About

5th Annual Clinical Trials Summit 2014

"A critical guide for successfully conducting clinical trials”

10th & 11th June 2014, Kohinoor Continental Hotel, Mumbai, India


Day 1 (10th June)  – Workshop

Workshop Title - Clinical Trials in India in 2020

•     Analysing the US/EU Landscape in 2014 and find out on how customers in India can relate to what is happening elsewhere
•     How can Indian market benefit from this
•     The Indian Regulatory Environment – Including Vision for Indian R&D Community
•     Updates on Protocol Design / Complexity
•     Risk-based Monitoring
•     Clinical Trial Supply Chain Optimization
•     Transforming Indian R&D in 2014

Workshop Leader from Medidata (UK)


Day 2 (11th June)  – Conference

Key Themes Discussed at this Summit:
•     Overview of Indian healthcare and clinical trial system towards 2015
•     Analysing the recent government rules and guidelines
•     Discovering the new trends in global clinical trials and their role in India
•     Technologies that drive efficiencies in global clinical trials
•     Strategies to conduct successful interventional oncology trials in India
•     Updates on design of clinical drug
•     What are the expectations of regulatory authorities and what type of regulatory structure does India currently have?
•     Overcoming challenges faced in regulatory approval processes – obtaining drug/ clinical supplies import and export licenses in Asia
•     Regulatory review at the drugs controller general of India (DCGI) and central drugs standard control organization (CDSCO): science, quality, and speed
•     Effectively incorporating GCP & GCPs – Knowing what TO-DO and what NOT TO-DO
•     Adapting to India’s transformed regulatory landscapes to conduct clinical trials
•     Re-Thinking patient recruitment and patient experience
•     Finding the ideal partner in outsourcing your logistics operations in India how to identify smart packaging solutions to balance quality and costs
•     Identifying the decision criteria for partnering with the right vendors in Asia
•     How to manage risks in clinical trials effectively and how to successfully incorporate risk sharing models in clinical trials
•     Finding the right clinical trial supply chain model to optimize the costs
•     Avoiding mistakes in data collection and ensuring profitability and to understand the long term operation strategies for managing clinical trials.
•     Understanding new e-clinical technologies to improve data quality and optimise clinical outcomes
•     Next generation of clinical trials – How big will the market be?

Key Speakers:
•     Arun Bhatt, President, Clininvent Research
•     Bhavesh Kotak, Vice President, Astrazeneca
•     Sofi Joseph, Head – Regulatory Operations, Pfizer
•     Bhaswat Chakraborty, Senior VP & Chair, Research & Development Core Committee, Cadila Pharmaceuticals
•     Chirag Trivedi, Associate Director - Project Management & Strategic Initiatives, Sanofi
•     Ravisekhar Kasibhatta, Vice President – Clinical Research, Lupin
•     Kedar Suvarnapathaki, Head - Regulatory Affairs, Boehringer Ingelheim
•     Mubarak Naqvi, Senior Director & Head, Clinical Study Unit, Sanofi
•     Suresh Maroli, Head Clinical Pharmacology, Reliance Life Sciences
•     Ashwani Pandita, Head Quality Management & Training, Glenmark
•     Saji Vijayan, Head – Clinical Endpoint & Manager-Clinical Trials, Lupin
•     Sujay Salvi, Head, CTSM, SIRO Clinpharm
•     Prashant Bodhe, Associate Director, Quintiles Research
•     Deepti Sanghavi, Senior Medical Writer-Medical Writing, SIRO Clinpharm
•     Amey Mane, DGM-Medical Affairs, Wockhardt
Plus Many More...
Who Should Attend:
CEO's, CTO's, CIO's, Presidents, Vice Presidents, Directors Heads & Managers of:
Clinical Research & Development, Clinical Research Services, Clinical Operations, Clinical Data Management, Clinical IT, Clinical Trials, Medical Affairs, Regulatory Affairs, Compliance, Quality control / Assurance/GCP, Clinical Study Design, Safety Surveillance, Subject Recruitment, E-Clinical Systems.

Why Should You Attend:

5th Annual Clinical Trials Summit 2014 -“A critical guide for successfully conducting clinical trials” Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking drinks time, meet the leading international vendors expand your knowledge of the latest business models and strategies in the high-level conference. Show casing the products of tomorrow in the co-located exhibition.

Conference Booking Details:
For Standard Price, Group Discounts, Spot Registration on the day of the Conference, Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to –TEL: + 91 7401150416. Email – nisha@virtueinsight.net