CRO/Sponsor Summit on Data Integrity in Clinical Research

Страна: Индия

Город: Mumbai

Тезисы до: 30.11.2016

Даты: 02.03.17 — 03.03.17

Е-мейл Оргкомитета:

Организаторы: SELECTBIO


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. 

Agenda Topics

    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

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