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SELECTBIO Conferences Quality, Compliance & Audit in Clinical Trials

Quality, Compliance & Audit in Clinical Trials

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


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. 

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:
    • 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

Confirmed Speakers to date

Amer Alghabban, Vice President, Karyopharm Therapeutics
Sanjay Bajaj, MD, Select Biosciences India Pvt Ltd
Sanjay Bajaj, Managing Director, Select Biosciences India Pvt Ltd
Umesh Banakar, Professor and President, Banakar Consulting Services
Ramakrishna Bangaru, Sr. Vice President, Mylan Laboratories
Arun Bhatt, Consultant, Clinical Research & Development
Ravindra Bhavsar, CEO & Managing Director, Pharmadesk Solutions Pvt Ltd
Bobby George, Vice President & Head Regulatory Affairs, Reliance Life Sciences Pvt Ltd
Diego Herrera, Head of Global Data Management and Project Information, Almirall S.A.
Radhika Inapakolla, Asst. Director, Lupin Limited
Ashish Mungantiwar, President, Macleods Pharmaceuticals Ltd
Mita Nandy, Consultant, Central Drugs Standard Control Organization
Elayaraja Natarajan, Associate Director – Quality Assurance and Formulation Development, Rubicon Research Pvt Ltd
Anil Pareek, President, Ipca Laboratories Ltd
J Ramniwas, CEO & Managing Consultant, Sai Pharma Solutions Inc
Vimal Sachdeva, Lead Inspector (Technical Officer), World Health Organization

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

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