Highlighted features at 2-day conference includes
• Regulatory submissions implementation in eCTD format
• The ASEAN Labelling Harmonisation Effort
• Registration and approval timeline – combination products and exemptions
• What’s new with clinical regulatory requirements in Asia Pacific?
• Global trends vs. specific region’s updates for pharmacovigilance
• Regulatory affairs support in providing advices to commercial team for inspection
• Global Guidelines for the Development of Biologics