Conference on Clinical Trials Asia Summit 2010

Clinical trials in India are finally becoming transparent. ( There has been a dramatic increase in the number of trials that have got officially registered in Clinical Trials Registry-India (CTRI). According to records collected by the Indian Council of Medical Research and the Drug Controller General’s office, between July-December 2007, only 11 trials were registered. The number increased to 137 between Jan-Dec 2008 and then to an all-time high of 546 between Jan-Dec 2009. This year, while January saw 58 trials registered, February recorded 60. India has all the competitive advantages for conducting clinical trials. As the country is increasingly becoming a favoured destination for clinical trials, a gap analysis needs to be done to scale up all resources for clinical trials. This scale up is essential for India to cope with the large global clinical trial projects. It is no coincidence over the last decade or more of economic liberalization, and years of unprecedented growth, that India and parts of South Asia are becoming a preferred clinical research destination for multinational pharmaceutical and biotechnology corporations.

CTAS 2010 will examine the current issues faced in clinical trials operations, addressing the risks, timeline and budget stipulations, while effectively tackling key challenges in overcoming trials agreement and site contract arbitration problems. This summit will discuss the operational element of trial site management, strategic partnership with CROs and SMOs, patient, talent & investigators management in order to improve & optimise the overall drug development effectiveness and ROI. Discover on how to implement and benefit from electronic data management & monitoring cost effectively. This conference will be shared by leading industrial practitioners across the region to promote practical discussions; especially on the know-how to manage needs, variability of different countries and institutions to enhance clinical operational excellence and vigilance. Attendees will have the chance to learn, network and benchmark against the global top pharmas and local industry leaders on the best practices in talent, site, budget and performance management in clinical trials. The conference aims to provide a detailed analysis of what it takes to conduct clinical trials from a biopharmaceuticals and vaccines perspective in India and China and also addressing risk/benefit balance, anecdotal experiences of the multinational pharmaceutical industry in India and China, selection and role of CROs, logistics of operations, clinical trials management, government policies and pharmacovigilance.

CTAS 2010 will provide you with the data that you need to recognize this complex and rapidly-expanding sector. Knowing the future market, and what impact will that have on future business opportunities? This is your opportunity to stay ahead by learning the latest trends and networking with the trend setters. It gives us immense pleasure in welcoming you to the Clinical Trials Asia Summit ‘2010.

Key Speakers Include:

Akhilesh Sharma, Vice President & Global head Clinical management & Global Pharmacovigilance, Dr. Reddy’s, Bakulesh Khamar, Executive Director – Research Cadila, Deven Parmar Vice President – Clinical Research & Pharmacovigilance, Wockhardt, Shashidhar Rao, India Operations Head (IID and IA&R), Novartis, Mohan Bangalore, Senior Director & Site Head, Pfizer, Parminder Kaur, Managing Director, RegPak BioPharma, Consulting, (Netherlands), Ramesh Jagannathan, Director-Clinical Research, AstraZeneca, Deepti Sanghavi, Medical Advisor- Clinical Research, Wockhardt Limited, Arun Bhatt, President, Clininvent Research, Milind Antani, Head-Pharma LifeSciences group, Nishith Desai, Associates, Sanjay Zodpey, Director, Indian Institute of Public Health, S.K.Bhattacharya, Medical Officer, Depart of Communicable Diseases, WHO (World Health Organisation), Shailesh Mehta, Director Clinical R&D and Med Affairs, South Asia, Glaxosmithkline, Roopa Basrur, Associate Director – Clinical Writing and Document, Quality, Pfizer, Yamin ’Mo’ Khan, Executive Vice President, Clinical Development Pharma-Olam (U.K), Marcus Hompesch, President – CEO, Clinical Research, (USA), Larisa Nagra Singh, General Manager and Project Director, Voisin Consulting Life Science, Darshan Bhatt, Consultant, Patient Safety and Pharmacovigilance, Mala Srivastava, Partner, Nextvel Consulting, R Ezhil Arasan, Managing Director, VRE Research Laboratories, (Former Head of Medical Affairs & Differentiated Products, Development at Dr.Reddy’s)

Key Themes Discussed at this conference:

* Current trends of clinical trials environment. * How can you take advantage of the global market for clinical trials? * Discovering technologies and strategies for successful clinical trial management. * Analyzing the successes and challenges of Phase I and Phase II clinical trials. * Setting up clinical trial research hub & techniques for applying risk management principles. * Discover how to improve your supplier-client relationships. * Complete trials on schedule & budget by overcoming hurdles in investigator/patient recruitment. * Avoiding potential pitfalls of trials agreement. * Gather the latest regulatory updates impacting global and Indian clinical development. * Explore innovative strategies for outsourcing, what should you be looking for in a CRO? * Improving and optimizing site management and overall productivity of clinical operations. * Data management, CMC SCM, operational requirements & CRO infrastructure in India & South Asia. * Optimising clinical trials operation effectiveness and ROI through strategic site, patient, data and risk management in the regulated markets. * What are the issues with off-shoring trials to countries such as India & South Asia? – Solutions? * Working with limited budget to ensure on time study completion. * Motivating and managing clinical project teams to improve timeline and progress. * Exploring the efficacy and safety of new interventions in clinical trials. * Drawing and retaining clinical talent pool to minimise turnover in clinical studies. * Next generation of clinical trials – How big will the market be?

Who Should Attend:

* 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.

Target Audience – Industry:

* Pharmaceutical Organisations, * Generic pharmaceutical companies, * Contract Research Organisations , * Patient Recruitment Companies, * Government- Department of Health, * Non-profit Organisations/Association, * Academics, Consultants.

Why should you attend: Clinical Trials Asia Summit 2010 – “Improving clinical practice & trial success rates with improved technologies, strategies & alliance management”

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. showcasing the technology of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and technologies in the high-level conference.

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