Pre Event Press Release of CRO/Sponsors Summit on Data Integrity in Clinical Research 2017
Sci Journo is official media partner for SELECTBIO’s 2nd International Conference on “CRO/Sponsors Summit on Data Integrity in Clinical Research” which is to be held on 2nd and 3rd March at The Orchid Hotel, Mumbai.
What is Data Integrity in Clinical Research?
The historical mishaps and the subsequent efforts aimed towards safe guarding the right and safety of human subjects in clinical trials have helped carve the much needed niche for “Data Integrity” in clinical
trials. Data integrity in generic terms can be defined as “maintaining and assuring the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data”.
Purpose of the conference:
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. For regulatory success both the CRO conducting the study and the Sponsors have to play a pivotal role in ensuring Data Integrity.
Delegates attending the conference:
President, Vice-President, Director, Managers and Scientist from CRO or Pharmaceutical Company from the departments like formulation development, quality assurance, quality control, outsourcing management, Clinical research and development, pharmacovigilance, medical affairs.
- Ravisekhar Kasibhatta, Senior Vice President, Lupin Bioresearch Center, India
- Ravindra Bhavsar, CEO & Managing Director, Pharmadesk Solutions Pvt Ltd, India
- Shehnaz Vakharia, Managing Director, ADAMAS Consulting APAC, India
- Diego Herrera, Head of Global Data Management and Project Information, Almirall S.A., Spain
- Bodo Lutz, Data Integrity Officer, Novartis, Germany
- Bapuji Akula, Senior Vice President, Aurobindo Pharma, India
- Jayam Ravi, Global Compliance Head, Dr. Reddy’s Laboratories Ltd, India
- Ambrish Srivastava, Vice President, Alkem Labs Ltd, India
- Arun Bhatt, Consultant, Clinical Research & Development, India
- Umesh Banakar, Professor and President, Banakar Consulting Services, United States of America
- Chitra Bargaje, Principal Consultant, ADAMAS Clinical Quality Consulting Pvt Ltd, Indi
- Manish S Yadav, CEO, ETHIXINN Consulting & Research Solutions, India
- Prashant Bodhe, Consultant, CliniSearch, India
- Stephanie Croft, Technical Officer Inspector, World Health Organization, Switzerland
- Prashant Pandya, General Manager, Reliance Life Sciences Pvt Ltd, India
- Amer Alghabban, Vice President, Karyopharm Therapeutics, Switzerland
SELECTBIO was established in 1999 and it is a provider of of global conferences to the biomedical and life science sectors. They also offer a managed events service from small workshops to international congresses. They have offices in the UK, USA, India and South East Asia, It is a leading provider of global conferences to the biomedical and life science sectors.
In 2010 Select Biosciences won the coveted Queen’s Award for Enterprise, acknowledging our eleven-fold growth in overseas sales over six years.