 |
|
||||
|
Conference Booking Details: Early Bird Discounted Price - Conference Delegate Pass (INR 04,000 + Tax (12.36%) per delegate) - Book and Pay before 30th June 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 30th June 2012 - Conference Delegate Pass (INR 06,000 + Tax (12.36%) 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 05,000 + Tax (12.36%) per delegate) Group Discounts - 4 and above Delegates - (INR 04,000 + Tax (12.36%) 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 Pharmacovigilance 2010 & 2011, Virtue Insight is proud to announce its 3rd Annual Pharmacovigilance 2012 in India. The Pharmaceutical industry in India is valued at Rs. 90,000 Crore and is growing at the rate of 12 – 14 % per annum. Exports are growing at 25 % Compound Annual Growth Rate (CAGR) every year. The total export of pharma products is to the extent of Rs. 40,000 Crore. India is now being recognized as the ‘Global pharmacy of Generic Drugs’ & has distinction of providing generic quality drugs at affordable cost. India is also emerging rapidly as a hub of Global Clinical trials & a destination for Drug Discovery & Development. Indian pharmaceutical industry is said to reach $20 billion by 2015, making it one of the world's top 10 pharmaceuticals markets. There is a surfeit of drug brands more than 6000 licensed drug manufactures and over 60,000 branded formulations. All medicines have potential risk as well as benefits. In 2011 India exported USD 10.3 billion worth of pharma products, registering 17.5 per cent growth over a year before. India's largest export destination for pharma products is still the USA, followed by the UK, Germany, South Africa and Russia. By 2020, the size of the global pharmaceutical market is anticipated to grow to USD 1.3 trillion, with the E7 countries -- Brazil, China, India, Indonesia, Mexico, Russia and Turkey The rapid induction in the market throws up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base. All medicines (pharmaceuticals and vaccines) have side effects. Some of these side effects are known, while many are still unknown even though that medicine has been in clinical use for several years. It is important to monitor both the known and hitherto unknown side effects of medicines in order to determine any new information available in relation to their safety profile. In a vast country like India with a population of over 1.2 Billion with vast ethnic variability, different disease prevalence patterns, practice of different systems of medicines, different socioeconomic status, it is important to have a standardized and robust pharmacovigilance and drug safety monitoring programe for the nation. Collecting this information in a systematic manner and analyzing the data to reach a meaningful conclusion on the continued use of these medicines. More clinical research activities being conducted in India, there is an immense need to understand the importance of pharmacovigilance and how it impacts the life cycle of the product. A good pharmacovigilance will easily identify the risk factors in the shortest time so that the harmful effects can be avoided or minimized. There are 2,000 deaths/year from unnecessary surgery; 7000 deaths/year from medication errors in hospitals; 20,000 deaths/year from other errors in hospitals; 80,000 deaths/year from infections in hospitals; 106,000 deaths/year from non-error, adverse effects of medications - these total up to 225,000 deaths per year in the US. Based on the findings of one major study, medical errors kill some 44,000 people in U.S. hospitals each year. Another study puts the number much higher, at 98,000. Even using the lower estimate, more people die from medical mistakes each year than from highway accidents, breast cancer, or AIDS. And deaths from medication errors that take place both in and out of hospitals are aid to be more than 7,000 annually. Pharmacovigilance 2012 will discuss the pressing concerns confronted with regard to drug safety, addressing the risks, time line, budget constrains, effectively tackling key challenges, overcoming trial agreement and site contract negotiation hurdles. Top pharmaceutical, biotech, and regulatory representatives will discuss the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development The Conference will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry experiences. Pharmacovigilance 2012 is the latest in Virtue Insight’s series of successful pharmacovigilance events. Also it can help you control your product's lifecycle, your patient's trust, and your revenue. Hence, 3rd Annual Pharmacovigilance 2012 will provide an important platform for pharmacovigilance stakeholders from India to discuss and share best practices in expediting pharmacovigilance development in India. It gives me great pleasure in welcoming all of you to the virtue insight’s 3rd Annual Pharmacovigilance 2012. I wish and pray that all our efforts will be beneficial to our industries and to our country at large. Key Themes Discussed at this Conference:
Key Speakers:
And many more... Who should attend: VP’s, Directors, CRO’s, Heads and Managers of:
Why should you attend: 3rd Annual Pharmacovigilance 2012- “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk 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 products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference. |
08:30 – Coffee and registration
09:30 – Morning Chair’s opening remarks
Babita Kirodian, Head-Country Pharmacovigilance, Bristol Myers Squibb
09:40 – Morning Keynote Address 1: Bridging the gap of clinical trial pharmacovigilance to post-marketing phase
- Understanding the various deliverables starting from the clinical phase
- How to gather the safety information data during clinical trials and reflect the same into post marketing activities?
- Assessing the risks and new information gathered after marking and its effect on the ongoing trials as well as the post marketing phase
10:10 – Morning Keynote Address 2: Cardiovascular Risk in Diabetes: Bridging disease markers and hard outcomes
- The CV risk continuum in diabetes
- The relationship between CV risk and diabetes treatment
- Specific challenges and issues in Asia Pacific
- Ongoing mechanisms to bridge the gap between surrogate markers and hard outcomes
- What additional things can be done in the interim to assess drug safety
Vinod Mattoo, Medical Director, Metabolic Disease Strategy, Asia-Pacific, Bristol-Myers Squibb (Singapore)
10:40 – Morning coffee & Networking
11:00 – Panel Discussion - Overcoming the latest pharmacovigilance challenges
Over the last two years, both large and samll pharmaceutical companies face an increasingly complex set of domestic and international regulations in their commitment to patient safety and good pharmacovigilance practices. Meeting international requirements has never been this challenging particularly when operating within the European regulatory framework while managing increased inspections and audits.
- Greatest Challenges to PV Compliance in current market
- The problems of a large population that is predominantly rural
- Extensive use of traditional medicines and poor spontaneous reporting
- Lack of physician and consumer awareness
- Rapid introduction of several new molecules and inadequate post marketing surveillance
- Economic pressure of PV EU pharmaceutical regulations
- Identifying the key opportunities for biopharmaceutical outsourcing in the area of PV
- Litigation, risk and latest developments and trends within PV technology
Moderator –
Siddarth Chachad, Head - Medical Services, Cipla
Panelists –
Dilip Pawar, Director and Head - Clinical Development, Dr Reddys
Rajani Rokade, Head - Pharmacovigilance, Sanofi Aventis
Simrat Sohal, Clinical Research Physician - Patient safety and Critical care, Eli Lilly
11:40 – Recent Updates on Regulations in Pharmacovigilance
Arun Bhatt, President, Clininvent Research
12:10 - Proactive PV risk management plans during the pre-approval phases
- Evaluating the importance of pharmacovigilance during clinical trials
- Explaining the practical pharmacovigilance evaluation strategies
- Predicting the clinical relevance of drug interactions during the pre-approval phase
12:40 - Networking luncheon / Networking / Exhibition Visit
Afternoon Chairperson
Deepti Sanghavi, Senior Medical Writer, SiroClinPharm
14:00 – Panel Discussion: In Pharmacovigilance where does fault lie?
- Adequate sharing of information between stake holders
- No rapport with practising physicians & peripheral centres
- Increasing availability of drugs, due to which too many drugs and irrational combinations and aggressive marketing
- Irrational practice of treatment without provisional diagnosis, Wrong choice & incorrect dose, lack of documentation, Resultant medical errors leading to ADEs and not necessarily ADRs
- Pharmacovigilance Audits from a Sponsor’s Perspective:
- Risk Management Plans (RMPS) & Risk Evaluation Mitigation Strategy (REMS)
Moderator –
Speaker (TBC)
Panelists –
Bhaswat S. Chakraborty, Senior VP & Chair, Research and Development, Cadila
Hari Prasad, CEO, Apollo Hospitals
Manish R Garg, Country Medical Director India, Bayer
Indu Nambiar, Clinical Safety Officer (CSO), Boehringer Ingelheim
14:40 – Benchmarking drug safety and Pharmacovigilance
- How to choose among the available drug safety vendors
- Discover how to improve supplier-client relationship
- How to optimize and strengthen your drug safety team?
- Importance of improving your communication with the FDA
- Identify the most important challenges towards improved safety and monitoring of drugs.
- Aligning the team and assigning responsibilities for investigational and post-market products
15:10 – PV Audit & inspections - preparation, implementation and lessons to be learn
- What are relevant interactions during the PV inspections
- Audits to develop, establish, promote and align with international standards
- Identifying best criteria for PV inspections to maintain constant vigilance
- Standardizing PV auditing procedures
- Integrating PV into clinical practice, through training and education
15:40 – Afternoon coffee & Networking
16:00 - Bayesian Estimations of Strong Toxic Signals following Mining of PV Databases
Bhaswat S. Chakraborty, Senior VP & Chair, Research and Development, Cadila
16:30 - Panel Discussion: Update on Indian PV regulations & Overcoming regulatory challenges in Asian PV market - Today & Tomorrow
Improved communication between national drug regulatory authorities and national PV centers and ensuring that regulatory decisions with possible international implications are rapidly communicated to avoid widespread public concern or panic
- Update on PVPI, India regulation - way forward
- Current PV practices in India and examining various methods to improve PV in Asia
- Important insights on rapidly evolving PV regulations in the market
- Strategic challenges in the evolution of Indian PV regulations in next decade
- Keep abreast with the changing International regulations of PV
Moderator –
Babita Kirodian, Head - Country Pharmacovigilance, Bristol Myers Squibb
Panelists –
D.K. Chauhan, ADCI, CDSCO – Mumbai Port, (Central Drug Standard Control Organisation)
SK Gupta, Professor Emeritus and Head, Clinical Research, DIPSAR (University of Delhi) & Advisor To Pharmacovigilance Program of India (PvPI)
Milind Antani, Head - Pharma LifeSciences group, Nishith Desai Associates
17:10 – Chairperson’s closing remarks and end of conference
Deepti Sanghavi, Senior Medical Writer, SiroClinPharm
17:20 – 18:20 Networking Drinks Session
Organised 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.
Supported By
Reports and Reports
ReportsandReports comprises of an online library of 50,000 reports, in-depth market research studies of over 5000 micro markets, and 25 industry specific websites.
Our client list boasts of almost all well-known publishers of such reports across the globe. We, as a third party reseller of market research reports employ number of marketing tools such as press releases, email-marketing and effective search engine optimization technique to drive revenues for our clients.
Markets and Markets
MarketsandMarkets is a full service and consulting firm that produces strategically analyzed full length reports track more than 10 industries. M&M plans to launch industry-wise and country wise market tracker for all the verticals tracked. This intelligence database comprising of about 60000 reports a year will form one of the world's largest intelligence resources worldwide. MarketsandMarkets has effectively used technology to automate management of large and complex data for forecasts. MarketsandMarkets aspires to help its client to achieve sustainable growth by providing incisive business insights into their respective business partners. Our 200 global strategic accounts with topline revenues in excess of USD 1 Billion annually. Delivered syndicated research studies to top publishers globally on a subcontracting model. The major industries that we cover in our market intelligence deliverables are Pharma & Biotech, Telecom & IT, Healthcare & Life sciences, Chemical & Advanced Material, Electronics & Semiconductors and Foods & Beverages.
PharmaAsia
A Leading Resource for the Pharmaceutical Industry:
In the race to manufacture new drugs for the burgeoning Asia market, drug manufacturers need updated, informative and objective content in an easily accessible, functional format.
PharmaAsia is the answer. The authoritative source of information for drug manufacturers, it delivers expert commentary and industry news as well as the latest trends and technologies in all aspects of the drug manufacturing process. These include both management and technical stories about drug production, testing, and achieving operational excellence. With a readership base in the Asia Pacific region, the engine that is driving the growth of the global pharmaceutical industry, PharmaAsia is the ideal platform for you to connect with your target audience of industry movers and shakers.
PharmaInsight
Pharma and Healthcare Insight provides subscribers with analysis, forecasts and company profiles on a country-by-country basis, covering the key trends impacting on global pharma and healthcare markets. The service includes online access to the very latest analysis and data, a searchable archive, and PDF access to the monthly regional Insight reports.
Published by Business Monitor International, the global market specialists, Pharma and Healthcare Insight is broken down into five regional services: Asia, Western Europe, Emerging Europe, the Middle East & Africa and the Americas.
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.
Medical News Today
Medical News Today is the largest independent medical and health news site on the web - with over 2,500,000 unique monthly users it is ranked number one for medical news on Google and Yahoo!. Medical News Today is used by Blue Chip pharmaceutical and health organizations, advertising agencies, PR companies and vertical ad networks to deliver targeted disease/condition and general health campaigns. For more information contact peter@medicalnewstoday.com or visit www.medicalnewstoday.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, 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