Other key areas of discussion & interest:
• Major elements in setting up drug registration strategies especially in key Asian markets such as Japan, Korea, China, Indonesia, Vietnam, Thailand and Taiwan
• Drug applications for new drugs, orphan drugs, and combination drugs in various markets
• Updates on regulatory guidelines in various markets
• Obtain essential regulatory advice on combination products registration in Europe, USA and Asia-Pacific
• Packaging requirements for combination products
• Regulatory requirements for different type of combination products in different Asian markets
• Priority Reviews
• Ensuring pre-clinical and clinical studies comply to key Asian regulations including GLP, GCP and FDA requirements
• Improving the procedures and approval process for various product types including biosimilars and generics
• Marketing and life cycle management to ensure the success of product
• Strategies for entry into highly localized markets such as Japan
• Regulatory requirements on conducting multi-regional / national clinical trials in various markets in Asia.
• Effective industry communication between regulatory agencies and pharmaceutical companies
• Asean harmonization on pharmaceutical products – comparing it to requirements in EU and US
For additional information and registration
