OverviewEnsuring 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 OpportunitiesManinderjit Singh, Exhibition Manager mjsingh@selectbio.com 7696225050
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Distinguished FacultyElayaraja Natarajan, Associate Director – Quality Assurance and Formulation Development, Rubicon Research Pvt Ltd Radhika Inapakolla, Asst. Director, Lupin Limited J Ramniwas, CEO & Managing Consultant, Sai Pharma Solutions Inc Ravindra Bhavsar, CEO & Managing Director, Pharmadesk Solutions Pvt Ltd Arun Bhatt, Consultant, Clinical Research & Development Mita Nandy, Consultant, Central Drugs Standard Control Organization Diego Herrera, Head of Global Data Management and Project Information, Almirall S.A. Vimal Sachdeva, Lead Inspector (Technical Officer), World Health Organization Vimal Sachdeva, Lead Inspector (Technical Officer), World Health Organization Sanjay Bajaj, Managing Director, Select Biosciences India Pvt Ltd Sanjay Bajaj, MD, Select Biosciences India Pvt Ltd Ashish Mungantiwar, President, Macleods Pharmaceuticals Ltd Ashish Mungantiwar, President, Macleods Pharmaceuticals Ltd Anil Pareek, President, Ipca Laboratories Ltd Umesh Banakar, Professor and President, Banakar Consulting Services Ramakrishna Bangaru, Sr. Vice President, Mylan Laboratories Amer Alghabban, Vice President, Karyopharm Therapeutics Bobby George, Vice President & Head Regulatory Affairs, Reliance Life Sciences Pvt Ltd
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