3rd November 2017
Registration opens soon
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Registrations per company are limited to 20% of maximum attendance.
Submission Readiness and TA Standards: Theory, Perspectives and Practice
With the requirements of implementation of data standards and the rejection process released by the FDA, preparing and ensuring a successful submission is a big challenge and requires thoughtful strategy planning and oversight. This event will focus on the understanding and discussion of agency requirements and expectations, submission packs, key deliverables, implementations of TA standards analysis and reporting, and other forward-thinking considerations. We will hear from experts from pharmaceutical companies and CROs, who will share their knowledge, experience and thoughts regarding updated processes, innovative technology, examples and case studies for collecting, analysing and submitting TA-specific trial data, issues impacting the future submissions and TA specific application and implementation.
Novartis Campus, Shanghai
Catering and refreshments will be provided throughout the day.
Peng Wan, MSD
Jingwei Gao, Boehringer Ingelheim
If you have any questions, or require any information, please contact the SDE Co-Chair.
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