Pharmaceutical R&D Asia 2014

IBCLIFE SCIENCES

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26-29AUGUST 2014

S i n g a p o r e

Featuring Expert Insights

Part of:

Why You Must AttendHear from 25+ R&D Expert Speakers

Gain Insights on Licensing, M&A, Regulationsand More!

R&D Investment and Funding Opportunitiesfrom Leading Venture Capitalists

Craft IP Strategies and Ensure FormulaConfidentiality in the Asian region

New Interactive and In-Depth Formats: PanelDiscussions, Roundtable Discussions, VIPLunch Tables

Jun BaoSenior Vice President &Chief Business Officer,Shenogen Pharma

Group, China

Joe ZhangExecutive Deputy Head,Center of Medical andTranslational Sciences,Shanghai CP Guojian

Pharmaceutical, China

Kantharaj EthirajuluHead, Research & Development,Technical- Drug Discovery &Development,The Biomedical Sciences

Institute (BMSI), Singapore

Ben NiHead & Senior Director,Partnering & ExternalInnovation,Sanofi R&D, China

Dr. Narendra VutlaExecutive Vice President &Head of R&D-Wellness, OralHealth & Site Operations,GSK Consumer Healthcare,India

P A R K R O Y A Lon Beach Road

Pre- Conference Special Focus Day26 August 2014 • 9am – 5pm

Clinical Trial Development in Asia

Post Conference Workshop29 August 2014 • 9am – 5pm

China R&D

www.pharmaconasia.com

Peter W. TsaoVice President BusinessDevelopment,TaiGen Biotechnology,Taiwan

Supported by:

Sponsors:

LifeSciences

8:00 Registration Opens & Morning Coffee

8:50 Welcome from IBC Asia & Morning Ice Breaker

9:00 Chairperson’s Opening Remarks

Asia’s Pharmaceutical Market Outlook & Regulatory Updates

9:10 Asia Pharmaceutical Investment Opportunities &Development• Where is the Asian pharmaceutical market heading towards?• What are the investment and market opportunities available in

Asia?• How are pharma companies in Asia coping with intensifying

competition and investment from overseas?• Selecting the best business model, communication and operations

to maximize market share in Asia• How regional integration has affected product launch and

marketing in the prescription and non-prescription market

Jun Bao, Senior Vice President & Chief Business Officer,Shenogen Pharma Group, ChinaBilly Sarvanantham Urudr, Chief Commercial Officer,CCM Pharmaceuticals Sdn Bhd, MalaysiaDr. Narendra Vutla, Executive Vice President & Head of R&D –Wellness, Oral Health & Site Operations, GSK ConsumerHealthcare, IndiaCarl Firth, CEO, Asia Pharmaceuticals, Singapore

10:00 Asia’s Evolving Regulatory Landscape & Development• Current initiatives and regulatory trends in Southeast Asia• International models, frameworks and standards for Asia to adopt• Regulatory trends and their impact on R&D investment• Recent pharma marketing regulations changes, expected new

guidelines and compliance process under AEC• Are pharma companies ready for the implementation and the

liberalization of health care services?• Current regulatory challenges faced and how they can be tackled• ASEAN harmonization and to what extent will it drive Asian

innovation?

Joy Chen, Director, Regulatory Affairs, Reckitt Benckiser,SingaporeAriel Valencia, Deputy Director, Food & Drug Administration,PhilippinesKoichi Miyazaki, Senior Director, Regulatory Affairs Group, AsiaDevelopment Department, Daiichi Sankyo, Japan

10:40 Morning Networking & Refreshment Break

Financing, Partnerships & Collaboration

11.25 Chairperson’s Opening RemarksJun Bao, Senior Vice President & Chief Business Officer,Shenogen Pharma Group, China

11.30 Strategic Partnerships & Collaboration as a Key to DrivingAsian Drug Innovation• Introduction to a multi collaboration and partnership model to

drive innovation• Getting the best out of your partnerships• Approaches to incorporate partnerships into your R&D modelBen Ni, Head & Senior Director, Partnering & External Innovation,Sanofi R&D, China

12.10 Strategic Licensing, Mergers & Acquisitions Trends forPharma R&D Development• Evaluating recent licensing and M&A trends in Asia• What do these trends signify?• Different licensing trends for large and small companies, its

challenges and how they can be tackled• Where is the Asian pharmaceutical market headed to?

Yariv Hefez, Vice President Business Development, PortfolioManagement, Strategy and Partnering, Biosimilars Unit,Merck Serono, SwitzerlandPeter W. Tsao, Vice President Business Development,TaiGen Biotechnology, Taiwan

REGISTER TODAY! +65 6508 2401 [email protected] www.pharmaconasia.com

27CONFERENCE DAY ONE

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12:50 Speed Networking

13:00 Networking LunchHave a chance to have an informal chat with VIP guests duringthe networking lunch breakVIP 1: Yuan Hua Ding, Senior Director & Head of External R&D

Innovation – Asia, Pfizer Worldwide Research &Development, Pfizer, USA

VIP 2: Ben Ni, Head & Senior Director, Partnering & ExternalInnovation, Sanofi R&D, China

14:00 Venture Capital Opportunities for Drug Discovery &Development in Asia• Funding models and investment opportunities in Asia• Latest innovations and fields that are gathering interests among

venture capitalists• What constitutes a good business model and presentation• Collaboration opportunities with venture capitalists• Key criteria for investmentGoro Takeda, Venture Partner, Sofinnova Ventures, JapanJun Wu, Chairman & Managing Director, Cenova Ventures,ChinaJason Mann, Managing Director, Fenex Capital Management,China

14:40 Discovery Outsourcing to Asia: Lessons Learnt• What are the challenges faced by a global western company when

outsourcing to Asia?• Key concerns from the West• What approach was taken when tackling the challenges faced in

Asia?

15:10 Afternoon Networking & Refreshment Break

Clinical Trial Development in Asia

15:50 Managing Risks in Clinical Outsourcing to Southeast Asia• Understanding regulations, clinical infrastructure and risks when

conducting clinical trials in Asia• Handling ethnicity and cultural differences within Southeast Asia:

What are the differences and similarities in risks?• Strategies to minimize and manage these risks• Establishing standards and IP protection in clinical trials in Southeast

Asia

16:30 Developing Clinical Trials in Oncology in Singapore• Difficulties faced in conducting oncology clinical research and

how were they tackled• Advice in clinical trials design for oncology in Singapore• Tackling oncology clinical trials unique risks and managing them• Ways to carry out the trials efficiently without compromising on

quality and safetyJoanne Chio, Head, Clinical Trials, Haematology-OncologyResearch Group, National University Cancer Institute (NCIS),National University Hospital, Singapore

Intellectual Property Rights

17:00 IP Trends & Patent Strategies• Insight into compulsory licensing in India and Indonesia• Viewpoint of the compulsory licensing system in Asia• Singapore’s patent linking system for generics• What are the common issues in intellectual property and how can

they be addressed?• Laws protecting and ensuring confidentiality when conducting

research in AsiaDebolina Partap, Associate Vice President & Head of Legal,Wockhardt Group, IndiaSoh Kar Liang, Managing Director, Ella Cheong LLC, SingaporeManh Hung Tran, Principal & Managing Lawyer, BMVNInternational LLC, a member of Baker & McKenzieInternational, Vietnam

17:40 Chairperson’s Summary of the Day &End of Conference Day One

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8:30 Morning Networking & Coffee

9:00 Chairperson’s Opening Remarks

Kantharaj Ethirajulu, Head, Research & Development, Technical– Drug Discovery & Development, The Biomedical Sciences


Generics & Biosimilars R&D in Asia

9:10 Biosimilars & Generics R&D in Asia – What Can We Do To

Maintain the Lead?• Overview of the generics and biosimilars industry in Asia• A review of science and technology developments for making

complex generic drugs• Strategies in retaining Asia’s stronghold in follow-on drug R&D to

ensure Return On Investment (ROI) in sales• If not follow-on drugs, what’s next?

ModeratorGene Ching-Hung Hsu, Senior Vice President, HEC Pharm

Group, ChinaPanelistsKasibhatta Ravisekhar, Vice President, Clinical Research,Lupin Pharmaceuticals, IndiaQiang Lu, Chief Scientific Officer, Yangtze River

Pharmaceutical Group, China

Joe Zhang, Executive Deputy Head, Center of Medical andTranslational Sciences, Shanghai CP Guojian Pharmaceutical,China


Driving Drug Innovation in R&D

10:20 Biomedical Innovation & Pharmaceutical Growth• How is pharmaceutical growth in Asia fueling biomedical

innovation in the region?• Potential and current growth areas of focus in Asian biomedical

innovation• Challenges Asia is facing that could limit its growth potential and

what can be doneYuan Hua Ding, Senior Director & Head of External R&DInnovation – Asia, Pfizer Worldwide Research &

Development, USA

11:00 Challenges in Drug Discovery & Development in Asia• Challenges faced in Asia and how to tackle them• Overcoming lack of fundamental knowledge for drug discovery• Streamlining drug development process for efficiency• Drug candidates discovered and developed in AsiaKantharaj Ethirajulu, Head, Research & Development, Technical– Drug Discovery and Development, The Biomedical Sciences


Scientific Advances Showcase

11:40 Aggregation in Biosimilars: Orthogonal Analytical Tools

in Assessment of Monoclonal Antibodies• Developing analytical methods to study structural change in

biosimilar monoclonal antibodies• Eliminating structural change due to change in process conditions• Minimizing structural modifications without compromising on

potency of drugDr. Kalyan Sundaram, Senior Research Scientist, Lupin, India

12:20 Networking Lunch

13:40 Drug Discovery from Natural Medicines by NovelApproaches• Post-absorption/metabolism drugs (PAMD ) concept• Discovery of active metabolite in ginseng which is currently in

phase III clinical trials for anti-depression• Results of pharmacokinetics/pharmacodynamics (PK/PD) studies

of the metabolite and clinical trials• Future work and initiatives in areas of natural products drug

discoveryWilliam Jia, Chief Scientific Advisor, SAPHRONTM DatabaseService Centre, Shanghai Innovative Research Centre of

Traditional Chinese Medicine (SIRC/TCM), China

Infrastructure & Resource Development for R&D

14:20 Establishing R&D Infrastructure & Talent Resources• Current status of clinical and R&D facilities infrastructure• What are governments in the region doing to improve and promote

clinical and R&D development?• Creating a quality and innovative facility in the Philippines: What

is required?• Current R&D talent pool outlook in the Philippines• What can be done to further develop, attract and retain R&D talent?Rodel Sibulo, Director of R&D, Pascual Laboratories,Philippines

Technology Transfer in Drug Discovery R&D

15:00 Ensuring Reproducibility during Knowledge & Technology

Transfer in R&D Outsourcing• Determining the right conditions for technology transfer• Partnering and selecting the right organizations for collaboration• Advice and methods in ensuring data quality and reproducibility

during knowledge transfer• Getting the maximum benefits out of the collaborationQiang Lu, Chief Scientific Officer, Yangtze River

Pharmaceutical Group, China


Interactive Round Table Sessions

16:20 Roundtable 1: Pharmacokinetics/pharmacodynamics

(PK/PD) Guided Clinical Research for Generics

Kasibhatta Ravisekhar, Vice President, Clinical Research,Lupin Pharmaceuticals, India____________________________________________________Roundtable 2: Inhouse vs Outsourced R&D

Hwee Ching Ang , Head of Science Hub, Singapore RegionGlobal External Innovation & Alliances, Bayer Healthcare,Singapore____________________________________________________Roundtable 3: R&D Strategies for an Innovative Pipeline

James Garner, Head, Unit Operations, Sanofi-Aventis,Singapore

17:40 Chairperson’s Closing Remarks &

End of the Pharmaceutical R&D Conference

28CONFERENCE DAY TWO

AUGUST 2014 | Thursday


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POST-CONFERENCE WORKSHOP29 AUGUST 2014, FRIDAY (0900 – 1700)

WORKSHOPS

8:30 Registration & Morning Coffee

8:50 IntroductionNaeem Noordin, Managing Director, Siara Pte Ltd,Singapore

9:00 Session 1: Clinical Trial Requirements & Regulationsin Asia• Insights into clinical trials requirements and regulations in Asia

Pacific• Preparing for a regulatory inspection and tips on what the

regulators are looking for• Crafting and submitting what is required in a clinical trial

application (CTA)Christophe Tournerie, CEO, ClinActis, Singapore


11:00 Improving & Ensuring the Quality of Clinical Trials& Data• Quality standards in clinical trials• Strategies to ensure, monitor and improve clinical trials data

quality during outsourcing of clinical trials• Creating a strategy to minimize risks for data integrityEmily Tan, Vice President, Clinical Operations Asia Pacific,inVentiv Health Clinical, Singapore

12:30 Networking Lunch Break

13:30 Clinical Site Management & Use of Site ManagementOrganizations (SMO)• Selection and evaluation of a clinical trial site• Integration of a quality system, SOPs and training to ensure

quality trial data in different clinical sites• Employing a risk based management to ensure clinical quality

at site• Use of site management organization (SMO)Shashi Adsul, Head of Clinical Operations, South East Asia,Boehringer-Ingelheim, Singapore

14:30 Application of Digital Technologies for PatientRecruitment & Retention• Utilizing digital technologies for a patient centric and efficient

patient recruitment procedure• Cutting costs and time through digital recruitment• Case studies and applicationsRamita Tandon, Senior Vice President & General Manager,inVentiv Health Clinical Trial Recruitment Solutions, USA


16:00 Informed Consent in Clinical Trials• Informed consent implementation process, guidelines and the

people involved• Systematic development of the informed consent form• Cultural issues and challenges to be taken into considerationNaeem Noordin, Managing Director, Siara Pte Ltd,Singapore

17:00 End of Clinical Trial Development in Asia Workshop

8:30 Registration & Morning Coffee

8:50 Introduction

9:00 China Pharmaceutical Market Outlook• Current pharmaceutical market outlook and progress in China• Trends and changes in R&D areas of focus in China• Is it still all about biosimilars in China?


10:30 Creating Successful Partnerships in China• Key considerations when partnering with Chinese companies• Critical advice in getting the most out of your partnership

11:30 R&D Development Models for China• Crafting a R&D development plan• How to select a R&D model most suitable for your organization

12:30 Networking Lunch

14:00 Challenges of Selecting and Collaborating with China-Based Preclinical Contract Laboratories• Selecting pre-clinical contract laboratories in China• How to access the cost, facilities and labour skills before selecting• Tips in maintaining confidentiality and ensuring quality in

preclinical research


16:00 Integrating Regulatory Concerns with DrugDevelopment in China• Recent regulatory changes in China• Overcoming the ever changing regulations during drug

development

17:00 End of China R&D Workshop

Clinical Trial Developmentin Asia

This interactive multi-speaker workshop aims to acquaint theparticipant with the essential skills to develop a quality and

regulatory compliant clinical trial in Asia.

PRE-CONFERENCE SPECIAL FOCUS DAY26 AUGUST 2014, TUESDAY (0900 – 1700)

China R&DThis workshop aims to introduce you to one of the world’s largest

and highly competitive markets – the China R&D market. It willbring you through the important aspects on what is required, the

investments, opportunities and key insights on entering andoperating in the China R&D market.

About Your Workshop Leaders

Gene Ching-Hung Hsu, Senior Vice President,HEC Pharm Group, ChinaDr. Hsu is the Senior Vice President at HEC Pharm Group (China). Heearned his Ph.D. from Massachusetts Institute of Technology (MIT) andcompleted his postdoctoral training at University of California at Berkeley.Prior to HEC Pharm, Dr. Hsu was the Chief Scientific Officer and VicePresident of Shanghai InnoStar Bio-Tech Co. (China). His professional

experience also includes executive and technical positions at TaiGen Biotech Co.(Taiwan), Merck & Co. (USA), and US Federal Government. Dr. Hsu has co-authoredover 150 scientific publications, book chapters, and technical reports. He publishesbooks titled “Clinical Pathology in Experimental Animals” and “Cancer Risk Assessment”(John Wiley & Sons, Inc.). Currently, Dr. Hsu serves on the Editorial Board of twointernational peer-reviewed journals and is the President-Elect of American Associationof Chinese Toxicology (a special interest group of the Society of Toxicology, USA). Heis board-certified by the American Board of Toxicology. Dr. Hsu is a recipient of theprestigious “Global Expert Award” by the China Central Government

Joe Zhang, Executive Deputy Head, Center of Medical andTranslational Sciences, Shanghai CP GuojianPharmaceutical, ChinaDr. Zhang joined Shanghai CP Guojian Pharmaceutical Co. Ltd. in February2014 as the Executive Deputy Head of the Center of Medical andTranslational Sciences, overseeing the entire preclinical (GLP tox) andclinical (Phase I to IV) development activities of the company. He also

is the architect and a member of the company’s R&D Committee with responsibilitiesof reviewing and approving key milestones and associated budget for each R&Dproject. Prior to joining Shanghai CP Guojian, Dr. Zhang served quite a number of rolesduring his almost 20 years of professional career from scientist to vice president in avariety of organizations including China FDA, Covance, Boehringer Ingelheim, andRoche. Dr. Zhang is a pharmaceutical industry veteran trained in the United States andChina with significant experiences in drug R&D activities. He received his Ph.D. inToxicology from Indiana University and is a certified toxicologist by American Boardof Toxicology. He also has a medical degree and a MPH from Beijing Medical University.Dr. Zhang has been very active in different scientific committees and organizations.He served as a group leader for RDPAC Preclinical Focus Group, a board member forGenetic Toxicology Association (GTA) and American Chinese Society of Toxicology(ACSOT) and is currently a full member of SOT, GTA, BioSafe, SAPA, and AACT.


IBCLIFE SCIENCES

26-29AUGUST 2014

S i n g a p o r e

P A R K R O Y A Lon Beach Road


IBC Asia’s premier Pharma R&D Asia conference aims to facilitatea better understanding of the complex Asian emergingpharmaceutical R&D industry, the opportunities, the challengesand the strategies that senior level decision makers are employingto get the best out of the region. Hear from pharmaceutical R&Dexperts on the investment opportunities, clinical trialdevelopments, regulatory approval progress, technology transfer,IP protection and more, in this structured learning, networkingand value packed four day program. You will no doubt, go homewith new business relationships and strategies to successfullygrow an innovative R&D pipeline in Asia.

Sponsorship OpportunitiesRAISE awareness of your products and services to regional andinternational pharmaceutical professionals!

Stand out from the competition with this branding opportunityMeet and develop new client relationships and also affirm existing ones with yourpresence at this eventAre you launching new R&D technology or clinical trials services? Now is the timeto showcase at this eventRaise and maintain your corporate profile edge

To check out our tailored sponsorship solutions, please contact: Yvonne Leong, BusinessDevelopment Manager at Tel: +65 6508 2489 or Email: [email protected]

Who You Will Meet

■ Singapore 35%

■ Malaysia 15%

■ Indonesia 10%

■ Thailand 10%

■ India 10%

■ Rest of Sotheast Asia 5%

■ North Asia 10%

■ US/Europe 2%

■ Australia/New Zealand 3%

■ Pharmaceutical/Biotech/Generics 45%

■ Research Institute/Universities 25%

■ Government Agencies 5%

■ CROs 15%

■ Law Firms & Consultants 8%

■ R&D Software Solutions Providers 2%

Partnerships and Collaboration OpportunitiesLicensing, M&A Trends in AsiaRegulatory Trends and Their Impact on your R&D PipelineMarket & Investment Opportunities in AsiaIntellectual Property Right Issues & Patent Strategies in AsiaOutsourcing vs Inhouse R&DClinical Trial Requirements & DevelopmentR&D Strategies for an Innovative Product Pipeline

Key Conference Highlights:

Part of:

Showcase Your Research... Present a PosterIf you have new results/data on topics relevant to this conference, we encourage you to submit a poster presentation.

Any registered conference attendee may present a poster. Full payment of conference registration and poster fees must bereceived for the abstract to be included in the conference materials and a poster board assignment to be made (see theregistration page for details on the poster fee). Only one poster presentation is allowed per registered attendee/author.

For more information, please email: [email protected]

WHO SHOULD ATTEND?• Head of Medical Affairs• Medical Affairs Directors• MSLs• Chief Medical Officer• Scientific Directors• Medical Directors• Medical and Scientific Affairs Executives

IBCLIFE SCIENCES 4 Successful Events Under 1 Roof!

26 - 29 AUGUST 2014 | PARKROYAL ON BEACH ROAD, SINGAPORE

What is PharmaCon?The Pharmaceutical Congress Asia (PharmaCon) is the leading annual event that brings together Government, pharmaceutical companies andsuppliers in Asia across:

4 Conferences 10 Workshops 4 Days of value-packed information Hours of networking opportunities

The dynamic program and networking platform aims to enable companies to develop strong partnerships, drive innovation and growth, aswell as winning products and services, in Asia’s growing pharmaceutical industry.

Asia’s premier Pharma R&D conference is designedfor professionals in the pharmaceutical R&D sectorto find out the latest investment, partnership andcollaboration opportunities, challenges facing drugdiscovery and clinical development and how toimprove R&D innovation and productivity in Asia.

WHO SHOULD ATTEND?Senior level professionals from:

Designed for regulatory professionals in thepharmaceutical industry to come together to discusseffective regulatory strategies for product accessinto Asia and also globally as well as to gain clarityon the complex and ever changing regulations inthe region.

WHO SHOULD ATTEND?Professionals dealing with:• Global/Regional Regulatory Affairs• Regulatory Compliance• Regulatory Submissions & Publishing• Pharmacovigilance• Market Access

Designed for senior executives from marketing inprescription and consumer health sectors, theconference pinpoints key success factors instrategizing pricing, distribution, advertising &promotion and product differentiation strategy inthis competitive market. This event is Asia’s one andonly platform to provide updated and in-depthevaluation on marketing strategies in thepharmaceutical industry.

WHO SHOULD ATTEND?

• CEO• Chief Marketing Officer• President/Managing Director/Vice

President of Asia• Country Manager• Regional Marketing Director• Head of Corporate Planning• Head of Commercialization• Head of Marketing & Sales• Head of Market Access• Head of Business Development

• Head of Multi-Channel Marketing• Head of Digital Marketing• Head of Product Development• Head of Packaging and Labeling• Head of Procurement & Sourcing• Head of Compliance

MEDICAL AFFAIRS FORUM ASIA is the region’slongest running medical affairs forum where bestpractices are shared and common issues with like-minded peers are discussed. This event will bringinsights on how to be more effective in enhancingyour company’s scientific reputation andcommunicating the value of your products.

• R&D• Drug Discovery• Clinical Trial and

Development• Business Development• Partnerships & Licensing

• Strategic AllianceManagement

• Strategy & PortfolioManagement

• Investment• Mergers & Acquisitions


ENJOY SUBSTANTIAL SAVINGS WITHOUR MULTIPLE BOOKING DISCOUNT!

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❑ Yes! I/We will attend the Pharma R&D Asia 2014 | 26 – 29 August 2014, ParkRoyal Hotel on Beach Road, Singapore

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Should you be unable to attend, a substitute delegate is welcomeat no extra charge. Cancellations must be received in writing atleast 10 business days before the start of the event, to receive arefund less 10% processing fee per registration. The companyregrets that no refund will be made available for cancellationnotifications received less than 10 business days before the event.

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MAIL the attached registration form with yourcheque to IBC Asia (S) Pte Ltdc/o Informa Regional Business Services111 Somerset Road, TripleOne Somerset#10-06, Singapore 238164

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❑ 2 Day Conference only

SGD 3,895 SGD 4,095 SGD 4,295 SGD 3,795❑ 4 Day Package: 2 Day Conference + All Workshops

SGD 2,595 SGD 2,795 SGD 2,995 SGD 2,495

• Multiple Bookings Discount pricing is applicable to groups of 3 or more delegates from the same organisation registering for the same event, at the same time. Fee statedis the discounted price PER DELEGATE. Only one discount applies; either the early bird rate OR special rate OR group rate.

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❑ 3 Day Package: 2 Day Conference❑ Pre-Conference Workshop OR❑ Post-Conference Workshop

SGD 3,295 SGD 3,495 SGD 3,695 SGD 3,195

PARKROYAL on Beach Road7500 Beach Road, Singapore 199591Hotel mainline: +65 6505 5666Contact Person: Teo Hui LingTel: +65 6505 5696Email: [email protected]

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4 Successful Events Under 1 Roof

180+ Attendees to Network With

4+ Days of Expert Knowledge Sharing

80+ Expert PharmaceuticalStakeholders & Key Decision Makers

15+ Interactive Formats to Get To KnowYour Peers & Customers

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