Managing clinical studies in Asia can be both rewarding and challenging, as researchers face such issues as language, regulatory requirements and logistics. However, delays and frustrations can also arise if local practices -- such as standard treatments, insurance and reimbursement, indemnification of sites and investigators, and administration of study grants -- are not considered and anticipated. In addition to a well-structured feasibility study which provides meaningful information and data, the unique considerations of "locality" and corresponding solutions would be of value.

Whether or not a sponsor engages a CRO for Asian studies, it is important that they thoroughly understand the differences, the uniqueness (what and why things are done the way they are in Asia), and the latest on the local regulatory fronts, in order to assemble a solid and achievable clinical management plan.

Focused on China, Taiwan, Hong Kong, South Korea, Japan, Thailand and Singapore, this presentation draws on the benefits and challenges of managing clinical trials in Asia, based on recent experiences. The speaker also addresses critical points to ensure successful project start-up and conduct.

This audio conference covers:

• Information/demographics for various Asian countries
• Regulatory and ethics submissions
• Study institutions and investigators
• Benefits and challenges of managing clinical trials in Asia
• Unique considerations to maximize successful project start-up and conduct

About the speaker:

Edward C. Ian is Director of Operations in Asia for PRA International. As such, he has a strong interest in promoting the region for global clinical trials, and is familiar with local requirements as well as the clinical research infrastructure in a number of Asian countries. Edward was instrumental in establishing the Asian components of PRA in Singapore, China, Hong Kong and Taiwan. Prior to joining PRA, he held various managerial positions with multinational and local companies such as Bayer USA, Kaiser Permanente (USA) and SGS, where he was responsible for Business Management, Operations and Quality Management.

Edward received his B.S. degree from Missouri State University and completed his internship at Research Medical Center in Kansas City. He is a certified Lead ISO Assessor and licensed Clinical Lab Scientist (ASCP and California-US), and is currently completing an MBA program.

Who should attend?

• Heads of Research and Development
• VPs of Clinical Development
• Directors of Clinical Operations
• Therapeutic Area Leaders
• Program and Clinical Study/Project Managers
• Directors of Outsourcing and Procurement

ForeignExchange Translations provides specialized Korean, Japanese, Thai, and Chinese translation services to medical device and pharmaceutical companies.