I am writing to make you aware of our upcoming event:- 7th Pharmacovigilance 2014 taking place on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.

1. Conference Hashtag - #VI_Pharma
7th Pharmacovigilance 2014
21st November 2014, Kohinoor Continental Hotel, Mumbai, India
“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance
drug safety and risk management”
KEY SPEAKERS:-
Mazhar Maruf, Head of Pharmacovigilance, Glenmark
Karthik Babu, Affiliate Pharmacovigilance Head, Sanofi
Abhay Chimankar, Head - Global Drug Safety, Cipla
Rahul Chauhan, Associate Director – Regulatory Affairs & Pharmacovigilance, Eli Lilly
Bhaswat Chakraborty, Senior Vice President, Cadila
Babita Kirodian, Head of Country Pharmacovigilance, Bristol Myers Squibb
Manish Verma, Director Medical Affairs, Sanofi
Indu Nambiar, Clinical Safety Officer, Boehringer Ingelheim
Amit Arora, Head Medical Affairs, Merck Serono
Manish Shah, General Manager, Global Clinical Operations, Wockhardt
V K Sharma, Associate Vice President, Unichem Laboratories
Girish Parhate, Senior Manager – Regulatory Affairs, Bayer
Kamlesh Patel, GM, Medical Affairs & Pharmacovigilance, Abbott
Milind Antani, Head - Pharma LifeSciences, Nishith Desai Associates
Vandana Jolad Shivangi, Director, VIaTAL Pharma Consulting
Plus Many More...

2. ORGANIZED BY
SUPPORTED BY
7th Pharmacovigilance 2014
21st November 2014, Kohinoor Continental Hotel, Mumbai, India
ASSOCIATE PARTNER

3. 7th Pharmacovigilance 2014
21st November 2014, Kohinoor Continental Hotel, Mumbai, India
CONFERENCE INTRODUCTION:-
After the successful journey of a series of 6 Pharmacovigilance yearly conferences, Virtue Insight is proud to announce its 7th Pharmacovigilance 2014 in India.
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. India’s bio-pharma market forecast to reach $7 billion by FY2015.
Pharmaceutical sales in India are expected to rise by 14.4 per cent to USD 27 billion in 2016 from last year, but the life sciences and health care industry is up against
challenges such as quality management and meeting global standards.
Pharmaceutical companies have been inspected by regulatory authorities for almost 15 years. This has meant that there is now a level of expectation from the
regulators and industry that there has been enough time and knowledge to understand what is required as a responsible licence holder. companies need to ensure that
all pharmaceutical products are managed properly in terms of the collection, assessment and reporting of adverse reactions such that any serious safety issues can be
identified early and acted upon quickly to protect patients from harm. The aim of this conference is that through both a practical review of the purpose of internal
audits to assess a company’s current systems and understand potential pitfalls, there is also a review of the current Regulatory attitudes and mechanisms for
Inspections, the level of findings and penalties which are facing pharmaceutical companies – both big and small; innovator and generic. As the regulatory landscape
continues to evolve it is crucial that you are keeping abreast of the changes impacting the drug safety industry to ensure that your pharmacovigilance strategies are
robust and geared to compliance. In addition to this effective risk management and minimisation efforts and comprehensive benefit: risk analysis of drugs must lay
the foundations for a strong drug safety strategy.
7th Pharmacovigilance 2014 will discuss the pressing concerns confronted with regard to drug safety, addressing the risks, time line, budget constraints, 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. It’s 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, this event 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 7th Pharmacovigilance 2014. 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:-
• Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions
• Identifying the latest regulatory framework for pharmacovigilance
• Crisis management within drug safety
• Impact of technology – learn and explore
• Explaining how to use the data sources and observational research for effective safety analysis
• Latest developments in pharmacovigilance, drug safety and risk management to ensure safer drugs to market
• Stay ahead of computing and electronic communications in pharmacovigilance
• Risk management plans
• Risk/benefit determinations
• Implications for safety reporting in global clinical trials
• Compliance and drug safety
• Training for drug safety - reporting duties, audits and expectations – risk based inspections
• safety reporting in licensing agreement
• Good supply chain management practices for medicine distribution
• Accelerating new medicine introduction in developing world & overcoming challenges
• Analyzing the information on current industry projects and trends
• How will PV activities change with clinical trial transformation initiative?
• Recent successful strategies and business models to bring out new medicines
• Exploiting the pharmacy automations and technologies for enhancement of medication safety
• Determining the steps and strategies for enhancing quality in healthcare
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
TARGET AUDIANCE-INDUSTRY:-
Pharmaceutical organisations, Generic pharmaceutical companies, Contract research organisations, Patient recruitment companies, Government-
Department of health, Non-profit organisations/ Association, Consultans
WHY SHOULD YOU ATTEND?
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

4. 7th Pharmacovigilance 2014
21st November 2014, Kohinoor Continental Hotel, Mumbai, India
08:30 – Coffee and registration – An opportunity to meet and to
network with your conference colleagues.
09:30 – Morning Chair’s opening remarks
V K Sharma, Associate Vice President, Unichem Laboratories
(https://www.linkedin.com/pub/v-k-sharma/23/ba/197)
09:40 – Morning Keynote Address 1:
Sharing the experience of
Pharmacovigilance inspection in order to enhance internal
readiness and to ensure good PV quality management
• Revising GVP module I to stress on the importance of quality focus
within the PV system and report filing
• Improving internal readiness by enhancing the equipment and
training of the individuals involved
• Presenting inspection findings and disclose what authorities expect
to see to ensure favourable reviews upon inspection
• Revising methods to maintain up to date master files to comply
with GVP guidelines
• Providing advice and feedback on the creation of KPIs to determine
the ideal strategy for business
10:10 – Evaluating the process excellence methods in ICSR
operations to improve the quality and process efficiency
• Introducing new opportunities of streamlining and developing
processes to optimise data efficiency and quality at the same time
• Discussing about the tools and solutions for efficient integration of
regional site within the global system
• Finding different ways of how technology can improve the process
flow to maximise efficiency of data
10:40 – Morning Coffee/Tea & Networking
11:00 – Panel Discussion: Keeping updated with the
opportunities and new technology offers to
Pharmacovigilance research and surveillance
• Reviewing current guidelines to check how the required
information has to be treated, stored and reported in order to
comply with guidelines
• Investigating electronic tools to automatically screen the internet
content and to extract relevant information from increasing signal
volumes in order to reduce workload
• Measuring the quality of information against the workload
involved in order to ensure the success of social media strategy
• Increasing opportunities to enhance patient interaction – from
patient diaries to social media blogs – to get information on
customer sentiment
• Discussing the future role of social media in the
pharmacovigilance research and safety processes to evaluate the
benefits and challenges
Moderator:
V K Sharma, Associate Vice President, Unichem Laboratories
(https://www.linkedin.com/pub/v-k-sharma/23/ba/197)
Panellists:
Manish Verma, Director Medical Affairs,
Bhaswat Chakraborty, Senior Vice President,
Sanofi
Cadila
(https://www.linkedin.com/pub/bhaswat-chakraborty/18/34/27)
Manish Shah, General Manager, Global Clinical Operations,
(https://www.linkedin.com/pub/manish-shah/18/678/1a2)
Babita Kirodian, Head of Country Pharmacovigilance,
11:40 – Signals from detection to validation
• What are the challenges faced in signal validation?
• Role and differences in classical and statistical signal detection in the
ongoing safety surveillance of medical products
• Outline on how to apply signal detection within their function based
on possibilities and limitations of methodology and data
• Utilizing information gained through improved collaboration to
improve investigation signals and find potential issues with drugs
• Rising the internal communications to guarantee that signals are
discovered as soon as possible and investigated to the best of the
companies ability
• Calculating the differences between signal detection in clinical trials
and post-authorization to develop action plans for both
12:10 – Role of text mining in pharmacovigilance
• Need to evaluate both structured and unstructured data in
pharmacovigilance
• Text mining for signal detection: is it a reality?
• Applying text mining for the improvement of quality of
pharmacovigilance databases
• Understanding the role of signal detection to maximise your risk
management and to minimise efforts
Mazhar Maruf, Head of Pharmacovigilance, Glenmark
(https://www.linkedin.com/pub/dr-mazhar-maruf/b/303/2b5)
12:40 - Networking luncheon
- Take your discussions
further & build new relationships in a relaxed
& informal setting...
MARKET OVERVIEW & ANALYSIS
CHALLENGES & OPPORTUNITIES
SAFETY – SIGNAL DETECTION
Wockhardt
Bristol
Myers Squibb
(https://www.linkedin.com/pub/babita-kirodian/10/736/8bb)

5. 7th Pharmacovigilance 2014
21st November 2014, Kohinoor Continental Hotel, Mumbai, India
Milind Antani, Head - Pharma LifeSciences,
(https://www.linkedin.com/pub/dr-milind-antani/3/792/22b)
(https://www.linkedin.com/in/abhayphansalkar09)
(https://www.linkedin.com/pub/dr-kamlesh-patel/2/1b1/324)
17:00 – Chairperson’s closing remarks and end of conference
V K Sharma, Associate Vice President, Unichem Laboratories
(https://www.linkedin.com/pub/v-k-sharma/23/ba/197)
17:10 - 18:10 - Networking Drinks
- Take your
discussions further & build new relationships
in a relaxed & informal setting.
RISK MANAGEMENT & PLANNING
13:50 - Panel Discussion - Examining and sharing the best
practice to overcome the challenges of preparing robust
pharmacovigilance risk management and risk minimisation
plans
• Assessing the current complexities and controversies in
pharmacovigilance and management of risk throughout all phases
of development and marketed use
• Exploring optimal strategies for risk assessment; case examples of
risk assessments, minimisation methods and the challenges in
performing high-quality risk management in a global environment
• Understanding the complexities and requirements when identifying
risk for generics and biosimilars; what additional considerations
are made for these products if any?
Indu Nambiar, Clinical Safety Officer,
(https://www.linkedin.com/in/drkarthikbabu)
(https://www.linkedin.com/pub/girish-parhate/1b/704/100)
14:30 – Identifying and implementing the tools to measure
and refine risk management plans and to minimise risk
• Improving and adjusting risk management process by measuring
them correctly
• Using different tools and showcasing their direct impacts on a
company’s drug risk minimisation strategies
• Sharing practical examples of risk minimisation and highlighting
the positive and negative outcomes
• Presenting feedback from agencies in order to verify the
effectiveness of the applied tools
15:00 – Improving quality systems that ensure valuable data
for timely reactions to potential flaws and increased patient
safety
• Producing quality systems to be implemented to bring together the
data received and evaluate cases effectively
• Integrating the newest legislation in order to improve quality
management systems and satisfy regulators
• Troubleshooting problems that arise from poor quality data or data
which reveals issues with the drugs to improve patient safety
• Integration of the quality systems across all affiliates to be sure
that high standards are met across the company
15:30 Afternoon Coffee/Tea & Networking
–
15:50 – EU regulations and its impact
Abhay Chimankar, Head - Global Drug Safety, Cipla
(https://www.linkedin.com/pub/abhay-chimankar/a/794/5a8)
16:20 – Panel Discussion: Overall regulatory expectations -
Feedback on current risk
• Providing guidance on legislation – GVP Module V and XVI – to
clarify authority expectations and to avoid speculation and
differing interpretation of the current guidelines
• Delivering inspection results and experiences in order to address
the uncertainty surrounding the content and effectiveness of
existing risk minimisation plans
• Recognising the importance of consistency and common industry
standards to define important and unimportant risks
• Increasing focus on patient communication to guarantee
maximum patient safety
• Introducing new risk minimisation measures and assessing their
effectiveness
• Addressing the challenges of combining global and local RMPs to
identify possible improvements
• Collaboration with internal stockholders : Medical Affairs , QC, PV
and Regulatory
• Ambiguity and grey area regarding Branded Genrics vs Innovator
products for PV aspects- Indian perspective and current status
Moderator:
Panellists:
Rahul Chauhan, Associate Director – Regulatory Affairs &
Pharmacovigilance,
Abhay Chimankar, Head- Global Drug Safety,
Kamlesh Patel, GM, Medical Affairs & Pharmacovigilance,
Amit Arora, Head Medical Affairs,
Nishith Desai
Associates
Eli Lilly
Cipla
Abbott
Merck Serono
(https://www.linkedin.com/in/arora007)
DATA COLLECTION & MANAGEMENT
REGULATION OVERVIEW & UPDATE
Moderator:
Panellists:
Karthik Babu, Affiliate Pharmacovigilance Head,
Girish Parhate, Senior Manager – Regulatory Affairs,
Vandana Jolad Shivangi, Director,
Boehringer Ingelheim
Sanofi
Bayer
VIaTAL Pharma Consulting

6. FLOOR PLAN:- Book your stalls now before they run out !!!
FLOOR PLAN - Book your stalls now before they run out !!!
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7. Partial list of attendees from our previous Pharmacovigiliance:-
Abbott
Accenture Services
Accutest Research Laboratories
Acunova
Adcock Ingram Healthcare
Agilent Technologies
Ajanta Pharma
Ajaxdotcom
Alembic Pharmaceuticals
Amgen Technology
Apollo Hospitals
Aris Global,
Arklus CTSS
Astellas Pharma
Astrazeneca
Bagdad medical college
Baxter
Bayer Health Care
Bayer Pharmaceuticals
Bharat Serums & Vaccines
Biocon
BioScreening
BioSpectrum India
Bluefish Pharmaceuticals
BMS
Bodhi Global
Boehringer Ingelheim
Bookmytraining.com
Bristol Myers Squibb
Business Vibes
Cadila
CADILA CRO
Cadila Pharmaceuticals
Center for Cellular & Molecular Biology
Chiltern International
Cipla
CISCO SYSTEMS
Clinical Research & Healthcare
Clinigene International
Cliniminds
Clininvent Research
Cognizant Technology Solutions
CSIR Emeritus Scientist
DBMS Consulting
DNA India
Dr Lal Path Labs
Dr Reddys
Ecron Acunova
Ege University
Elder Pharmaceuticals
Eli Lilly
Eli Lilly & Company
Ennovent
Express Pharma
EXTEDO
Famy Care
FDC
Forte Researce
Fresenius Kabi
Oncology
Fulford
Generic Licensing
Glenmark Generics
Global PharmaTek
Going to Meet
Good Compliance Services
HCL Technologies - BPO Services
i3 Research
ICR
IIHMR
Indian Immunologicals
Innovaro
Inventia Healthcare
Ipca LaboratoriesI
ITS-DCHRC
JASIC Asia Bio Network
JB Chemicals & Pharmaceuticals
Johnson & Johnson
K.J Somaiya Medical College
Karmic Labs
Karmic Lifesciences
KEM Hospital
Kinapse
KPMG
L.T. Medical College
Lambda Therapeutic Research
Launtech Teaching Hospital
LG Life Sciences India Pvt. Ltd
Lotus Labs
Lupin Limited
Macro Care
Maharashtra University of Health Sciences
Medical Newstoday
Mega Lifesciences
MGM School of Biomedical Sciences
Micro Therapeutic Research labs
MMS
MSD India
Mumbai University
Mylan Laboratories
Niko Infra Licensing
Nishith Desai Associates
Norwich Clinical Services
Novartis
Oracle Life Sciences
Oviya MedSafe
Panacea Biotec
Pfizer
PharCast
Pharma & Healthcare Insights
Pharma Asia
Pharma Focus Asia
Pharma Mirror
Pharmacovigilance.co.in
pharmaphorum
PharmaVOICE
Piramal Life Sciences
Plethico Pharmaceuticals
PPCE Pvt. Ltd
Provenance research
PVCON Pharmacovigilance Consulting Services- India
Quintiles
Raaj GPRAC
Ranbaxy Research Laboratory
Rasayani Biologics
RegPak BioPharma Consulting
Reliance Life Sciences
Research and Marketing
Roche Products
Saffron Media
Sanofi Aventis
Sciformix Technologies
SIRO Clinipharma
SLARC
SRL
Sun Pharmaceutical Industries
Swami Samarth Pharmatech
Synowledge
TAKE Solutions
Tata Consultancy Services
TCS
Tech Observer
Techsol
Techsol Corporation
Torrent Pharmaceutical Ltd
Torrent Research Center
Until ROI
Veeda Clinical Research
VIVAN Life Sciences
Voisin Consulting Life Sciences
Watson Pharma
Wipro
Wockhardt
Wockhardtin
World Pharma Today
Xylem Clinical research
YourStory.in

8. Registration Form
21st November 2014, Kohinoor Continental Hotel, Mumbai, India
Queries:
Should you have any questions on bookings,
Please feel free to contact us.
Email:
info@virtueinsight.com
Web:
http://www.virtueinsight.com
India Office: Tel: +91 044 64536444
General information Venue:
Kohinoor Continental Hotel
Andheri Kurla Road
Andheri ( E )
Mumbai 400059 - India
Tel: 91 22 66919000 / 91 22 28209999
Payment terms:
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.
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.
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.
Fee:
The conference fee includes lunch, refreshments and conference papers
provided on the day. This fee does not include travel or hotel
accommodation.
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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
RESERVATION PRICING:
Early Bird Discount Rate Till 07th October 2014
1 Day conference per delegate - Fee: INR 06,000 + Tax
Standard Rate (From 08th October 2014)
1 or 2 delegates - per delegate - Fee: INR 07,000 + Tax
Group Discounts
3 or 4 delegates - per delegate - Fee: INR 06,500 + Tax
Group Discounts
For 5 and above delegates - per delegate - Fee: INR 06,000 + Tax
Spot Registration:-
1 Day conference per delegate - Fee: INR 08,000 + Tax
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