| Date : August 19-20, 2010 | | | | Operations, Asia Pacific, ICON Clinical Research |
| Venue : Taj Residency (M.G. Road), Bangalore, | | | | * Marcus Hompesch, President – CEO, Profil |
| India | | | | Institute - Clinical Research, (USA) |
| Clinical trials in India are finally becoming | | | | * Milind Antani, Head-Pharma LifeSciences group, |
| transparent. There has been a dramatic increase | | | | Nishith Desai Associates |
| in the number of trials that have got officially | | | | * Sanjay Zodpey, Director, Indian Institute of |
| registered in Clinical Trials Registry-India (CTRI). | | | | Public Health |
| According to records collected by the Indian | | | | * Darshan Bhatt, Consultant, Patient Safety and |
| Council of Medical Research and the Drug | | | | Pharmacovigilance |
| Controller General's office, between | | | | * Mala Srivastava, Partner, Nextvel Consulting |
| July-December 2007, only 11 trials were | | | | * R Ezhil Arasan, Managing Director, VRE |
| registered. The number increased to 137 between | | | | Research Laboratories (Former Head of Medical |
| Jan-Dec 2008 and then to an all-time high of 546 | | | | Affairs & Differentiated Products |
| between Jan-Dec 2009. This year, while January | | | | Development at Dr.Reddy's) |
| saw 58 trials registered, February recorded 60. | | | | Key Themes Discussed at this Summit: |
| India has all the competitive advantages for | | | | * Current trends of clinical trials environment |
| conducting clinical trials. As the country is | | | | * How can you take advantage of the global |
| increasingly becoming a favoured destination for | | | | market for clinical trials? |
| clinical trials, a gap analysis needs to be done to | | | | * Discovering technologies and strategies for |
| scale up all resources for clinical trials. This scale up | | | | successful clinical trial management |
| is essential for India to cope with the large global | | | | * Analyzing the successes and challenges of |
| clinical trial projects. It is no coincidence over the | | | | Phase I and Phase II clinical trials |
| last decade or more of economic liberalization, and | | | | * Setting up clinical trial research hub & |
| years of unprecedented growth, that India and | | | | techniques for applying risk management principles. |
| parts of South Asia are becoming a preferred | | | | * Discover how to improve your supplier-client |
| clinical research destination for multinational | | | | relationships |
| pharmaceutical and biotechnology corporations. | | | | * Complete trials on schedule & budget by |
| Conference Agenda | | | | overcoming hurdles in investigator/patient |
| CTAS 2010 will examine the current issues faced | | | | recruitment |
| in clinical trials operations, addressing the risks, | | | | * Avoiding potential pitfalls of trials agreement |
| timeline and budget stipulations, while effectively | | | | * Gather the latest regulatory updates impacting |
| tackling key challenges in overcoming trials | | | | global and Indian clinical development |
| agreement and site contract arbitration problems. | | | | * Explore innovative strategies for outsourcing, |
| This summit will discuss the operational element of | | | | what should you be looking for in a CRO? |
| trial site management, strategic partnership with | | | | * Improving and optimizing site management and |
| CROs and SMOs, patient, talent & | | | | overall productivity of clinical operations |
| investigators management in order to improve | | | | * Data management, CMC SCM, operational |
| & optimise the overall drug development | | | | requirements & CRO infrastructure in India |
| effectiveness and ROI. Discover on how to | | | | & South Asia |
| implement and benefit from electronic data | | | | * Optimising clinical trials operation effectiveness |
| management & monitoring cost effectively. | | | | and ROI through strategic site, patient, data and |
| This conference will be shared by leading industrial | | | | risk management in the regulated markets |
| practitioners across the region to promote | | | | * What are the issues with off-shoring trials to |
| practical discussions; especially on the know-how | | | | countries such as India & South Asia? – |
| to manage needs, variability of different countries | | | | Solutions? |
| and institutions to enhance clinical operational | | | | * Working with limited budget to ensure on time |
| excellence and vigilance. Attendees will have the | | | | study completion |
| chance to learn, network and benchmark against | | | | * Motivating and managing clinical project teams |
| the global top pharmas and local industry leaders | | | | to improve timeline and progress |
| on the best practices in talent, site, budget and | | | | * Exploring the efficacy and safety of new |
| performance management in clinical trials. The | | | | interventions in clinical trials |
| conference aims to provide a detailed analysis of | | | | * Drawing and retaining clinical talent pool to |
| what it takes to conduct clinical trials from a | | | | minimise turnover in clinical studies |
| biopharmaceuticals and vaccines perspective in | | | | * Next generation of clinical trials – How big will |
| India and China and also addressing risk/benefit | | | | the market be? |
| balance, anecdotal experiences of the multinational | | | | Who Should Attend: |
| pharmaceutical industry in India and China, | | | | Vice Presidents, Directors Heads & Managers |
| selection and role of CROs, logistics of operations, | | | | of: |
| clinical trials management, government policies and | | | | * Clinical Research & Development |
| pharmacovigilance. | | | | * Clinical Research Services |
| CTAS 2010 will provide you with the data that | | | | * Clinical Operations |
| you need to recognize this complex and | | | | * Clinical Data Management |
| rapidly-expanding sector. Knowing the future | | | | * Clinical IT |
| market, and what impact will that have on future | | | | * Clinical Trials |
| business opportunities? This is your opportunity to | | | | * Medical Affairs |
| stay ahead by learning the latest trends and | | | | * Regulatory Affairs |
| networking with the trend setters. | | | | * Compliance |
| It gives us immense pleasure in welcoming you to | | | | * Quality Control/Assurance/GCP |
| the Clinical Trials Asia Summit '2010. | | | | * Clinical Study Design |
| Key Speakers Include: | | | | * Safety Surveillance |
| * Akhilesh Sharma, Vice President & Global | | | | * Subject Recruitment |
| head Clinical management & Global | | | | * E-Clinical Systems |
| Pharmacovigilance, Dr. Reddy's | | | | Target Audience: |
| * Bakulesh Khamar, Executive Director – | | | | * Pharmaceutical Organisations |
| Research, Cadila | | | | * Generic pharmaceutical companies |
| * Shailesh Mehta, Director Clinical R&D and | | | | * Contract Research Organisations |
| Med Affairs, South Asia, Glaxosmithkline | | | | * Patient Recruitment Companies |
| * S.K.Bhattacharya, Medical Officer, Depart of | | | | * Government- Department of Health |
| Communicable Diseases, WHO (World Health | | | | * Non-profit Organisations/Association |
| Organisation) | | | | * Academics |
| * Shashidhar Rao, India Operations Head (IID and | | | | * Consultants |
| IA&R), Novartis | | | | Why Should you Attend: |
| * Deven Parmar, Vice President - Clinical Research | | | | Clinical Trials Asia Summit 2010 - "Improving clinical |
| & Pharamacovigilance, Wockhardt | | | | practice & trial success rates with improved |
| * Mohan Bangalore , Senior Director & Site | | | | technologies, strategies & alliance |
| Head, Pfizer | | | | management" |
| * Arun Bhatt, President, Clininvent Research | | | | Get more from the event, with a broader scope |
| * Yamin 'Mo' Khan, Executive Vice President, | | | | bringing the whole communications value chain |
| Clinical Development, Pharma-Olam (U.K) | | | | together. Enjoy and make the best out of our |
| * Parminder Kaur, Managing Director, RegPak | | | | dedicated networking drinks time, meet the |
| BioPharma Consulting, (Netherlands) | | | | leading international vendorsExpand your |
| * Deepti Sanghavi, Medical Advisor - Clinicla | | | | knowledge of the latest business models and |
| Research, Wockhardt Limited | | | | technologies in the high-level conference. |
| * Roopa Basrur, Associate Director - Clinical | | | | showcasing the technology of tomorrow in the |
| Writing and Document Quality, Pfizer | | | | co-located exhibition. |
| * Larisa Nagra Singh, Senior Director Clinical | | | | |