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Conference Booking Details: Early Bird Discounted Price - Conference Delegate Pass (INR 4,000 + Tax (10.3%) per delegate) - Book and Pay before 10th January 2012 to avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: + 91 44 64536444. Email – delegate@virtueinsight.com Standard Price after 10th January 2012- Conference Delegate Pass (INR 6,000 + Tax (10.3%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: + 91 44 64536444. Email – delegate@virtueinsight.com Group Discounts - 2 or 3 Delegates - (INR 5,000 + Tax (10.3%) per delegate) Group Discounts - 4 and above Delegates - (INR 4,000 + Tax (10.3%) per delegate) Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibiton Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to –TEL: + 91 44 64536444. Email - sponsor@virtueinsight.com 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:
Key Speakers Include:
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:
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. |
08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.
09:30 – Chairperson opening remarks
Viraj Rajadhyaksha, Associate Director, Medical Affairs and Prayas initiatives, Sanofi Aventis
09:40–Morning Keynote Address: – New trends in global clinical trials and the role in India
- Overview of Indian healthcare and clinical trial system
- Development strategy design, regulatory, clinical and market considerations
- An overview of Indian CRO industry and CRO selection options
- Clinical development activities and managing clinical development in Asia
- Managing clinical trials : Patient recruitment and patient retention
- What is new in clinical safety monitoring and reporting?
Arun Bhatt, President, Clininvent Research
10:20 – Challenges facing Investigators and Sponsors/CRO for successful patient recruitment and retention
Rakesh Chugh, DGM - International Clinical Research, Wockhardt
10:50 – Morning coffee & Discussion
11:10 – Panel Discussion: Growing challenges & opportunities of clinical trial in India
- Exploring therapeutic-specific and phase-specific clinical development opportunities in the Asia
- Evaluating the economics of conducting clinical development in the Asia
- Challenges of clinical trial product development during phase 1-4: An Indian Perspective
- Enhancing investigator and patients relationship to ensure a successful trial
- How to manage risks in clinical trials effectively and how to successfully incorporate risk sharing models in clinical trials
Moderator:
Deven Parmar, Vice President - Global Clinical Research, Wockhardt
Panellists:
Viraj Rajadhyaksha, Associate Director, Medical Affairs and Prayas initiatives, Sanofi Aventis
R. H. Jani, Senior Vice President, Clinical R&D, Cadila Healthcare
Ammar Raza, Head-Medical Affairs, Novartis Healthcare - Vaccines Division
11:50 – Risk based approach to monitoring
- Onsite and remote monitoring approaches
- Recurrent risks and mitigation through monitoring
- Quality-by-design
Swapnali A Raut, Head of Monitoring, Pfizer
12:20 - Contemporary challenges and evolution in clinical research
R. H. Jani, Senior Vice President, Clinical R&D, Cadila Healthcare
12:50 – Networking Luncheon:
Afternoon chair person
Deepti Sanghavi, Senior Medical Writer, SiroClinPharm
14:20 – Afternoon Keynote - Panel Discussion - Relationships: Sponsor – Site - CRO
- An effective three-way relationship between sponsors, sites and CROs - Realistic expectations, clear communications, shared understandings, practical policies, and efficient problem resolution
- Identifying the awaited advantages of a collaborative clinical trial alliance for superior efficiency and cost reduction
- Quantitative evaluation reveals rapid changes in the industry and trends for the future. How can sponsors, sites and CROs meet the challenges?
- How to source the right partners, sponsor, vendor partnerships and avoiding mistakes in selecting an outsourcing partner to conduct clinical trials
- Analysing the present opportunities for indian CRO's to invest in early stage drug discovery or biotechnology start-ups
Moderator:
Suresh Maroli, Head Clinical Pharmacology, Reliance Life Sciences
Panellists:
Anish Desai, Director Medical Affairs and Clinical Operations, Johnson & Johnson Medical India
Subhashri Shivkumar, Hub Unit Director Regional Clinical Operations, Bristol-Myers Squibb
Goutam Pujari, Vice President and Head Global Clinical Research Operations, Glenmark Pharmaceuticals
Arani Chatterjee, Vice President, Clinical Research, Panacea Biotec
Narendra Maharaj, Associate Vice President, Tata Consultancy Services
15:00 – Clinical Research in Practice
- Clinical development and operations
- PI - Principal Investigator or Pure Implementer?
- In India for India, Asia and the World
- Comparative effectiveness research
- GCP and GCRP
Viraj Suvarna, Medical Director, Boehringer Ingelheim
15:30 – Afternoon Coffee & Discussion
15:50 – Clinical Trial Applications and Voluntary Harmonisation Program in EU
Delphine Decker, Director, Drugs & Biologics, Voisin Consulting Life Sciences (France)
16:20 - Panel Discussion: Update yourself towards guidelines and regulations in the Indian clinical trial market.
- Regulatory review at the Drugs Controller General of India (DCGI) and Central Drugs Standard Control Organization (CDSCO): science, quality, and speed.
- Assessing the current regulatory environment, infrastructure built up and talent availability in India to determine your clinical trial strategies
- Identifying the main challenges in regulatory for the global expansion in clinical trial.
- In the clinical trial environment implementation – Implementing right global strategies at the right time?
- How to efficiently work with regulatory agencies to ensure successful and timely approvals
- Understanding the recent changes and new developments in clinical trial, across Asia
- An overview of current regulatory challenges in Asia and how it can be overcome
Moderator:
Milind Antani, Head-Pharma LifeSciences group, Nishith Desai Associates
Panellists:
Premnath Shenoy, Director-Regulatory Affairs, AstraZeneca
Yasmin Shenoy, Director-Regulatory Affairs, Sanofi Aventis
Ramakrishnan Sundaram, GRS Director, Bristol-Myers Squibb
D. Roy, Deputy Drugs Controller (India), CDSCO - North Zone (Central Drug Standard Control Organisation)
17:00 - Chairperson’s closing remarks
Deepti Sanghavi, Senior Medical Writer, SiroClinPharm
17:10 – 18:00 – Networking Drinks
Organized By
Virtue Insight
Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.
Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.
Associate Partner
ByteMindz
We, The ByteMindz an emerging company incorporated with an aim of providing business solutions across Web Designing, Web Application Development, Software Development and Multimedia Services inclusive of various value-added services. We work on a diverse product line of services which are developed compatible for various frameworks, providing a complete project design and development using our high standard technical team.
We believe not only to produce exceptional in-house application we focus also on enhancing the commercial values for the customer end user applications. We extend our power of imagination across various verticals of IT services making the customer highly satisfied by providing an individual attention to each and every customer irrespective of the high, medium & large scale of organization.
Our Value Added service includes the service apart from our core standard service, we give a valuable testing unit and a complete support from our back end .We would like to hear from the customer periodically and we monitor our growth based on the customer quotes & comments and work hard on fixing those reported problems and include the fixes in our library based on the system designs and code compatible requirements. For more information log on to www.bytemindz.com
Bronze Partner
Oncquest Laboratories
Supported By
Pharmaphorum
Kongposh
KONGPOSH Publications are one of the leading Pharma publishers of India. The Pharma Review is a bi-monthly journal, appropriately referred to as “THE UMBRELLA JOURNAL OF INDIAN PHARMA INDUSTRY. Covering articles on various fields of pharmacy including Clinical Trials, Biotechnology, Review/Research papers, Herbal Medicine and much more. Contributions received from Eminent pharma personalities from India as well as other countries which helps us to have a varied and rich content matter. The journal is Abstracted & Indexed in International Pharmaceutical Abstract & Chemical Abstract – USA, Index Copernicus – Poland & Ulrich's Journal Database - USA for the quality of its content. For details of our other publications visit our webite www.kppub.com
Sponsorship or exhibition is the best way to speed network with decision makers. The world leader speakers in our conferences attract niche delegates from all over the world. This would be a wonderful opportunity to reach the right audience and save money and time on all your other advertising gimmicks. To give you an advertising edge we constantly update the industry pioneers via emails/newsletters about the event and advertise the event via different forms of media.
For Sponsorship Opportunities for Europe conferences, Contact – sponsor.uk@virtueinsight.com
For Sponsorship Opportunities for Indian conferences, Contact – sponsor@virtueinsight.com
Our potent conference agenda delivering the latest information and the world class leaders as speakers attract delegates to attend from around the world. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.
To book a Delegate Place, for Europe conferences, Contact – delegate.uk@virtueinsight.com
To book a Delegate Place, for Indian conferences, Contact – delegate@virtueinsight.com
JAIC Asia Bio Network
JAIC Asia Bio Network (JABN) is an on-line service platform which provides information sharing and business collaboration opportunities to enhance the biomedical business ties between Japan and Asia. JABN Japanese site provides industry news, company and product information, business partnering opportunities in Japanese with a focus on overseas market, whereas the English site provides similar information in English with a focus more on Japanese market. We also provide customized consulting services to meet specific needs. Please visit http://www.apbiotech-japan.com or send email to sales@apbiotech-japan.com for enquiry.
Innovaro Pharmalicensing
Innovaro Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide.
Actively supporting all forms of partnering and in- and out-licensing activities, Innovaro Pharmalicensing utilizes the unique Partnering Search service and its global network of industry experts to enable companies to identify and engage with appropriate partners around the world.
Innovaro Pharmalicensing, and its sister service Innovaro Medical Device Licensing (www.medicaldevicelicensingcom) are actively utilized by over 200,000 industry professionals each month. Innovaro Pharmalicensing is part of Innovaro Inc, listed on AMEX (INV).
Pharma Focus Asia
Pharma Focus Asia is a bi-annual magazine from Ochre Media Pvt. Ltd. Pharma Focus Asia covers important issues and trends shaping the future of the Pharma industry across Asia and rest of the world. It is the leading Pharma title in print as well as digital versions serving the information needs of key executives from the world’s leading pharmaceutical companies.
Best Web Design Agencies
CR Network
Great administration of entire programme session by session, pleasant surprise is that 95% of speakers as planned turned up
Excellent Organisation and facilities
Conference was informative, a great opportunity to converse and interact with esteemed and prominent delegates and speakers from renowned organisations. Being a trainee it helped me out in understanding CR industry diversely and scenario globally
This is a really well managed, informative, interactive and learning event also allowing us to network together and its absolute a value for money. I wish them the “All is The Best”. Keep up the “GOOD SHOW”
Very Insightful....
Delphine Decker, Voisin Consulting Life Sciences Swapnali Raut, Pfizer Limited Viraj Suvarna, Boehringer Ingelheim India Pvt Ltd Rakesh Chugh, Wockhardt Ltd Rajendra H Jani, Zydus Cadila Sponsorship or exhibition is the best way to speed network with decision makers. The world leader speakers in our conferences attract niche delegates from all over the world. This would be a wonderful opportunity to reach the right audience and save money and time on all your other advertising gimmicks.
To give you an advertising edge we constantly update the industry pioneers via emails/newsletters about the event and advertise the event via different forms of media.
For Sponsorship Opportunities, India - sponsor@virtueinsight.com United Kingdom - sponsor.uk@virtueinsight.com
Our potent conference agenda delivering the latest information and the world class leaders as speakers attract delegates to attend from around the world. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.
To book a Delegate Place, India - delegate@virtueinsight.com United Kingdom - delegate.uk@virtueinsight.com