pharmaceutical congress china 29-30 march 2016
TRANSCRIPT
Produced by:
LifeSciences
29 - 30 March 2016 Grand Hyatt Shanghai
CHINA
Co-Located Events:
The leading event that brings togetherChina’s leading pharmaceuticalcompanies and industry in one place!
Li ChenCEO,Hua Medicine,China
Xian Ping LuCEO & CSO,Shenzhen
Chipscreen
Biosciences, China
Friedhelm BlobelCEO,SciClone
Pharmaceuticals,USA & China
Ming-Chu HsuChairman of theBoard & CEO,TaiGen
Biotechnology,Taiwan
Weikang TaoCEO, R&D Centre,Shanghai Hengrui
Medicine, China
Yin Xiang WangCEO & CSO,Betta
Pharmaceuticals,China
Ming-QiangZhangCorporate Vice-President, Research &Development,Amgen, China
Joan ShenVice President,Development HeadChina R&D and ScientificAffairs, Janssen
Pharmaceuticals,
Johnson & Johnson,China
Steffanie Lim-HoVice President,Ethics & Compliance,Lilly, China
Masood AhmedVice President,Regional ComplianceOfficerAsia & JPAC,Sanofi Group,Singapore
Associate Sponsor: Session Spotlight Sponsor:Bronze Sponsor:
International MarketingPartner:
CHINA
Li YanVice President, HeadUnit Physician,Oncology R&D,GlaxoSmithKline
Pharmaceuticals,USA
Latest Updates on China’sPharmaceutical regulation andmarket trends
Practical Case Studies on theGround in China
75+ renowned speakers fromthe pharmaceutical industry
1 shared exhibition room toshowcase latest technology andservices
4 days of expert knowledgesharing
TOP REASONSTO ATTEND
www.pharmaconchina.com
Shanghai Food & DrugAdministration (SFDA)
Taiwan Food & DrugAdministration (TFDA)
Keynote Regulator Sessions from:
Industry Experts Include:
Ye HuaSenior Vice President,Clinical Development andRegulatory Affairs,Hutchison
Medipharma, China
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Exhibitors:
9.00 R&D Market Opportunities & Challenges• Current drug development scenario in China vs. the West• 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: Marrietta Wu, COO, Zai Laboratories, ChinaPanelists: Li Chen, CEO, Hua Medicine, China
Yin Xiang Wang, CEO & CSO, Zhejiang Beta Pharmaceuticals, ChinaFriedhelm Blobel, CEO, SciClone Pharmaceuticals, USA & ChinaMing-Chu Hsu, Chairman of the Board & CEO, TaiGen Biotechnology, TaiwanWeikang Tao, CEO, R&D Centre, Shanghai Hengrui Medicine, China
CHINA
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CONFERENCE DAY ONE TUESDAY 29 MARCH 2016
8.00 Registration & Morning Coffee
8.50 Welcome Address from IBC Asia & Get to Know Your Peers
8.55 Chairperson’s Opening Remarks
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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 supervisionModerator: Lin Hong, Associate Director – Regulatory Affairs, Asia Pacific, Russia CIS (APAC) Established Pharmaceuticals, AbbottPanelists: Dr Meir-Chyun Tzou, Senior Researcher & Former Director of Division of Pharmaceutical Affairs, Taiwan Food and Drug Administration (TFDA), TaiwanPA
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China’s Pharmaceutical Market Outlook
10.30 Morning Networking & Refreshment Break
• Choose Your Sessions Across 3 Different Tracks with a GOLD PASS! •
CHINA
11.15Chairperson’s Opening RemarksGu Chengming, Vice President & the head of medical affairsof Pfizer China & the Chairman Medical Affairs Group,RDPAC, China
Chairperson’s Opening RemarksLin Hong, Associate Director – Regulatory Affairs, AsiaPacific, Russia CIS (APAC) Established Pharmaceuticals,Abbott
Chairperson’s Opening RemarksEmmanuel Vignal, Partner, Greater China Leader, FraudInvestigation & Disputes Services, EY
Current Clinical Trial Landscapein Asia
Regulatory Updates to ImproveDrug Approval Timelines
China’s Healthcare Reform &Compliance Frameworks
Execution Gap in Global Drug Development: TheExpectation And Current Position of AsiaDan Paulson, Vice President, Global Clinical Development,Group Head, Cardiometabolism Risk Management andAnti-infectives, Bayer HealthCare Pharmaceuticals,China
Updates and Changes in Pharmaceutical Regulationin TaiwanDr Meir-Chyun Tzou, Senior Researcher & Former Directorof Division of Pharmaceutical Affairs, Taiwan Food andDrug Administration (TFDA)
The ABAC Risk is here to Stay – Key enforcementActions, Trends and Outlook for 2016 for the LifeSciences IndustryEmmanuel Vignal, Partner, Greater China Leader, FraudInvestigation & Disputes Services, EY
Accelerating the Global Drug Developmentin China
Panelists:
Dan Paulson, Vice President, Global Clinical Development,Group Head, Cardiometabolism Risk Management and Anti-infectives, Bayer HealthCare Pharmaceuticals, China
Ye Hua, Senior Vice President, Clinical Development andRegulatory Affairs, Hutchison Medipharma, China
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E-Labelling & Packaging
Concomitant Review and Assessment of PackageMaterials and ExcipientsMs Yan WANG, Head of Shanghai Food and Drug PackagingMaterial Control Center, Shanghai Municipal Food andDrug Administration (SFDA)
China Health Care Reform – Big Business & Big RiskRobert Youill, Senior Managing Director - Global Risk andInvestigations, FTI Consulting, China
Labelling
2.00
Latest Developments in Smart LabelingFrank Jaeger, Managing Director, Faubel & Co., Germany
Building Compliance TeamsImplementation of an Innovative Labeling Hubin AsiaRie Matsui, Director, Regional Labeling Head for Asia,Pfizer Japan
Building an Effective Compliance Team
12.40 Networking Lunch & Meet With VIP Guests
VIP Table 1: Samantha Du, CEO, Chairman of the Board, Zai Laboratories, ChinaVIP Table 2: Weikang Tao, CEO, R&D Centre, Shanghai Hengrui Medicine, ChinaVIP Table 3: Yin Xiang Wang, CEO, Betta Pharmaceuticals, China
11.30
12.10
CHINA
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Best Practices in ClinicalProject Management
PharmacovigilanceData Analytics in Compliance
2.40
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Navigating the Quality Control of Drugs and Post-Market RegulationMs Yan WANG, Head of Shanghai Food and Drug PackagingMaterial Control Center, Shanghai Food and DrugAdministration (SFDA)
Mitigating Risks and Demonstrating ReturnsThrough Data AnalyticsChi CHEN, Partner, Fraud Investigation & DisputesServices, EY
Differentiating Regulations in Japan, Korea andChina on Postmarketing Drug Special Monitoring
3.20 Afternoon Networking & Refreshment Break
4.00
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Risk Management Planning to Tackle EthnicDifferencesYu (Vivian) Sun, Associate Director, Safety Surveillance &Risk Management, China Research & Development Center,Pfizer Inc, China
The Compliance Landscapeand Approach in ChinaKaren Eryou, Senior Director, CorporateCompliance APAC, UCB, China
4.40
Collaboration Tactics and Organizational Strategiesfor Effective Clinical Trial BudgetingPanelists:Wang Xiao Mei, Director, Clinical Operations, TenNorTherapeutics, China
Geng Wu, Head of Clinical Project Management China,Development East Asia & Network, UCB, China
Daisuke Yamashita, Associate Director, Strategic ProjectManagement, Takeda Development Centre Shanghai,China
Quality Assurance andAnti-Counterfeiting
Building a Quality Culture – Not just a QualityManagement SystemMagnus Jahnsson, Director Regulatory Affairs,Pharmadule Morimatsu AB
Ensuring Sales, Marketing & DistributionPrograms Comply with Local MarketPracticesLily Dong, Sales Director, AstraZeneca, China
5.30 Chairperson’s Summary of the Day & End of Conference Day One
CONFERENCE DAY TWO WEDNESDAY 30 MARCH 20168.30 Morning Networking & Refreshment Break
• Choose Your Sessions Across 3 Different Tracks with a GOLD PASS! •
CHINA
8.55 Chairperson’s Opening RemarksYi Yang, Director, ASO (Internal Medicine), USPharmacovigilance, Sanofi, USA
Chairperson’s Opening RemarksMaija Burtmanis, Healthcare Compliance Officer, Asia PacificMedical Sciences, Johnson & Johnson, Singapore
Regional Partnerships andCoordination
9.00
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N Driving Resilient Partnerships for GrowthMay Wei Chun Fang, Global Regulatory Strategist,Bayer Healthcare Co Ltd ChinaLin Hong, Associate Director – Regulatory Affairs,Asia Pacific Russia CIS (APAC) EstablishedPharmaceuticals, AbbottYuko Kikuchi, Senior Director – Asia RegulatoryAffairs, Eisai Co Ltd
Third Party Compliance Program AssessmentMasood Ahmed, Vice President, Regional Compliance OfficerAsia & JPAC, Sanofi Group, Singapore
MRCT Guidelines andProduct Development
Keeping Drug Development Lean with InternationalMulti-Centre Clinical Trials (IMCT) GuidelinesMay Wei Chun Fang, Global Regulatory Strategist,Bayer Healthcare Co Ltd China
Choosing the Best ClinicalDevelopment Pathway
Accelerating Biologics Drug Development in ChinaGu Jin Ming, Executive Director, Biopharmaceutical R&D,Shanghai Hengrui Medicine, China
Impact of Recent CFDA Regulation on Cancer DrugDevelopment in China: Stakeholder DiscussionModerator:Li Yan, Vice President, Head Unit Physician, Oncology R&D,GlaxoSmithKline Pharmaceuticals, USAPanelists:Li Xu, Corporate Vice President and Head of Global Oncology,Hengrui Co., ChinaCaichun Zhou, Professor, Shanghai Chest Hospital,ChinaXiao Xu, President and CEO, Acea Co, USA &ChinaHua Mu, SVP, WiXi Apptec, ChinaDajun Yang, President and CEO, Ascentage Pharma,China
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Fostering an Ethical CultureSteffanie Lim-Ho, VP, Ethics & Compliance,Lilly, China
Transparent & Ethical Practices inLocal Markets
Chairperson’s Opening RemarksLin Hong, Associate Director – Regulatory Affairs, AsiaPacific, Russia CIS (APAC) Established Pharmaceuticals,Abbott
How to Make the Successful Transition fromRegistration Trials to Phase IV Studies?
Moderator:Shell Li, Former Head of Clinical Research, BoehringerIngelheim Pharmaceuticals,Chief Medical Officer, Vice President, Global ClinicalDevelopment, HRYZ Biotech, China
Panelists:Benny Li, Group Chief Medical Officer, HansohPharmaceuticals, China
Cristina Chang, Country Medical Director, Celgene, Taiwan
Yan Gong, Head of Clinical Development and Medical AffairsII, Boehringer Ingelheim Pharmaceuticals, China
CHINA
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Medical Device Regulations
Medical Device Regulations Overview in the MainEstablished Markets: EU, USA, Japan, Canada andAustraliaVal Theisz, Director Regulatory Affairs, MedicalTechnology Association of Australia (MTAA)
9.40 Southeast Asia as a Key Platform for theAcceleration of Global Clinical TrialTimelines for Chinese PharmaJeffrey Yablon, Vice President, Business Development,General Manager – Asia, Indipharm, Malaysia
Streamlining RegulatoryPathways & Strategies
Regulation on Fixed-Dose Combinations andCo-Packaged DrugsMay Wei Chun Fang, Global Regulatory Strategist,Bayer Healthcare Co Ltd China
Tone at the Middle and Managing PatientRelationshipRiza Faith Ybanez, Legal and Compliance Head – OncologyAsia Pacific, South Africa, Novartis Asia PacificPharmaceuticals Ptd Ltd, Singapore
10.20 Morning Networking & Refreshment Break
10.50 Clinical Development Pathway in TaiwanNathan Chen, Vice President, Chief MedicalOfficer & Head of Global Medicine Development,OBI Pharma, Taiwan
Best Practice ComplianceStrategies & Programs
Leapfrogging the Life-Cycle ManagementRegulatory Pathways: How Efficient Can We Get?Yuko Kikuchi, Senior Director – Asia Regulatory Affairs,Eisai Co Ltd Internal Compliance Program Assessment
Jill Dailey, Assistant General Counsel, Asia Pacific ComplianceLead, Pfizer, US
Strategic Partnerships &Clinical Outsourcing
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11.40
Implementing Global Strategic Partnerships on aRegional Level: Shaping the Future of Fast and Cost-Effective Clinical Trials in China
Dejun Tang, Head, Analytics, Integrated InformationSciences China, Novartis, China
Christina Bodurow, Senior Director, External Sourcing,Development Center of Excellence, Eli Lilly and Co, USA
Yi Yang, Director, ASO (Internal Medicine), USPV, Sanofi,USA
Tracking Drug Approval Timelines – Getting it Rightat Initial Regulatory Submissions
Ensuring Compliance During Business DevelopmentTransactions & PartnershipKaren Choi, Compliance Director / Corporate Compliance,Pfizer, Korea
12.10 Networking Lunch & Meet With VIP Guests
VIP Table 1: Christina Bodurow, Senior Director, External Sourcing, Development Center of Excellence, Eli Lilly and Co, USAVIP Table 2: Yi Yang, Director, ASO (Internal Medicine), US Pharmacovigilance, Sanofi, USAVIP Table 3: Shell Li, Chief Medical Officer, Vice President, Global Clinical Development, HRYZ Biotech, China
Good Clinical Practice (GCP)and Site ManagemenT
1.30 Exploring Evolving Partnership Models and CROSelection Considerations in ChinaChristina Bodurow, Senior Director, External Sourcing,Development Center of Excellence, Eli Lilly and Co, USA
FDA 505(b)(2) Pathway For New Drug ApplicationLingyan Li, Project Manager – Senior Pharmaceutical AffairsScientist, Tasly Holding Group
How are Compliance Programs Evolving in China vsthe Region?
2.10
Leveraging the Sponsor Relationship Between KOLand Sites for Successful Trials in ChinaYi (Gloria) Wang, Chief China Medical Development andMedical Monitor Asia, United Therapeutics, China
E-CTDs and Dossier Submissions
Risk ManagementAcross Functions
Common Legal Issues and Risk Mitigation with ThirdPartiesTom Chan, Head of Legal Greater China, Takeda (China)Holdings Co. Ltd, China
3.10 Afternoon Networking & Refreshment Break
3.20
Clinical Data Quality
Quality Assurance Measures and Compliance inTrials: Ensuring Inspection Readiness Across MultipleTrial Sites
Liping Zhou, Global Inspection Manager, R&D Quality,Bayer HealthCare, China
Guoying Cao, Director of GCP Office, Huashan Hospital,Fudan University, China
Tackling E-CTDs and Dossiers amidst ChangingRegulatory DevelopmentsJannie Ren, Director – China Head of PPLS (Publishing &Product License Support), Pfizer Regulatory Operation
Coordinating Risk ManagementAcross Functions
Coordinating Risk Management Across FunctionsMaija Burtmanis, Healthcare Compliance Officer, Asia PacificMedical Sciences, Johnson & Johnson, Singapore
4.00
Improved Processes and Vendor Oversight for ClinicalTrials in China: Ensuring Quality, Compliance andROI for Outsourced Trials
Intellectual PropertyLaws & Legal Issues
IP and Patent LitigationSow Wei Wong, Legal Counsel, Takeda Global Research& Development Centre (Asia), Singapore
4.45 Chairperson’s Summary of the Day & End of Conference
29 - 30 March 2016 Grand Hyatt Shanghai
CHINA
Co-Located:
CHINA
Early Confirmed Companies Include:
REGISTER TODAY! +65 6508 2401 [email protected] 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 isRaiding ForeignCompanies At Dawn
~ Business Insider
Singapore,
January 2015
China's rigidregulations hamperbio-pharmaceuticalindustry
~ Channel News Asia, July 2015
China'sPharmaceuticalFuture - BothComplex and Growing
~ FDA Voice, June 2015
Navigate through a complex R&D environment?
Seek clarity on pharmaceutical regulations anddrug approvals in China?
Ensure your organization is operating compliantly?
Areyou
lookingto:
Areyou
lookingto:
If you answered yes to the above questions, then this conference is for you!The Pharmaceutical Congress (PharmaCon) China brings together a timely platform to explore domestic pharmaceutical
research investments, developments and commercial operations.
WHO SHOULD ATTEND:WHO SHOULD ATTEND:
SPONSORSHIP OPPORTUNITIESWould 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: [email protected]
Abbott • Acea Co. • Allergan • Amgen • Astrazeneca • Bayer Healthcare Co Ltd China • Bayer Healthcare
Pharmaceuticals • Biocon • Zhejiang Betta Pharmaceuticals • Boehringer Ingelheim Pharmaceuticals • 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 • Medical Technology 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
University Health Science Center • Pfizer (China) Research & Development Co Ltd Center • Pharmadule Morimatsu
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 • TenNor Therapeutics • UCB • US China Anti-Cancer Association • United Therapeutics • Zai Laboratories
Plus many more...
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29 - 30 March 2016 Grand Hyatt Shanghai
CHINA