Conference Day 2: 21 March 2012

• › Dr Kezhou Zhang, Vice President, Medical Director, Novo Nordisk (China) Pharmaceuticals

Leveraging on successful regulatory compliance models to conduct clinical trials effectively in Asia 

• Formulating your regulatory strategy to enhance overall drug development lead-time
• Best practices: Adopting different approaches to fulfill regulatory requirements for local and global trials in Asia

• › Ms Yamin Wang, Head of Global Regulatory Affairs, Bayer Healthcare

• Addressing multiple submission needs to expedite drug approval in different Asian markets
• Establishing synergies between sponsors, CROs and regulatory agencies
• Working smarter, not harder: Overcoming regulatory challenges effectively and efficiently

• › Mr Andrew Notley, Director, Regulatory Affairs, APAC, ReSearch Pharmaceutical Services

• Evaluating critical factors that influences the development of regulatory affairs for clinical trials in Asia
• Fostering successful collaborations with your regulatory affairs counterparts and the country’s authorities
• Case study: Requirements for submissions and approvals of clinical trials to Japan’s regulators

• › Mr Tetsuomi Takano, Senior Director, Head of Asian Development Strategy, Asian Development, Astellas Pharma Inc.

• Capitalising on the best practices of regulatory systems in Taiwan and Korea to enhance your regional strategy
• Aligning company strategies and market insights from clients for efficient planning of regional trial operations
• Case study: Proposing a regional clinical development strategy for East Asia

• › Dr Cristina Chang, Medical Director, Taiwan, Abbott Nutrition

• Overcoming the challenges of site selection and patient recruitment for rare diseases in South Korea
• Designing  trials with innovative strategies to enhance biomedicine development
• Case study: Clinical trials for a special population – rare diseases and the terminally ill in South Korea

• › Dr Seong-Choon Choe, Senior Vice President, Chief Medical Officer, HanAll Biopharma

• Outlining the growth opportunities for various therapeutic clinical studies in Indonesia
• Evaluating the regulatory climate in Indonesia and its potential as a clinical trial hub in Asia
• Balancing flexibility and quality standards when conducting clinical trials in Indonesia

• › Mr Rianto Setiabudy, Prodia Expert Team, Prodia the CRO

• Capitalizing on a thorough understanding of Southeast Asian countries to overcome barriers in clinical trials
• Maximizing trial efficiency through careful planning and resource management
• Case study: Tapping on Malaysia and Thailand’s experienced healthcare workforce to conduct clinical trials

• › Dr Alvin Luk, Senior Director, Global Clinical Affairs & Operations, Biogen Idec Hemophilia

• Formulating approaches for maintaining standard of care at Asian sites with high patient load
• Maintaining control over trials with flexibility for CROs’ input
• Success case study: Engaging CROs for increased data quality and patient safety
   

• › Ms Patrecia Valone, Director, Development Operations, Takeda Global Research & Development Center

• Overcoming challenges in early phase clinical trials in China to accelerate market penetration of drug
• Optimising your harmonisation strategy when managing Asian sites in global clinical trials for effective global operations
• Case study: Leveraging on the advantages of conducting oncology clinical trials in China for efficient pipeline development
   

• › Dr Li Yan, Head, Clinical Development, Emerging Markets, Merck & Co., Inc