Agendas

Day 1 May 24, 2015

8:30 AM — 9:30 AM

Session 0402 Application of Bayesian Methods for Clinical Trials

8:30 AM — 9:30 AM

Session 0502 Effective Risk Management

8:30 AM — 9:30 AM

Session 0505 Post Marketing Safety Surveillance

8:30 AM — 9:30 AM

Session 0602 Managing Post-Approval CMC Changes in China and the US - II

8:30 AM — 9:30 AM

Session 0605 ChP Townhall

8:30 AM — 9:30 AM

Session 0704 Development of Biosimilars in China: Interpretation of Biosimilar Guidance, Opportunities and Challenges - II

8:30 AM — 9:30 AM

Session 0705 Detection and Evaluation of Immunogenicity of Biologics

8:30 AM — 9:30 AM

Session 0802 Breakthrough of Innovative Cancer Therapies and Impact on Local Innovation in China

8:30 AM — 9:30 AM

Session 0804 How is DAA Era Changing the Chronic HCV Management - Efficient Clinical Development

8:30 AM — 9:30 AM

Session 0902 Embrace the Dynamic Environmental Change: Innovations Lead to New Opportunities and Solutions

8:30 AM — 9:30 AM

Session 0904 Technology Leads to New Opportunities for Meeting Customer Medical Information Needs

8:30 AM — 9:30 AM

Session 0905 Regulatory Writing: CTD, ICH E3 - Compliant CSR, and China Submission Dossier Preparation

8:30 AM — 9:30 AM

Session 1004 Newer Than New-Innovations to Create New Health Solutions

8:30 AM — 9:30 AM

Session 1005 Generic Drug Forum - I - Global Requirements and Regulatory Initiatives

8:30 AM — 9:30 AM

Session 1202 Public/Private Partnerships to Accelerate Product Development for the Developing World

Day 2 May 25, 2015

1:30 PM — 5:30 PM

Opening Plenary Session

Day 3 May 26, 2015

8:30 AM — 10:00 AM

INNOVATION: WHY SHOULD I CARE?

8:30 AM — 10:00 AM

PATIENT AND THERAPEUTIC CENTRIC CLINICAL MATERIALS

8:30 AM — 10:00 AM

RISK BASED SAFETY MONITORING

8:30 AM — 10:00 AM

Session 0101 Successful Stories of Bringing Innovative Product into China Market

8:30 AM — 10:00 AM

Session 0301 The Responsibilities to Speed Up Clinical Trials

8:30 AM — 10:00 AM

Session 0401 Statistical Methods for Oncology Clinical Trials

8:30 AM — 10:00 AM

Session 0501 Drug Safety in Clinical Development – Benefit / Risk Based Decision

8:30 AM — 10:00 AM

Session 0601 Managing Post-Approval CMC Changes in China and the US - I

8:30 AM — 10:00 AM

Session 0701 New Trend/Technology in Biologic Development

8:30 AM — 10:00 AM

Session 0801 Breakthrough by Innovative Disease Therapies

8:30 AM — 10:00 AM

Session 0901 Medical Writing Evolution and Expansion: from Global to China, from the Past to the Future

8:30 AM — 10:00 AM

Session 1001 Developing New Drugs from Traditional Chinese Medicine for Unmet Public Health Needs (Part I)

10:30 AM — 12:00 PM

CFDA Townhall

10:30 AM — 12:00 PM

Session 0102 Future Direction of Global Drug Development With ICH E17 Guideline Focusing on MRCTs

10:30 AM — 12:00 PM

Session 0302 The Feasibility of Initiating Clinical Trials by Single IRB Approving in China

10:30 AM — 12:00 PM

Session 0702 Safety Evaluation of New Types of Antibodies

10:30 AM — 12:00 PM

Session 1002 Developing New Drugs from Traditional Chinese Medicine for Unmet Public Health Needs - II

1:30 PM — 3:00 PM

Session 0703 Development of Biosimilars in China: Interpretation of Biosimilar Guidance, Opportunities and Challenges - I

1:30 PM — 3:00 PM

Session 0803 Breakthrough Therapies in Diabetes Diseases

1:30 PM — 3:00 PM

Session 0903 Why is Professional Medical Writer Needed in Boosting Scientific Publication in China

1:30 PM — 3:00 PM

Session 1003 WHO Pre-Qualification and Global Collaborations: Running Pharmaceutical Business Beyond China

Day 4 May 27, 2015

8:30 AM — 10:00 AM

Bringing Drug to Patients Sooner: Parallel Global Clinical Development in the Age of Personalized Medicine

8:30 AM — 10:00 AM

PARTNERSHIP STRATEGIES AND CREATIVE FRAMEWORKS IN THE NEW ERA

8:30 AM — 10:00 AM

Session 0105 How Far Away is the Innovative Medicine to China Patients? - I

8:30 AM — 10:00 AM

Session 0305 Clinical Science - I - Development Strategy

8:30 AM — 10:00 AM

Session 0405 Evolving CDM Role in Clinical Trials

8:30 AM — 10:00 AM

Session 1205 Medical Affairs - How to Deliver the Latest Medical Knowledge to the Health Professional

10:30 AM — 12:00 PM

Session 0106 How Far Away is the Innovative Medicine to China Patients? - II

10:30 AM — 12:00 PM

Session 0306 Clinical Science - II - IMCT Latest Guidance: Population PK Value in Development

10:30 AM — 12:00 PM

Session 0406 Quality and Integrity of Clinical Trial Data

10:30 AM — 12:00 PM

Session 0506 Active Safety Surveillance

10:30 AM — 12:00 PM

Session 0906 Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to GCP

10:30 AM — 12:00 PM

Session 1006 Generic Drug Forum - II - Product Development for Quality Consistency

10:30 AM — 12:00 PM

Session 1206 On the Way - China Innovative Pharmaceutical Company

10:30 AM — 12:00 PM

Special Session Brain Storm - Discussion in Depth of China SMO Practice

1:30 PM — 5:30 PM

GENERIC DRUG FORUM (PART IV)

1:30 PM — 3:00 PM

Session 0107 How Overseas Production Site Inspection be Done Efficiently and Effectively

1:30 PM — 3:00 PM

Session 0307 Clinical Operation - Risk Based Monitoring

1:30 PM — 3:00 PM

Session 0407 Statistics and Data Management Joint Session - The Collaboration of DM and Statistics - I

1:30 PM — 3:00 PM

Session 0507 Vaccine Safety and Risk Management

1:30 PM — 3:00 PM

Session 0907 Site Management & SMO

1:30 PM — 3:00 PM

Session 1007 Generic Drug Forum - III - Lessons Learned from Quality and Compliance Inspections

1:30 PM — 3:00 PM

Session 1107 Chinese Pharma/Biotech from Local to Global: From Strategies to Tactics

1:30 PM — 3:00 PM

Session 1207 Drug-Diagnostic Co-Development and Regulatory Requirement and Challenges for Companion Diagnostic Test

3:30 PM — 5:00 PM

Session 0108 How Multiple-Disciplinary Department in Authority Works Together Collaboratively to

3:30 PM — 5:00 PM

Session 0308 Project Management - Study Wide

3:30 PM — 5:00 PM

Session 0408 Statistics and Data Management Joint Session - The Collaboration of DM and Statistics - II

3:30 PM — 5:00 PM

Session 0508 Herbs Safety

3:30 PM — 5:00 PM

Session 0908 Internationalization of Chinese CRO in china

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The 7th DIA China Annual Meeting

Agendas

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