2nd Annual Pharmacovigilance 2011

Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management 19th August 2011, ITC Maratha, Sahar, Mumbai, India.

Key Speakers:
Arun Bhatt, President, Clininvent Research Vivek Ahuja, Regional Director, Pharmacovigilance, Baxter Healthcare, Asia Pacific Khalid Saifuddin, Group Head Pharmacovigilance Operations - Drug Safety & Epidemiology, Novartis Moin Don, Executive Director, PVCON Pharmacovigilance Consulting Services Manish R Garg , Country Medical Director, Bayer Simrat Sohal,Clinical Research Physician - Patient safety , Critical Care, Cardiac Care & BHGT, Eli Lilly Khushboo Baxi, Senior Member Pharma Team, Nishith Desai Associates Anurita Majumdar, Medical Director, Eli Lilly

Ramaswamy Valliappan, Pharmacovigilance Expert (PVE) Babita Kirodian, Head-Country Pharmacovigilance, Bristol - Integrated Hospital Care Drug Safety and Epidemiology, Novartis Myers Squibb Parminder Kaur, Managing Director, RegPak BioPharma Consulting (Netherlands) Deven Parmar, Vice President-Clinical Research, Wockhardt Julius Vaz, Senior Vice-President (Global Medical Affairs), Dr.Reddy's Deepti Sanghavi, Medical Advisor- Clinical Research, Wockhardt Rajani Rokade, Head Pharmacovigilance, Sanofi Aventis Group

Plus many more .....

Silver Partner

Associate Partner

Supported By

Organized By

2nd Annual Pharmacovigilance 2011 19th August 2011, ITC Maratha, Sahar, Mumbai, India.

Conference Intro:
At the outset, a very cordial and warm invitation is being extended to all who attended the Pharmacovigilance Conference in the year 2010 and its representatives for the Conference to be held in early 2011. The pharmaceutical industry is facing a tough road ahead in the future marketplace. Though pharmaceuticals remain the most cost-effective healthcare intervention, everyone should bring about a significant transformation in their organizations to realize a glorious future. Pharmacovigilance is a scientific and organized study of this subject to unfold, discover, and to evaluate the methods and means of preventing adverse and harmful effects of drugs. Its primary aim is to make use of medicines available in the market for treatment and also prevention of diseases. Some medicines may not suit or agree with some patients due to their physical health condition. Any such harmful effect on patients may bring discredit to the medicines and the industry. A good Pharmacovigilance will easily identify the risk factors in the shortest time so that the harmful effects can be avoided or minimized. In 2009, FDA reported more than 1,742 recall in comparison to 426 in 2008 and fast pace of drug recalls seems to be continuing in 2010 totaled 296 from January through June of this year. According to peer-reviewed published studies, FDA-approved prescription drugs injure 2.2 million and kill approximately 100,000 Americans each year and more realistic estimates put the number of deaths at over 200,000 people annually in the United States alone. Pharmacovigilance 2011 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. 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. Hence, 2nd Annual Pharmacovigilance 2011 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 2nd Annual Pharmacovigilance 2011. 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 summit:

Exploiting the latest technologies and methodologies on work practices of Pharmacovigilance Keeping abreast of the changes impacting the drug safety industry to ensure the pharmacovigilance strategies are robust and geared to compliance Learn to implement best practices in drug safety and surveillance Recent successful strategies and business models to manufacture new medicine Global marketing strategies in order to engage with regulatory centers of excellence on pharmacovigilance Introducing newer medicines with limited real-world safety data Accelerating new medicine introduction in developing world & overcoming challenges Recognizing the most effective pharmacovigilance system Future studies of pharmacovigilance activity levels globally Discuss and share best practices in expediting PV development in India Stay ahead of computing and electronic communications in pharmacovigilance Analyzing the information on current industry projects and trends Good supply chain management practices for medicine distribution Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions Latest developments in pharmacovigilance, drug safety and risk management to ensure safer drugs to market Be part of a major networking opportunity

Who should attend?

Vice Presidents, Directors, CROs, 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?

2nd Annual Pharmacovigilance 2011 - 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.

Sponsorship & Exhibition Opportunities:

Delegate Registration:
If you would like to benefit by promoting your organization at one of our events then exhibit is perfect for you. Hosting a networking drinks reception Increase and maintain brand awareness Taking an exhibition space at the conference Target your marketing campaign
Advertising in the delegate documentation pack Providing branded bags, pens, gifts, etc. Network with industry decision-makers Meet potential clients & Present your products and ideas To register and to book your seats at the conference please email your interest to delegate@virtueinsight.com

Any questions on Sponsorships or Exhibition Email your queries to sponsor@virtueinsight.com

2nd Annual Pharmacovigilance 2011 19th August 2011, ITC Maratha, Sahar, Mumbai, India.

08:30 - Coffee and registration - An opportunity to meet and to 11:40 EU Risk Minimisation Plan for Marketing Authorisation Applications network with your conference colleagues. 09:30 - Chairperson opening remarks Vivek Ahuja, Regional Director, Pharmacovigilance, Baxter Healthcare, Asia Pacific (http://in.linkedin.com/pub/vivek-ahuja/16/177/1b9) 09:40 - Analysing the current global PV scene and perspectives of the future Analyzing fundamental statistics & economic concepts of PV under the present market trend Latest PV concepts and applying these methods to drug issues Thought provoking ideas for new methods Consideration of future directions for the PV development Discover how PV will change and adapt from 2011 to 2015
Parminder Kaur, Managing Director, RegPak BioPharma Consulting (Netherlands) (http://nl.linkedin.com/pub/parminderkaur/3/6b2/5b4)

12:20 - Networking luncheon - Take your discussions further & build new relationships in a relaxed & informal setting...

Afternoon Chairperson: Moin Don, Executive Director, PVCON Pharmacovigilance Consulting Services- India
(http://in.linkedin.com/pub/moin-don/2/33a/653)

Vivek Ahuja, Regional Director, Pharmacovigilance, Baxter Healthcare, Asia Pacific (http://in.linkedin.com/pub/vivek-ahuja/16/177/1b9) 10:10 - Topic TBC Speaker TBC, EXTEDO (Germany)

13:30 Economic implication of outsourcing PV India is becoming the most obvious choice for offshore outsourcing of PV activities. Vendors should educate pharmaceutical companies about technology implications and its importance in their day-to-day operations Identifying the key opportunities for biopharmaceutical outsourcing in the area of PV SWOT analysis of India, as an outsourcing target for PV Economic Implications of Top Outsourcing Providers

10:40 Morning coffee & Discussion

11:00 Panel Discussion: Evaluating key emerging markets for improved strategy for present and future market Challenges and opportunities in PV lifecycle management Meeting unmet needs in PV How can long-latency adverse effects be detected readily Live licensing-commercially beneficial? Overcoming challenges & to achieve balance between hig productivity, high quality and shorter cycle-times

14:00 Panel Discussion: Why do drugs fail? Pre-approval stages encircling the PV guidelines Analyzing & reviewing the successes and challenges of Phase I and Phase II clinical trials A new medicine must comply with: good quality, effectiveness and safety for the purpose Adverse reaction of drug reporting To initiate follow up on adverse reports about drugs Ongoing risk-benefit assessment during the post-marketing period PV through pre clinical trails and practical approach to PV

Moderator: Vivek Ahuja, Regional Director, Pharmacovigilance, Baxter Healthcare, Asia Pacific (http://in.linkedin.com/pub/vivek-ahuja/16/177/1b9) Panellists: Deepti Sanghavi, Medical Advisor - Clinical research, Wockhardt (http://in.linkedin.com/pub/dr-deepti-sanghavi/5/591/b76) Manish R Garg, Country Medical Director, Bayer
(http://in.linkedin.com/pub/manish-garg-md/a/114/526)

Moderator: Babita Kirodian, Head-Country Pharmacovigilance, Bristol Myers Squibb (http://in.linkedin.com/pub/babita-kirodian/10/736/8bb) Panellists: Deven Parmar, Vice President-Clinical Research, Wockhardt
(http://in.linkedin.com/pub/deven-parmar/15/615/331)

Khalid Saifuddin, Group Head Pharmacovigilance Operations - Drug Safety & Epidemiology, Novartis
(http://in.linkedin.com/in/drkhalidsaifuddin)

Arun Bhatt, President, Clininvent Research

(http://in.linkedin.com/pub/arun-bhatt/5/431/958)

Julius Vaz, Senior Vice-President (Global Medical Affairs) Dr.Reddy's, (http://in.linkedin.com/pub/julius-vaz/21/796/103)

2nd Annual Pharmacovigilance 2011 19th August 2011, ITC Maratha, Sahar, Mumbai, India.

14:30 A good PV system - Dependent upon Information 16:30 Developing Pharmacovigilance into high quality management system and its components: Technology (IT) systems Safety signal detection - Merging IT into clinical safety practice Electronic data management & monitoring cost effectively Discover latest technologies and strategies Computer-automated pattern discovery procedures Analysing the recent growth on electronic safety data reporting Discover how software application serves as a warehouse for adverse cases across India Find out the importance of drug safety surveillance that is required to address all relevant quality Communication relating to drug safety and ensuring that they are transparent and able to function efficiently in times of emergency Centralized position to track quality and compliance in line with activities Consistent process to monitor, analyze and resolve incidents

15:00 Afternoon Coffee / Tea 15:20 Panel Discussion: 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 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

Simrat Sohal, Clinical Research Physician - Patient safety, Critical Care, Cardiac Care & BHGT, Eli Lilly
(http://in.linkedin.com/pub/simrat-sohal/10/2a0/614)

17:00 - Chairperson's closing remarks and end of conference

17:10 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting...

Moderator: Moin Don, Executive Director, PVCON Pharmacovigilance Consulting Services- India
(http://in.linkedin.com/pub/moin-don/2/33a/653)

Panellists: Rajani Rokade, Head-Pharmacovigilance, Sanofi Aventis Group Khushboo Baxi, Senior Member Pharma Team, Nishith Desai Associates (http://in.linkedin.com/pub/khushboo-baxi/9/146/391) Anurita Majumdar, Medical Director, Eli Lilly
(http://in.linkedin.com/pub/dr-anurita-majumdar/20/a57/a86)

16:00 Importance and impact of safety signal detection and management in life cycle of a therapeutic drug The need for Signal detection right from developmental phase and continously in the post marketing phase of a drug Adaptive methods in clinical trials for developmental drugs Preparedness for the unexpectedness and addressing the same from developmental phase to post marketing phase Appropriate time for the initiation of postmarketing safety studies Translating the safety information observed with a molecule in the postmarketing phases and translating the same into the clinical trials for the same product in another indication, dosage etc.

Ramaswamy Valliappan, Pharmacovigilance Expert (PVE) Integrated Hospital Care Drug Safety and Epidemiology, Novartis (http://in.linkedin.com/pub/dr-ramaswamy-valliappan/9/a/7b6)

2nd Annual Pharmacovigilance 2011 19th August 2011, ITC Maratha, Sahar, Mumbai, India.

FLOOR PLAN - 2nd Annual Pharmacovigilance 2011

Book your stalls now before they run out !!!

2 3 4 CONFERENCE HALL1 CONFERENCE HALL 2 CONFERENCE HALL 3 5 6 7 1 3 5 7 9 8 9

EXHIBITION AREA
10 2 4 6 8
REGISTRATION DESK

10

CORRIDOR

Partial list of attendees from our previous Pharmacovigilance 2010

Accenture Services Accutest Research Laboratory Acunova Astrazeneca Bagdad medical college, Bharat Serums & Vaccines Biocon BioSpectrum India Cadila Center for Cellular & Molecular Biology Chiltern International Cipla CISCO SYSTEMS Clinical Research & Healthcare Clinigene International Clininvent Research Cognizant Technology Solutions CSIR DBMS Consulting DNA India Dr. Reddy's Ege University Elder Pharmaceuticals Eli Lilly & Company Ennovent Foresight group Fresenius Kabi Oncology Fulford Glenmark Generics Good Compliance Services HCL Technologies - BPO Services i3 Research IIHMR, Jaipur. IPCA Laboratories Lambda Launtech Teaching Hospital LG Life Sciences Lupin Limited Macro Care Manipal AcuNova MedZine Mega Lifesciences MMS MSD India Mumbai University Niko Infra Licensing Nishith Desai Associates Oracle Life Sciences Panacea Biotec Pfizer
Piramal Life Sciences Plethico Pharmaceuticals PPCE Pvt. Ltd PPD Provenance research Public Health Foundation of India Quintiles RegPak BioPharma Consulting Saffron Media Sanofi Aventis Sciformix Technologies SIRO Clinpharm Sitec Labs Pvt Ltd Sri. Devaraj URS Medical College Swami Samarth Pharmatech Synowledge TAKE Solutions TCS Torrent Research Center Until ROI Wockhardt

Registration Form 2nd Annual Pharmacovigilance 2011 19th August 2011, ITC Maratha, Sahar, Mumbai, India.

For Multiple Bookings

Photocopy this form...

Queries:
Should you have any questions on bookings, Please feel free to contact us.

Special Price INR (Please Tick)

1 Day conference Fee: INR 05,000 + Tax Email: info@virtueinsight.com Web: http://www.virtueinsight.com India Office: Tel: +0091 44 2377 0517

Registration Form Details:

Forename ............................Surname ................................

General information Venue:

ITC Maratha - A Luxury Collection Hotel, Sahar, Mumbai - 400 099, India, Direct Nos: (91-22) 28317866 Board Line: (91-22) 28303030

Job Title ..............................Company ................................

Payment terms:
Official Contact Number ....................................................... Virtue Insight requires the full amount to be paid before the conference. Virtue Insight may refuse entry to delegates who have not paid their invoice in full.

Address .............................................................................

Substitutions/name changes or cancellations:

There is a 50% liability on all bookings once made, whether by post, fax, or email. There is a no refund policy for cancellations received on or after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places between conferences and executive briefings. However, if you cannot attend the conference, you may make a substitution/name change at any time, as long as we are informed in writing by email, fax or post. Name changes and substitutions must be from the same company or organization and are not transferable between countries.

.............................................................................

Country ...............................Postcode..................................

Phone ..................................Fax ........................................

Email .................................................................................

Indemnity:
Virtue Insight reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled due to unforeseen events beyond the control of Virtue Insight. If such a situation arises, we will refund your registration fee and we will try to reschedule the event.

I confirm that I have read & agree to the terms and conditions of booking..... (Please Tick)

Signature ...........................................................................

Fee: Methods of Payments:

By Cheque - Complete and return the above registration form via post or email, together with your cheque payable to Virtue Insight. By Bank Transfer Account Name - Virtue Insight Account Number - 830092431 Bank Address - Indian Bank. 118 - 119, Indira Nagar, Valasaravakkam, Chennai 600 087,Tiruvallur district,Tamil Nadu, India The conference fee includes lunch, refreshments and conference papers provided on the day. This fee does not include travel or hotel accommodation.

How we will contact you:

Virtue Insight's preferred method of communication is by email and phone. Please ensure that you complete the registration form in full so that we can contact you.

News Updates: Please tick if you do not wish to receive email updates in the future

www.virtueinsight.com