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

CRO/Sponsor Summit on Data Integrity in Clinical Research

Guest of Honour

K Bangarurajan

K Bangarurajan
Deputy Drugs Controller, Central Drugs Standard Control Organisation (CDSCO)


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. 

Venue and Dates: The Orchid Hotel, Mumbai, India on March 02 -03, 2017.

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.      

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

Sponsorship and Exhibition Opportunities

Maninderjit Singh, Exhibition Manager

Distinguished Faculty

Manish S Yadav, CEO, ETHIXINN Consulting & Research Solutions
Ravindra Bhavsar, CEO & Managing Director, Pharmadesk Solutions Pvt Ltd
Arun Bhatt, Consultant, Clinical Research & Development
Prashant Bodhe, Consultant, CliniSearch
Bodo Lutz, Data Integrity Officer, Novartis
Prashant Pandya, General Manager, Reliance Life Sciences Pvt Ltd
Jayam Ravi, Global Compliance Head, Dr. Reddy's Laboratories Ltd
Diego Herrera, Head of Global Data Management and Project Information, Almirall S.A.
Shehnaz Vakharia, Managing Director, ADAMAS Consulting APAC
Chitra Bargaje, Principal Consultant, ADAMAS Clinical Quality Consulting Pvt Ltd
Umesh Banakar, Professor and President, Banakar Consulting Services
Bapuji Akula, Senior Vice President, Aurobindo Pharma
Ravisekhar Kasibhatta, Senior Vice President, Lupin Bioresearch Center
Stephanie Croft, Technical Officer Inspector, World Health Organization
Amer Alghabban, Vice President, Karyopharm Therapeutics
Ambrish Srivastava, Vice President, Alkem Labs Ltd

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