| Click on the session title for a complete description. |
| Day |
Session Link |
| Monday |
Asia Pacific: Simultaneous Global Development |
| Monday |
Medical Writer Competency Model: Understanding Skills, Knowledge, and Behaviors for Use in Hiring, Training, and Evaluating Medical Writers |
| Monday |
Prevention of Fraud and Noncompliance in Clinical Research: What Was and Is Being Done? |
| Monday |
Regulatory Data Protection |
| Monday |
The New "Next Door" in Global Development: When East Goes West or West Goes East |
| Monday |
PMDA Update: PMDA Initiatives and Challenges for Faster Review and Better Life-Cycle Management of Drugs |
| Monday |
Regulatory Harmonization Initiative in APEC LSIF (Life Science Innovation Forum) |
| Monday |
Training of Investigators and IRB Members in Asia |
| Monday |
GCPs in China: Similarities and Differences from ICH GCPs |
| Tuesday |
Pediatric Drug Development: A Global Challenge |
| Tuesday |
Update on Clinical Safety and Pharmacovigilance in Japan |
| Tuesday |
Japan Regulatory CMC Requirements: J-CTD, Application Form, Site Accreditation, Change Control and Timing |
| Tuesday |
Conducting Global Clinical Trials in Emerging Markets |
| Tuesday |
Hot Topics in Publication Writing: Challenges and Solutions |
| Tuesday |
Sixth Update: Outlook for Changes in the Japanese Regulatory and Clinical Development Environment |
| Tuesday |
Pharmacovigilance on a Budget |
| Tuesday |
The Practice of Adaptive Research |
| Tuesday |
Site Relationship Management (SRM) Initiatives for Improving Site Performance: One Year Later |
| Tuesday |
Site Preferences for EDC: A Comparison of European and North American Perspectives |
| Tuesday |
Adaptive Trial Design: Critical Path at Five Years |
| Tuesday |
Development Safety Update Report (ICH E2F): Update, Current Status, and Major Provisions |
| Tuesday |
Comparing Risk Management Approaches of the US and Japan (Asia): Implications for Global Drug Development |
| Tuesday |
FDA Goes Global: Domestic Mission – Global Presence |
| Tuesday |
Challenges of R&D Outsourcing in Japan: Successful NDA Preparation, and Strategy Planning Area for Global Development |
| Tuesday |
Developing Responsible Systems for the Ethical Review of Clinical Trials: A Global Approach Based on Ethical Principles and GCP |
| Tuesday |
Drug Development and Statistics in Asia: Issues and Challenges |
| Tuesday |
China SFDA and CDE Update |
| Wednesday |
US-EU: Administrative Simplification - Status Report of Exchange of Information among Regulators |
| Wednesday |
Dealing with an FDA Audit: What We Can Learn from Warning Letters and Audits |
| Wednesday |
RNAi Therapeutics: From Concept to Implementation |
| Wednesday |
Changes in International Drug Development: Effects on Common Technical Document Preparation in Japan |
| Wednesday |
Asian Regulatory Collaboration Update for Multinational Clinical Trials |
| Wednesday |
Global Simultaneous Development and Asia/Japan: Strategic and Regulatory Issues to Overcome |
| Wednesday |
Experience with GCPs Worldwide |
| Wednesday |
Recent Advancement of Risk Management in the Asian Pacific Region |
| Wednesday |
Recent Advancement of Advanced Therapy in the Asian Pacific Region |
| Wednesday |
Nurture the Clinical Trial Leader of Tomorrow |
| Wednesday |
Drug Registrations and Clinical Trials in Pharmerging Countries and N-11 Countries |
| Wednesday |
An International Perspective on the Use of Computerized Systems in GCP |
| Wednesday |
Natural Health Products: Current Research and Development |
| Wednesday |
Current Clinical Research Training in Japan |
| Thursday |
Go East, Go West: Outsourcing in Asia |
| Thursday |
Remote Source Document Verification (SDV): Case Studies in Implementation - The Processes Used and Savings Achieved for Pivotal Phase 2 and 3 Trials |
| Thursday |
Global Working Environment Synergy: When an American Team Leader, Japanese Project Manager and European Team Members Work Together |
| Thursday |
Recent Advancement of Emerging Technology in the Asia-Pacific Region |
| Thursday |
Efforts Promoting Global Clinical Trials Environment in Korea |
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