Shanghai, China

Submission Readiness and TA Standards: Theory, Perspectives and Practice



The PHUSE Shanghai Single Day Event took place on 3rd November at the Novartis campus in Shanghai. The event was a great success with over 160 attendees from 23 companies, including global and local pharma, CROs, Consulting, and software vendors. The event focused 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. Victor Wu, Chair of China CDISC Coordinating Committee (C3C), provided the overview of data submission requirements history, current status and look into the future, the challenges we face and thoughts on how to get ourselves well prepared. Anita Shen, Director of CDM from Janssen China R&D, focused on CFDA-required unique DMP & DMR for China NDA submission as well as how DM leaders and professionals are positioning themselves in this highly-demand market. Eason Yang, Principal Programmer from Novartis, gave a high-level summary of the electronic data submission requirements to health authorities in the US, EU, Japan and China. In addition, several experienced professional shared their knowledge and practice in the preparation of eSub data package, statistical and programming consideration in TA specific topics particularly in oncology studies, and SAS advanced programming in their daily operation. The day finished with closing remarks and future expectations from Wei Chen, site head of Novartis data science and programming, Jingwei Gao and Peng Wan, SDE co-chairs. 


China CFDA Data Submission Regulatory Requirements and Updates Victor Wu, Data Science Express Consulting

New CFDA Regulations and Clinical Data Management Report and DM Position in MRCTAnita Shen, Janssen

e-Data Submission Overview in the US/EU/Japan/China – Eason Yang, Novartis

Study Data Reviewer's Guide (SDRG) Automation Using R MarkdownQiang Wang, dMed

Legacy Study Submission Components Review – Step-by-StepYuguang Zhao, FMD K&L

Experiences in Preparing OSI Deliverables for FDA SubmissionMina Chen, Roche

Statistical Evaluations in Oncology TrialsYuan Geng, Boehringer Ingelheim

Statistical Programming Analysis Considerations for Oncology Studies: A Phase III Trial of PD-1 on NSCLC Patients 
Jianling Ren, Hengrui

Programming Practice in Oncology Studies with RECIST 1.1 and irRC Liang Guo, FMD K&L

Project Standards for Hematology StudiesEric Huang, Amgen

Time to Recurrent Composite EndpointYu Ruo, Novartis

Adaptive SAS Programming for Adaptive Submission Needs – Hui Liu, MSD

Introduction to SAS Grid for ConsiderationQuting Zhang, PPD

Download the event brochure.


SDE Chairs:

Peng Wan, MSD

Jingwei Gao, Boehringer Ingelheim






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