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Shanghai International Convention Center

May 11, 2014 8:00 AM - May 14, 2014 5:30 PM

No. 2727, Riverside Avenue, Pudong, 200120 Shanghai, China

6th DIA China Annual Meeting

Agenda

1:30 PM — 5:30 PM

Opening Plenary Session

8:30 AM — 10:00 AM

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

8:30 AM — 10:00 AM

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

8:30 AM — 10:00 AM

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

8:30 AM — 10:00 AM

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

8:30 AM — 10:00 AM

Session 0501: MEETING GLOBAL STANDARDS: CHALLENGES, OPPORTUNITIES AND THE PATH FORWARD

8:30 AM — 10:00 AM

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

8:30 AM — 10:00 AM

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

8:30 AM — 10:00 AM

Session 0901: HANDLE CLINICAL TRAIL TRANSPORTATION IN COMPLIANT WAY (BY TNT INTERNATIONAL EXPRESS)

8:30 AM — 12:00 PM

Special Session: China-Led Global Development

10:30 AM — 12:00 PM

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

10:30 AM — 12:00 PM

Session 0202: EXPERIENCE OF FORMAL CONSULTATION MEETINGS WITH CDE

10:30 AM — 12:00 PM

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

10:30 AM — 12:00 PM

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

10:30 AM — 12:00 PM

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

10:30 AM — 12:00 PM

Session 0602: CUSTOMER-CENTRIC MEDICAL COMMUNICATION

10:30 AM — 12:00 PM

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

10:30 AM — 12:00 PM

Session 0902: STRATEGIC INTEGRATION IN DRUG DEVELOPMENT: FROM PRECLINICAL TO POC (BY COVANCE)

1:30 PM — 3:00 PM

Session 0203: CFDA TOWN HALL - CHINA REGULATION AND NEW INITIATIVES

1:30 PM — 3:00 PM

Session 0204: CFDA TOWN HALL - CHINA REGULATION AND NEW INITIATIVES

1:30 PM — 3:00 PM

Session 0503: QUANTITATIVE PHARMACOLOGY IN DRUG DEVELOPMENT

1:30 PM — 3:00 PM

Session 0603: MEDICAL WRITING AND MEDICAL TRANSLATION

1:30 PM — 3:00 PM

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

3:00 PM — 5:30 PM

Session 0504: PRECLINICAL DMPK: BUILDING QUALITY DATA AND SYSTEM

8:30 AM — 9:30 AM

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

8:30 AM — 10:00 AM

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

8:30 AM — 10:00 AM

Session 0405: STATISTICAL METHODOLOGIES FOR ONCOLOGY CLINICAL TRIALS

8:30 AM — 10:00 AM

Session 0705: GMP FORUM (PART I)

8:30 AM — 10:00 AM

Session 0905: INDUSTRY STUDIES: THE STATE OF PATIENT RECRUITMENT AND CRC IN CHINA (BY JSURE HEALTH INC.)

8:30 AM — 10:00 AM

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

8:30 AM — 10:30 AM

Session 1105: PRE-MARKETING RISK ASSESSMENT

8:30 AM — 10:00 AM

Session 1205: PROJECT MANAGEMENT IN DRUG DEVELOPMENT

8:30 AM — 10:00 AM

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

10:30 AM — 12:00 PM

Session 0106: RISK BASED APPROACH TO CLINICAL TRIALS

10:30 AM — 12:00 PM

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

10:30 AM — 12:00 PM

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

10:30 AM — 12:00 PM

Session 0706: GMP FORUM (PART II)

10:30 AM — 12:00 PM

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

10:30 AM — 12:00 PM

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

10:30 AM — 12:00 PM

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

10:30 AM — 12:00 PM

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

1:30 PM — 3:00 PM

Session 0107: JOURNEY TOWARD PROACTIVE GCP COMPLIANCE

1:30 PM — 3:00 PM

Session 0207: INTERNATIONAL REGULATIONS - NEW INITIATIVES

1:30 PM — 3:00 PM

Session 0407: DATA STANDARDIZATION IN CLINICAL RESEARCH: CDISC STANDARDS AND IMPLEMENTATION

1:30 PM — 5:30 PM

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

1:30 PM — 3:00 PM

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

1:30 PM — 3:00 PM

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

1:30 PM — 3:00 PM

Session 1107: LABELING AND SAFETY RISK MANAGEMENT

1:30 PM — 3:00 PM

Session 1307: ENHANCING CLINICAL TRAIL QUALITY WITH INTERNET TECHNOLOGIES

1:30 PM — 3:00 PM

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

3:30 PM — 5:00 PM

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

3:30 PM — 5:30 PM

Session 0208: MULTI-REGIONAL CLINICAL TRIALS (MRCTs) UPDATE

3:30 PM — 5:30 PM

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

3:30 PM — 5:30 PM

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

3:30 PM — 5:30 PM

Session 1108: QUALITY IN PHARMACOVIGILANCE

3:30 PM — 5:30 PM

Session 1208: CLINICAL PROJECT MANAGEMENT

3:30 PM — 5:30 PM

Session 1308: NEW COLLABORATION MODELS FOR HOSPITALS AND SMOs

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