Featuring 50+ Speakers Including:

REGISTER TODAY! +65 6508 2401 www.clinicalpartnershipsasia.com

Where Key Stakeholders Collaborate to Drive Clinical Trial Success and Partnering in Asia

A TRULY INTERNATIONAL EVENT!

Yingmei TuDirector, Clinical Research,Merck

Bhaswat ChakrabortySenior Vice President &Chair Scientific Committee,Cadila Pharmaceuticals

Simon McErlaneVice President & HeadTakeda Development

Center Asia

Yanping ZhengDirector, Clinical Affairs &Medical Monitor,Mallinckrodt Pharmaceuticals

Sumant TiwariDeputy Director, Drugs,Food and Drug

Administration (FDA)

Victoria ElegantVice President, Medical,Clinical & Regulatory Affairs,Baxter

Hassan MovahhedSenior Vice President, GlobalDevelopment Operations,United Therapeutics

Joan ShenChief Medical Officer,Jiangsu Hengrui

Medicine

Henry YauManaging Director, ClinicalTrials Centre,The University of

Hong Kong

Loke Meng OngHead of Clinical ResearchCenter,Ministry of Health

150+ Attendees 10+ Countries 80% New Speakers

Bayer Healthcare, ChinaGlaxosmithkline, SingaporeCadila Pharmaceuticals, IndiaMerck, USAWanbang Biopharmaceuticals, Fosun PharmaGroup, ChinaPfizer, ChinaBoehringer Ingelheim, ChinaEli Lilly & Co, USAAsia Training Consortium & Merck PolytechnicInstitute, USAUnited Therapeutics, USAOtsuka Pharmaceuticals, USAAllergan Biologics, USASanofi, ChinaLundbeck, ThailandSanofi Aventis, ChinaAslan Pharmaceutical, SingaporeWuXiPRA, ChinaAstrazeneca, ChinaRoche, ChinaSchool of Medicine, Tsinghua University, ChinaGlaxosmithkline, ChinaTakeda Development Center Shanghai, ChinaOxford University Clinical Research Unit, VietnamGlenmark Pharmaceuticals, IndiaJiangsu Hengrui Medicine, ChinaBristol-Myers Squibb, IndiaPeking University People's Hospital, China

Senior Level Attendees Acrossthe Clinical Value Chain Will BeAttending Including:

Do more business in 3 daysacross the clinical trial ecosystem

than in your entire year!

Introducing

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6th Annual

ASIA16 - 18 September 2014 | Sheraton Shanghai Hongqiao | Shanghai | China

NEW!

REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.clinicalpartnershipsasia.com

PRE-CONFERENCE WORKSHOPS: 16 SEPTEMBER 2014 | TUESDAY

John Constantine, Chairperson, Asia Training Consortium &Exeucitve Director, Merck Polytechnic Institute, USAJohn is a veteran of 24 years’ experience in the pharmaceutical industry, mostly at GlaxoSmithKline priorto joining Merck as Executive Director and Dean, MPI in 2008. His background includes Sales, Marketing,Corporate Staffs, Information Technology, Research and Development, and 15 years in Learning anddevelopment. John has served on the Board of Directors of the Society of Pharmaceutical and Biotech

Trainers for 15 years, including 2 years as President. He is also a member of the American Society of Training andDevelopment.

Preparing for Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice(GCP) and PV/Risk Management inspections by stringent regulatory authorities, including the FDA and theWHO, is critical for meeting quality and safety standards. This hands-on workshop dives deep into criticalsuccess factors for regulatory and safety compliance in clinical trials.

Learning Objectives:

• Preparing for FDA audits in various clinical studies• Handling the actual audit with confidence• Focusing on the most critical audit areas – Corrective and preventive action (CAPA) processes AEs/SAE

reporting• Acquiring the critical skills you need to maintain excellence in preparing, conducting and responding

to audits

Workshop Leaders:

Eric Morfin, Senior Director, Project Management, Allergan Biologics, USAEric Morfin is a partner with Critical Skills Inc. and the Clinical Excellence Research Institute and has over27 years of leadership and managerial experience in Life Sciences. Mr. Morfin has led many departments,such as Project Management, QA/QC, Data Management, Operations, Clinical Trials and others for companiessuch as Merck, Novartis, Pfizer, GSK, Roche, Aventis, BMS, Amylin, the National Cancer Institute, Astrazeneca,Quintiles and many others. He has worked with large pharmaceuticals, small biotech, medical devices

companies and CROs around the world. Over the past 10 years, Mr. Morfin has spent more than 50% of his time in Asia(Singapore, China, Taiwan, Malaysia, India, South Korea and Japan mostly) and has consulted with many companies suchas Roche Shanghai, Pfizer Asia Pacific, Novo Nordisk China, Hangzhou MSD, Kanghong Pharmaceutical, Quintiles, MalaysiaBiotech Corp, SFDA, CK Life Sciences, Otsuka and more.

R. Stephen Porter, Chairman & CEO, VDDI Pharmaceuticals, andFounder & Director, Dragon Bio-Consultants, USADr. Porter also serves as Chief Science Officer to Integrated Healing technologies. He served as ChiefScientific Advisor and Officer to MPI Research a full service preclinical CRO where he continues to serveas an advisor. He has served in China for the last 8 years successfully establishing and selling a PreclinicalCRO JV and has been working with Asian and Chinese nationals for the past 25 yrs. as a Sino expert. He

is the President of Pharmacotherapy Consultants which engages in business development and advisory consultationservices to CROs, biotech and pharmaceutical industries. Dr. Porter has over thirty years of experience in medical education,healthcare delivery, pharmaceutical research and pharmaceutical product development.

Workshop C (1330-1700)

Mitigating Risk & Risk Based Monitoring in Clinical Trials

This workshop aims to provide a general overview of risk-based monitoring in the clinical research industry,factors for consideration when developing a monitoring plan, challenges and recommendations to ensureany risks are minimized throughout a clinical trial.

Workshop Leaders:

Cheong Guan Leong, Regional Manager, Clinical Development Quality Assurance,Glaxosmithkline, SingaporeLeong Cheong Guan is involved in audit planning, investigator site audit scheduling, site and externalvendor auditing, regulatory agency inspection hosting, and reviewing corrective and preventive actionplans with the internal business partners. Prior to this role, he was a Program Manager in Johnson & Johnsoninvolved in auditing investigator sites, hosting regulatory agency inspections within AP, auditing computerized

systems such as electronic case report systems, interactive voice response systems and ECG monitoring systems. Theseaudits were conducted globally and have received excellent recognition from internal business partners. He has morethan 13 years of experience in the information and technology division in the pharmaceutical industry.

Ting (Lois) Hong, Principal Advisor of Clinical Development Quality Assurance, Glaxosmithkline,ChinaLois joined Glaxosmithkline in 2012 and currently acts as a Principal Advisor of Clinical Development QualityAssurance. In this role, she conducts investigator site audit, External Vendor Audit, for-cause investigation,hosts regulatory agency inspection, and provides consultancy to internal business partners. Since graduatedfrom Jiangxi Traditional Chinese Medicine University in 2003, Lois has various experiences in clinical research,

started with the role of study monitor in a CRO; followed with responsibility of monitoring, project management andtraining/quality management in GSK; then as a QA Manager/regional auditor in Merck Serono.

Haitao (Heidi) Liu, Principal Advisor, Clinical Development Quality Assurance, Glaxosmithkline,ChinaHeidi joined Glaxosmithkline Pte Ltd in 2012 and currently acts as a Principal Advisor of Clinical DevelopmentQuality Assurance. In this role, she conducts investigator site audit for-cause investigation, hosts regulatoryagency inspection, and provides consultancy to internal business partners. Graduating from the ShanghaiMedical University, Heidi had her clinical practice in Shanghai Zhongshan Hospital as a General Physician.

She completed her Master Degree of International Public Health in Sydney University in 2004. Since then, she has hadvarious experience in clinical research, including a pharmaceutical company as clinical monitor and project manager,monitoring and auditing the WHO TDR’s projects; as a medical officer in the Forum of Ethical Review Committees inAsian & Western Pacific Region (FERCAP); as a Training and Compliance Officer in the Clinical Research Institute ofShanghai Huashan Hospital, Fudan University; the Office Director for Peking University Institutional Review Board, mainlyresponsible for IRB administration, developing and implementing IRB policies and procedures; as well as providing andorganizing training activities.

Workshop A: 0900 – 1700

Managing Data Quality for Clinical Trials in China

Workshop Leader:

Workshop B: 0900-1230

Ensuring Audit & Good Clinical Practice (GCP) Compliance Excellencein Clinical Trials

Enjoy Lunch While Learning withExperts during Informal Roundtable

Discussions:

COMPANY TYPE■ Pharmaceutical, Biopharmaceutical 30%

■ Contract Research Organisations 35%

■ Site Management Organisations 10%

■ Medical Device Companies 5%

■ Research Institutes, Hospitals & Universities 5%

■ Government Regulatory Bodies & Ethics Committee 5%

■ Clinical Trial Logistics & other Supply Chain Solutions 2%

■ Technology & Service Provider 8%

COUNTRY■ China & North Asia 50%

■ Rest of Asia 25%

■ Europe 10%

■ USA 10%

■ Rest of the World 5%

Exchange Business Cards &Have a Chat with VIPs During the

Networking Cocktail

Speak, Sponsor, Exhibit and Network atPartnerships in Clinical Trials AsiaThis event offers you a unique opportunity to showcase your products and services in frontof key decision-makers. Access local, regional, and multinational pharmaceutical and biotechsponsors conducting clinical trials in Asia and position your company as the leading serviceprovider.

For inquiries, contact:

APACYvonne Leong

Yvonne.Leong@ibcasia.com.sg+65 6508 2489

Europe & USASharon Ames

sames@iirusa.com+1 646 895 7475

Who Should Attend

10%Clinical &MedicalAffairs

40%Clinical Research,Operations, &Development

35%GlobalOutsourcing &Procurement

15%DataManagement,Drug Safety &QualityAssurance

JOB FUNCTION

RegulatoryChallenges for

Clinical TrialMaterial

Importation &Exportation

Good ClinicalLaboratory

Practice Standardfor Clinical Trial

SampleManagement &

Testing

Phase IIOutcomes:

Go or No Go toPhase III

ReducingEmployeeTurnover –

What are theIncentives that

Work Best?

How to ConductMedical Device

Clinical Trialsin China

Preparing INDApplications

for SFDA

DownstreamImplicationsof Poor Data

Collection

NEW!

Key Topics to Discuss:

• Data Quality in China: Understanding potential concerns from a pharmaceutical perspective• Overcoming challenges faced with data quality by CROs in China sites & the strategies used by global

CROs• Implementing standardized assessments for clinical research professionals to improve data quality• Roundtable Discussions: Discussing potential strategies for improving site quality• Roundtable Discussions: Analyzing different uses for online training

8:00 Registration Opens & Morning Coffee

8:45 Welcome Address from IBC Asia/IIR USASpeed Networking: Exchange Business Cards & Get to Know Industry Peers

8:50 Chairperson’s Opening RemarksSimon McErlane, Vice President & Head, Takeda Development Center Asia,Singapore

REGULATORY UPDATES & QUALITY CONTROL IN GLOBAL CLINICAL TRIALS

9:15 Global Regulatory Updates for Clinical Trials• Differentiating US, Europe, Australia, Middle East and Asia in clinical trials• Regulatory updates and developments• International standards and protocols• Ethical and cultural diversity issues• Dealing with changing regulations and different regulations per country• ASEAN harmonization of standards• Localizing protocols for Asia’s marketPanelists:Nguyen Ngo Quang, Deputy Director, General of Science, Technology &TrainingAdministration (STTA) & Vice Chair, Independent Ethic Committee (IEC), Ministryof Health, VietnamSumant Tiwari, Deputy Director, Drugs, Food & Drug Administration (FDA),IndiaLoke Meng Ong, Head of Clinical Research Center, Ministry of Health, MalaysiaBeno Yakubu, Chief Regulatory Officer, National Agency for Food and DrugAdministration & Control (NAFDAC), Nigeria

10:00 Quality Driven Drug Development in the Asia Pacific Region• Driving quality in global clinical trials in Asia Pacific• Sharing of case studies- key successes, failures and lessons learnt• Using Quality Control to improve patient outcomes• How to successfully overcome an FDA/SFDA audit?Panelists:Carl Firth, Chief Executive Officer, Aslan Pharmaceutical, SingaporeHassan Movahhed, Senior Vice President, Global Development Operations, UnitedTherapeutics, USAVictoria Elegant, Vice President, Medical, Clinical & Regulatory Affairs, Baxter,ChinaDuanghatai Chirapathomsakul, Associate Director Global Clinical QualityAssurance, Lundbeck, ThailandJohn Gong, Senior Vice President, Clinical Operations, Beigene, China

10:45 Morning Network & Refreshment Break

11:15 Enhancing Data Quality of Clinical Trials in China• Examining the challenges faced by CROs with data quality in China sites• Identifying the strategies used by global CROs in addressing key

pharmaceutical concerns• The impact of effective trainingModerator:John Constantine, Chairperson, Asia Training Consortium, Executive Director,Merck Polytechnic Institute, USAPanelists:Yanping Zheng, Director, Clinical Affairs/Medical Monitor, MallinckrodtPharmaceuticals, USAJunfang Li, Vice President, Biostatistics, Otsuka Pharmaceuticals, USAEd Jones, Global Head, Strategic Resourcing, Statistical Programming and Analysis(PDBP), F. Hoffman-La Roche and Genentech, USA

12:00 How Does Risk-Based Quality Management Reduce Cost & Time of ClinicalTrials?• Detecting the highest possible risk efficiently• Adverse event reporting and management• Identifying real examples of implementation in AsiaPanelists:Matthias Boedding, Global Safety Leader, Pharmacovigilance & Risk Management,Bayer Healthcare, ChinaCheong Guan Leong, Regional Manager, Clinical Development Quality Assurance,Glaxosmithkline, SingaporePatrecia Flynn Valone, Senior Director, Development Operations, TakedaDevelopment Center Asia, Singapore & Takeda Development CenterShanghai, China

12:45 Mastering Clinical Trial Conduct & Protocol Compliance in China• What are the operational considerations to conducting a trial in China?• The risks and benefits of China trials• The synergy of a global and local CRO to optimize best practices in

conducting trialsJames Pusey, President & General Manager, WuXiPRA, China

1:15 Networking Lunch2:00 Roundtable Discussions: Limited Seats Available!

Roundtable 1 Regulatory Challenges for Clinical Trial Material Importationand ExportationJin Shun, Head of Regulatory Affairs, Asia, Takeda DevelopmentCenter Asia, Singapore and Takeda Development CenterShanghai, China

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Roundtable 2 Good Clinical Laboratory Practice Standard for Clinical TrialSample Management and TestingMotiur Rahman, Head of Laboratories, Oxford UniversityClinical Research Unit, Vietnam

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Roundtable 3 How to Conduct Medical Device Clinical Trial in ChinaJimmy Lu, Senior Clinical Specialist, Roche Diagnostics, China

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Roundtable 4 Downstream Implications of Poor Data CollectionEd Jones, Global Head, Strategic Resourcing, StatisticalProgramming and Analysis (PDBP), F. Hoffman-La Roche andGenentech, USA

2:30 Ensuring Quality Protocols in Clinical TrialsIn recent years, there’s been a large increase in protocol amendments whichadds on significant time, effort and costs to the clinical development process.According to a study by the Tufts Center for the Study of Drug Development,69% of all protocols have at least one amendment which adds an average of61 days to the clinical timeline and costs more than $450,000 to implement.This session sheds light into:• How to dissect a protocol to ensure quality protocols that minimizes

amendments?• Examining the decision making process in creating protocols – how to make

the best choices?Eric Morfin, Senior Director, Project Management, Allergan Biologics, USA

3:00 Incorporating HEOR Data into Global & Regional Development• Examine what clinical trial data to incorporate for favorable formulary and

reimbursement decisions• Avoid adding trial endpoints post-study to increase costs and time spent• Discuss the changing role of HEOR oversight within pharmaceutical

companiesLi Yan, Head of Clinical Development, Infectious Disease, Respiratory & Immunology,Oncology, Emerging Markets, Merck, USA

3:45 Afternoon Networking & Refreshment Break

OPTIMIZING RELATIONSHIPS & COLLABORATION

4:15 Innovative Approaches to Clinical Partnering• Case examples of different kinds of partnerships in clinical trials (eg.

academia/pharma; pharma/pharma; pharma/CRO & more)• Determining pros and cons of partnering with local vs. global SMOs & CROs• Maintaining relationship and generating good quality supporting protocolsPanelists:Ben Ni, Head, Scouting & Partnering for China, Sanofi, ChinaYuntao Wan, Head of Clinical Operations, Early Development, Roche, ChinaYingmei Tu, Director, Clinical Research, Merck, ChinaJohn Gong, Senior Vice President, Clinical Operations, Beigene, China

5:00 Pharma – Investigator Collaboration: Meeting Needs Through MotivationCollaborating with investigators is a key element to clinical trial success inChina. Through a proven process, United Therapeutics has been able to builda plan to engage with investigators and site staff in clinical trials in China.• Building a Toolbox for CROs• Answering the question of what drives Investigators and how can we fulfill

those needs?• Creating a customized engagement program within the constraints of

typical benchmarksHassan Movahhed, Senior Vice President, Global Development Operations, UnitedTherapeutics, USA

5:45 Chairperson’s Summary of the Day & End of Conference Day OneSimon McErlane, Vice President & Head Takeda Development Center Asia,Singapore

6:00 Networking CocktailExchange Business Cards & Have an Informal Chat with the Below VIPs!VIP 1 Maggie Gu, Director, Clinical Development, Astrazeneca, ChinaVIP 2 Yi Fang, Director of Phase I Clinical Trials Unit, Peking University

People's Hospital, ChinaVIP 3 BL Das, Joint Director, Food and Drug Administration (FDA), IndiaVIP 4 Nasri Abdallah, Associate Director Clinical Studies, Boehringer Ingelheim,

China

Conference Day One: 17 September 2014 l Wednesday

Conference Day Two: 18 September 2014 l Thursday

1.00 Roundtable Discussions: Limited Seats Available!

Roundtable 1 Phase II Outcomes: Go or No Go to Phase IIIBhaswat Chakraborty, Senior VP Chair Scientific Committee,Cadila Pharmaceuticals, India

________________________________________________________________________________________________________

Roundtable 2 Reducing Employee Turnover – What are the Incentivesthat Work Best?Christina Bodurow, Senior Director, External Sourcing,Eli Lilly & Co., USA

________________________________________________________________________________________________________

Roundtable 3 Preparing IND Application for SFDACard Edwards, Professor of Medicine, West China Hospital,Sichuan University & Vice President Preclinical Development &Project Management, Hinova Pharmaceuticals, China

1:30 Collaboration in the Development of BiosimilarsThe future of biosimilar drug development is rapidly growing with 63 billiondollars in global biologic sales products due to come off patent by 2016. Whilepartnering with local China companies can bring economies of scale, marketknowledge and better networks, there are also learning opportunities frompartnering with MNCs in terms of quality assurance, improved R&D processesand technology transfer. Understand the best practices in the operations andoutsourcing of biosimilar clinical trials.Yi Fang, Director, Preclinical Safety, China R&D, Sanofi Aventis, China

2.00 Alignment of Global and Local Clinical Strategies• Successful vendor selection process• Aligning financial and business goals• Specifying in scope and out of scope services to avoid confusion• Avoiding partnership disputesChristina Bodurow, Senior Director, External Sourcing, Eli Lilly & Co., USA

2:30 Afternoon Networking & Refreshment Break

3:00 Bringing High-Quality Central Lab Services to Support Clinical Trials• Achieving a robust global central laboratory operations• Enhancing clinical trials in central labs• Efficiently managing clinical trialsZhanghua Lan, Acting Site Head & Clinical Data Services Lead, Pfizer, ChinaLigong Chen, Principal Investigator, School of Medicine, Tsinghua University& Visiting Scientist, Center of Therapeutic Innovation, Pfizer, China

4:00 Vendor Performance Metrics – To What Extent Can Vendors be Tracked &Managed?• Accurately tracking and measuring performance of vendors• Communicating with vendors effectively• Monitoring clinical activities• Bridging the gap between modern technology and conventional monitoringPanelists:Allan Riting Liu, Vice President/Senior Advisor,Wanbang Biopharmaceuticals, ChinaHamzeh Awad, Principal Investigator, King Saud University, UAE

4:45 Chairman’s Summary of the DayCory Williams, Head, Clinical Trial Management, Pfizer R&D Center, China

5:00 End of Conference – See you next year!

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08:45 Chairperson’s Recap of Day One

Cory Williams, Head, Clinical Trial Management, Pfizer R&D Center, China

PATIENT RECRUITMENT, INFORMED CONSENT & CARE

9:00 Developments in Informed Consent for Improved Patient Outcomes• Assessing the best strategy in obtaining informed consent• Considering language and culture differences and the associated translation

requirements• Embracing new technologies to streamline the informed consent processPanelists:Bhaswat Chakraborty, Senior Vice President & Chair Scientific Committee,Cadila Pharmaceuticals, IndiaCarlos Linn, Asia-Pacific Regional Medical Director, Diversified Products,Pfizer, ChinaJoan Shen, Chief Medical Officer, Jiangsu Hengrui Medicine, ChinaHenry Yau, Managing Director, Clinical Trials Centre, The University ofHong Kong, Hong Kong

9:45 Quality not Just Quantity: How to Create a Patient Recruitment Plan duringStudy StartupIn recent years, a challenge in conducting trials in the Asia-Pacific region hasnot only been recruiting patients but attracting the appropriate candidates toenroll. Learn case study insights to successful patient recruitment plans in thisinteractive session including how to:• Attract better quality candidates via precise inclusion/exclusion criteria• Overcoming cultural barriers to drive recruitment• Create well-designed screening scriptsYanping Zheng, Director, Clinical Affairs/Medical Monitor, MallinckrodtPharmaceuticals, USA

10:15 EHRs, Confidentiality, Data Security & Protection of Patient’s Records• Transitioning to EHR’s• Dealing with different data privacy rules• Retrieving patient medical records efficiently• Getting patient informed consentArun Maseeh, Vice President, Medical Affairs, Cadila Pharmaceuticals, India

11:00 Morning Networking & Refreshment Break

CLINICAL STRATEGIES & VENDOR MANAGEMENT

11:30 Clinical Trial Design and Compliance – Medical Devices vs. Pharmaceuticals• Examining the differences between medical device and pharmaceutical

trials• What are the medical device trial design considerations?• Compliance – GCP vs. ISO14155Timothy Low, Vice President, Medical Affairs Asia Pacific, Covidien, Singapore

12:15 Networking Lunch

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REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.clinicalpartnershipsasia.com

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Be ready with a

handful of business

cards and meet

industry peers just

before the

conference begins.

Sign up for the VIP

Roundtables which

allow you to meet

with key speakers at

the conference and

discuss issues over

lunch.

Network while

having drinks to

connect and engage

with your clients,

partners and peers in

the industry.

More VIP

Roundtables await

you! Sign up now and

learn from these

experts over lunch.

TM

6th Annual

ASIA16 - 18 September 2014 | Sheraton Shanghai Hongqiao | Shanghai | China

Yanping ZhengDirector, Clinical Affairs &Medical Monitor,MallinckrodtPharmaceuticals, USA

NEW Networking Opportunities: Roundtable Discussions, Speed Networking & Networking Cocktail

INTRODUCING Partnering 360: Event-specific networking tool for registered participants before, duringand following the 3-day event

REGISTER TODAY! +65 6508 2401 www.clinicalpartnershipsasia.com

This label contains your priority booking code. To expedite registration, please do not remove label. If you havealready received a copy of this brochure, we apologise. For reasons of confidentiality, your full particulars were notavailable to IBC Asia (S) Pte Ltd for deduplication prior to mail drop.

Keynote Speakers

Victoria ElegantVice President, Medical,Clinical & Regulatory Affairs,Baxter, China

Yingmei TuDirector, Clinical Research,Merck, China

Where Key StakeholdersCollaborate to DriveClinical Trial Success andPartnering in Asia

80% New ExpertSpeakers

10+ Panel Discussions &Case Studies

150+ Attendees from10+ Countries

www.clinicalpartnershipsasia.comTM

6th Annual

ASIA16 - 18 September 2014 | Sheraton Shanghai Hongqiao | Shanghai | China

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111 Somerset Road,TripleOne Somerset #10-06, Singapore 238164Tel: +65 6508 2400 Fax: +65 6508 2408