Shopping Cart (0)
My Account

Shopping Cart
SELECTBIO Conferences CRO/Sponsor Summit on Data Integrity in Clinical Research

CRO/Sponsor Summit on Data Integrity in Clinical Research

Keynote Speakers

Umesh Banakar
Professor and President, Banakar Consulting Services

Stephanie Croft
Technical Officer Inspector, World Health Organization


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. 

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

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 a platform for 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 from the following departments.

Sponsor/Pharma Organizations - Formulation Development, Regulatory Affairs, 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  

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

Distinguished Faculty

K Umamaheshwar, Chief Executive , AET Clinical Services Pvt Ltd
C N Ramchand, Chief Executive Officer, Saksin Lifesciences Pvt Ltd
K Senthilkumar, Chief Executive Officer, Spinos Life Science and Research Pvt Ltd
Marc E Brooks, Chief Executive Officer, Elderbrook Solutions GmbH
Rajendra M Prasad, Chief Executive Officer & Executive Director, Jeevan Scientific Technology Limited
Prashant Bodhe, Consultant, CliniSearch
Anders Fuglsang, Consultant and Founder, Fuglsang Pharma
Bodo Lutz, Data Integrity Officer, Novartis
Saral Thangam, Managing Director & CEO, Norwich Clinical Service
Ravisekhar Kasibhatta, Senior Vice President, Lupin Bioresearch Center
Arani Chatterjee, Senior Vice President, Biological E Limited
Bhaswat Chakraborty, Senior Vice President & Chairman, Cadila Pharmaceuticals
Chandra Sekhar, Vice President Quality, Reliance Life Sciences

Corporate SponsorsWeb SponsorsOffical Journal PartnerNetworking
Drug Discovery WorldU-Networks