Informedia proudly presents the inaugural conference on

For more details, visit www.globalpharma-summit.com

Best Practice in Service Outsourcing

Conference: 3rd - 4th December 2008 | Venue: Hotel J W Marriott, Mumbai

Global Pharmaceuticals Research & Manufacturing India 2008Global Pharmaceuticals Research & Manufacturing India 2008

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nActis Biologics

nAll India Institute of Medical Sciences

nAmgen India

nAstraZeneca Pharma

nCadila Pharmaceuticals

nDr Reddy's Laboratories

nEisai India

nEli Lilly &Co.

nEvolva Biotech

nFDA Maharashtra State

nGlaxoSmithKline

Pharmaceuticals

nInstitute of Clinical

Research India

nNishith Desai Associates

nNovartis

nNycomed Pharma USA

nPfizer

nSandoz

nSanofi–Aventis

nTakeda Global Research and Development

nUSV

nWockhardt

nWyeth

nZydus Cadila

Abbott India

Top Level Speakers from

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Find out how to outsource your clinical trials to India

Harness the benefits of Indian CRAMS/CSOs within the

current global pharma business model

Evaluate the implications of moving global R&D offshore

to India

Examine the influence and input of biotech companies in

the Indian pharma market

Learn about the emerging and innovative business

models for partnerships and collaboration

Key Note Speakers

Mr Ranga IyerPresident OPPI and Managing Director

Wyeth

Mr Suhas ChaudhariJoint Commissioner (Greater Mumbai)

FDA Maharashtra State

Uma Nandan MisraVice President -

Operations & Site Manager

AstraZeneca Pharma

Mr Ranjit ShahaniVice Chairman,

Managing Director and Country President

Novartis

Mr Harjit Singh, Senior Development

Manager, Takeda Global Research

and Development, UK

Principal Media Partner

Media PartnersOnline Media Partners

InternationalMedia Partner

10.00 am Evaluating the implications of moving global R&D offshore vs outsourcing to India

Globalisation of drug development processes

What impact will Indian CROs have on shaping the global R&D landscape?

Indian CROs view on the offshoring operations - how do they view their interaction and experiences when working with US and European pharmas?

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Dr Chandrashekhar PotkarManaging Director, Clinical ResearchPfizer

8.30 am Registration

9.00 am Chairman's Welcome and Opening Address

9.35 am Harnessing the benefits of Indian CRAMS/CSOs within the current global pharma business model

Comparing CRO (Contract Research Organisation) and CM (Contract Manufacturing) activities within India, externally and looking at prospects for future development

Retrospective analysis of how the CRAMS/CSOs business model has evolved - where we are now?

Analysis of the long-term prospects for the CRAMS/CSOs industry and its ultimate effect on the Indian pharma business

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Dr Ish KhannaDr Reddy's Laboratories USA

Mr Ranjit ShahaniVice Chairman, Managing Director and Country PresidentNovartis

9.10 am Overview of the Indian pharma sector in an economic context

What is the current development status of the industry?

Is the cost advantage of investing in India now diminishing because of escalating operating costs?

Dealing with the declining ROI of pharma businesses - proposed solutions to maintain sustainable growth of the industry

Indian pharma in comparison to other emerging markets: China, South East Asia and Latin America

Evaluating offshore process outsourcing from a regulatory and cost perspective

Predicting future prospects: how the Indian economy is expected to develop - where will we be in 2020?

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Globalisation of the Indian pharma industrySession I:

Wednesday 3rd December, 2008DAY 1:

2.40 pm Three years on from the Indian Patents Act 2005

Myths about patents

Features of the Act

Unfinished agenda

Path forward

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Mr Ranga IyerPresident, OPPI and Managing DirectorWyeth

3.05 pm Pharmacovigilance, PMS and PSUR in India: Current status and the road map. Assessing the development of methodologies for monitoring drug safety

Addressing the increasing concerns over drug safety and post-approval surveillance

Ensuring proactive pharmacovigilance throughout the product lifecycle

Improving patient safety by increasing the transparency of safety data

Transferring the pharmacovigilance advancements of the West to emerging markets

Exploring the relationship between pharmacovigilance and risk management

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Mr YK GuptaHead, Department of Pharmacology,Zonal Pharmacovigilance Centre All India Institute of Medical Sciences

10.25 am Morning Refreshments & Networking Break

11.20 am The evolving regulation landscape in India

Discussing the current Indian regulatory environment

Recognising the requirements of Indian regulations towards approval of drugs developed

Ensuring effective protection of intellectual property rights and development processes

Standard operating procedures for conducting clinical trials in India - Schedule Y of the Drugs and Cosmetics Act in India and guidelines for biomedical research

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Dr Surinder Singh Drugs Controller General of India

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Mr Suhas ChaudhariJoint Commissioner (Greater Mumbai)FDA, Maharashtra State

10.55 am Harmonisation of the global pharma regulatory environment

Evaluating the impact of globalisation on the pharma regulatory landscape and how this will affect research and manufacturing processes

Finding a common set of regulations which are acceptable to all countries

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Indian and worldwide regulatory policies and legislative framework

Session II:

2.00 pm The viewpoint from two industry specialists on managing legal and regulatory considerations in clinical outsourcing

The patent regime and present status of R&D in India

Government initiatives to shorten the clinical trials application time

Clinical research landscape in India

Discussing the market prospects for further development

Analysing the reason for the gap in the amount of research between India and the rest of the world

Investigating pharmacovigilance practices in India for the clinical trials market and for future REITs

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Dr SK Gupta, Director GeneralInstitute of Clinical Research India

Ms Gowree Gokhale, PartnerNishith Desai Associates

www.globalpharma-summit.com

For an Updated Conference Programme, Please log on to:

* Awaiting final confirmation

12.30 pm Luncheon

11.45 am SPEED NETWORKINGThe quicker way to do business

3rd - 4th December, 2008 Global Pharmaceuticals Global Pharmaceuticals Research & Manufacturing India 2008

3.30 pm

Dr Sham Nikam, Chief Scientific OfficerNycomed Pharma USA

Evaluating the current status of drug R&D in India

Drug discovery in India, along with CROs in Indian pharma industry

Exploring the contract research market from preclinical to phase 3Emerging opportunities for conducting exploratory proof-of concept studies

Trends on outsourcing drug discovery and development (DD&D)

Producing cost-effective NCEs (New Chemical Entities) targeting lifestyle, resistant infectious diseases with improved efficacy and minimal side effectProducing a pipeline of promising drug candidates - DD&D and NCEs

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4.15 pm

Dr PM Murali, Managing DirectorEvolva Biotech

Building an indigenous value based ecosystem for cost effective drug discovery in India. Six key aspects leading to a sub half billion dollar NDA in the future Indian discovery landscape

INVESTMENT: Arrival of startup VCs redefining the discovery landscape in India – those with longer acceptable incubation periods for their ROI and a higher risk taking ability

EXPERTISE: Influx of returning Indians from elsewhere with prior experience in drug discovery and development

FACILITIES: Availability of world class CRAMS/CSOs in biology, chemistry and pharmacology

RESEARCH CONSULTANTS: Networking with scientific clusters of excellence, who are willing to collaborate with industry

INTERFACE & SCALEUP OPERATIONS: English speaking population and FDA approved facilities – both available with largest numbers outside United States

CLINICAL TRIALS: Huge patient population with diversity and CSIR's efforts in systematic mapping of heterogenicity, enables effective clinical trials, pharmacogenomics and pharmacovigilance

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Dr Veena Jaguste, Director, Global Development Operations, Amgen India

4.40 pm The impact of outsourcing on drug development performance and implications for more effective collaboration with CROs

Clinical research and trials outsourcing - overcoming challenges and impediments

Incorporating emerging regions into clinical development plans - a unique set of opportunities and challenges

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Mr Harjit Singh, Senior Development ManagerTakeda Global Research and Development UK

5.05 pm Clinical research and trials outsourcing - challenges and hurdles in India

Conducting phase 1 and 2 clinical trials in IndiaClinical quality assurance and its significance in global drug registration Clinical safety and risk evaluation in trialsConducting ethical clinical trials Managing clinical trial sites successfully Feasibility studies for investigational site selection Non clinical: technical and operational procedures and how to address them

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3.55 pm Afternoon Refreshments & Networking Break

Mr Sanjeev SaxenaChairman and CEOActis Biologics

Evaluating the influence and input of biotech firms on the Indian pharma market

Evaluating global biotechnology development and India's role in the process

Ensuring global biotech opportunities within India and overseas

Gaining advantage of innovative bio-technologies

Forming partnerships with Indian biotech firms

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9.10 am

Thursday 4th December, 2008DAY 2:R&D in India: the landscape of opportunities and challenges

Session III:

8.30 am Registration

9.00 am Chairman's Opening Remarks

Emerging trends in biotechnologySession IV:

Benefits of contract manufacturing for Indian producers

Session V:

10.40 am Morning Refreshments & Networking Break

9.35 am

Mr Subash Kapre *Executive DirectorSerum Institute of India

Key issues affecting biopharmaceutical manufacturing

Manufacturing biologics from the CMO (Contract Manufacturing Organisation) perspective

Where is biopharma manufacturing going in the next 10 years?

Regulatory initiatives impacting biopharmaceutical development and manufacturing

Entry of biosimilar and bio-generic products

Ensuring quality and safety in bio-processes

Strategies for ensuring product comparability and safety after manufacturing process changes

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10.00 am Global harmonisation and the perception of Indian CM to the rest of the pharma industry

Evaluating international trends and global harmonisation opportunities

CMO management throughout the relationship between CMO and outsourcer lifecycle

Obtaining and understanding how process changes can affect the structure and biological activity of the final product (in technology transfer)

Implementing successful approaches in manufacturing

Evaluating the role of globalisation on the regulatory landscape and manufacturing process

Contract manufacturing - in house vs outsourcing

Emerging fields in the pharma outsourcing market - why should you outsource manufacturing and risk costly technology transfer delays?

A critical assessment of the current manufacturing outsourcing strategies

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Mr Sanjit Lamba, President and CEOEisai India

Mr Lakshminarayana Neti, Director OperationsAbbott India

For enquiries write to jayesh.kanaskar@informedia-india.com

5.40 pm Informedia’s Cocktail Reception

5.30 pm Chairman's Closing Remarks and End of Day One

* Awaiting final confirmation

3rd - 4th December, 2008 Global Pharmaceuticals Global Pharmaceuticals Research & Manufacturing India 2008

Mr Uma Nandan MisraVice President, Operations and Site ManagerAstraZeneca Pharma

11.50 am Case Study - Achieving operational excellence in a pharma manufacturing plant

Cultural transformation

Aligning manufacturing priorities with business

Identifying & monitoring critical performance parameters

Engaging all employees for continuous improvement

Achieving excellence in focussed areas

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12.55 pm Luncheon

2.10 pm Implementing strategies to ensure that the contractors comply with quality agreements

Compliance with GMP requirements

Demonstrating how cGMP is essential for survival in the pharma business

Gain a competitive edge with a GMP compliant designed facility

Learn the importance of well written procedures, validation, documentation and SOPs for cGMP compliance

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Dr PM NaikProject DirectorZydus Cadila

Evolving partnering and business modelsSession VI:

2.35 pm Implementation of risk management strategies in outsourced manufacturing

Risk and risk management in pharmaceutical and biopharmaceutical outsourcing

Measuring risk as a preventative technique - ensuring operational excellence

Identifying, understanding and rating risk throughout all processes

Implementing effective methods to avoid risk

Identifying and overcoming cost issues in CM outsourcing

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Mr TS AnandDirector, Contract Manufacturing and OutsourcingDr Reddy's Laboratories

3.00 pm Innovative models of collaborating opportunities with CRAMS/CSOs

Different models of collaboration that can be established between Indian firms and MNCs

New business and partnership models evolving in India

In and out licensing of drug discovery research

Partnering opportunities - strategic involvements

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Ms Mukta AroraHead of Global SourcingEli Lilly & Co.

3.45 pm External sourcing in the pharma space

Requirements for external sourcing

Basic aspects of external sourcing

Challenges faced by the Indian pharma business as compared to international businesses and other sectors

How do you choose the right partner?

Relationship building for the longer term - an essential part of the pharma business

Legal and contractual issues

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Mr Debabrata GuptaDirector and Chief Operating OfficerUSV

4.45 pm

4.35 pm

End of Day Two and Close of the Conference

Chairman's Closing Remarks

4.10 pm What are the strengths that the outsourcing organisation is looking for while selecting the CRAMS/CSOs?

What the contract givers and contract acceptors should be aware of to continue long-term business relationshipsWho is the owner of the intellectual property developed during the cooperation and why?How to face audits from the outsourcing organisation to get approved as a CSOWhy continuous communication is essential in such a relationshipWhy the customer should be kept informed of the failures and mistakes that take placeAt what stage does the product need to be optimised during CRO or CSO?How process changes from established practice could affect the customer and the relationship

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Dr Sunil KanvindeDeputy General Manager, Technical ServicesSandoz

11.10 am Two key opinion leaders demonstrate how to establish successful technology transfer in CMO to ensure an effective manufacturing process

Technology transfer for outsourcing and contract manufacture

Implementing technology transfer to ensure an effective manufacturing process

Critical factors and timelines for a successful technology transfer

Success factors during process comparability and validation

Developing and implementing clear quality agreements with CMOs

Incorporating knowledge to ensure process comparability, validation and GMP requirements

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Mr KK Ambardar, General Manager, Contract Manufacturing, Cadila Pharmaceuticals

Dr Ashoke Banerjee, Executive Director GlaxoSmithKline Pharmaceuticals

12.15 pm Panel Session:Two industry leaders viewpoint on quality management - developing and implementing sustainable quality agreements with CMOs

What are the ‘rules of engagement’ between the sponsor and client for proper management of mutual quality and quality-regulatory needs in an outsourcing arrangement?

One size does not fit all - How to design and put a workable and sustainable quality management system into practice?

How does a quality agreement separate or link to other agreements like commercial and technical?

What are the regulatory and legal requirements that should be addressed in a quality agreement?

How should critical quality activities of change management, deviations, investigations, product release, GMP audits and regulatory inspections be integrated in to a good quality agreement?

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Mr Satish Rajkondawar, Senior Director, External Manufacturing Site, Sanofi-Aventis

Mr Viswajit Sahu, DGM Contract Manufacturing Services, Wockhardt

3.25 pm Afternoon Refreshments & Networking Break

3rd - 4th December, 2008 Global Pharmaceuticals Global Pharmaceuticals Research & Manufacturing India 2008

About Informedia

Informedia India Pvt Ltd is a leading conference organiser which specialises in professional high level business conferences targeted at senior management in a number of industry sectors. We are a subsidiary company of the Expomedia Group Plc., a leading International media group with offices in 13 countries worldwide.

Dedicated to in-depth research, our conferences provide you with relevant information about what you want to know, when, and from whom. Straightforward and industry oriented, our conferences are a very time efficient way to gain a head start

and secure your competitive advantage. Our focused events create a platform to network with both new and experienced peers from various industries and feature the most relevant case scenarios in order to equip you with valuable knowledge and current know-how.

www.informedia-india.com

Attracting the industry's most powerful and influential delegates

àBusiness Development

àClinical Research Outsourcing

àManufacturing

àDrug Discovery & Development

àMedical Affairs

àPharmaceutical Development

àPharmacoviligance

àPreclinical Development

àProcurement

àProduction Planning & Manufacturing

àPurchasing

àQuality Control & Assurance

àRegulatory Affairs

àRisk & Safety Assessment

Heads of Divisions

àCXOs

àProject Directors

Who will be there?The Global Pharmaceuticals conference has been developed with the following executives in mind:

Which industry sectors should attend?

àPharmaceutical Companies

àBiotech Companies

àCROs and CMOs

àPharmaceutical Manufacturers

àResearch Laboratories and Institutes

àBusiness Consulting Firms

àGovernment Institutions and Regulators

àPrivate Equity Funds

àVenture Capitalists

Sponsorship...helps you to do business and deliver your message to the Global Pharmaceutical market.

Contact our Sponsorship Director on sponsorship@expomediagroup.com or call +91 22-28500104 in India and +44 (0) 1923 491 067 in the UK to tailor your package

Q.1 Could you benefit from presenting a case study or hosting a workshop in front of your target audience and demonstrating your expertise?

If your answer is yes to any of these questions then the

Global Pharmaceuticals Research and Manufacturing India 2008 is

the most important place for you to be.

6 simple questions to determine value from sponsorship

Q.2 Do you want to do business with senior decision makers from the leading Pharmaceutical and Biotech companies from India, Asia and the rest of the World?

Q.3 Can you benefit from the impact of outsourcing on Clinical Research or Contract Manufacturing?

Q.4 Can you provide a solution to the bad perception of manufacturing from a CMO's perspective?

Q.6 Do you want to collaborate on drug development performance with CRO's?

Q.5 Are you able to demonstrate the best way to run effective proof of concept trials?

Sponsoring the Global Pharmaceuticals Research and Manufacturing India 2008 forum will enable you to:

Raise your company’s profile

Increase your chances of being chosen as the logical choice of supplier, when they hear and see you can exceed their needs.

Don't pass business opportunities by, whilst your competitors walk away with them.

Find your all year round marketing solution

There are a limited number of opportunities for you to get your message across to the leading International Pharmaceutical and Biotechnology Companies, so act now to avoid disappointment.

Put simply, you can't afford to miss out!

The conference helps you to overcome common business development hurdles, like access and face to face networking with the right people with hours of scheduled networking time. Global Pharmaceuticals will put you face to face with people that matter in this industry.

Join our existing partners at this prestigious event

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Provided the total fee has been paid, substitutions can be made at any time free of charge. Cancellations must be received in writing by mail or fax 5 working days before the conference in order to qualify for a Credit Note which will be valid for 6 months after the date of issue. Thereafter, a Credit note cannot be issued. Nonpayment or non-attendance does not constitute cancellation. If, for any reason, Informedia India Pvt. Ltd. decides to cancel or postpone this conference and / or workshop/s, Informedia India Pvt. Ltd. is not responsible for covering airfare, hotel or other travel costs incurred by the delegate. In case of cancellation or postponement, the fee qualifies for a credit note equal in value for any future event organized by Informedia India Pvt. Ltd.

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Please note that 12.36% service tax will be applicable on the above mentioned fees

Fees Package

Euro 1,399

Euro 899

For International DelegatesFor Indian Delegates

Conference: 3rd - 4th December 2008 | Venue: Hotel J W Marriott, Mumbai

Juhu Tara Road,Mumbai - 400 049, IndiaTel: +91 22 66933000Fax: +91 22 66933100

www.marriott.comBest Practice in Service Outsourcing

Global Pharmaceuticals Research & Manufacturing India 2008Global Pharmaceuticals Research & Manufacturing India 2008