Partnerships Asia Pacific Session Spotlight: Overcoming Regulatory Challenges in Clinical Trials

Each week leading up to Partnerships in Clinical Trials Asia Pacific, we'll be highlighting a session from the upcoming conference. It will take place October 5-7, 2010, in Singapore. For more information, visit our webpage to download the brochure.

Featured Session: Overcoming Regulatory Challenges in Clinical Trials - Communicating Effectively with Regulatory Authorities to Enhance Approval Lead Time
Panelists: Wen Chang, PhD, Head of Regulatory Intelligence and Advocacy, Asia and the Pacific, Global Drug Regulatory Affairs, NOVARTIS, China
Geoff Fatzinger, Executive Director, Regulatory Affairs and Strategic Product Development, Europe & Asia Pacific, INC RESEARCH, UK
Dra. Endang Woro, MSc, Director of Directorate of Drug and Biological Product Evaluation, NATIONAL AGENCY FOR DRUG AND FOOD CONTROL, Indonesia
Byungja Marciante, Investigator / Assistant Director, US-FDA SHANGHAI OFFICE, China

About the session:
With the rapid evolution of clinical infrastructures and the patient base, Asia is poised to contribute further to the development of experimental drugs and clinical evaluation of therapy. However, the ethical and regulatory landscape is so diverse. Compared with accepted guidelines and criteria for successful trials in the West, Asia’s regulatory landscape is rapidly evolving. In this session, representatives from the region will share experiences in challenges encountered when conducting clinical trials, providing guidance on how to facilitate this process.

• Navigate the diverse ethical and regulatory landscape
• Adapt to meet local and cultural demands
• Lessons learned from regional experts