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SELECTBIO Conferences Issues and Challenges in Clinical Studies - A CRO/Sponsor Summit

Issues and Challenges in Clinical Studies - A CRO/Sponsor Summit

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


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 Clinical Research related conference entitle "Issues and Challenges in Clinical Studies - A CRO/Sponsor Summit" in April 2018 in Mumbai. 

The theme for the deliberations will be "Best Practices for Successful Clinical Studies". 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

  • 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 Data Integrity Issues
  • Software Validation/Qualification in CT Studies
  • Sponsors' Perspective on Data Integrity Issues
  • Volunteer Cross Participation - Challanges & Solutions
  • Whistle Blowing Mechanism - Understanding and Managing

Sponsorship and Exhibition Opportunities

Maninderjit Singh, Exhibition Manager

Corporate Sponsors Media Sponsors Official Journal Partner Networking
Drug Discovery WoMetaTagsrld U-Networks

Agenda is not currently available
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