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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

    Workshop1: Career Development
    Sino-American Pharmaceutical Professionals Association-China Chapter (SAPA-China) and DIA will co-host a Career Development workshop during 2014 DIA China Conference on May 11th (Sunday). The invited speakers are all returnees who had been working in major pharmaceutical companies or academy in US for many years before they returned to China for their career development. Most of these speakers are senior leaders in the organizations they are working for or started their own business. They would like to share their experience with you on how to grow up yourself in a big MNC or domestic company or work as an entrepreneur to start your own business. Coming to join us. You will find this is a fruitful and joyful day!
  • 8:30AM - 5:30PM

    Workshop2: Principles for Successful GXP Inspections: A Hands-On Interactive Approach based on FDA, WHO and Industry Experiences
    Preparing for GMP, GLP, GCP, PV/Risk Management inspections by stringent regulatory authorities, including from the FDA and the WHO, is critical for meeting quality and safety standards. This workshop will allow participants to learn from instructors with backgrounds from regulatory agencies and industry, and with first-hand experience in conducting inspections and undergoing inspections. Both didactic and interactive learning will be provided.
  • 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
      Medical Reviewer
      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


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    • 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
  • ASKLEP CHINA Inc.
  • Barrington James
  • Beijing BioKnow Information Technology Co., Ltd.
  • Beijing Bionovo Medicine Development Co., Ltd.
  • Beijing BioTell Consulting Co., Ltd.
  • Beijing Clinical Service Center
  • Beijing CTSmed Co., Ltd.
  • Beijing Lawke Health Laboratory Co., Ltd.
  • Beijing Pan Tong Logistics Co., Ltd.
  • Bestudy Medical Technolgy Co., Ltd.
  • BioClinica Inc.
  • Blue Jidian Medical Science Co., Ltd.
  • BMD (Su Zhou) Co., Ltd.
  • Brightech International
  • C3i, Inc.
  • Cardinal Health China
  • CCBR Clinical Research
  • CCRF (Beijing) Inc.
  • Choice Pharma
  • Covance

Registration Fees 

Other Fees

Member Student
¥500.00
NonMember Student
¥700.00
Patient Advocate Rate
¥500.00
One Day Rate
¥2000.00

Member

Charitable Nonprofit/Academia Member
¥2800.00
Member Government
¥2800.00
Member Standard
¥4700.00

Non-Member

Charitable Nonprofit/Academia Nonmember
¥3600.00
NonMember Government
¥3600.00
NonMember Standard
¥5400.00
Registration Fees for Additional Offerings
Workshop1: Career Development - Standard Rate
¥800.00
Workshop2: Principles for Successful GXP Inspec - Standard Rate
¥1200.00
Workshop3: Early Clinical Development FIH to POC - Standard Rate
¥1200.00
Workshop4: Project Management in Clinical Data Man - Standard Rate
¥1200.00
Workshop5: Data Safety Monitoring Board - Standard Rate
¥1200.00
Half-day Workshop1: Individual Case Safety Report - Standard Rate
¥800.00
Group Discounts

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