CRO/Sponsor Summit on Data Integrity in Clinical Research
SELECTBIO, for the first time in India, will bring both CROs and Sponsors at a single platform at "CRO/Sponsors Summit on Data Integrity in Clinical Research" which is scheduled to be held on July 21-22, 2016 in Hotel Radisson HITEC City, Hyderabad, India.
Keynote Speakers
Umesh Banakar - Professor and President, Banakar Consulting Services
Overview
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.
The theme for the deliberations will be "Best Data Practices for Patient Safety & Regulatory Success".This event will address various issues and challenges faced as well as best data practices followed by CROs and Sponsors for regulatory success in conducting Bio- equivalence studies. This event will also provide select CROs to showcase their capabilities and help the sponsors to evaluate CROs for future business propositions.
Running alongside the conference will be an Exhibition covering the latest technological advances within the related fields. We look forward to welcoming you at the "CRO/Sponsor Summit on Data Integrity in Clinical Research" and Exhibition and hope that the days will be both informative and enjoyable.
Delegate Profile:
President, Vice-President, Director, Managers and Scientist from CRO or Pharmaceutical Company
Call for Papers:
If you would like to be considered for an oral presentation at this meeting, Submit an abstract for review now!
Oral Presentation Submission Deadline: 31 March 2016
Agenda Topics:
Computers, IT, Electronic Data Management & Archival Systems
Calibration, Validation, 21 CFR Part 11 compliance, Archival and Back up
CRO Audits-Vital Requirements & Audit Points
Case study, Issues, Suggestions and Solutions
Managing Unannounced Audits
CRO Showcase
CRO/Sponsor - Bridging Gaps
Elements of Master Service agreement
Roles, Responsibilities, BE-NOC Approvals
Ensuring Data Integrity in Clinical Study
Role of IT personnel in data integrity
Significance, Issues and Challenges
Training, Verification and Audits
Ensuring Successful BABE Studies in Light of Regulatory Requirements
Discriminatory dissolution profile benchmarking vis a vis BE response
Ensuring Pivotal BE study outcome while benchmarking Pilot BE study
Success rate of Pivotal BABE study
Evolving US/European Markets and CT/GCP Guidelines
Regulatory and QA Perspective in Pharma and Clinical Research
Indian CRO - Issues, Challenges and Possible Solutions
Regaining and Retaining Integrity
Volunteer Cross Participation
Sponsorship and Exhibition Opportunities:
Maninderjit Singh, Exhibition Manager
[email protected]
7696225050
Confirmed Speakers to date:
Marc E Brooks, Chief Executive Officer, Elderbrook Solutions GmbH
Bodo Lutz, Senior Manager, Sandoz International GmbH
