KEY SPEAKERS:-
Bhaswat S. Chakraborty, Senior VP & Chair, Research and Development, Cadila
Arun Bhatt, President, Clininvent Research
Vinod Mattoo, Medical Director, Metabolic Disease Strategy, Asia-Pacific, Bristol-Myers Squibb (Singapore)
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)
Dilip Pawar, Director and Head – Clinical Development, Dr Reddys
Babita Kirodian, Head – Country Pharmacovigilance, Bristol Myers Squibb
Hari Prasad, CEO, Apollo Hospitals
Rajani Rokade, Head – Pharmacovigilance, Sanofi Aventis
Moin Don, Executive Director & Founder, Pharmacovigilance, PVCON Pharmacovigilance Auditing Consulting Services
Manish R Garg, Country Medical Director India, Bayer
Siddarth Chachad, Head – Medical Services, Cipla
Deepti Sanghavi, Senior Medical Writer, SiroClinPharm
Indu Nambiar, Clinical Safety Officer(CSO), Boehringer Ingelheim
Simrat Sohal, Clinical Research Physician – Patient safety and Critical care, Eli Lilly
Milind Antani, Head – Pharma LifeSciences group, Nishith Desai Associates
CONFERENCE INTRODUCTION:-
After the successful journey of 1st & 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 & 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. Business Report
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:-
Exploiting the latest technologies, methodologies and Introducing pharmacy automations on work practices of Pharmacovigilance
Keeping abreast of the changes impacting the drug safety industry to ensure the pharmacovigilance strategies 0r robust & geared to compliance
Recent successful strategies and business models to bring out new medicines
How will PV activities change with Clinical Trial Transformation Initiative?
Identifying essential antidote requirements and learn to implement best practices in drug safety and surveillance
Exploiting the pharmacy automations and technologies for enhancement of medication safety
Stay ahead of computing and electronic communications in pharmacovigilance
Latest developments in pharmacovigilance, drug safety and risk management to ensure safer drugs to market
Establishing the importance of pharmacovigilance for the safety of the patient info@bharatbook.com
Determining the steps and strategies for enhancing quality in healthcare
Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions
Analyzing the information on current industry projects and trends
Identifying the latest regulatory framework for pharmacovigilance
Global marketing strategies in order to engage with regulatory centers of excellence on pharmacovigilance
Accelerating new medicine introduction in developing world & overcoming challenges
Explaining how to use the data sources and observational research for effective safety analysis
Good supply chain management practices for medicine distribution
Be part of a major networking opportunity
WHO SHOULD ATTEND?
Vice Presidents, Directors, CRO’s, Heads and Managers of:
Pharmacovigilance Strategy, Drug Safety/Risk Management, Information and Clinical Data Management, Clinical Research, Research & Development, Product Safety/Assurance Assessment, Patient Safety & Outcomes Research & Data Analysis, Epidemiology project management, Regulatory Affairs and Compliance, Sales & Marketing, Biotech manufacturers
WHY SHOULD YOU ATTEND?
3rd Annual Pharmacovigilance 2012-“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management info@bharatbook.com
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.
DAY ONE
08:30 – Coffee and registration
09:30 – Morning Chair’s opening remarks
Moin Don, Executive Director & Founder, Pharmacovigilance, PVCON Pharmacovigilance Auditing Consulting Services
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 small 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 – Assuring Quality in Pharmacovigilance Function
• Importance of QA in PV vis-a-vis Reg Inspections
• Tools & Processes ti implement PV QA
• Proactive risk bases PV audits
Moin Don, Executive Director & Founder, Pharmacovigilance, PVCON Pharmacovigilance Auditing Consulting Services
12:40 - Networking luncheon - Take your discussions further & build new relationships in a relaxed & informal setting...
Afternoon Chair person
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)
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