Although in the past Asia Pacific was deemed an emerging region for clinical research, it has now evolved and emerged, catching the interest of global pharmaceutical and biotech companies. Good Clinical Practice (GCP) was adopted as a local regulatory requirement in most of these counties in the late 1990s. Since then, industry-funded clinical research has grown rapidly in the eleven countries that are routinely considered for global IND studies.

The reasons for this growth are simple: Asia Pacific provides sponsors with several advantages, including streamlined regulatory and IRB processes, highly educated investigators and study personnel, well-equipped qualified study institutions, strengthened clinical research infrastructure, and internationally recognized standard treatments.

This presentation reviews the major factors that have made Asia Pacific such an attractive region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing clinical trials in the Asia Pacific region. Attendees also receive practical advice on critical points to take into account when conducting trials in Asia Pacific.

This audio conference covers:

• Reviewing the most current clinical research environment in Asia Pacific
• Understanding the key elements in rapid study start-up in Asia Pacific
• Getting ready for an emerged Asia Pacific to support your clinical projects
• Ensuring quality of the study sites by drawing on FDA GCP compliance inspections
• Reasons Asia Pacific must be considered by global sponsors for clinical development (quality, efficiency, cost, and transparency)

About the speaker:

Edward C. Ian has significant experience in clinical research and laboratory medicine, and is familiar with the local requirements and clinical research infrastructure in a number of countries in Asia-Pacific. He has a strong interest in promoting the region for global clinical trials and was instrumental in establishing the Asian components of PRA. In addition to his operational responsibilities for India, Singapore, China, Hong Kong and Taiwan, Mr. Ian is also heading the International Partner Program in Malaysia and Japan.

Mr. Ian has 14 years of experience in clinical research, focusing on business management, operations, project management and quality systems. He received his MBA from National Chengchi University in Taiwan and a BS degree from Missouri State University, and is a certified Lead ISO Assessor and licensed Clinical Lab Scientist.

Who should attend?

• Heads of Research & Development
• VPs of Clinical Development
• Directors of Clinical Operations
• Therapeutic Area Leaders
• Program & Clinical Study Managers
• Directors of Outsourcing and Procurement, and Strategic Planning
• VPs of Global Data Management

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.

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