| The 1st DIA Regulatory Communications Workshop in Japan | |
| Tokyo, Japan | |
| 26/11/2009 | |
| URL: | Click here for the event website. |
| Organizer: | Drug Information Association |
| Description: | |
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Regulatory communications is new for Japan, and was a modified concept from medical communications in the western world, which involves academia, government, and industry as well as patients. The scope of regulatory communications focuses on “communication between sponsor and reviewer during the NDA review process”. The objective of this training session is to explain how to use issued queries and responses from both sides (reviewer and sponsor) to openly discuss why miscommunication occurs, and identify ways to avoid it. This should help us reduce the review period by more effective regulatory communication. |
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