Bringing 3 Significant Events Under 1 Roof!
The Pharmaceutical Congress China, part of IBC’s PharmaCon Series, recognizes the importance of regulation, clinical operation efficiencies, tackling pharmaceutical compliance issues and bringing products and services successfully in the market in China’s rapidly advancing pharmaceutical industry.
Grafana in space: Monitoring Japan's SLIM moon lander in real time
Pharmaceutical Congress China 29-30 March 2016
1. Produced by:
Life
Sciences
29 - 30 March 2016
Grand Hyatt Shanghai
CHINA
Co-Located Events:
The leading event that brings together
China’s leading pharmaceutical
companies and industry in one place!
Li Chen
CEO,
Hua Medicine,
China
Xian Ping Lu
CEO & CSO,
Shenzhen
Chipscreen
Biosciences, China
Friedhelm Blobel
CEO,
SciClone
Pharmaceuticals,
USA & China
Ming-Chu Hsu
Chairman of the
Board & CEO,
TaiGen
Biotechnology,
Taiwan
Weikang Tao
CEO, R&D Centre,
Shanghai Hengrui
Medicine, China
Yin Xiang Wang
CEO & CSO,
Betta
Pharmaceuticals,
China
Ming-Qiang
Zhang
Corporate Vice-
President, Research &
Development,
Amgen, China
Joan Shen
Vice President,
Development Head
ChinaR&DandScientific
Affairs, Janssen
Pharmaceuticals,
Johnson & Johnson,
China
Steffanie Lim-Ho
VicePresident,
Ethics&Compliance,
Lilly, China
Masood Ahmed
Vice President,
Regional Compliance
Officer
Asia & JPAC,
Sanofi Group,
Singapore
Associate Sponsor: Session Spotlight Sponsor:Bronze Sponsor:
International Marketing
Partner:
CHINA
Li Yan
Vice President, Head
Unit Physician,
Oncology R&D,
GlaxoSmithKline
Pharmaceuticals,
USA
Latest Updates on China’s
Pharmaceutical regulation and
market trends
Practical Case Studies on the
Ground in China
75+ renowned speakers from
the pharmaceutical industry
1 shared exhibition room to
showcase latest technology and
services
4 days of expert knowledge
sharing
TOP REASONS
TO ATTEND
www.pharmaconchina.com
Shanghai Food & Drug
Administration (SFDA)
Taiwan Food & Drug
Administration (TFDA)
Keynote Regulator Sessions from:
Industry Experts Include:
Ye Hua
Senior Vice President,
ClinicalDevelopmentand
Regulatory Affairs,
Hutchison
Medipharma, China
Optimize
your Time & Money
with a Gold Pass
- Full Access to
ALL Events is Possible!
Gold Sponsor:
Exhibitors:
2. 9.00 R&D Market Opportunities & Challenges
• Current drug development scenario in China vs. theWest
• How do you bring products to market quickly and cost effectively in China?
• Can the local Chinese pharma companies sustain R&D innovation?
• Encouraging innovation and healthy development of the pharmaceutical industry
• What is the future of drug development in China?
Moderator: MarriettaWu, COO, Zai Laboratories, China
Panelists: Li Chen, CEO, Hua Medicine, China
Yin XiangWang, CEO&CSO, Zhejiang Beta Pharmaceuticals, China
Friedhelm Blobel, CEO, SciClone Pharmaceuticals, USA & China
Ming-Chu Hsu, ChairmanoftheBoard&CEO, TaiGen Biotechnology,Taiwan
WeikangTao, CEO,R&DCentre, Shanghai Hengrui Medicine, China
CHINA
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaconchina.com
CONFERENCE DAY ONE TUESDAY 29 MARCH 2016
8.00 Registration & Morning Coffee
8.50 Welcome Address from IBC Asia & Get to KnowYour Peers
8.55 Chairperson’s Opening Remarks
KEYNOTEC-LEVELPANEL
DISCUSSION
9.50 Regulatory Updates and Changes in the Pharmaceutical Sector –What’s New,Trends and Impact
• Encouraging innovation and healthy development of the pharmaceutical industry
• Recent changes and updates in the pharmaceutical and medical device sectors –What to look out for?
• Meeting the growing clinical development demand and addressing approval delays and review process
• Enhancing your talent pool with the right experts to spearhead governmental oversight and supervision
Moderator: Lin Hong, AssociateDirector–RegulatoryAffairs,AsiaPacific,RussiaCIS(APAC)EstablishedPharmaceuticals, Abbott
Panelists: Dr Meir-ChyunTzou, SeniorResearcher&FormerDirectorofDivisionofPharmaceuticalAffairs, Taiwan Food and Drug Administration (TFDA),Taiwan
PANELDISCUSSION
China’s Pharmaceutical Market Outlook
10.30 Morning Networking & Refreshment Break
• Choose Your Sessions Across 3 Different Tracks with a GOLD PASS! •
CHINA
11.15
Chairperson’s Opening Remarks
GuChengming,VicePresident&theheadofmedicalaffairs
of Pfizer China & theChairmanMedicalAffairsGroup,
RDPAC, China
Chairperson’s Opening Remarks
Lin Hong, AssociateDirector–RegulatoryAffairs,Asia
Pacific,RussiaCIS(APAC)EstablishedPharmaceuticals,
Abbott
Chairperson’s Opening Remarks
EmmanuelVignal, Partner,GreaterChinaLeader,Fraud
Investigation&DisputesServices, EY
Current Clinical Trial Landscape
in Asia
Regulatory Updates to Improve
Drug Approval Timelines
China’s Healthcare Reform &
Compliance Frameworks
Execution Gap in Global Drug Development:The
Expectation And Current Position of Asia
Dan Paulson, VicePresident,GlobalClinicalDevelopment,
GroupHead,CardiometabolismRiskManagementand
Anti-infectives, Bayer HealthCare Pharmaceuticals,
China
UpdatesandChangesinPharmaceuticalRegulation
inTaiwan
DrMeir-ChyunTzou,SeniorResearcher&FormerDirector
ofDivisionofPharmaceuticalAffairs, Taiwan Food and
Drug Administration (TFDA)
The ABAC Risk is here to Stay – Key enforcement
Actions,Trends and Outlook for 2016 for the Life
Sciences Industry
EmmanuelVignal, Partner,GreaterChinaLeader,Fraud
Investigation&DisputesServices, EY
Accelerating the Global Drug Development
in China
Panelists:
Dan Paulson, VicePresident,GlobalClinicalDevelopment,
GroupHead,CardiometabolismRiskManagementandAnti-
infectives, Bayer HealthCare Pharmaceuticals, China
Ye Hua, SeniorVicePresident,ClinicalDevelopmentand
RegulatoryAffairs, Hutchison Medipharma, China
PANELDISCUSSION
E-Labelling & Packaging
Concomitant Review and Assessment of Package
Materials and Excipients
MsYanWANG,HeadofShanghaiFoodandDrugPackaging
MaterialControlCenter, Shanghai Municipal Food and
Drug Administration (SFDA)
China Health Care Reform – Big Business & Big Risk
RobertYouill, SeniorManagingDirector-GlobalRiskand
Investigations, FTI Consulting, China
Labelling
2.00
Latest Developments in Smart Labeling
FrankJaeger,ManagingDirector,Faubel&Co.,Germany
Building Compliance TeamsImplementation of an Innovative Labeling Hub
in Asia
Rie Matsui, Director,RegionalLabelingHeadforAsia,
Pfizer Japan
Building an Effective ComplianceTeam
12.40 Networking Lunch & MeetWithVIP Guests
VIPTable 1: Samantha Du,CEO,ChairmanoftheBoard, Zai Laboratories, China
VIPTable 2:WeikangTao, CEO,R&DCentre, Shanghai Hengrui Medicine, China
VIPTable 3:Yin XiangWang, CEO, Betta Pharmaceuticals, China
11.30
12.10
3. CHINA
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaconchina.com
Best Practices in Clinical
Project Management
Pharmacovigilance
Data Analytics in Compliance
2.40
PANELDISCUSSION
Navigating the Quality Control of Drugs and Post-
Market Regulation
MsYanWANG,HeadofShanghaiFoodandDrugPackaging
MaterialControlCenter, Shanghai Food and Drug
Administration (SFDA)
MitigatingRisksandDemonstratingReturns
Through Data Analytics
Chi CHEN, Partner,FraudInvestigation&Disputes
Services, EY
Differentiating Regulations in Japan, Korea and
China on Postmarketing Drug Special Monitoring
3.20 Afternoon Networking & Refreshment Break
4.00
PANELDISCUSSION
Risk Management Planning toTackle Ethnic
Differences
Yu (Vivian) Sun, AssociateDirector,SafetySurveillance&
RiskManagement,ChinaResearch&DevelopmentCenter,
Pfizer Inc, China
The Compliance Landscape
and Approach in China
Karen Eryou, SeniorDirector,Corporate
ComplianceAPAC, UCB, China
4.40
CollaborationTacticsandOrganizationalStrategies
for Effective ClinicalTrial Budgeting
Panelists:
Wang Xiao Mei, Director,ClinicalOperations, TenNor
Therapeutics, China
GengWu, HeadofClinicalProjectManagementChina,
DevelopmentEastAsia&Network, UCB, China
DaisukeYamashita, AssociateDirector,StrategicProject
Management,TakedaDevelopmentCentreShanghai,
China
Quality Assurance and
Anti-Counterfeiting
Building a Quality Culture – Not just a Quality
Management System
Magnus Jahnsson, DirectorRegulatoryAffairs,
Pharmadule Morimatsu AB
Ensuring Sales, Marketing & Distribution
Programs Comply with Local Market
Practices
Lily Dong, SalesDirector, AstraZeneca, China
5.30 Chairperson’s Summary of the Day & End of Conference Day One
CONFERENCE DAY TWO WEDNESDAY 30 MARCH 2016
8.30 Morning Networking & Refreshment Break
• Choose Your Sessions Across 3 Different Tracks with a GOLD PASS! •
CHINA
8.55 Chairperson’s Opening Remarks
YiYang, Director,ASO(InternalMedicine),US
Pharmacovigilance, Sanofi, USA
Chairperson’s Opening Remarks
MaijaBurtmanis,HealthcareComplianceOfficer,AsiaPacific
MedicalSciences, Johnson & Johnson, Singapore
Regional Partnerships and
Coordination
9.00
PANELDISCUSSION
Driving Resilient Partnerships for Growth
MayWei Chun Fang, GlobalRegulatoryStrategist,
Bayer Healthcare Co Ltd China
Lin Hong, AssociateDirector–RegulatoryAffairs,
AsiaPacificRussiaCIS(APAC)Established
Pharmaceuticals, Abbott
Yuko Kikuchi, SeniorDirector–AsiaRegulatory
Affairs, Eisai Co Ltd
Third Party Compliance Program Assessment
MasoodAhmed,VicePresident,RegionalComplianceOfficer
Asia&JPAC, Sanofi Group, Singapore
MRCT Guidelines and
Product Development
KeepingDrugDevelopmentLeanwithInternational
Multi-Centre ClinicalTrials (IMCT) Guidelines
MayWei Chun Fang, GlobalRegulatoryStrategist,
Bayer Healthcare Co Ltd China
Choosing the Best Clinical
Development Pathway
Accelerating Biologics Drug Development in China
Gu Jin Ming, ExecutiveDirector,BiopharmaceuticalR&D,
Shanghai Hengrui Medicine, China
Impact of Recent CFDA Regulation on Cancer Drug
Development in China: Stakeholder Discussion
Moderator:
LiYan, VicePresident,HeadUnitPhysician,OncologyR&D,
GlaxoSmithKline Pharmaceuticals, USA
Panelists:
LiXu,CorporateVicePresidentandHeadofGlobalOncology,
Hengrui Co., China
Caichun Zhou, Professor, Shanghai Chest Hospital,
China
Xiao Xu, PresidentandCEO, Acea Co, USA &China
Hua Mu, SVP, WiXi Apptec, China
DajunYang, PresidentandCEO, Ascentage Pharma,
China
PANELDISCUSSION
Fostering an Ethical Culture
Steffanie Lim-Ho, VP,Ethics&Compliance,
Lilly, China
Transparent & Ethical Practices in
Local Markets
Chairperson’s Opening Remarks
Lin Hong, AssociateDirector–RegulatoryAffairs,Asia
Pacific,RussiaCIS(APAC)EstablishedPharmaceuticals,
Abbott
How to Make the SuccessfulTransition from
RegistrationTrials to Phase IV Studies?
Moderator:
Shell Li, FormerHeadofClinicalResearch, Boehringer
Ingelheim Pharmaceuticals,
ChiefMedicalOfficer,VicePresident,GlobalClinical
Development, HRYZ Biotech, China
Panelists:
Benny Li, GroupChiefMedicalOfficer, Hansoh
Pharmaceuticals, China
CristinaChang,CountryMedicalDirector,Celgene,Taiwan
YanGong,HeadofClinicalDevelopmentandMedicalAffairs
II, Boehringer Ingelheim Pharmaceuticals, China
4. CHINA
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaconchina.com
Medical Device Regulations
Medical Device Regulations Overview in the Main
Established Markets: EU, USA, Japan, Canada and
Australia
ValTheisz, DirectorRegulatoryAffairs, Medical
Technology Association of Australia (MTAA)
9.40 Southeast Asia as a Key Platform for the
Acceleration of Global ClinicalTrial
Timelines for Chinese Pharma
JeffreyYablon, VicePresident,BusinessDevelopment,
GeneralManager–Asia, Indipharm, Malaysia
Streamlining Regulatory
Pathways & Strategies
Regulation on Fixed-Dose Combinations and
Co-Packaged Drugs
MayWei Chun Fang, GlobalRegulatoryStrategist,
Bayer Healthcare Co Ltd China
Tone at the Middle and Managing Patient
Relationship
RizaFaithYbanez,LegalandComplianceHead–Oncology
AsiaPacific,SouthAfrica, Novartis Asia Pacific
Pharmaceuticals Ptd Ltd, Singapore
10.20 Morning Networking & Refreshment Break
10.50 Clinical Development Pathway inTaiwan
Nathan Chen, VicePresident,ChiefMedical
Officer&HeadofGlobalMedicineDevelopment,
OBI Pharma,Taiwan
Best Practice Compliance
Strategies & Programs
Leapfrogging the Life-Cycle Management
Regulatory Pathways: How Efficient CanWe Get?
Yuko Kikuchi, SeniorDirector–AsiaRegulatoryAffairs,
Eisai Co Ltd Internal Compliance Program Assessment
JillDailey,AssistantGeneralCounsel,AsiaPacificCompliance
Lead, Pfizer, US
Strategic Partnerships &
Clinical Outsourcing
PANELDISCUSSION
11.40
Implementing Global Strategic Partnerships on a
RegionalLevel:ShapingtheFutureofFastandCost-
Effective ClinicalTrials in China
DejunTang, Head,Analytics,IntegratedInformation
SciencesChina, Novartis, China
Christina Bodurow, SeniorDirector,ExternalSourcing,
DevelopmentCenterofExcellence, Eli Lilly and Co, USA
YiYang, Director,ASO(InternalMedicine),USPV, Sanofi,
USA
TrackingDrugApprovalTimelines–GettingitRight
at Initial Regulatory Submissions
Ensuring Compliance During Business Development
Transactions & Partnership
Karen Choi, ComplianceDirector/CorporateCompliance,
Pfizer, Korea
12.10 Networking Lunch & MeetWithVIP Guests
VIPTable 1: Christina Bodurow, SeniorDirector,ExternalSourcing,DevelopmentCenterofExcellence, Eli Lilly and Co, USA
VIPTable 2:YiYang, Director,ASO(InternalMedicine),USPharmacovigilance, Sanofi, USA
VIPTable 3: Shell Li, ChiefMedicalOfficer,VicePresident,GlobalClinicalDevelopment, HRYZ Biotech, China
Good Clinical Practice (GCP)
and Site ManagemenT
1.30 Exploring Evolving Partnership Models and CRO
Selection Considerations in China
Christina Bodurow, SeniorDirector,ExternalSourcing,
DevelopmentCenterofExcellence, Eli Lilly and Co, USA
FDA 505(b)(2) Pathway For New Drug Application
LingyanLi,ProjectManager–SeniorPharmaceuticalAffairs
Scientist, Tasly Holding Group
How are Compliance Programs Evolving in China vs
the Region?
2.10
Leveraging the Sponsor Relationship Between KOL
and Sites for SuccessfulTrials in China
Yi (Gloria)Wang, ChiefChinaMedicalDevelopmentand
MedicalMonitorAsia, UnitedTherapeutics, China
E-CTDs and Dossier Submissions
Risk Management
Across Functions
Common Legal Issues and Risk Mitigation withThird
Parties
Tom Chan, HeadofLegalGreaterChina, Takeda (China)
Holdings Co. Ltd, China
3.10 Afternoon Networking & Refreshment Break
3.20
Clinical Data Quality
Quality Assurance Measures and Compliance in
Trials:EnsuringInspectionReadinessAcrossMultiple
Trial Sites
Liping Zhou, GlobalInspectionManager,R&DQuality,
Bayer HealthCare, China
Guoying Cao, DirectorofGCPOffice,HuashanHospital,
Fudan University, China
Tackling E-CTDs and Dossiers amidst Changing
Regulatory Developments
Jannie Ren, Director–ChinaHeadofPPLS(Publishing&
ProductLicenseSupport), Pfizer Regulatory Operation
Coordinating Risk Management
Across Functions
Coordinating Risk Management Across Functions
MaijaBurtmanis,HealthcareComplianceOfficer,AsiaPacific
MedicalSciences, Johnson & Johnson, Singapore
4.00
ImprovedProcessesandVendorOversightforClinical
Trials in China: Ensuring Quality, Compliance and
ROI for OutsourcedTrials
Intellectual Property
Laws & Legal Issues
IP and Patent Litigation
SowWeiWong, LegalCounsel, Takeda Global Research
& Development Centre (Asia), Singapore
4.45 Chairperson’s Summary of the Day & End of Conference
5. 29 - 30 March 2016
Grand Hyatt Shanghai
CHINA
Co-Located:
CHINA
Early Confirmed Companies Include:
REGISTER TODAY! +65 6508 2401 register@ibcasia.com.sg www.pharmaconchina.com
■ China/Hong Kong/Taiwan 60%
■ Japan/Korea 5%
■ Singapore 10%
■ Rest of Asia 10%
■ India/Middle East 5%
■ Australia/NZ 5%
■ US/Europe 5%
■ Pharma/Biopharma 60%
■ Government 5%
■ CROs 15%
■ Legal/Finance/Consultants 5%
■ Technology & Solution
Providers 10%
■ Research Institutes/Hospitals 5%
Why China is
Raiding Foreign
Companies At Dawn
~ Business Insider
Singapore,
January 2015
China's rigid
regulations hamper
bio-pharmaceutical
industry
~ Channel News Asia, July 2015
China's
Pharmaceutical
Future - Both
Complex and Growing
~ FDA Voice, June 2015
Navigate through a complex R&D environment?
Seek clarity on pharmaceutical regulations and
drug approvals in China?
Ensure your organization is operating compliantly?
Are
you
looking
to:
Are
you
looking
to:
If you answered yes to the above questions, then this conference is for you!
ThePharmaceuticalCongress(PharmaCon)Chinabringstogetheratimelyplatformtoexploredomesticpharmaceutical
research investments, developments and commercial operations.
WHO SHOULD ATTEND:WHO SHOULD ATTEND:
SPONSORSHIP OPPORTUNITIES
Would you like to raise your visibility in China’s pharmaceutical industry industry?
Could you benefit from showcasing your products & services before key industry players?
Are you seeking the lowest cost way of meeting a target audience of decision-makers?
If so, we can help you achieve your goals! 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 Yvonne Leong, Business Development Manager ~
Tel: +65 6508 2489 or Email: yvonne.leong@ibcasia.com.sg
Abbott • Acea Co. • Allergan • Amgen • Astrazeneca • Bayer Healthcare Co Ltd China • Bayer Healthcare
Pharmaceuticals•Biocon•ZhejiangBettaPharmaceuticals•BoehringerIngelheimPharmaceuticals•Bristol-
Myers Squibb • Cardinal Health • Celgene • China Chamber of Commerce for Import and Export of Medicines
and Health Products (CCCMHPIE) • China Pharmaceutical Innovation and Research Development Association
(PhIRDA) • Eisai Co Ltd • Eli Lilly & Co. • Faubel & Co. • Fountain Medical Development • FTI Consulting •
Fudan University • GEC Risk Advisory LLC • GlaxoSmithKline Pharmaceuticals • Hengrui Co. • Hua Medicine
• Hutchison Medipharma • HYRZ Biotech • Indian Society for Clinical Research • Indipharm • Janssen
Pharmaceuticals • Johnson & Johnson • Jones Day • Lilly China • MedicalTechnology Association of Australia
(MTAA) • Novartis Pharmaceuticals (China) • Novartis Asia Pacific Pharmaceuticals • Novo Nordisk (China)
Pharmaceutical Co., Ltd • NUS East Asian Institute (EAI) • OBI Pharma Inc • PAREXEL International • Peking
UniversityHealthScienceCenter•Pfizer(China)Research&DevelopmentCoLtdCenter•PharmaduleMorimatsu
AB • R&G PharmaStudies • RDPAC • Sanofi-Aventis • SciClone Pharmaceuticals • Shanghai Chest Hospital
• Shanghai Food and Drug Administration (SFDA) • Shanghai Hengrui Pharmaceuticals • Shenzhen Chipscreen
Biosciences •TaiGen Biotechnology •Taiwan Food and Drug Administration (TFDA) •Takeda (China) Holdings
• Takeda Global Research & Development Centre (Asia) Pte Ltd • Takeda Pharmaceuticals • Tasly Holding
Group•TenNorTherapeutics•UCB•USChinaAnti-CancerAssociation•UnitedTherapeutics•ZaiLaboratories
Plus many more...
6. Email
register@ibcasia.com.sg
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+65 6508 2407
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+65 6508 2401
Web
www.pharmaconchina.com
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CHINA
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■ Clinical Trials China ■■ Pharmaceutical Regulatory Summit China ■■ Pharmaceutical Compliance
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CHINA