Bengaluru, India

eSubmission and Public Disclosure

                                                                                                                                                                                        

 

Summary:

The Bengaluru SDE took place on 22nd April 2017, the theme of the event was "eSubmission and Public Disclosure". The event was attended by 187 delegates from 18 companies. There were ten presenters, each of them shared experiences, opinions and perspectives around the theme. 

The day concluded with a panel discussion covering clinical data transparency initiatives, data anonymization, CRT packages and other related topics, actively engaging the audience. Above all, the event served as a platform to network with colleagues from the industry. A very big thanks to all the people who made this event a grand success and the largest PhUSE SDE to date.

 

Presentations:

Welcome and Overview of PhUSE – Sarvesh Singh, PhUSE Asia Director

Keynote – Surendra Yajamanam, GlaxoSmithKline Pharmaceuticals

Changing Scenario of Disclosure and Transparency of Clinical Trials
Chandrima Pal, Chandni Ahuja & Vatsa Hansoty, GlaxoSmithKline Pharmaceuticals

Regulatory Submissions in IndiaAnitha Gandham, PPD

US FDA’s Study Data Technical Conformance Guide – JKG Sujith & Loganathan Ramasamy, Chiltern

Significance of Data Standards in eSubmissions – Franklin Moses & Ramanan Bathala, ACI Clinical 

Study Data and Electronic Submission Formats – Soma Sekhar Koramatla, Quartesian

FDA Submissions – What a Programmer Needs to Know – Satish Movva & Deepthi BM, Novartis

Good eSubmission Practice – eGSP – Uma Maheswaran Ponnusamy, ICON

A Standardized Approach to De-identification – Sreekanth Yelchuri, MMSH Clinical Research

Data Anonymization – A 'Risky' Affair? – Manjusha Gode, Cytel

Panel Discussion and Q&A – Gaurab Chakraborty, Jayapandian N, Smitha Nalam & Surendra Yajamanam

Wrap-up and Closing Remarks – Sarvesh Singh, PhUSE Asia Director

Download the event brochure.

 

SDE Chairs:

Surendra Yajamanam, GSK

Smitha Nalam, Quintiles

If you have any questions, or require any information, please contact the SDE Co-Chair.

 

Sponsors:

                

                

                                   

      

 

Photos from the Day:

    

 

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