Conference Introduction:

After the successful journey of 1st and 2nd Annual Clinical Trial 2010 & 2011, Virtue Insight is proud to announce its 3rd Annual Clinical Trial Asia Summit 2012 in India.

The Indian pharmaceutical industry is the world's second-largest by volume and is likely to lead the manufacturing sector of India. Clinical research in India has grown at an unprecedented rate in the last few years opening many new opportunities. Also India is ranked as the third largest emerging market and is growing fastest in conducting number of trials. India is now emerging new destination for global pharma companies and will be a favoured country for placing clinical trials; this will bring new challenges in Indian clinical scene.

The clinical trial industry in India is undergoing a positive metamorphosis. It is gradually being viewed as a drug discovery rather than a mere drug development destination, with more companies looking at innovation. Global sourcing of drugs/vaccines is from India and India is making a global contribution. India offers a suitable population for clinical trials because of its diverse gene pools covering a large number of diseases. Due to the rising costs of R&D abroad, many global companies are looking for contract research in India especially US and European companies. In terms of cost efficiency India is better, as the cost of conducting a trial here is lower by 50-60% than in the United States or the European Union. While lower costs has been a crucial factor in making India an attractive destination for global companies looking to conduct large-scale trials, there are other factors like skilled and knowledgeable investigators and expertise, increased compliance towards quality issues, a large patient pool and unmet medical needs of the population also help to lure foreign companies.

Global clinical trial services revenues will touch $32.73 billion in 2015, with India and China becoming the major destinations for outsourcing of drug development by leading pharmaceutical firms. According to a report, off shoring clinical trials to emerging markets, particularly India and China, will create revenue growth for global CROs. The clinical trial outsourced market in India is forecasted to grow at a compound annual growth rate( CAGR) of around 31% during 2010-2012.

Presently, the market is characterized by the dominance of phase III and phase II trials, which currently hold more than 80% of the market. A study says that by 2020, India is expected to surface amongst the Top 5 global markets for pharmaceutical products by the increased consumer spending on drugs and enormous domestic demand. Indian pharma industry expected to emerge amongst the Top 5 by 2020. Moreover, India is expected to join the league of top 10 global pharmaceuticals markets in terms of sales by 2020 with the total value reaching US$ 50 billion Indian pharmaceutical market is predicted to grow to US$ 55 billion by 2020 from US$ 12.6 billion in 2011. The drugs and pharmaceuticals sector attracted foreign direct investment (FDI) worth US$ 2,942 million between April to May 2011-12, there are 169 FDA approved plants in India and the pharma sector has been growing at the rate of 14% per annum.

3nd Annual Clinical Trials Asia Summit 2012 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. 3nd Annual Clinical Trials Asia Summit 2012 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 3rd Annual Clinical Trials Asia Summit 2012.

Key Themes Discussed:-

• Overview of Indian healthcare and clinical trial system towards 2013


• Discovering the new trends in global clinical trials and their role in India


• Strategies to conduct successful interventional oncology trials in India


• 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


• How to achieve open and effective outsourcing partnerships


• How to Identify smart packaging solutions to balance quality and costs


• Identifying the decision criteria for partnering with the right vendors in Asia


• Identifying the main challenges to secure and increase global drug supply in the public sector


• How to manage risks in clinical trials effectively and how to successfully incorporate risk sharing models in clinical trials


• Extended Information for accelerating patient recruitment & retention in clinical trials.


• Finding the right clinical trial supply chain model to optimize the costs


• How to avoid 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 Include:

• Arun Bhatt, President, Clininvent Research


• Deven Parmar, Vice President - Global Clinical Research,  Wockhardt


• Arani Chatterjee, Senior Vice President, Clinical Research, Panacea Biotec


• D. Roy, Deputy Drugs Controller (India), CDSCO - North Zone (Central Drug Standard Control Organisation)


• Viraj Rajadhyaksha, Associate Director, Medical Affairs and Prayas initiatives, Sanofi Aventis


• R. H. Jani, Senior Vice President, Clinical R&D, Cadila Healthcare


• Swapnali A Raut, Head of Monitoring, Pfizer


• Suresh Maroli, Head Clinical Pharmacology, Reliance Life Sciences


• Narendra Maharaj, Associate Vice President, Tata Consultancy Services


• Delphine Decker, Director, Drugs & Biologics, Voisin Consulting Life Sciences (France)


• Subhashri Shivkumar, Hub Unit Director Regional Clinical Operations, Bristol-Myers Squibb


• Viraj Suvarna, Medical Director, Boehringer Ingelheim


• Goutam Pujari, Vice President and Head Global Clinical Research Operations, Glenmark Pharmaceuticals 


• Ammar Raza, Head-Medical Affairs, Novartis Healthcare - Vaccines Division 


• Ramakrishnan Sundaram, GRS Director, Bristol-Myers Squibb


• Rakesh Chugh, DGM - International Clinical Research, Wockhardt


• Deepti Sanghavi, Senior Medical Writer, SiroClinPharm


• Anish Desai, Director Medical Affairs and Clinical Operations, Johnson & Johnson Medical India


• Premnath Shenoy, Director-Regulatory Affairs, AstraZeneca


• Yasmin Shenoy, Director-Regulatory Affairs, Sanofi Aventis


• Milind Antani, Head-Pharma LifeSciences  group, Nishith Desai Associates

 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.

Target Audiance-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:-

3rd Annual Clinical Trials Asia Summit -“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 vendorsExpand your knowledge of the latest business models and strategies in the high-level conference.showcasing the products of tomorrow in the co-located exhibition.