This document provides information about the 5th Pharmacovigilance Congregation conference taking place on November 20th, 2013 in Mumbai, India. The conference will discuss ensuring safer drugs reach the market through analyzing developments in pharmacovigilance, drug safety, and risk management. It will feature keynote speakers from various pharmaceutical companies and overviews of the latest challenges and opportunities in pharmacovigilance. The event aims to provide a platform for stakeholders to discuss best practices and advancing pharmacovigilance in India.

1. Conference Hashtag - #VI_Pharma
5th Pharmacovigilance Congregation 2013
20th November 2013, Kohinoor Continental Hotel, Mumbai, India
“Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance
drug safety and risk management”
Key Speakers Include:Deepa Arora, Global Head, Drug Safety & Risk Management, Lupin
Arun Bhatt, President, Clininvent Research
Prashant Bodhe, Director, CliniSearch
Chetna Desai, Professor of Pharmacology, BJ Medical College (Ahmedabad)
Parminder Kaur, Owner & Regulatory Affairs & PhV Consultant (QPPV), RegPak BioPharma
Consulting (Netherlands, UK)
Babita Kirodian, Head - Pharmacovigilance, Bristol-Myers Squibb
Rajani Rokade, Head - Pharmacovigilance, Sanofi Aventis
Veena Rajan, Head - Patient Safety, AstraZeneca
Sofi Joseph, Head - Regulatory Operations, Pfizer
Manish Mistry, Medical Director, Novartis
Abhay Chimankar, Global Safety Officer, Cipla
Manish Shaw, Head Pharmacovigilance, Wockhardt
Girish Parhate, Senior Manager – Regulatory Affairs, Bayer
Indu Nambiar, Clinical Safety Officer, Boehringer Ingelheim
Deepti Sanghavi, Senior Medical Writer - Medical Writing, SIRO Clinpharm
Milind Antani, Head – Pharma LifeSciences group, Nishith Desai Associates
Anish Desai, Director Medical Affairs and Clinical Operations, Johnson & Johnson
Plus Many More...

2. 5th Pharmacovigilance Congregation 2013
20th November 2013, Kohinoor Continental Hotel, Mumbai, India
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3. 5th Pharmacovigilance Congregation 2013
20th November 2013, Kohinoor Continental Hotel, Mumbai, India
CONFERENCE INTRODUCTION:After the successful journey of our previous 4 years of annual Pharmacovigilance conferences, Virtue Insight is proud to announce its
5th Pharmacovigilance Congregation 2013 in India.
The emerging markets are rapidly evolving to compete with the standards set by the developed world. Many life sciences companies in India are
now focusing strongly on drug safety management and pharmacovigilance. Demand from emerging markets is opening up various opportunities
across multiple sectors. Life sciences companies have several compelling reasons to build a presence in emerging markets. By 2020, the size of
the global pharmaceutical market is anticipated to grow to USD 1.3 trillion, with the E7 countries -- Brazil, China, India, Indonesia, Mexico, Russia
and Turkey. The rapid induction in the market throws up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base.
All medicines (pharmaceuticals and vaccines) have side effects. Some of these side effects are known, while many are still unknown even though
that medicine has been in clinical use for several years. It is important to monitor both the known and hitherto unknown side effects of medicines
in order to determine any new information available in relation to their safety profile. In a vast country like India with a population of over 1.2
Billion with vast ethnic variability, different disease prevalence patterns, practice of different systems of medicines, different socioeconomic status,
it is important to have a standardized and robust pharmacovigilance and drug safety monitoring programme for the nation. Collecting this
information in a systematic manner and analyzing the data to reach a meaningful conclusion on the continued use of these medicines. More
clinical research activities being conducted in India, there is an immense need to understand the importance of pharmacovigilance and how it
impacts the life cycle of the product. A good pharmacovigilance will easily identify the risk factors in the shortest time so that the harmful effects
can be avoided or minimized.
5th Pharmacovigilance Congregation 2013 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. 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. Also it can help you control your product's lifecycle, your
patient's trust, and your revenue. Hence, this conference 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 5th Pharmacovigilance Congregation 2013. 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:•
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Exploiting the latest technologies, methodologies & automations 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
Recent successful strategies and business models to bring out new medicines
How will PV activities change with Clinical Trial Transformation Initiative?
Identifying essential antidote requirements and learn to implement best practices in drug safety and surveillance
Exploiting the pharmacy automations and technologies for enhancement of medication safety
Stay ahead of computing and electronic communications in pharmacovigilance
Latest developments in pharmacovigilance, drug safety and risk management to ensure safer drugs to market
Establishing the importance of pharmacovigilance for the safety of the patient
Determining the steps and strategies for enhancing quality in healthcare
Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions
Analyzing the information on current industry projects and trends
Identifying the latest regulatory framework for pharmacovigilance
Global marketing strategies in order to engage with regulatory centres of excellence on pharmacovigilance
Accelerating new medicine introduction in developing world & overcoming challenges
Explaining how to use the data sources and observational research for effective safety analysis
Good supply chain management practices for medicine distribution
Be part of a major networking opportunity
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
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. 5th Pharmacovigilance Congregation 2013
20th November 2013, Kohinoor Continental Hotel, Mumbai, India
08:30 – Coffee and registration – An opportunity to meet and to
network with your conference colleagues.
11:30 – Morning coffee & Discussion
11:50 – Signal Detection in Pharmacovigilance
09:30 – Morning Chairperson opening remarks
Prashant Bodhe, Director, CliniSearch
(http://www.linkedin.com/pub/dr-prashant-bodhe/6/b88/2a5)
09:40 – Morning Keynote Address 1: Impact of Recent
Regulations on Pharmacovigilance in India
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Recent compensation rules
Reporting process
SAE - related to trial or drug
Causality assessment
Safety data base - local / global drug development
Arun Bhatt, President, Clininvent Research
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12:20 - Generating and assessing critical safety data during
development
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(http://www.linkedin.com/pub/arun-bhatt/5/431/958)
10:20 – Morning Keynote Address 2: Bridging the gap of
clinical trial pharmacovigilance to post-marketing phase
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Understanding the various deliverables starting from the
clinical phase
How to gather the safety information data during clinical
trials and reflect the same into post marketing activities?
Assessing the risks and new information gathered after
marking and its effect on the ongoing trials as well as the
post marketing phase
Parminder Kaur, Owner & Regulatory Affairs & PhV Consultant
(QPPV), RegPak BioPharma Consulting (Netherlands, UK)
Methods and effective detection of signals
Role of IT in enhancing signal detection effectiveness
Regulatory requirements & approach to signal detection
Importance of astute clinical perspective
What are the consequences of over-reliance on technology
Work to international standards by meeting regulatory
requirements for product safety
Perform signaling and risk management functions
Collect, assess, report, and analyze adverse events
Create signaling analyses based on FDA Good Pharmacovigilance
Practices
12:50 - Networking luncheon - Take your discussions
further & build new relationships in a relaxed
& informal setting...
Afternoon Chairperson opening remarks
Prashant Bodhe, Director, CliniSearch
(http://www.linkedin.com/pub/dr-prashant-bodhe/6/b88/2a5)
13:50 – Afternoon Keynote - Panel Discussion - In
pharmacovigilance where does fault lie?
(http://www.linkedin.com/pub/parminderkaur/3/6b2/5b4)
10:50 – Panel Discussion: What are the latest challenges in
pharmacovigilance and the opportunities?
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Challenges to PV compliance currently
Extensive use of traditional medicines and poor spontaneous
reporting
Rapid introduction of several new molecules and inadequate post
marketing surveillance
Identifying the key opportunities for biopharmaceutical
outsourcing in the area of PV
Litigation, risk and latest developments and trends within PV
technology
Case studies: what can we learn from successful experiences
from RoW?
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Updates on ADR reporting requirements
Adequate sharing of information between stake holders
No rapport with practising physicians & peripheral centres
Increasing availability of drugs, due to which too many drugs
and irrational combinations and aggressive marketing
Irrational practice of treatment without provisional diagnosis,
Wrong choice & incorrect dose, lack of documentation, Resultant
medical errors leading to ADEs and not necessarily ADRs
Pharmacovigilance Audits from a Sponsor’s Perspective:
Risk Management Plans (RMPS) & Risk Evaluation Mitigation
Strategy (REMS)
Moderator –
Prashant Bodhe, Director, CliniSearch
(http://www.linkedin.com/pub/dr-prashant-bodhe/6/b88/2a5)
Moderator –
Panelists –
Prashant Bodhe, Director, CliniSearch
Babita Kirodian, Head Pharmacovigilance, Bristol-Myers Squibb
(http://www.linkedin.com/pub/dr-prashant-bodhe/6/b88/2a5)
(http://www.linkedin.com/pub/babita-kirodian/10/736/8bb)
Panelists –
Parminder Kaur, Owner & Regulatory Affairs & PhV Consultant
(QPPV), RegPak BioPharma Consulting (Netherlands, UK)
Veena Rajan, Head, Patient Safety, AstraZeneca
(http://www.linkedin.com/pub/parminderkaur/3/6b2/5b4)
(http://www.linkedin.com/pub/veena-rajan/9/533/375)
Chetna Desai, Professor of Pharmacology, BJ Medical College
(Ahmedabad) (http://www.linkedin.com/pub/chetna-desai/9/40/92b)
Rajani Rokade, Head - Pharmacovigilance, Sanofi Aventis
(http://www.linkedin.com/pub/dr-rajani-rokade/22/89a/521)
Manish Shaw, Head Pharmacovigilance, Wockhardt
Anish Desai, Director Medical Affairs and Clinical Operations,
Johnson & Johnson (http://www.linkedin.com/pub/dr-anish-desai-m-dfcp/8/966/800)

5. 5th Pharmacovigilance Congregation 2013
20th November 2013, Kohinoor Continental Hotel, Mumbai, India
14:30 – Benchmarking Drug Safety and Pharmacovigilance
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How to choose among the available drug safety vendors
Discover how to improve supplier-client relationship
How to optimize and strengthen your drug safety team?
Importance of improving your communication with the FDA
Identify the most important challenges towards improved safety
and monitoring of drugs.
Aligning the team and assigning responsibilities for investigational
and post-market products
Abhay Chimankar, Global Safety Officer, Cipla
(http://www.linkedin.com/pub/abhay-chimankar/a/794/5a8)
15:00 – Afternoon Coffee & Discussion
15:20 – Pharmacovigilance Benefit/Risk assessments and
striking the right balance
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Risk management throughout a product’s lifecycle: integrated
safety business
Implementation and monitoring of a risk management plan
Maintaining constant pharmacovigilance and making the best pre
and post marketing safety judgements
Making accurate determinations of whether a product is in fact
safe and what can alter the determinations
16:20 – Panel Discussion: Update on Indian PV regulations &
Overcoming regulatory challenges in Asian PV market
–Today & Tomorrow
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Update on PVPI, India regulation - way forward
Developing regulatory strategies for new products which comply
with global safety requirements
ICMR guidelines’ impact on pharmaceutical industry –how to
adjust to the new guidelines?
Clarifying PV and ADR reporting guidelines and fields
Strategic challenges in the evolution of Indian PV regulations in
next decade
Keep abreast with the changing International regulations of PV
Moderator –
Milind Antani, Head – Pharma LifeSciences Group, Nishith
Desai Associates (http://www.linkedin.com/pub/milindantani/2/69a/5b5)
Panelists –
Deepa Arora, Global Head, Drug Safety & Risk Management,
Lupin (http://www.linkedin.com/pub/deepa-arora/31/67a/794)
Sofi Joseph, Head – Regulatory Operations, Pfizer
(http://www.linkedin.com/pub/sofi-joseph/12/307/632)
15:50 – Panel Discussion - PV Audit & inspections preparation, implementation and lessons to be learnt
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What are relevant interactions during the PV inspections
Audits to develop, establish, promote and align with
international standards
Identifying best criteria for PV inspections to maintain constant
vigilance
Standardizing PV auditing procedures
Integrating PV into clinical practice, through training and
education
Indu Nambiar, Clinical Safety Manager, Boehringer
Ingelheim (http://www.linkedin.com/pub/indu-nambiar/7/1a8/8a)
Girish Parhate, Senior Manager – Regulatory Affairs, Bayer
(http://www.linkedin.com/pub/girish-parhate/1b/704/100)
17:00 – Afternoon Chairperson's closing remarks
Prashant Bodhe, Director, CliniSearch
(http://www.linkedin.com/pub/dr-prashant-bodhe/6/b88/2a5)
Moderator –
Deepti Sanghavi, Senior Medical Writer, SIRO Clinpharm
(http://www.linkedin.com/pub/dr-deepti-sanghavi/5/591/b76)
Panelists –
Abhay Chimankar, Global Safety Officer, Cipla
(http://www.linkedin.com/pub/abhay-chimankar/a/794/5a8)
Manish Mistry, Medical Director, Novartis
(http://www.linkedin.com/pub/manish-mistry/9/479/34a)
17:10 - 18:00 - Networking Drinks - Take your
discussions further & build new relationships
in a relaxed & informal setting.

6. 5th Pharmacovigilance Congregation 2013
FLOOR PLAN - Book your stalls now before they run out !!!
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CONFERENCE HALL 2
3
CONFERENCE HALL 3
POOL
SIDE AREA
NETWORKING
LUNCHEON
CONFERENCE HALL 1
5
4
Coffee / Tea / Networking Area
REGISTRATION
DESK
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6
1
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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
Quintiles
Glenmark Generics
Raaj GPRAC
Global PharmaTek
Ranbaxy Research Laboratory
Going to Meet
Rasayani Biologics
Good Compliance Services
RegPak BioPharma Consulting
HCL Technologies - BPO Services
Reliance Life Sciences
i3 Research
Research and Marketing
ICR
Roche Products
IIHMR
Saffron Media
Indian Immunologicals
Sanofi Aventis
Innovaro
Sciformix Technologies
Inventia Healthcare
SIRO Clinipharma
Ipca LaboratoriesI
SLARC
ITS-DCHRC
SRL
JASIC Asia Bio Network
Sun Pharmaceutical Industries
JB Chemicals & Pharmaceuticals
Swami Samarth Pharmatech
Johnson & Johnson
Synowledge
K.J Somaiya Medical College
TAKE Solutions
Karmic Labs
Tata Consultancy Services
Karmic Lifesciences
TCS
KEM Hospital
Tech Observer
Kinapse
Techsol
KPMG
Techsol Corporation
L.T. Medical College
Torrent Pharmaceutical Ltd
Lambda Therapeutic Research
Torrent Research Center
Launtech Teaching Hospital
Until ROI
LG Life Sciences India Pvt. Ltd
Veeda Clinical Research
Lotus Labs
VIVAN Life Sciences
Lupin Limited
Voisin Consulting Life Sciences
Macro Care
Watson Pharma
Maharashtra University of Health Sciences
Wipro
Medical Newstoday
Wockhardt
Mega Lifesciences
Wockhardtin
MGM School of Biomedical Sciences
World Pharma Today
Micro Therapeutic Research labs
Xylem Clinical research
MMS
YourStory.in
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

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20th November 2013, Kohinoor Continental Hotel, Mumbai, India
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