2nd Annual Pharma Regulatory Affairs Asia

Venue: singapore

Location: singapore, Singapore

Event Date/Time: Apr 25, 2012 End Date/Time: Apr 26, 2012
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"This event will mainly focus on 1) regulatory guidelines in SEA, China and Korea, 2) best practices in drug registration/combination products registration in different markets in particular Japan, Korea, China, Indonesia, Vietnam, Thailand and Philippines 3) Lifecycle management of products

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