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SELECTBIO Conferences CRO/Sponsor Summit on Data Integrity, "Quality, Compliance & Audit in Clinical Trials"

CRO/Sponsor Summit on Data Integrity, "Quality, Compliance & Audit in Clinical Trials"

Date: Thursday, 12 April 2018 - Friday, 13 April 2018
Location: Mumbai


Overview

Ensuring integrity of the clinical data generated for regulatory submissions is a major challenge today for both the Clinical Research Organizations (CROs) as well as the Sponsors Pharmaceutical Organizations. 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 quality in clinical studies. 

After successfully bringing together both CROs and Sponsors at a single platform in Hyderabad, and Mumbai, SELECTBIO is pleased to present the third edition of CRO/Sponsor Summit on Data Integrity, "Quality, Compliance & Audit in Clinical Trials" on April 12-13, 2018 in Mumbai. 

The theme for the deliberations will be "Quality Compliance & Audit in Clinical Trials". This event will address best 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. 

Delegate Profile: President, Vice-President, Director, Managers and Scientist from CRO or Pharmaceutical Company from the following departments.

Sponsor/Pharma Organizations - Formulation Development, Regulatory Affairs, Analytical/Bio-analytical Development, Quality Control, Quality Assurance, Investigator Site Management, Outsourcing Management, Auditors

CRO/Clinical Trials Organizations -  Clinical Research and Development, Analytical Method Development, IT & Data management, Pharmacovigilance, Medical Affairs R&D and Strategic issues, Business Development  

Sponsorship: Sponsorship Opportunities are also available for CROs and Pharma Companies. For details, please contact the Exhibition Manager. 

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 January 2018

Agenda Topics

  • Bioethics and Regulatory Compliance
  • CRO-Sponsor Collaboration: Expectations and Challenges
  • eCTD with CDISC: Regulatory Requirements
  • GCP/GLP & Other Requirements for CT/BE Studies
  • IT Compliance – 21 CFR Part 11
  • Management of Regulatory Audits
  • Panel Discussion Topics:
    • Data Fraud in Clinical Research: Detection, Prevention and its Solution
    • Overcoming Challenges of Volunteer Cross Participation
  • Quality Assurance Programme in Clinical Studies
  • Risk Mitigation Programme in CRO
  • Root Cause Investigation of Data Integrity Issues
  • Software Validation/Qualification in CT Studies
  • USFDA Warning Letters – How to Respond?

Sponsorship and Exhibition Opportunities

Maninderjit Singh, Exhibition Manager
mjsingh@selectbio.com
7696225050


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Add to Calendar ▼2018-04-12 00:00:002018-04-13 00:00:00Europe/LondonCRO/Sponsor Summit on Data Integrity, "Quality, Compliance and Audit in Clinical Trials"CRO/Sponsor Summit on Data Integrity, "Quality, Compliance and Audit in Clinical Trials" in MumbaiMumbaiSELECTBIOenquiries@selectbiosciences.com