Clinical Research Organizations (CRO)/Sponsor Summit is organized by Select Biosciences India Pvt. Ltd. and will be held from May 23 - 24, 2019 at Sheraton Hyderabad Hotel, Hyderabad, Telengana, India.
Ensuring the quality 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 three successful CRO/Sponsor Summits, Select Biosciences India is pleased to present its fourth edition of CRO/Sponsor Summit on the theme, "Building Quality in Clinical Trials" on May 23-24, 2019 in Hyderabad.
This event will address best practices followed by CROs and Sponsors for regulatory success in Clinical studies. We thank all the Speakers from WHO, CDSCO, Pharma Industry, and CRO Companies and 100+ participants of last year event and look forward to similar participation this year as well.
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.
For details regarding speakers and presentation at the conference please write to Ms Pooja Sharma, for any queries at Email: firstname.lastname@example.org or Call: +91 7696325050.
• Building Strong CRO-Sponsor Collaboration
• GCP/GLP in CT/BE Studies
• IT Compliance and Infrastructure Quality
○ 21 CFR Part 11
• Regulatory Audits - How to Manage?
• Regulatory Requirements and Compliance
○ eCTD with CDISC
• Risk Assessment & Management
• Robust Quality Assurance Program
• Root Cause Investigation for Data Quality
• Warning Letters - How to Reply?
Call for Papers
If you would like to be considered for an oral presentation at this meeting, Submit an abstract for review now!
Oral Submission Deadline: 31st Dec 2018
Exhibition & Registration
Cell: 7696125050, 7696525050
Overseas Industry Scientist $ 600
Overseas Business Delegate $ 800
|Contact No. :||7696125050
March 31, 2019
|Registration Type||Due Date||Price|
|Indian Business Delegate Fee||23 May,2019||INR 25000.00|
|Indian Industry Scientist Fee||23 May,2019||INR 18000.00|