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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
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