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6th DIA China Annual Meeting

May 11 2014 8:00AM - May 14 2014 5:30PM | Shanghai International Convention Center No. 2727, Riverside Avenue Pudong 200120 Shanghai China

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Overview 

Final Program Now Available


ANNUAL MEETING SNAPSHOT
6th DIA China Annual Meeting - "Quality and Compliance - Meeting Patients’ Needs" will be held on May 11-14 at the Shanghai International Convention Center. This program includes plenary and concurrent sessions, preconference workshops, forums, town hall meeting with the CFDA, poster presentations, an exhibit hall, networking receptions, and more!

Held once a year in China, the DIA China Annual Meeting is expected to attract 1400 participants. As the largest annual meeting held in the Asia Pacific region, the DIA China Annual Meeting will provide a neutral platform for information exchange, featuring speakers that include high-level representatives from government, industry and academia in China and abroad.

PRECONFERENCE WORKSHOPS
Maximize your learning at the 6th DIA China Annual Meeting by attending a preconference workshop!

Full day:

  • Career Development
  • Principles for Successful GxP Inspections: A Hands-on Interactive Approach Based on FDA, WHO and Industry Experiences
  • Early Clinical Development from First-in-Human (FIH) to Proof of Concept (POC)
  • Project Management in Clinical Data Management
  • Data Safety Monitoring Board

Half-day:

  • Individual Case Safety Report (ICSR) Medical Review (morning)
  • CANCELLED:  Good Clinical Data Management Practice Post Trial Data Collection: SAS Programming (afternoon)

To Register, click here.

Contact Information 

For general inquiries and registration, contact
Mr. Fei XIE
Phone +86.10.6260.2240
fei.xie@diachina.org or dia@diachina.org

For exhibiting, hosting, and advertising inquiries, contact
Ms. Jean XU
Phone: +86.10.5923.1096
jxu@kellencompany.com

To Register, click here.

Program Committee 

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Agenda  

Tutorials Sunday, May 11, 2014

  • 8:30AM - 5:30PM

    Workshop3: Early Clinical Development from First-in-Human (FIH) to Proof of Concept (POC)
    The workshop is designed to meet the growing needs in China for training of early drug development from First-in-human (FIH) to Proof of Concept (POC), where the first evidence of clinical efficacy is demonstrated in the target disease of interest. How to safely and efficiently to manage this early phase of clinical development using clinical pharmacology principles, modelling and simulation approaches, innovative POC design, robust clinical operation and monitoring will be discussed. At the end of the workshop, a panel discussion will be organized with regards to current challenges and future perspectives in early clinical development in China.
  • 8:30AM - 5:30PM

    Workshop4: Project Management in Clinical Data Management

    Clinical trial data include various sources, can be collected via paper or electronically, either way has advantages and disadvantages in data quality, operation, project budget control, et al. Selecting the most
    suitable data collection approach, implementing well considered data quality control procedures and applying appropriate risk control via good project management, are extremely important for quality data collection starting from clinical trial planning stage to database lock. This one day workshop will discuss best approaches for EDC study related clinical data, central lab data, ePRO and IV/WRS quality data acquisition.

  • 8:30AM - 5:30PM

    Workshop5: Data Safety Monitoring Board
    The DIA Data Safety Monitoring Board workshop will be led by Harvard Multi-Regional Clinical Trials Center and DIA. Faculty from Harvard, CFDA and representatives from industry will discuss various aspects of how clinical data can be  monitored by an independent board – the DMC or DSMB. The format will be a workshop including lectures, discussion and case studies.
  • 8:30AM - 12:00PM

    Half-day Workshop1: Individual Case Safety Report (ICSR) Medical Review (morning)
    Individual case safety report (ICSR) is fundamental in the safety surveillance of medicines. It is therefore important to capture information on ICSRs in a structured manner and to the highest possible quality standards to support accurate  detection and analysis of drug safety signals. With the quick development of Chinese pharmaceutical companies and contract research organizations, there is an urgent need for our local reviewers to have both higher capacities and more  experience in ICSR medical review, keeping the pace with the professionals around the world. Moreover, local pharmaceutical community will need to comply with the global standards of ICSRs reporting, such as major agencies’ requirement and ICH guidelines, to make the products approved globally, to improve the monitoring of the medicinal products already on the market, thereby to ensure the safety of patients using medicinal products. The most common challenges in ICSR  medical review are accurate event coding, expectedness and causality assessment. This workshop will provide the audience both introduction of global standards and practicing experience.
  • Day 1 Monday, May 12, 2014

    • 1:30PM - 5:30PM

      Opening Plenary Session

      Speaker(s):

      • Haijun Dong, PhD, MBA
        Senior Vice President and Managing Director, DIA China
        DIA China, China
      • Barbara Lopez Kunz, MS
        Global Chief Executive
        DIA, United States
      • Dayao ZHAO, MD, PhD
        Vice President, Head of R&D
        Johnson & Johnson, China
      • Yajun Zhao
        Director-General
        China Center for Food and Drug International Exchange (CCFDIE), China
      • Welcome Addresses from CFDA
        Li YIN, PhD
        Vice Minister
        China Food and Drug Adminsitration (CFDA) , China
      • Mutually Beneficial Collaboration Between Academia and Industry
        Yigong SHI, PhD
        Dean, School of Life Sciences
        Tsinghua University, China
      • Towards Global Development
        Jay P. Siegel, MD
        Johnson & Johnson, United States

    Day 2 Tuesday, May 13, 2014

    • 8:30AM - 10:00AM

      Session 0101: HOW TO BUILD A HIGH QUALITY CLINICAL RESEARCH CENTER


      Session Chair(s):

      • No-image Haiyan LI, MD
        Professor of Cardiology, Director of Clinical Trial Center
        Peking University Third Hospital, China

      Successful drug development is highly dependent on the conduct of high-quality clinical trials. Since the initiation of National Major Scientific and Technological Special Project for “Key New Drug Innovation Plan”, more than 60 hospitals nationwide have been funded to set up the high-quality GCP center, designed to provide facility support for innovative drugs clinical research in the "Eleventh Five-Year" and "Twelfth Five-Year" period of time. This session will cover the establishment of the collaborative innovation mechanism, training of professionals, technology platform support, and clinical studies capability enhancement.

      Speaker(s):

      • The Role of Phase I Unit for Drug Development in China
        Pei HU
        Chief Physician
        Peking Union Medical College Hospital, China
      • Yongjun Wang
        Beijing Tiantan Hospital, Capital Medical University, China
      • Lixin Jiang
        National Centre for Cardiovascular Diseases (NCCD), China
    • 8:30AM - 10:00AM

      Session 0201: THE PRACTICE OF NEW DRUG IN FIRST-IN-HUMAN STUDIES IN CHINA


      Session Chair(s):

      • Jian Peng
        Clinical Research Director
        Sanofi (China), China

      First-in-Human (FIH) studies are part of the exploratory phase of drug development and represent significant milestone in the clinical development of new drugs. The session shares several practical considerations from CFDA/CDE experts’ point of view about the China FIH studies, as well as discusses regulatory and clinical issues and experience in FIH studies.

      Speaker(s):

      • CDE Reviewer’s View on FIM Studies
        Representative Invited
        CDE, Taiwan
      • Regulatory Requirements for FIM Clinical Studies Focus on GCP, CFDA
        Representative Invited
        China
      • Case Studies of FIH on Innovative Drug Development in China
        Representative Invited
        United States
    • 8:30AM - 10:00AM

      Session 0301: HOW GxP IMPACTS THE MEDICAL PRODUCT REVIEW AND APPROVAL DECISION? (PART I)


      Session Chair(s):

      • Florence Houn, MD, MPH, FACP
        Vice President, Regulatory Affairs; Co-chair
        Celgene Corporation; FDA Alumni Association International Network, United States

      This session will illustrate key principles regarding regulators’ approach to how compliance issues with GxP impacts medical product application decision-making and how the application review impacts GxP inspections. These principles are based on FDA, industry, and CFDA experiences. Current and past decision makers on drug applications will share their views on how compliance with GxP affects their decision making based on previous cases in the public domain.

      Speaker(s):

      • Key Principles on GxP Impact on Medical Product Review & Approval Decision-Making: The Medical Reviewer’s Perspective
        Mark Goldberger, MD, MPH
        Divisional Vice President
        AbbVie, United States
      • CMC Reviewer’s Role in Pre-approval Manufacturing Site Inspections
        Chi-Wan CHEN, PhD
        Executive Director, Global CMC
        Pfizer Inc, United States
      • CFDA Current and Future Directions
        Zhimin YANG, MD
        Deputy Director, Senior Reviewer on Clinical Trials
        Division I of Clinical Trials for Pharmaceuticals, CDE, CFDA, China
    • 8:30AM - 10:00AM

      Session 0401: STATISTICAL LEADERSHIP IN PHARMACEUTICAL DEVELOPMENT AND BIOSTATISTICIAN'S ROLE IN REGULATORY ADVISORY MEETINGS


      Session Chair(s):

      • Tony Guo
        Associate Biostatistics Manager
        Sanofi-aventis (China) Investment Co., Ltd, China

      As pharmaceutical development relies increasingly on data driven and quantitative principles, statistical scientists are playing important roles not only in pharmaceutical development design and execution, but also in the regulatory submission and review process (including the critical advisory review meetings). In this session we will invite top statistical leaders from academia, government and industry to discuss the opportunities and challenges facing the profession.

      Speaker(s):

      • Statistical Leadership in Regulatory Agency and Academia
        Lisa M. LaVange, PhD
        Director, Office of Biostatistics, Office of Translational Science, CDER
        FDA, United States
      • Statistical Leadership in Pharmaceutical Industry
        Jerald S. Schindler, DrPH
        Vice President, Late Development Statistics, BARDS
        Merck Research Laboratories, United States
      • Feng Chen, PhD
        Professor, Dean
        School of Public Health, Nanjing Medical University, China
      • Marcia J Levenstein
        Vice President and Head of Global Statistics
        Pfizer, United States
    • 8:30AM - 10:00AM

      Session 0501: PRECLINICAL RESEARCH - GLOBAL STANDARDS, CHALLENGES, OPPORTUNITIES AND THE PATH FORWARD


      Session Chair(s):

      • No-image Representative Invited
        Representative to India
        WHO, India

      In recent years, there has been tremendous growth in Toxicology and DMPK that has strengthened China’s R&D capability in new drug development. Although successes were demonstrated in the submission of IND/CTA packages that contained preclinical data generated in China, still challenges existed preventing China generated preclinical data from being readily accepted by global regulatory authorities. As a country that is not part of MAD member countries, what kind of impact does this have on the acceptability of the data in supporting global clinical trials and registration? How is the data meeting international standards? What are the next steps? This program will review and explore the challenges and opportunities.

      Speaker(s):

      • Current Challenges and Opportunities in Preclinical Development - GLP Data in China
        Helen Han Hsu
        Janssen Pharmaceutical Company, China
      • OECD “Mutual Acceptance of Data” - How can China Participate
        Additional Speakers Invited
        United States
    • 8:30AM - 10:00AM

      Session 0601: MEDICAL AFFAIRS, MEDICAL COMMUNICATION AND EDUCATION - VALUE PROPOSITION AND PRACTICES

      Speaker(s):

      • Medical Affairs and Best Practices in the US
        Pamela A. Cyrus, MD
        Medical Director
        Bayer Corporation, United States
      • DIA 2014: The Value Proposition of Medical Affairs in China
        Avery Basil Ince
        Medical Director
        MSD China, China
    • 8:30AM - 10:00AM

      Session 0701: GENERIC DRUG DEVELOPMENT IN CHINA (PART I)


      Session Chair(s):

      • No-image Yi REN, PhD, MBA
        General Manager
        Nanjing Medichem Bio-Pharmaceutical Development Co. , China

      Session 0701: GENERIC DRUG DEVELOPMENT IN CHINA (PART I)

      Speaker(s):

      • Current Status of Generic Drug Consistency Evaluation
        Bo LI
        Deputy Division Director
        Food and Drug Administration, Hunan Province, China
      • Effect and Implementation Status of No. EU62 ~ Chinese version only
        Zuojun Dong
        Zhejiang University of Technology, China
      • Scientific Approach in Quality Consistency Evaluation of Generic Drug
        Daniel Song
        Janssen Pharmaceutical Companies, Johnson & Johnson, China
    • 8:30AM - 10:00AM

      Session 0901: HANDLE CLINICAL TRAIL TRANSPORTATION IN COMPLIANT WAY (BY TNT INTERNATIONAL EXPRESS)
    • 8:30AM - 12:00PM

      Special Session: China-Led Global Development


      Session Chair(s):

      • No-image Hua MU, MD, PhD
        Global Head of Product Development Service and Partnership Business Unit
        WuXi AppTec, China
      • No-image Steve Yang, PhD
        Executive Vice President and Chief Operational Officer
        Wuxi Pharma Tech Inc., China

      During the last few years, an increasing number of new drug development programs in China are driven by Chinese domestic companies. These companies include both large pharmaceutical companies with integrated R&D capabilities or specialized, smaller biotech companies. The products under development include both small and large molecules. While some of these development efforts are for China market, a few programs are positioned towards a China led early clinical development followed by subsequent global or Asian development. What is the future direction of China-led development programs? What are the learning from such efforts? We have invited R&D heads of the domestic pharmaceutical companies, chief executives of the Chinese biotech companies, and senior executives of major CRO company to reflect on their progress and share their insights on Chinaled local and global development. This special session will be the only forum in this DIA China annual meeting dedicated to Chinese domestic companies. Senior executives from Yangzijiang, Hengrui, Zhejiang Beta Pharma, Hutchison MediPharma, and leading CRO company such as Wuxi AppTec will share the stage to have an open discussion on the global strategy of China new drug development.

      Speaker(s):

      • New Drug R&D in China: Opportunities and Challenges
        Speaker Invited
        United States
      • Icotinib, the Story of Developing New Drug in China, and Its Status Quo
        Yinxiang Wang, PhD
        CEO & CSO
        Zhejiang Beta Pharma Inc, China
      • Li CHEN
        Hua Medicine Limited, China
      • Peng Wang, PhD
        President
        Yabao Pharmaceutical Group, Beijing Research Institute, China
    • 10:30AM - 12:00PM

      Session 0102: DESIGN AND CONDUCT VALUE-ADDED AND HIGH QUALITY POSTMARKETING STUDIES


      Session Chair(s):

      • No-image Jane LIN, MD
        VP, Strategic Medical Affairs
        Johnson & Johnson Medical (China) Ltd., China

      Post-marketing studies account for a large portion of studies in the product life cycle. The objectives and methodologies applied in the post-marketing phase are diversified. Different research methodologies have their specific features, strengths and limitations, and are subject to different rules and regulations. As of today, there are no clear official guidelines in China to define these studies. In this session, speakers from industry and academia will discuss the scientific, operational and regulatory aspects of various methodologies and how these principles can be applied in China to enhance value, quality and compliance of post-marketing studies to maximize benefits and reduce risk to the patients.

      Speaker(s):

      • Considerations In Design and Successful Execution of Observational Research
        Agnes Rivaille PINATEL, PhD
        Scientific Affairs Director, Late Phase Services
        PRA, France
      • Observational Research to Enhance Innovative Medicines' Impact on Patients and Society
        Wei DONG
        Senior Director, Deputy Site Head for Global Product Development in AP PDY
        Roche, China
      • Using Outcomes Research for Product Life Cycle Management & Payer Support
        Nancy A. Dreyer, PhD, MPH, FISPE
        Global Chief of Scientific Affairs, Real-World and Late Phase Research
        Quintiles Outcome, United States
    • 10:30AM - 12:00PM

      Session 0202: EXPERIENCE OF FORMAL CONSULTATION MEETINGS WITH CDE


      Session Chair(s):

      • Chris Huang
        CEO
        Pharmacons Tech CO.,LTD, China

      Following the policies to encourage innovative drug development, the number of CDE formal consultation meetings (communication meetings) increased significantly and the topics covered most areas of new drug development. In this session, speakers from domestic and multinational pharmaceutical companies will share their experience about formal consultation meetings with CDE on various stage of new drug development. A speaker from CDE will give an overview about communication meetings with sponsors and provide suggestions on how to manage the communication meetings with CDE better.

      Speaker(s):

      • A Formal Two-Way Communication Meeting with CDE on IND of a Novel Anti-Cancer Drug Using Innovative Development Strategy
        Hua MU, MD, PhD
        Global Head of Product Development Service and Partnership Business Unit
        WuXi AppTec, China
      • Effective CDE Consultation Meeting
        Mary Sun
        Regulatory Affairs Manager
        Pfizer Investment Co., Ltd, China
      • New IND Process for the First in Class Drug CTA Approval at China CDE
        Li CHEN
        Hua Medicine Limited, China
      • Topic TBD
        Representative Invited
        CDE, Taiwan
    • 10:30AM - 12:00PM

      Session 0302: HOW GxP IMPACTS THE MEDICAL PRODUCT REVIEW AND APPROVAL DECISION? (PART II)


      Session Chair(s):

      • Yi FENG
        Office of Evaluation Management and Communication
        Center for Drug Evaluation of CFDA , China

      This session will build on the previous session and expand on key principles regarding the impact of GxP compliance on medical product decision-making based on FDA, industry, and TFDA experiences. Current and past decision makers on drug applications will share their views on how compliance with GxP affects their decision making based on previous cases in the public domain.

      Speaker(s):

      • GLP Excellence and Impact on Regulatory Review and Approval
        Dylan YAO, MD, PhD
        Senior Vice President and CSO
        Joinn Laboratories, Inc., China
      • GLP Excellence and Impact on Regulatory Review and Approval
        Representative Invited
        Mexico
      • Biologics - Device Reviewer’s Perspective on the GMP
        Gang WANG, PhD
        FDA, United States
      • TFDA Current and Future Directions
        Lih-Jiuan HSU
        / ktب姌{+UҦ`+XMzqµjpy7ː: Center for Drug Evaluation, Taiwan
    • 10:30AM - 12:00PM

      Session 0402: STATISTICAL ISSUES IN INTERNATIONAL MULTI-REGIONAL CLINICAL TRIALS


      Session Chair(s):

      • Gang CHEN, PhD
        Johnson & Johnson, China

      The impact of ethnic factors on efficacy, safety, and dosage of a new treatment has been described in the International Conference on Harmonization (ICH) guideline “Ethnic Factors in the Acceptability of Foreign Clinical Data” (ICH E5, 1998). In New drug development of China, the results from international multi-regional clinical trials (MRCT) alone are often inadequate to assess such impact due to small sample sizes and other statistical concerns. In this session we will discuss those potential statistical issues, the relationship between international MRCT and China registration clinical trials and possible solutions. Panel Discussion: A bull in a china shop - How to spend the fragile Alpha; A holistic view on global vs. local strategies; Adaptive licensing on the MRCT or global development; MRCT: Concept and concerns from statistical perspectives; Why MRCT; Practical consideration from local registration perspectives

      Speaker(s):

      • Jielai Xia, PhD
        Professor
        4th Military Medical University, China
      • William Wang, PhD
        Head of Asia Pacific Hub, Biostatistics and Research Decision Sciences (BARDS)
        Merck Research Laboratories, Merck & Co., Inc., China
      • Ning Li, MD, PhD
        Vice President, GRA Head, Medical Policy, Asia
        Sanofi, China
      • Dayao ZHAO, MD, PhD
        Vice President, Head of R&D
        Johnson & Johnson, China
      • Representative Invited
        United States
    • 10:30AM - 12:00PM

      Session 0502: CRITICAL ELEMENTS IN BUILDING HIGH QUALITY TOXICOLOGY ASSESSMENT CENTERS - CASE STUDIES


      Session Chair(s):

      • No-image Nata Menabde
        Representative to India
        WHO, India

      In recent years, there has been tremendous growth in Toxicology and DMPK that has strengthened China’s R&D capability in new drug development. Although successes were demonstrated in the submission of IND/CTA packages that contained preclinical data generated in China, still challenges existed preventing China generated preclinical data from being readily accepted by global regulatory authorities. As a country that is not part of MAD member countries, what kind of impact does this have on the acceptability of the data in supporting global clinical trials and registration? How is the data meeting international standards? What are the next steps? This program will review and explore the challenges and opportunities.

      Speaker(s):

      • Preclinical Data Integrity and Scientific Quality from a Regulatory Reviewer’s Perspective
        Qingli WANG
        Deputy Director, Senior Reviewer on Clinical Trials
        Division of Pharmacological and Toxicological Review, CDE, CFDA , China
      • FDA's Expectation on Nonclinical Data Integrity with Special Emphases on Data Generated by CROs - Case Study
        Dylan YAO, MD, PhD
        Senior Vice President and CSO
        Joinn Laboratories, Inc., China
      • Honggang Bi, PhD
        Corporate Vice President, General Manager China
        Covance, China
      • Robert Coldreck
        Vice President, GLP QA
        WuXi AppTec (Suzhou) Co., Ltd., China
    • 10:30AM - 12:00PM

      Session 0602: INNOVATIONS AND TALENT DEVELOPMENT TO SUPPORT VALUE CREATION


      Session Chair(s):

      • No-image Nata Menabde
        Representative to India
        WHO, India

      In this session, the role of MSL, medical education/communication and real life evidence collection (e.g. claim database analysis) will be discussed.

      Speaker(s):

      • Understanding MSL Activities Across the Product Lifecycle
        Felix Cao
        Associate Medical Director
        Pfizer, China
      • Introduction of Electronic Healthcare Databases in Western Countries and Asia Pacific
        Yanfang LIU
        Directorof Epidemiology Asia Pacific
        Janssen Pharmaceutical R&D, Singapore
      • Innovations in Medical and Scientific Communications
        Justin Daniels
        Director
        Bayer Healthcare Pharmaceuticals, Inc., China
    • 10:30AM - 12:00PM

      Session 0702: GENERIC DRUG DEVELOPMENT IN CHINA (PART II)


      Session Chair(s):

      • Chi-Wan CHEN, PhD
        Executive Director, Global CMC
        Pfizer Inc, United States

      Session 0702: GENERIC DRUG DEVELOPMENT IN CHINA (PART II)

      Speaker(s):

      • Generic Drug Review and Approval Process in China
        CFDA Invited Speaker
        China
    • 10:30AM - 12:00PM

      Session 0902: STRATEGIC INTEGRATION IN DRUG DEVELOPMENT: FROM PRECLINICAL TO POC (BY COVANCE)
    • 1:30PM - 3:00PM

      Session 0203: CFDA TOWN HALL - CHINA REGULATION AND NEW INITIATIVES
    • 1:30PM - 3:00PM

      Session 0204: CFDA TOWN HALL - CHINA REGULATION AND NEW INITIATIVES
    • 1:30PM - 3:00PM

      Session 0503: QUANTITATIVE PHARMACOLOGY IN DRUG DEVELOPMENT


      Session Chair(s):

      • No-image Nata Menabde
        Representative to India
        WHO, India

      The session will focus on the state-of-the-art concepts, implementation and impact of model-based drug development (MBDD) in drug development, starting from an overview of MBDD in pharmaceutical industry; AP bridging strategy; and modeling and simulation in clinical practice.

      Speaker(s):

      • An Overview of Modelling & Simulation in Small & Large Molecule Development
        Honghui Zhou, PhD
        Senior Director, Pharmacokinetics & Pharmacometrics
        Janssen R&D / Johnson & Johnson, United States
      • Clinical Pharmacological Approaches to Deal with Ethnic Differences
        Representative Invited
        United States
      • Clinical Pharmacological Approaches to Deal with Ethnic Differences
        Peimin Ma
        China GlaxoSmithKline R&D, China
      • Modeling & Simulation in Clinic Practice
        Wei LU
        Peking University, China
      • Modeling and Simulation - A "Toolkit" for Modern Drug Development
        E. Dennis Bashaw, PharmD
        Director, Division of Clinical Pharmacology 3
        FDA, United States
    • 1:30PM - 3:00PM

      Session 0603: MEDICAL WRITING AND MEDICAL TRANSLATION


      Session Chair(s):

      • Xing Li
        Janssen Pharmaceutical Research and Development L.L.C, China

      Medical writing and medical translation are relatively new and promising areas in China. The writers and translators are playing a critical role to deliver scientifically correct and logically well-organized messages to audiences. The speakers from multinational pharmaceutical companies and academia will share their experience regarding role of medical writers in clinical development, and the future trend for professional translation (i.e. medical translation).

      Speaker(s):

      • Role of Medical Writing in Clinical Development
        Helle-Mai Gawrylewski, MA
        Senior Director, Medical Affairs and Alliance Management in Medical Writing
        Janssen Research & Development, LLC, United States
      • Development of Professional Translation in China and Its Impact on Medical Translation
        Jeffrey Yao
        Shanghai International Studies University (SISU), China
      • Talent Development in Medical Affairs - McKinsey Report
        Fangning Zhang
        McKinsey & Company, China
    • 1:30PM - 3:00PM

      Session 0704: REGULATORY PERSPECTIVES ON DRUG-DEVICE COMBINATION PRODUCTS IN THE UNITED STATES AND IN CHINA


      Session Chair(s):

      • Chi-Wan CHEN, PhD
        Executive Director, Global CMC
        Pfizer Inc, United States

      Drug-device combination products is a rapidly growing field of medical products designed to enable targeted drug delivery, reduce physiological barriers to drug transport, provide dosing convenience, and/or enhance patient compliance. These products range from simple pre-filled syringes to more complex products like transdermal delivery systems and drug-eluting stents. This session will introduce how drugdevice combination products are regulated in the United States and discuss the technical and regulatory challenges in developing and approving these products for marketing. Product characterization, process controls, and quality assurance issues unique to pre-filled syringes, transdermal delivery systems, and drug-eluting stents will be presented.

      Speaker(s):

      • Drug-Device Combination Products in US
        Duu-Gong Wu, PhD
        Director, Global Regulatory Affairs, Pharmaceutical Product Development
        Pharmanet - i3, United States
      • Drug-Device Combination Products in US
        David LIN, PhD
        Senior Consultant
        Biologics Consulting Group, Inc., United States
      • Drug-Device Combination Products in China
        Xinli SHI
        CFDA Center for Medical Equipment & Skill Evaluation, China
    • 3:00PM - 5:30PM

      Session 0504: PRECLINICAL DMPK: BUILDING QUALITY DATA AND SYSTEM


      Session Chair(s):

      • No-image Representative Invited
        Representative to India
        WHO, India

      Drug metabolism and Pharmacokinetics (DMPK) has played a critical role in drug discovery and development. How to get quality data and build a quality system for research and preclinical DMPK is essential for the China pharmaceutical industry. This session will start with using quality animals for in vivo PK/safety studies and building a quality system for bioanalysis. It will then discuss the importance of quality PK data for anti-body drug conjugate (ADC) drug development.

      Speaker(s):

      • The Importance of the Quality of Animals in Conducting Tox/DMPK Studies
        Kobe Liu
        GlaxoSmithKline R&D Shanghai, China
      • Building a Quality Program for Bioanalysis
        JinSong Xing
        Wuxi AppTec, China
      • Yuanguo Cheng
        Academy of Military Medical Science, China

    Day 3 Wednesday, May 14, 2014

    • 8:30AM - 9:30AM

      Session 0105: EVOLVEMENT IN DIABETES AND OBESITY PREVENTION AND TREATMENT - IMPACT ON DRUG DEVELOPMENT


      Session Chair(s):

      • No-image Jessica Liu, MD
        VP Clinical Development, General Medicine BU, Asia-Pacific Region
        INC (Beijing) Medical Technology Co., Ltd., China

      Diabetes and obesity special discussion will invite well-known Chinese diabetes expert to share the landscape of diabetes incidence in China and the research progress on preventing; Foreign experts on drug development will share their rich experience on designing diabetes drug development plan and the choice of assessment endpoints, eventually how to cooperate with the authorities on efficacy and safety requirements and evaluation.

      Speaker(s):

      • Early Phase Clinical Research and Development For Diabetes and Obesity
        Marcus Hompesch, MD
        President & CEO
        Profil Institute for Clinical Research, United States
      • New Model to Tackle the Operational Challenges in Diabetes Drug Clinical Development
        Andreas Koester, MD, PhD
        Vice President, Clinical Trial Innovation, External Alliances
        Janssen Pharmaceutical Companies of Johnson & Johnson, United States
      • Quality Control for Multi-Center Clinical Trials
        Jim Wang
        Senior Director
        Novo Nordisk A/S, China
    • 8:30AM - 10:00AM

      Session 0205: THE CONSIDERATIONS OF AMENDMENT FOR DRUG ADMINISTRATION LAW (PART I)


      Session Chair(s):

      • No-image Zhiang WU, PhD
        Shenyang Pharmaceutical University, China

      China has initiated the amendment of drug administration law. What will be the key focus of the new law under the new environment? How significant will the changes be? The experts from government, academia, industry and pharmaceutical associations will share perspectives and exchange opinions with audience.

      Speaker(s):

      • Innovation in Management of Drug Safety System
        Representative Invited
        China
      • Amendment of Drug Administration Law - The Perspective of Innovation in Drug Regulatory System
        Rong SHAO
        Dean, School of International Pharmaceutical Business
        China Pharmaceutical University(CPU), China
      • Amendment of Drug Administration Law - The Perspective of Multinational Pharmaceutical Companies
        Weiping Li
        Xi'An Janssen Pharmaceuticals Ltd., China
    • 8:30AM - 10:00AM

      Session 0405: STATISTICAL METHODOLOGIES FOR ONCOLOGY CLINICAL TRIALS


      Session Chair(s):

      • Jacqueline Law, PhD
        Roche, China

      Oncology is one of the most active areas in new drug research and development, with significant unmet medical needs. Even with the advancement in the last decade in the development of personalized medicines, biomarker testing, computing technology and statistical methodologies, the design and analysis of oncology clinical trials still present many unique features and challenges. This session will focus on statistical methodologies in oncology clinical trials.

      Speaker(s):

      • Evaluation of Confounding Effect on OS by Non-Protocol Therapies after Disease Progression in Oncology Clinical Trials
        Nichole F. LI, PhD
        Associate Director
        Roche, China
      • Treatment Effects on Disease Progression and Overall Survival in Oncology Clinical Trials
        Qi Jiang, PhD
        Executive Director, Global Biostatistical Science
        Amgen Inc., United States
      • Use of Bayesian Augmented Control Design in Phase II Oncology Clinical Trials
        Chao Zhu
        Bristol-Myers Squibb, United States
    • 8:30AM - 10:00AM

      Session 0705: GMP FORUM (PART I)


      Session Chair(s):

      • No-image Representative Invited
        Representative to India
        WHO, India

      Speaker(s):

      • Current Status of Implementing China 2010 GMP
        Representative Invited
        China
      • US FDA’s Experience from Inspection of API Establishments in China
        Gang WANG, PhD
        FDA, United States
      • Current Issues Relating to GMP from EU Perspective
        David Cockburn
        Head of Manufacturing and Quality Compliance Service
        European Medicines Agency, European Union , United Kingdom
    • 8:30AM - 10:00AM

      Session 0905: INDUSTRY STUDIES: THE STATE OF PATIENT RECRUITMENT AND CRC IN CHINA (BY JSURE HEALTH INC.)
    • 8:30AM - 10:00AM

      Session 1005: SPEEDING UP DRUG DISCOVERY BY TRANSLATIONAL MODELING OF EFFICACY AND SAFETY (PART I)


      Session Chair(s):

      • Jimmy Jin
        TSU AsiaPacific, Sanofi R&D, China

      Speaker(s):

      • To Explore the Unexplorable
        Jun Wang
        Beijing Genomics Institute, China
      • Ubiquitination-dependent Regulation of mTOR Signaling in Tumor Cell Proliferation
        Daming Gao
        Shanghai Institute for Biological Sciences, CAS, China
      • Patient-Derived Xenograft (PDX) Model and Improved Translatability in Drug Discovery
        Danyi Wen
        Shanghai LIDE Biotech, China
    • 8:30AM - 10:30AM

      Session 1105: PRE-MARKETING RISK ASSESSMENT


      Session Chair(s):

      • Yuhong WANG, MD
        Drug Safety Lead
        Shanghai Roche Pharmaceuticals Ltd, China

      Risk assessment occurs throughout a product’s lifecycle, from the early identification of a potential product, through the premarketing development process, and after approval during marketing. Premarketing risk assessment is particularly important as the assessment of underlying risks and benefits during the premarketing period is critical to the regulatory authority’s decision on product approval. Moreover, safety is the predominant reason why products are withdrawn from the marketplace, and Drug-Induced Liver Injury (DILI) remains the most common single cause of safety-related drug marketing withdrawals, as it has been for the past 50 years. This session is intended to share views from the perspective of industry, academia and regulatory authority on premarketing assessment of liver toxicity, provide an overview on DILI risk assessment and management in clinical development program, and give an update on the advances in DILI research worldwide and nationwide.

      Speaker(s):

      • DILI Risk Assessment and Management in Clinical Development Program – Industry Perspective
        Sean ZHAO, MD, PhD
        Executive Director, Global Safety
        Amgen Inc., United States
      • Strengthening the Translational and Clinical Research on Drug-Induced Liver Injury (DILI) – Academic Perspective
        Yimin MAO
        Professor
        RenJi Hospital, China
      • Huaqiong SHEN, MD, PhD
        Chief Medical Officer
        Jiangsu Hengrui Medicine Co., Ltd., China
    • 8:30AM - 10:00AM

      Session 1205: PROJECT MANAGEMENT IN DRUG DEVELOPMENT


      Session Chair(s):

      • Yuan Li
        MSD China R&D, China

      Session 1205: PROJECT MANAGEMENT IN DRUG DEVELOPMENT

      Speaker(s):

      • Overview of Project Management in Drug Development
        Timothy M. Phelan, PhD
        Executive Director
        Merck & Co., Inc., United States
      • Value Added Project Leadership in New Drug Development, Opportunity and Challenge
        Maxwell Kirkby
        Global Product Vice President
        IRESSA , AstraZeneca, China
      • Clara GU
        TA Head Medical Affairs
        Bayer, China
      • Michael Jiang
        COO
        Lilly Suzhou pharmaceutical Co., Ltd., China
      • Kumar Penmetsa
        Senior Director
        BristolMyers Squibb, China
    • 8:30AM - 10:00AM

      Session 1505: REGULATORY, SCIENTIFIC, AND CONSIDERATIONS OF BIOSIMILAR DEVELOPMENT (PART I)


      Session Chair(s):

      • No-image Ning Li, MD, PhD
        Vice President, GRA Head, Medical Policy, Asia
        Sanofi, China

      The recent passage of law and publication of guidance in US provides a more defined pathway, as EU regulatory agencies did, for the development of biosimilar products by the pharmaceutical industry. However, unlike generic drugs of small molecules, the regulatory, scientific, and legal issues still present significant challenges due to the unique characteristics of individual biological products. This workshop will discuss the following: An update on the law and guidance for biosimilars and the newly approved products; The regulatory process for approval of biosimilars in US; The legal challenges pertaining to biosimilar products; The concept of comparability and the technical challenges related to biosimilar product development; and Immunogenicity as an important issue for biosimilars.

      Speaker(s):

      • Opening Remarks
        Ning Li, MD, PhD
        Vice President, GRA Head, Medical Policy, Asia
        Sanofi, China
      • Update on the Biosimilar Regulatory Pathway
        Duu-Gong Wu, PhD
        Director, Global Regulatory Affairs, Pharmaceutical Product Development
        Pharmanet - i3, United States
    • 10:30AM - 12:00PM

      Session 0106: RISK BASED APPROACH TO CLINICAL TRIALS


      Session Chair(s):

      • Qing ZURAW, MD, MBA
        Covance, Inc., United States

      The application of Risk-Based Monitoring (RBM) is a hot topic across the industry. How to better understand and implement regulatory guidance and what is the applicability to trial conduct in China? This session will discuss how to increase risk awareness, take appropriate monitoring approaches, and manage quality for clinical studies.

      Speaker(s):

      • Risk-Based Quality Management in Clinical Trials: A Risk Proportionate Approach
        David Cockburn
        Head of Manufacturing and Quality Compliance Service
        European Medicines Agency, European Union , United Kingdom
      • Risk-Based Monitoring from the Global Perspectives
        Qing ZURAW, MD, MBA
        Covance, Inc., United States
      • Jane LIN, MD
        VP, Strategic Medical Affairs
        Johnson & Johnson Medical (China) Ltd., China
      • Shuting LI, MD
        Director, GCP Center
        Cancer Institute & Hospital, Chinese Academy of Medical Sciences, China
      • Risk-Based Monitoring Current Practice & Challenges
        Yanxia Huang
        Sr. Clinical Research Manager
        MSD China, China
    • 10:30AM - 12:00PM

      Session 0206: THE CONSIDERATIONS OF AMENDMENT FOR DRUG ADMINISTRATION LAW (PART II)


      Session Chair(s):

      • No-image Zhiang WU, PhD
        Shenyang Pharmaceutical University, China

      Session 0206: THE CONSIDERATIONS OF AMENDMENT FOR DRUG ADMINISTRATION LAW (PART II)

      Speaker(s):

      • Ruilin SONG, JD
        ExecutivePresident
        Chinese Pharmaceutical Association, China
      • Speaker Invited
        China
      • Chen Yang, JD
        Partner
        Sidley Austin LLP Beijing Office, China
    • 10:30AM - 12:00PM

      Session 0406: CURRENT GLOBAL REGULATORY STATUS AND TREND OF CLINICAL DATA MANAGEMENT


      Session Chair(s):

      • Daniel Liu, PhD
        Chief Scientific Officer
        Beijing Clinical Service Center, China

      In the past years, there are some new regulations and guidance published in the world, such as US FDA risk-based monitoring guidance, e-source guidance, EMA TMF guidance, CFDA clinical data management guidance etc. This session will give an overview of these new regulations and guidance related to the data monitoring and quality management of clinical studies. By these presentations and discussion, the audience may have further understanding of the global standard status and trends as well as differences on the data quality and integrity of clinical studies. Moreover, US FDA and EMA updated regulations and guidance related to the data management of clinical studies as well as CFDA guidance and expectations on data quality management will be overviewed.

      Speaker(s):

      • Clinical Trial Regulation - Update
        Vincent Yeung, PhD, MBA, RPh
        GCP Operations Manager, Inspection, Enforcement, and Standards Division
        MHRA, United Kingdom
      • Updated Regulations and Guidance of CDM by FDA
        Sunil Singh
        President & CEO
        DBMS Consulting, Inc., China
      • Status and Trend of Clinical Data Management in China
        Jielai Xia, PhD
        Professor
        4th Military Medical University, China
    • 10:30AM - 12:00PM

      Session 0706: GMP FORUM (PART II)


      Session Chair(s):

      • No-image Representative Invited
        Representative to India
        WHO, India

      Session 0706: GMP FORUM (PART II)

      Speaker(s):

      • Oversea GMP Inspection by CFDA: Current Status and Future Outcome
        Representative Invited
        China
      • Comprehensive Quality Evaluation of Drugs Made in China ~ Chinese version only
        Bo Wang
        the Research Center of National Drug Policy and Ecosystem(NDPE), China
    • 10:30AM - 12:00PM

      Session 1006: SPEEDING UP DRUG DISCOVERY BY TRANSLATIONAL MODELING OF EFFICACY AND SAFETY (PART II)


      Session Chair(s):

      • Cai Li
        MSD R&D (China) Co., Ltd., China

      Speaker(s):

      • Interplay between Mesenchymal Stem Cells and Inflammation in the Tumor Microenvironment
        Ying Wang
        Shanghai Institutes for Biological Sciences,CAS, China
      • A New Frontier For Memory Enhancement
        Tim Tully
        Executive Vice President, Research & Development Chief Science Officer
        Dart NeuroScience LLC, USA, China
      • Ensuring the Smooth Translation of Pre-Clinical Data from Academia to Industry
        Michael W Jamieson, DrSc
        Adjunct Professor
        University of Southern California, International Center For Regulatory Sciences., Canada
    • 10:30AM - 12:00PM

      Session 1106: POST-MARKETING RESEARCHES/STUDIES-AS A TOOL FOR SAFETY


      Session Chair(s):

      • Xiaojun GUO, PhD
        Head
        GlaxoSmith-Kline, China

      After a drug is authorized in the market, the knowledge of its safety will continue expanding with the wide use of the drug in the real world. Post-marketing research as well as other post-marketing surveillance activities play an important role to monitor drug safety. The session will introduce the requirement of post-marketing researches from the regulatory perspective and will also discuss why and how a company should select the best suitable type of post-marketing studies to study drug safety, as well as the considerations in conducting these types of studies.

      Speaker(s):

      • Dan Wang
        CFDA- Wuxi FDA, China
      • Post-marketing Studies for Safety Evaluation: FDA Perspective
        Minzhu Li
        Postmarketing Safety Expert
        Postmarketing Safety Expert, China
      • Gang Cheng
        Assistant Director, National Center for ADR Monitor
        CFDA, China
      • Jingping Mo, MD, PhD
        Director
        Pfizer Inc., United States
      • Dayou WANG
        Huashan Hospital, Fudan University, China
      • Lei Sun
        Associate Clinical Research Manager
        GlaxoSmithKline(China) Investment Co., Ltd., China
    • 10:30AM - 12:00PM

      Session 1406: PATIENT FOCUSED CLINICAL SUPPLY MANAGEMENT (PART I)

      Speaker(s):

      • Expect of Investigators for A Good Investigational Drug Supply
        Shuting LI, MD
        Director, GCP Center
        Cancer Institute & Hospital, Chinese Academy of Medical Sciences, China
      • Song Qingchun Presentation
        Qingchun Song, MBA, PMP
        Vice President
        Clinical research Organization Union, China
      • Updates on ICH Q8 (R) and Q10 Guidelines
        Jiunn Horng Voo
        Senior Manager
        Covance (Asia) Pte Ltd., Singapore, China
    • 10:30AM - 12:00PM

      Session 1506: REGULATORY, SCIENTIFIC, AND CONSIDERATIONS OF BIOSIMILAR DEVELOPMENT (PART II)


      Session Chair(s):

      • No-image Ning Li, MD, PhD
        Vice President, GRA Head, Medical Policy, Asia
        Sanofi, China

      Session 1506: REGULATORY, SCIENTIFIC, AND CONSIDERATIONS OF BIOSIMILAR DEVELOPMENT (PART II)

      Speaker(s):

      • The Biosimilars Challenge in the US
        ChihLu Yu
        Counsel
        Schiff Hardin LLP, USA, China
      • Quality and Regulatory Considerations for Biosimilar Product Development in China
        Lichung Huang
        Henlius Biopharmaceuticals, Inc., China
      • Biosimilar - Legal and Regulatory Issues
        Shaoyu Chen, JD
        Manager Director, China Food and Drug Practice
        Covington & Burling LLP, China
    • 1:30PM - 3:00PM

      Session 0107: JOURNEY TOWARD PROACTIVE GCP COMPLIANCE


      Session Chair(s):

      • No-image Helen Li, MD, MBA
        Director, Emerging Market QA Asia Lead
        Pfizer Medical, China

      The journey toward proactive GCP compliance is long and challenging. In this session, the regulatory agencies from China, US, and Europe will share proactive approaches, requirements, and progress in GCP inspections, challenges, and trend in global initiative toward GCP compliance. FDA and EMA GCP inspection updates will be shared and discussed.

      Speaker(s):

      • CFDA Updates
        Representative Invited
        China
      • Update from FDA on GCP Compliance
        Leslie Ball, MD
        Assistant Commissioner and Deputy Director, OIP, OC
        FDA, United States
      • Facts and Figures of GCP Inspections Conducted - EMA Perspective
        David Cockburn
        Head of Manufacturing and Quality Compliance Service
        European Medicines Agency, European Union , United Kingdom
      • GCP Compliance, Challenges, Strategies and Experiences
        Vincent Yeung, PhD, MBA, RPh
        GCP Operations Manager, Inspection, Enforcement, and Standards Division
        MHRA, United Kingdom
    • 1:30PM - 3:00PM

      Session 0207: INTERNATIONAL REGULATIONS - NEW INITIATIVES


      Session Chair(s):

      • No-image Janet Lu, MS
        Head of Regulatory Asia Pacific
        Roche , China

      Adaptive licensing, break-through designation & approval in US, and the implementation of EU new Clinical Trials Regulation (CTR) are hot topics discussed by both regulatory agencies and industry. This session would provide the most recent updates on those initiatives and their impacts.

      Speaker(s):

      • Adaptive Licensing
        Lisa TAN, PhD
        Senior Regulatory Specialist
        Health Sciences Authority, Singapore
      • US Breakthrough and Oncology New Regulations/Policies
        Michelle Rohrer
        Head of US Regulatory Affairs, Global Regulatory Affairs
        Roche, United States
      • EU New Initiatives
        Anette Hjelmsmark, MS
        Senior Regulatory Intelligence Manager
        Novo Nordisk A/S, Denmark
    • 1:30PM - 3:00PM

      Session 0407: DATA STANDARDIZATION IN CLINICAL RESEARCH: CDISC STANDARD AND ITS IMPLEMENTATIONS


      Session Chair(s):

      • Zibao ZHANG, PhD
        Associate Director
        PPD, China

      Data standardization is considered as a critical factor in improving the overall effectiveness and efficiency in clinical research and the regulatory review process. This session will provide an overview of commitments to the use of open, consensus-based data standards from regulatory, community and industry. The topics will include the recent updates in data standardization from Chinese regulatory authority, and key issues, policy and guidance related to standardized study data; opportunities and challenges for regulatory and industry to ensure success in this area. Last, case studies will be shared by the standard development organization and the industry.

      Speaker(s):

      • Clinical Data Standard Updates from Chinese Regulatory Perspective
        Representative Invited
        CDE, Taiwan
      • Why CDISC Standards Make Difference in Clinical Data Quality and Efficiency
        Rebecca Kush, PhD
        President and CEO
        CDISC, United States
      • Standard-Based Real Time Data Analysis and Reporting – Is It a Dream or Reality
        Niklas Morton, MS
        Vice President
        PPD, United States
    • 1:30PM - 5:30PM

      Session 0408: CLINICAL DATA MANAGEMENT (CDM) ROLE IN THE RISK-BASED APPROACH TO MONITORING


      Session Chair(s):

      • Andrew Taylor
        Asia Pacific Head of Clinical Data Management
        Shanghai Roche Pharmaceuticals Ltd., China

      The Risk-Based Monitoring Approach makes use of central computerized review of clinical trial data and site metrics to determine if sites should receive more extensive quality review through onsite monitoring visits. This approach has a broad impact on almost all facets of clinical trial management, including people, process and technology as well as the quality and integrity of clinical data. What kind of challenges will this pose to data managers? What new role, responsibilities and skill sets will be needed for data managers to provide value in this approach? The speakers in this session will discuss real-life case study examples of risk-based monitoring and describe how to ensure data integrity with reduced expenditures on traditional 100% on-site monitoring and SDV from data manager perspective.

      Speaker(s):

      • Data Management Approach in Risk Based Monitoring
        Andrew Taylor
        Asia Pacific Head of Clinical Data Management
        Shanghai Roche Pharmaceuticals Ltd., China
      • Late Phase Centralized Site Management - an Integrated Approach Toward Risk-Based Monitoring
        Hady Khoury
        VP Global Head
        ICON, USA, China
      • Risk Based Monitoring: A case study from initiation to completion
        Carina Reinicke
        Regional Head of Clinical Data Management
        Boehringer Ingelheim Shanghai Pharmaceuticals Co, Ltd., China
    • 1:30PM - 3:00PM

      Session 0707: CMC REQUIREMENTS FOR THERAPEUTIC BIOLOGICAL PRODUCT AT DIFFERENT CLINICAL DEVELOPMENT STAGE (PART I)


      Session Chair(s):

      • Melly Lin
        Regulatory Manager
        Roche (China) Holding Ltd., China

      Speaker(s):

      • Regulatory Perspectives on Manufacturing Changes and Comparability Study for Biotechnology Products
        Lixin XU, MD, PhD
        Product Quality Reviewer
        FDA, United States
      • Regulatory expectations for specification setting at different stages of clinical development
        Wallace Lauzon
        Acting Chief of the Cytokines Division
        Health Canada, China
    • 1:30PM - 3:00PM

      Session 0803: HOW TO ENCOURAGE AND ACCELERATE CHINA PEDIATRIC DRUG DEVELOPMENT (PART I)


      Session Chair(s):

      • Zhimin YANG, MD
        Deputy Director, Senior Reviewer on Clinical Trials
        Division I of Clinical Trials for Pharmaceuticals, CDE, CFDA, China

      Session 0803: HOW TO ENCOURAGE AND ACCELERATE CHINA PEDIATRIC DRUG DEVELOPMENT (PART I)

      Speaker(s):

      • Physician Perspective: Pediatric Renal Disease Medication Comparison Study Between China and Foreign Countries
        Xuhui Zhong
        Peking University First Hospital, China
      • Industry Perspective: Operational Challenges and Opportunities in Pediatric Drug Devolopment in the US and EU
        Samuel D. Maldonado, MD, MPH
        Vice President, Head of Pediatric Drug Development Center of Excellence
        Johnson & Johnson Pharmaceuticals Research & Development, LLC, United States
    • 1:30PM - 3:00PM

      Session 1107: LABELING AND SAFETY RISK MANAGEMENT


      Session Chair(s):

      • No-image Vera Liang, MD
        Director and Global Safety Risk Lead, Safety Surveillance and Risk Management
        Pfizer (China) R&D Co., Ltd., China

      Drug product labeling summarizes the essential scientific information needed for the safe and effective use of the drug and is the primary source of information about a drug’s safety and effectiveness. Multinational pharmaceutical companies develop the core label for each of their drug products, ensuring the consistent communication of safety information across the countries. The core label is a living document – the change will occur anytime when new information is identified, particularly the new safety information, leading to the downstream label updates in the countries where the product is marketed. On the other hand, there have been increased numbers of safety labeling changes requested by the Health Authorities - namely if the Agency becomes aware of “new safety information” that it believes “should be included in the labeling of the drug, ” then it may trigger a process to rapidly amend the labeling for the product. Our session aims to provide an overview on what constitutes the label, how the label evolves, and safety label updates in the context of the continuous benefit/risk assessment. Otherwise, we will touch upon the practical challenges faced by the multinational companies in implementing the company core label. Also, the audience will hear the perspectives of the Health Authorities in China and EEA countries on the role of the label in communicating product safety information.

      Speaker(s):

      • Role of Labeling in Communicating Safety Risk Information – CFDA Perspectives
        HuiLai Xiao
        CFDA, China
      • Role of Labeling in Communicating Safety Risk Information – EU Perspectives
        Rozalina Kulaksazova
        Bulgarian Drug Agency, Bulgaria
      • Company Core Data Sheet – The Importance to Ensure Uniform Communication of Safety Information
        Rie Matsui, RPh
        Director, Regional Labeling Head for Asia International Labeling Group
        Pfizer Japan Inc., Japan
      • Gang Cheng
        Assistant Director, National Center for ADR Monitor
        CFDA, China
      • Jingping Mo, MD, PhD
        Director
        Pfizer Inc., United States
    • 1:30PM - 3:00PM

      Session 1307: ENHANCING CLINICAL TRAIL QUALITY WITH INTERNET TECHNOLOGIES


      Session Chair(s):

      • No-image Jessica Liu, MD
        VP Clinical Development, General Medicine BU, Asia-Pacific Region
        INC (Beijing) Medical Technology Co., Ltd., China

      This session will describe how to use internet technology to gradually change the traditional clinical trial management mode, which shows significant superiority for the subject recruitment, the process management of clinical trials, quality control and quality assurance, and information collection, etc. With the aid of internet technology, the quality of clinical trials should be improved and the efficiency of management should be increased. The specialist from hospital will show us how the informatics management system and the intelligent internet technology attribute and provide enhanced value to study sites. The big data transformation has revolutionized collaborations and how strategic partnerships between CROs and sponsors are formed. Discuss new tools and approaches to improve and centralized site management practices in late phase trials. We will also explore the “digital ecosystem” and showcase situations where digital, mobile and social channels have proven extremely effective in recruiting patients into clinical trials.

      Speaker(s):

      • Improve Quality and Efficiency Through Internet Technology Applications
        Zhi TENG, DrSc
        Fujitsu Limited, Japan
      • LI Lingsong Presentation
        Jingsong Li
        Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, China
      • Fueling Clinical Trial Recruitment through an Analysis of the Digital Ecosystem
        Ramita Tandon, MPH, MSc
        Consultant, United States
      • A Procurement View of Clinical Outsourcing
        James Chennells
        Head Strategic Sourcing
        Bayer Healthcare, United States
    • 1:30PM - 3:00PM

      Session 1407: PATIENT FOCUSED CLINICAL SUPPLY MANAGEMENT (PART II)

      Speaker(s):

      • The Patient Experience with Clinical Materials
        Christine Milligan
        Global Director
        Catalent Pharma Solutions, UK, China
    • 3:30PM - 5:00PM

      Session 0108: PROMOTIONAL EFFECT OF EC ACCREDITATION ON CONSTRUCTION OF EC IN CHINA


      Session Chair(s):

      • No-image Shuting LI, MD
        Director, GCP Center
        Cancer Institute & Hospital, Chinese Academy of Medical Sciences, China

      In recent years, some ECs in China have received accreditation by various international accreditation organizations. However, some questions have arisen such as what roles these accreditations play in EC work and do they really help in EC daily routines. Three experts who have experience in ethics accreditations will present and join the discussion. It is expected that the changes brought by accreditations to the ethics review will be better understood and promote the ethics accreditation in China.

      Speaker(s):

      • Management of Institutional Ethics Review System of Biomedical Research with Human Participants
        Ningning Xiong
        Jiangsu Province Hospital Of TCM Affiliated Hospital Of Nanjing University of TC, China
      • Effect on IRB Capacity Building in China by International Recognition Program
        Rong Wu
        Research Ethics Committee of Shanghai Medical Association, China
      • AAHRPP Accreditation Promote Clinical Research in Youan Hospital
        Meixia Wang
        Beijing Youan Hospital, Capital Medical University, China
    • 3:30PM - 5:30PM

      Session 0208: MULTI-REGIONAL CLINICAL TRIALS (MRCTS) – APEC UPDATE


      Session Chair(s):

      • Representative Invited
        China

      Session 0208: MULTI-REGIONAL CLINICAL TRIALS (MRCTS) – APEC UPDATE

      Speaker(s):

      • Topic TBD
        Representative Invited
        China
      • MRCT Data Safety Monitoring Board Program
        Steven Snapinn, PhD
        Vice President, Global Biostatistical Science
        Amgen Inc., United States
      • MRCT Center at Harvard: Protocol Ethics and PI Competency Initiatives
        Rebecca Li, PhD
        Executive Director
        Multi-Regional Clinical Trial (MRCT) Center, United States
      • MRCTs from China Perspective
        Dan Zhang, MD, MBA, MPH, MS
        Chairman & CEO
        Fountain Medical Development Ltd., United States
    • 3:30PM - 5:30PM

      Session 0708: CMC REQUIREMENTS FOR THERAPEUTIC BIOLOGICAL PRODUCT AT DIFFERENT CLINICAL DEVELOPMENT STAGE (PART II)

      Speaker(s):

      • Process Evaluation / Validation from Phase I to Phase III
        Armin Klein
        Technical Regulatory Lead
        F. HoffmannLa Roche Ltd., Switzerland, China
      • The Manufacture and Quality Control of the Drug Investigated in Clinical Trial
        Xinyan LI
        Executive Vice President
        Zesun (Shanghai) Science & Technology Co., Ltd., China
    • 3:30PM - 5:30PM

      Session 0804: HOW TO ENCOURAGE AND ACCELERATE CHINA PEDIATRIC DRUG DEVELOPMENT (PART II)

      Speaker(s):

      • Academia Perspecitve: Ethical Considerations in Pediatric Clinical Trials
        Kalle Hoppu
        Helsinki University Hospital, Finland
    • 3:30PM - 5:30PM

      Session 1108: QUALITY IN PHARMACOVIGILANCE


      Session Chair(s):

      • Xue TANG
        Country Safety Lead for China, Global Pharmacovigiliance Office, WSRO
        Pfizer Investment Co., Ltd., China

      Pharmacovigilance (PV) is an integrated system which combined multi-science to collect, identify, evaluate, monitor and analyze an adverse event. To ensure it is operating effectively and with high quality, a set of examination measures is necessary in order to identify the issue and risk as well as to resolve the issue in the end. Internal audit within the enterprise and the inspection by health authority are activities to improve the quality management of the PV system. Europe and the US has taken the steps with experience, EMA has issued Good Pharmacovigilance Practice in its new legislation in July 2012 and defined the legal responsibility of both health authority and the enterprise to implement the audit/inspection of PV.

      Speaker(s):

      • Introduction on "Guidance on the On-Site Inspection of Adverse Drug Reaction Reporting and Monitoring by Manufacturing Enterprises"
        Duo Dong
        CFDA CDE, China
      • Pharmacovigilance Inspections - Perspectives on Preparation and Management
        Helen Li, MD, MBA
        Director, Emerging Market QA Asia Lead
        Pfizer Medical, China
      • Yuan YAO
        Head of PVO China, AD
        Novartis China, China
    • 3:30PM - 5:30PM

      Session 1208: CLINICAL PROJECT MANAGEMENT (CPM)


      Session Chair(s):

      • Ran HU
        Sr. Manager, Trial Operation
        sanofi, China

      Session Highlight: To introduce the role of clinical project manager (CPM) with challenges and opportunities of the role faced in China; To share the working model of CPM; To share the implementation of technical tools used by CPM and introduce the innovation technical tools in Project management

      Speaker(s):

      • Challenge and Opportunity for CPM in China
        Nancy Tich, PhD
        Senior Director, Project Management
        Covance, Hong Kong
      • Clinical Project Manager - A Core Role to Success
        Biao Song
        AstraZeneca Pharmaceutical Co., Ltd (China), China
      • Introduction of Working Model for CPM
        Vivian Chang
        Shanghai Branch, Sanofi (China) Investment Co., Ltd., China
      • Innovation Technology Tool for Project Management
        Zheng Zhu
        Sr. Manager, Clinical Operations
        Covance Pharmaceutical R & D Co., Ltd. (Shanghai), China
    • 3:30PM - 5:30PM

      Session 1308: NEW COLLABORATION MODELS FOR HOSPITALS AND SMOs


      Session Chair(s):

      • Li Yang
        Deputy Director of Drug Clinical Trial Center
        Peking University 3rd Hospital, China

      This session will describe the future development of SMOs in China. A new model for collaboration between Hospital and SMO optimizes site performance and ensures the high quality of clinical trial. Achieving success in Site/SMO new collaboration, the traditional role of CRC has been changed into a practical site management and monitoring team. SMOs are also participating in patient recruitment to accelerate patient access in clinical trials. Panelists include speakers from both hospitals and SMOs, who will provide their perspectives and thoughts on the effective and efficient operational approaches to partnership management for site and SMOs.

      Speaker(s):

      • The Future Development of SMO in China
        Bin Li
        Pfizer Investment Co., Ltd., China
      • Investigation on the Cooperation Mode Between SMO, Sponsor and Drug Clinical Trial Center in China
        Tianxun Wang
        Rundo International Pharmaceutical Research & Development Co.,Ltd., China
      • The Roles of Clinical Research Coordinators (CRCs) in Clinical Trials
        Xiuqin Wang, MD
        Vice Director of Scientific Research Dept.
        Jiangsu Province Hospital, China
      • The Exploration and Analysis on the Recruitment Methods of SMO
        Hongdong Wang
        Beijing ASMO Medical Research Co., Ltd., China

    Exhibits  

    Exhibit and marketing opportunities are available for this conference, for more information please click:

    English  |  Chinese

    • A+ Inc.
    • Adaptive Clinical Systems
    • ADICON Clinical Laboratory, Inc.
    • Almac
    • ArisGlobal KK
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