CRO/Sponsor Summit on Data Integrity in Clinical Research
Abstr. due: 30.11.2016
Dates: 02.03.17 — 03.03.17
Organizing comittee e-mail: firstname.lastname@example.org
Ensuring integrity of the data generated for regulatory submissions is a major challenge today for both the CROs as well as the Sponsors. Where on one hand, computerization, automation and LIMS have helped in data management, on the other hand, it has also made data alterations much easier. Therefore, for regulatory success both the CRO conducting the study and the Sponsors have to play a pivotal role in ensuring Data Integrity.
After successfully bringing together both CROs and Sponsors at a single platform in Hyderabad, SELECTBIO is pleased to present its 2nd "CRO/Sponsors Summit on Data Integrity in Clinical Research" in 2017 in Mumbai.
The theme for the deliberations will be "Best Data Practices for Successful Clinical Studies". This event will address best data practices followed by CROs and Sponsors for regulatory success in Clinical studies. We thank all the 15+ Speakers and 100+ participants of last year event and look forward to similar participation this year as well.
Data Integrity in Bioanalytical Laboratory
GCP/GLP & Other Requirements for CT/BE Studies
IT compliance – 21 CFR Part 11
Management of Regulatory Audits
Quality Assurance Programme in Clinical Studies
Risk Mitigation Programme in CRO
Root Cause Investigation of Integrity Issues
Software Validation/Qualification in CT Studies
Sponsors' Perspective on Data Integrity
Volunteer Cross Participation - Challanges & Solutions
Whistle Blowing Mechanism - Understanding and Managing
Conference Web-Site: http://selectbiosciences.com/conferences/index.aspx?conf=DICR17&se=india
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