Conference on Pharmacovigilance 2010 (Pharmacovigilance)

Venue: ITC Maratha Sheraton Hotel

Location: Mumbai, India

Event Date/Time: Jan 21, 2010 End Date/Time: Jan 22, 2010
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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

* Akhilesh Sharma, Vice President & Global Head Clinical Management & Global Pharmacovigilance, Dr. Reddy’s
* Zoher Sihorwala, Vice President Global Regulatory Affairs, Dr. Reddy’s
* 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
* Subbaraju Sagi, Senior Solutions Consultant, Oracle Life Sciences
* 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
* Dipti Kadam, Consultant - Clinical technology & System, DBMS Consulting
* Vishwas Sovani, MD, VP, Pharma Delivery, TCS
* 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
* 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 – Keynote Address: Latest developments in pharmacovigilance - Changing EU, US & Rest of the world (RoW) requirements

Akhilesh Sharma, Vice President & Global Head Clinical Management & Global Pharmacovigilance, Dr. Reddy’s

10:20 – Enabling risk management: from safety signal to risk/benefit management

Subbaraju Sagi, Senior Solutions Consultant, Oracle Life Sciences

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


Gopal Pande, Scientist, Center for Cellular & Molecular Biology


Arunima Sen, Manager Medical Team, MMS Holdings Incorporation

Veena Rajan, Head - Patient Safety, AstraZeneca

12:30 – Role of Therapeutic alliance in PV

13:00 - Networking luncheon

14:10 - Signal detection with Oracle product

Dipti Kadam, Consultant - Clinical Technology & System, DBMS Consulting

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 –Emerging technologies & Strategies in drug safety evaluation

16:10 - 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


Milind Antani, Head-Pharma LifeSciences group, Nishith Desai Associates


Zoher Sihorwala, Vice - President Global Regulatory Affairs, Dr. Reddy's

Arun Bhatt, President, Clininvent Research

16:50 – 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



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 data management services: Challenges & Opportunities

Speaker TBC, Oracle Life Sciences

14:40 – 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

Vishwas Sovani, MD, Vice President, Pharma Delivery, TCS

15:20 – Afternoon tea

15:40 – 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

16:20 – Panel Discussion – SWOT analysis

Strength, Weakness, Opportunities & Threats of Pharmacovigilance in India (Overall review of this Pharmacovigilance 2010 conference)


Sanjay Zodpey, Director, Public Health Foundation of India


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


Platinum Sponsor

Oracle Health Sciences

Gold Sponsor


DBMS Consulting is specialized in Implementation and Deployment of Oracle Health Sciences (OHS) Applications. DBMS Consulting has performed over 100 installations for its clients globally. The clients include Global Pharmaceuticals, CROs, Biotechs, Medical Device Companies, Academic Institutions and Government Institutions throughout the U.S., Europe and Asia.

DBMS has been awarded with Oracle’s prestigious Partner of the year award for its life sciences business in India (2008). DBMS offers implementation support for OLS suite, Siebel - Clinical Trial management System and its integration with other Oracle Applications (like OC/TMS and Oracle Financials/e-business).

DBMS Consulting has recently received Honorable Mention in Life Sciences & Health Care Industry Solution Category at “Oracle Open World 2009 North America Alliances and Channels Titan Award Ceremony”

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Bronze Sponsor


Tata Consultancy Services is an IT services, business solutions and outsourcing organization that delivers real results to global businesses, ensuring a level of certainty no other firm can match. TCS offers a consulting-led, integrated portfolio of IT and IT-enabled services delivered through its unique Global Network Delivery Model, recognized as the benchmark of excellence. TCS BPO specializes in Industry specific services and leverages its IT heritage to offer transformational services including Platform BPO.

A part of the Tata Group, India’s largest industrial conglomerate, TCS has over 140,000 of the world's best trained IT consultants in 42 countries. The company generated consolidated revenues of US $6 billion for fiscal year ended 31 March 2009. For the H1 FY 2010 quarter, BPO revenues were close to 12%of TCS revenues. TCS is listed on the National Stock Exchange and Bombay Stock Exchange in India. For more information, visit

Online Media Marketing Partner

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Media Partner

Provenance Research

Provenance Research provides comprehensive end-to-end contract services to the pharmaceutical, biotechnology and medical device industries. We offer a range of services to our clients throughout the lifecycle of the product from clinical development to marketing. These services include Conceptualization of Trial design, Clinical study documents preparation, Clinical research operations, Pharmacovigilance, Regulatory services, Medical writing, and Medical marketing support services including promotional medical literatures, web content development, CME, e-marketing, and event management.

An educational website on Pharmacovigilance, aimed at creating awareness about the magnitude of drug safety problem in India and to convince health care professionals about the importance of reporting adverse drug reactions. The main objective of the site is to provide information about India’s national pharmacovigilance programme to healthcare professionals.

" is the world leading website designed specifically for pharmaceutical, clinical and biotechnology professionals. brings up-to-date information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to our visitors. It was created and is maintained by pharmaceutical and biotechnology professionals. Visit and discover for yourself why it is so popular among professionals."


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A particular feature of the underlying NetworkPharma platform is the high level of personal confidentiality and privacy provided to our users. This is of paramount importance when working within a sensitive, high technology environment such as the medical and pharmaceutical industries. Users will find a number of security features in place and, for instance, an important fundamental principle is that email addresses and other personal details of our individual users are never made public nor sold to third parties.

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Sponsorship Opportunities

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.

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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.

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ITC Maratha Sheraton Hotel, Mumbai, India