Description: In order to register a medicine globally, there are some countries that require registration sample testing. The registration sample and testing requirement presents a significant challenge due to complex international regulatory landscape. This can be overlooked easily and results in significant delay if not planned properly. Regulatory affairs cannot achieve this alone and requires critical cross functional teams to be integrated during global registration planning. Different companies organize differently and have different strength. The interactive session aims to facilitate collective sharing of experiences from different companies (and perhaps different countries) to understand what a potentially good integrated strategy may look like.
Learning Objectives:
Understand registration sample and testing requirements
Some ideas on how to navigate the complex international country requirement registration sample and testing
Some ideas to consider during internal cross functional planning for global registration
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