmark Research Centre, Glenmark Pharmaceuticals Ltd
14:35 Pharmacovigilance and Evolving Synergy of Academia,
Industry and Regulators
• Overview of the National Pharmacovigilance Programme
• Understanding the importance of a well developed
pharmacovigilance department
• Building a team with staff knowledgeable in Indian and global
regulations to ensure 100% compliance and safety
• Adopting a synergistic approach by working closely with
academic, industry and regulatory partners
Prof Y K Gupta, Head, Dept. of Pharmacology, All India Institute
of Medical Sciences; & Coordinator, Pharmacovigilance Programme
Of India
15:10 Clinical Trials Protocols and Adherence to
ICH-GCP Standards
• What are the current gaps in adherence to protocols and
GCP standards?
• Defining roles and responsibilities of clinical trials staff and
emphasis on adherence to protocols
• Establishing checks and balances to ensure that adherence
is practiced
Dr Rajinder Kumar Jalali, Director, Medical Affairs & Clinical Research,
Ranbaxy Laboratories Ltd
15:45 Afternoon Refreshments
Developing Robust Trial Design & Efficient
Clinical Trial Management
16:15 Planning and Execution of Clinical Trials to Optimise
Timing and Reliability
• During the planning process, how can sponsors optimise their
chances of on-time completion?
• What can be done to more effectively monitor, manage and
mitigate the impact of disruptive events eg investigator shortfalls,
protocol amendments?
• Creating innovative study designs to reduce the number of
studies or study patients while still providing robust data, to
be cost effective and enable earlier go/no go decisions
Dr Partha Gokhale, Head of Clinical Operations, Wyeth Research
16:50 Project Management of Clinical Trials
• Forecasting and Planning: Tools and methodologies eg ‘time-
sheeting’
• Success factors in achieving project milestones and optimising
resource control
• Adequately assessing expected variances and planning for
deviations
• Using technology and clinical trial management systems to
optimise trials
Celestine Juliet Rebello, Project Manager, Regulatory Affairs
(Clinical Research), Cipla Ltd
17:25 Establishing and Reviewing Project Scope and CTPs
to Optimise Clinical Development
• What are the best practices in project scope definition?
• What are some of the likely areas of conflict?
PANEL DISCUSSION
• How can existing contracts be used to resolve conflicts without
the need for change orders?
• Adequately training CRO staff on sponsor SOPs and policies
Panelists:
Dr Kiran Marthak, Executive Director, Clinical Research,
Veeda Clinical Research Pvt Ltd
Himanshu Bansal, Associate Director, Biomedical Operations,
Genzyme India
Dr Partha Gokhale, Head of Clinical Operations, Wyeth Research
17:55 Chairperson’s Remarks and End of Conference Day One
Email: register@ibcasia.com.sg
 Towards Global Standards and Excellence in Clinical Development
Tuesday 25 May 2010
09:00 Chairperson’s Opening Remarks
Outsourcing and Partnering in Clinical Trials
09:10 Outsourcing Options and Assessment of Potential
Partner Capabilities
• Establishing key criteria and due diligence to evaluate potential
partners’ capabilities, capacity, and constraints
• Best practices in conducting a comprehensive review of potential
partners’ capabilities
• Rules for successful sponsor, site and CRO partnerships
• Working and co-ordinating with multiple partners and vendors
Dr Mubarak Naqvi, CRU Director, Sanofi-aventis (India)
09:45 Global or Local Partnerships: Assessing the Pros and
Cons for Optimal Results
• Setting the ideal balance of global / local partners and key
considerations in a hybrid outsourcing model
• How have the capabilities of CROs developed to meet changing
conditions and requirements?
• Addressing data management and knowledge transfer issues
in working with different providers across multi-sites and
geographies
Sundeep Shrivastava, Post Marketing Clinical Associate, Asia,
Abbott Healthcare Pvt Ltd
10:20 Sponsor/ CRO Partnership: Beyond Study Execution to
Support Clinical Development
• Current level of CRO involvement in clinical development
(beyond clinical operations)
• How have the capabilities of CROs developed to meet changing
conditions and requirements?
• How can CROs be involved in clinical development beyond
clinical operations?
Dr Kiran Marthak, Executive Director, Clinical Research,
Veeda Clinical Research Pvt Ltd
10.55 Morning Refreshments
11:25 Communications and Management of Expectations
• How can CROs work with and manage sponsor expectations
to ensure successful outcomes?
• What are the dangers of over-commitment by CROs and how
can this be prevented?
• Defining the relationships and project scope between sponsors,
CROs, sites and other parties
• Discussing and preparing for ‘worst case scenarios’ to
pre-empt disputes
• Effectively managing contracts and conflict resolution
Dr Rajeev Shrivastava, Senior Manager, Clinical Research, Eli Lilly
& Co
12:00 Issues and Concerns with Conducting Clinical Trials
in India
• How can sponsors ensure IP protection in clinical trials?
• Addressing growing concerns relating to data protection and
confidentiality of study outcomes
• What precautions can be taken in data management?
• What are the legalities necessary to ensure IP protection?
• Responsibilities and liabilities of stakeholders in clinical trials
in India
Dr Milind Antani, Head-Pharma & Life Science Practice,
Nishith Desai Associates
12:35 Networking Lunch
Monitoring Clinical Trial Quality & Audits
14:00 Ensuring Optimal Standards in Clinical Trial Conduct
• How can sponsors and CROs ensure the reliability and accuracy
of clinical research?
• Where are the major weaknesses and how are they being
addressed?
• Measures taken to monitor lapses and prevent fraud and
misconduct in research
• Responsibilities and effectiveness of IRBs in ensuring safe trials
Dr Arun Bhatt, President, Clininvent Research
www.ibc-asia.com/cro
CONFERENCE DAY 2
14:35 Trial Audits and Field Monitoring
• What is the scope of and what are the best practices in
monitoring sites and trial audits?
• How can sponsors and service providers collaborate to foster
more effective field monitoring?
• What are good data review practices to ensure speedy and
efficient trial audits?
Dr Anil N Shinde, Clinical Operations Director, Novo Nordisk A/S
15:10 Clinical Development Perspectives from the Medical
Nutritrional Food Industry
• Distinctions between drug and food research regulations and
clinical trials
• Recruiting for studies in healthy consumers and patients in
hospital settings
• Consumer education and understanding the customers’
experiences – the importance of taste and appearance and
applications to pharma
Dr Sanjeev Ganguly, Medical Director-South Asia, Nestle Nutrition
15:45 Afternoon Refreshments
Clinical Research Infrastructure & Manpower Needs
16:15 Patient Recruitment and Retention Strategies
• Overcoming hurdles to patient recruitment eg inadequate
documentation and medical records and access to patient pools
in remote areas
• What can be done to realize the real benefits of India’s huge
patient pool?
• Challenges in multi-site studies and how these may be
addressed?
Dr Shailesh Mehta, Vice President, Clinical R & D, Medical Affairs
Biologicals - South Asia, Glaxosmithkline Pharmaceuticals Ltd
16:50 Raising Competencies of Trials Staff: Gaining ‘Buy-in’
and Training Needs
• What is the current level of competence of clinical trials staff
in India?
• What are the gaps in training and knowledge?
• Addressing the training gaps for CRAs eg in project and data
management
• Winning investigator ‘buy-in’, increasing co-operation,
commitment and adherence to global GCP protocols
Dr Ashis Patnaik, Senior Manager, Global Medical Affairs,
Dr. Reddys Laboratories
17:25 What are the Prospects for Clinical Trials in India?
• The India advantage - reducing costs and / or accelerating time
to market?
• How can the real value and costs of clinical outsourcing be
estimated?
• How can India move up the value chain in clinical trials?
PANEL DISCUSSION
Panelists:
Dr Rajeev Shrivastava, Senior Manager, Clinical Research, Eli Lilly
& Co
Dr Shailesh Mehta, Vice President, Clinical R & D, Medical Affairs
Biologicals - South Asia, Glaxosmithkline Pharmaceuticals Ltd
Dr Arun Bhatt, President, Clininvent Research
Dr Mubarak Naqvi, CRU Director, Sanofi-aventis (India)
17:55 Chairperson’s Closing Remarks and End of Conference
 Hyatt Regency Mumbai, India

Post-Conference Workshop Wednesday 26 May 2010

A Practical Guide for Effective Medical Writing from Pre- to Post- Authorisation
This workshop will run from 09:00 – 15:00, with a mid morning refreshment break and lunch. Registration begins 30 minutes before the workshop commences.

Workshop Objectives
Participants will learn effective medical writing, differences between scientific About Your Workshop Leader
writing and regulatory writing, medical writing for pre-authorisation and
post-authorisation periods. Dr Siddarth S. Chachad
Medical & Safety Expert (Regulatory Affairs),
This workshop has been designed for Cipla Ltd, India
Medical Directors, Clinical Research Coordinators, Project Managers, Medical
& Safety Experts, Clinical Research Physicians and Medical Advisors In his current role, Dr. Siddarth is responsible for project management
and development of preclinical and clinical study plans for regulatory
submissions. As a safety expert, he ensures that all safety reporting
Workshop Agenda requirements in clinical trials and pharmacovigilance obligations in
The essential components and tools required for effective medical writing post-authorisation period are met as per the regulatory requirements.
will be discussed in detail, under the main themes:
Prior to this, after achieving a postgraduate qualification in
• Scope of services in medical writing, Career in medical writing, Challenges Pharmacology from the University of Hertfordshire, UK, he worked
faced pertaining to medical writing as medical advisor to Intellectual Property Management Group,
• Clinical study documents: Lupin Limited.
- Protocol design
- CRF preparation
- ICD writing
- Patient Diary
- Investigators Brochure
- Study report writing
• Writing for Regulatory affairs Vast patient pool and high cost savings
- Preparation of clinical and non-clinical overviews
- Medical rationales/Concept notes
will drive India’s clinical trial outsourcing
- Scientific justification market to register a CAGR of more than
• Publication writing
30% during 2010-2012
• Preparation of SPCs, PILs, Posters, Presentations and promotional tools
• Pharmacovigilance related medical writing – Preparation of PSURs, RMPs Source: RNCOS report, Sep 2009

Bronze Sponsor
INC Research, a global contract research organization, uses its Trusted Process™
method of conducting Phase I – Phase IV trials so customers experience certain trial
excellence, helping to minimize potential risk factors and leading to more informed
and confident development decisions. With operations in 40 countries, INC Research
provides experienced project teams that support oncology, CNS, respiratory, Exhibitor
cardiovascular, infectious disease and endocrinology clinical research, as well as
pediatric and women’s health trials.

Sponsorship Opportunities
WANTED! CRO and Clinical Trial Expertise
Do you offer clinical research and related expertise for clinical development? This is your opportunity to further your business in the world’s fastest
growing clinical research hub!

• Do you find difficulty in reaching clinical heads and senior decision makers and successfully stimulating interest for your services?
• Or is it that they may not be aware of the value of your expertise and technologies and what these could do for them?
• Or are they not able to differentiate your company from your competition?

Perhaps what you need is a case study presentation and branding opportunity at this event! Increase your reach through our extensive marketing campaign,
targeted at your qualified business audience.

For information about placing your brand & profile top-of-mind to key buyers, contact Janice Tan, Business Development Manager
on Tel: +65 6835 5101 / janice.tan@ibcasia.com.sg

REGISTER TODAY! Tel: (65) 6514 3180 Fax: (65) 6733 5087 Email: register@ibcasia.com.sg