eSubmission and Public Disclosure
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.
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 India – Anitha 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.
Surendra Yajamanam, GSK
Smitha Nalam, Quintiles
If you have any questions, or require any information, please contact the SDE Co-Chair.
Photos from the Day:
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