Shanghai, China

3rd November 2017

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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 future submissions and TA specific application and implementation.   



Novartis Campus, Shanghai



TimePresentation Presenter
8.30 - 9.00am Registration  
9.00 - 9.05am Welcome Peng Wan, MSD &
Jingwei Gao, Boehringer Ingelheim
9.05 - 9.10am Opening Remarks Wei Chen,
9.10 - 9.40am China CFDA Data Submission Regulatory Requirements and Updates CFDA CDE Invited Speaker
Yazhong Deng, TrustCRO
9.40 - 10.05am New CFDA Regulations and Clinical Data Management Report and DM Position in MRCT Anita Shen,
10.05 - 10.30am e-Data Submission Overview in the US/EU/Japan/China Eason Yang,
10.30 - 10.50am Morning Break  
10.50 - 11.15am Study Data Reviewer's Guide (SDRG) Automation Using R Markdown Qiang Wang,
11.15 - 11.40am Legacy Study Submission Components Review – Step-by-Step Chao Wang,
11.40 - 12.10pm  Experiences in Preparing OSI Deliverables for FDA Submission Mina Chen,
12.10 - 1.30pm Lunch  
1.30 - 2.00pm Statistical Evaluations in Oncology Trials Yuan Geng,
Boehringer Ingelheim
2.00 - 2.30pm Statistical Programming Analysis Considerations for Oncology Studies: A Phase III Trial of PD-1 on NSCLC Patients Jianling Ren,
2.30 - 3.00pm

Programming Practice in Oncology Studies with RECIST 1.1 and irRC

Liang Guo,
3.00 - 3.20pm Afternoon Break  
3.20 - 3.50pm Project Standard for Hematology Studies Eric Huang,
3.50 - 4.15pm Time to Recurrent Composite Endpoint Yu Ruo,
4.15 - 4.45pm Adaptive SAS Programming for Adaptive Submission Needs Hui Liu,
4.45 - 5.15pm Introduction to SAS Grid for Consideration Quting Zhang,
5.15 - 5.30pm     Closing Remarks  

Catering and refreshments will be provided throughout the day.


SDE Chairs:

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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