Pharmacovigilance is the science and actions relating unfolding to detection, evaluation, understanding and prevention of adverse effects or any other likely medicine related problems. The main aim of pharmacovigilance is to improve patient care and safety in relation to use of medicines and other interventions. Despite all the benefits of medicines in disease management, there continues to be problems related to adverse reactions which are important cause for morbidity and mortality in many countries. Significant harm to even a few patients, not only destroys the credibility of the medicine, the patients also tend to loose trust on the the health system. A good Pharmacovigilance system will identify the risks in the shortest possible time, so that any harm can be avoided or minimized. The most frightening thought for any pharma company is the prospect of a drug withdrawal. As the costs associated with product withdrawals escalate the importance of pharmacovigilance increases.

India has more than half a million qualified Doctors and15,000 hospitals having bed strength of 6,24,000. It is the fourth largest producer of pharmaceuticals in the world. It is emerging as an important Clinical trial hub in the world. Many new drugs are being introduced in our country. Therefore, there is a need for a vibrant pharmacovigilance system in the country to protect the population from the potential harm that may be caused by some of these new drugs. The most effective way to avoid a safety crisis is to implement a progressive pharmacovigilance strategy now.

Pharmacovigilance 2010 conference will discuss the on-going pressing concerns faced in drug safety, addressing the risks, timeline and budget constraints. This conference brings together top pharmaceutical, biotechnology and regulatory representatives in a forum that addresses the key issues of the industry. The in-depth program covers discussions on the detection, analysis and prevention of adverse drug reactions with case studies and sharing of industry experiences and best practices. Understand and learn the latest insights, tools and knowledge to ensure that you and your firm catch up with the current and future market. Analyze along with the market leaders, the latest developments in pharmacovigilance which would shape your organization-wide risk management strategy.

Pharmacovigilance 2010 January 21st, 22nd 2010, Hotel (TBC), Mumbai, India. Conference Info Pharmacovigilance is the science and actions relating unfolding to detection, evaluation, understanding and prevention of adverse effects or any other likely medicine related problems. The main aim of pharmacovigilance is to improve patient care and safety in relation to use of medicines and other interventions. Despite all the benefits of medicines in disease management, there continues to be problems related to adverse reactions which are important cause for morbidity and mortality in many countries. Significant harm to even a few patients, not only destroys the credibility of the medicine, the patients also tend to loose trust on the the health system. A good Pharmacovigilance system will identify the risks in the shortest possible time, so that any harm can be avoided or minimized. The most frightening thought for any pharma company is the prospect of a drug withdrawal. As the costs associated with product withdrawals escalate the importance of pharmacovigilance increases. India has more than half a million qualified Doctors and15,000 hospitals having bed strength of 6,24,000. It is the fourth largest producer of pharmaceuticals in the world. It is emerging as an important Clinical trial hub in the world. Many new drugs are being introduced in our country. Therefore, there is a need for a vibrant pharmacovigilance system in the country to protect the population from the potential harm that may be caused by some of these new drugs. The most effective way to avoid a safety crisis is to implement a progressive pharmacovigilance strategy now. Pharmacovigilance 2010 conference will discuss the on-going pressing concerns faced in drug safety, addressing the risks, timeline and budget constraints. This conference brings together top pharmaceutical, biotechnology and regulatory representatives in a forum that addresses the key issues of the industry. The in-depth program covers discussions on the detection, analysis and prevention of adverse drug reactions with case studies and sharing of industry experiences and best practices. Understand and learn the latest insights, tools and knowledge to ensure that you and your firm catch up with the current and future market. Analyze along with the market leaders, the latest developments in pharmacovigilance which would shape your organization-wide risk management strategy. Key Themes Reviewing the best revenue generating models in suitable for current and future PV market. Grabbing the opportunity: learning about the challenges & complexities in the role Best practices, service offerings & deployment Global marketing strategies in order to engage with regulatory centres of excellence on pharmacovigilance and to understand their perspectives on best practice & future trends Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions Exploiting the role of electronic data standards and controlled vocabularies in pharmacovigilance Positioning yourself in light of new market entries Analyzing the worldwide trends in PV & lessons for India. Discover approaches for collecting, integrating and analyzing all of the safety data generated from preclinical models Updating yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practice in PV Dwell ahead of regulatory developments & improving your risk management strategies in a cost effective way Key Speakers Veena Rajan, Head - Patient Safety, AstraZeneca Viraj Rajadhyaksha, Senior Manager, Operations, Planning & Management Clinical Research, Pfizer Simrat Sohal, Head - Pharmacovigilance, Eli Lilly Bhaswat S. Chakraborty, Senior VP, R&D, Cadila Pharmaceuticals Prashanth BSB, Medical & Safety expert (Regulatory Affairs), Cipla Deven Parmar MD, Vice President - Clinical Research & Pharmacovigilaance, Wockhardt Milind Antani, Head-Pharma LifeSciences group, Nishith Desai Associates Arani Chatterjee, Vice President, Clinical Research, Panacea Biotec Siddarth S. Chachad, Medical & Safety Expert (Regulatory Affairs), Cipla Arun Bhatt, President, Clininvent Research Arunima Sen, Manager Medical Team, MMS Holdings Incorporation Krathish Bopanna, Senior Vice President, Acunova Sanjay Zodpey, Director, Public Health Foundation of India D.D. Gupta, Vice President, Indian Pharmacological Society Gopal Pande, Scientist, Center for Cellular & Molecular Biology Who should attend? VP’s, Directors, Heads and Managers of: Pharmacovigilance Strategy Drug Safety/Risk Management Information and Clinical Data Management Clinical Research Research & Development and Product Safety/Assurance Assessment Patient Safety and Outcomes Research and Data Analysis Epidemiology project management Regulatory Affairs and Compliance Sales & Marketing Why should you attend? Pharmacovigilance 2010 - “Overseeing risks & Optimizing drug safety in today’s pharma market” 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 1 08:45 – Coffee and registration – An opportunity to meet and to network with your conference colleagues. 09:30 – Chair’s opening remarks Arani Chatterjee, Vice President, Clinical Research Panacea Biotec 09:40 – Observe the current & future market of Pharmacovigilance Analysing the current market situation and revealing the key revenue drivers for the future markets. What are the steps to be taken if the industry is to achieve full potential? Challenges and Opportunities in 21st Century Safety Testing Determine the key considerations in implementing a progressive pharmacovigilance strategy 10:20 – Next generation pharmacovigilance – opportunities and finding solutions to the challenges of drug safety Highlighting the critical new importance of pharmacovigilance and risk management for successful drug development New opportunities for high performance in pharmacovigilance Elaborating the new globalization of pharmacovigilance standards 11:00 – Morning coffee & Discussion 11:20 - Pre-approval Periodic safety reporting using DSUR and Post Marketing reporting using PSUR – Understanding the essentials Sanish Davis, Clinical Research Manager, PGRD, Pfizer 12:00– Panel discussion: Challenges in upcoming markets What are the successful strategies to face the future challenges in pharmacovigilance Analyzing the changing business environment Evaluating where are the opportunities and threats in emerging markets Moderator: Gopal Pande, Scientist, Center for Cellular & Molecular Biology Panellists: Arunima Sen, Manager Medical Team, MMS Holdings Incorporation Veena Rajan, Head - Patient Safety, AstraZeneca 12:40 – Networking luncheon 14:00 - Role of Therapeutic alliance in PV D.D.Gupta, Vice President, Indian Pharmacological Society 14:40 – Growth of pharmacovigilance systems - India Benefits of developing PV in India Analyzing the current and the future of PV in India Demand for efficient PV by middle class Indians Deven Parmar MD, Vice President - Clinical Research & Pharmacovigilaance, Wockhardt 15:20 – Afternoon tea 15:40 – Panel Discussion - Regulator’s perspective Pharmacovigilance from the Regulator’s Perspective – Latest Updates Understanding how companies can work more successfully with regulators. What can the regulators do to help industry? Determining the best strategy to secure approval. An overview of the Global Regulatory Safety Information Database Moderator: Milind Antani, Head-Pharma LifeSciences group, Nishith Desai Associates Panellists: Arun Bhatt, President, Clininvent Research 16:20 – Emerging technologies and strategies for drug safety evaluation Assess key technologies for predicting drug safety in the earliest stages of discovery and clinical development Analyzing the role of public-private consortia in solving key issues within the field of predictive safety. Which predictive safety technologies can provide potential cost savings and improvements in attrition rates and assess the challenges and risks associated with the implementation. Understand the latest strategies to improve safety evaluation in early clinical development 17:00 – Chairperson’s closing remarks and End of Conference 17:20 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting. DAY 2 08:45 – Coffee and registration – An opportunity to meet and to network with your conference colleagues. 09:30 – Morning Chair’s opening remarks 09:40 – Data mining & signal detection in Pharmacovigilance Bhaswat S. Chakraborty, Senio VP, R&D, Cadila Pharmaceuticals 10:20 – Pharmacovigilance in focus Economic impact of ADR Thalidomide status through PV Real lessons from Vioxx Best selling drugs & adv through PV for these drugs Practical problems & Challenges in PV Penalties on non-complaint to PV Prashanth BSB, Medical & Safety expert (Regulatory affairs), Cipla 11:00 – Morning coffee & Discussion 11:20 – Panel Discussion - Working towards patient subject safety from early development Advanced Pharmacology Techniques and Methodologies to Improve Safety Putting the patient first – The importance of developing a comprehensive post-marketing surveillance strategy Moderator: Panellists: S. K. Kulkarni, Emeritus Scientist & Emeritus Professor of Pharmacology Siddarth S. Chachad, Medical & Safety Expert (Regulatory Expert), Cipla 12:00 – Challenges in local regulations for PV Simrat Sohal, Head - Pharmacovigilance, Eli Lilly 12:40 – Networking luncheon 13:50 – Afternoon Chair's opening remarks Sanjay Zodpey, Director, Public Health Foundation of India 14:00 – Pharmacovigilance quality assurance Pharmacovigilance QA as a Corporate competitive advantage Pharmacovigilance QA Surveillace Programme Application of Quality Risk Management principles for ensuring an effective PV audit programme Creation of PV Quality Indicators for monitoring status of quality and future auditing needs Electronic-submissions and the associated quality issues 14:40 – Risk management Lessons to be learned from extensive drug safety research Cutting-edge risk management, how to prepare for the worst Managing developments and adapting to changing information Constant improvement in risk management strategies Developing and maintaining exemplary drug safety standards 15:20 – Afternoon tea 15:40 – Challenges in Pharmacovigilance: Different Sponsors, Same Drug What are current “best practices” in this challenging area? How can “continuous safety monitoring” be achieved? What are issues in signal detection across sponsors and trans-nationally? Best methods for pharmacovigilance, signal detection, risk management in this setting 16:20 – Panel Discussion – SWOT analysis Strength, Weakness, Opportunities & Threats of Pharmacovigilance in India (Overall review of this Pharmacovigilance 2010 conference) Moderator: Sanjay Zodpey, Director, Public Health Foundation of India Panellists: Krathish Bopanna, Senior Vice President, Acunova Viraj Rajadhyaksha, Senior manager, Operations, Planning & Management Clinical Research, Pfizer 17:00 – Chairperson’s closing remarks and End of Conference