1. ARUN BHATT,
DEEPA ARORA,
BHASWAT CHAKRABORTY,
BABITA KIRODIAN,
NIPOM DEKA,
SHASHIDHAR SWAMY,
MANISH VERMA,
KARTHIK BABU,
CHIRAG TRIVEDI,
PRIYA CHATTERJEE,
MILIND ANTANI,
DEEPTI SANGHAVI,
SANDEEP SEWLIKAR,
GIRISH PARHATE,
ANAND HARUGERI,
ClinInvent Research,
Lupin,
Cadila,
Bristol Myers Squibb,
Abbott
Wockhardt,
Sanofi,
Sanofi,
Sanofi,
Merck Serono,
Nishith Desai Associates,
SIRO Clinpharm,
Johnson and Johnson,
Bayer Pharmaceuticals,
President
Vice President- Pharmacovigilance & Global Head- Drug Safety &
Risk Management
Senior Vice President
Head of Country Pharmacovigilance
Regional Pharmacovigilance Manager, Asia, Africa & Middle East
Head Pharmacovigilance
Director Medical Affairs
Affiliate Pharmacovigilance Head
Director & Head of Clinical Study Unit
Director - Regulatory Affairs
Partner In-Charge - Pharma LifeSciences
Patient Safety and Regulatory Affairs Manager
Senior Medical Writer
Manager – Clinical Affairs
Senior Manager - Regulatory Affairs
Astrazeneca,
MOHAMMAD SALIM, Pfizer,
Country Safety Lead
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Legislation, policies, systems, technology, communication strategies
Audits and Inspections
Benchmarking drug safety and pharmacovigilance
Improving patient care and safety
Safety reporting
PV for Biologics – new legislation, new requirements
Challenges and Opportunities
Enhancing quality in healthcare
Signal detection
Proper balance in relationships: Sponsor – Site – CRO & Patients
Developing regulatory framework
Be part of a major networking opportunity
Network in our combined exhibition and catering area
Key Speakers Include
Special reasons to 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.
Why Should You Attend
Learn, Partner, Innovate,
Suceed
Book now...
Register now to secure your seats
Call +91 44 64536444
or
email - info@virtueinsight.com
“Ensuring safer drugs to market by analyzing latest developments in pv, drug safety and risk management”
2nd September 2015, Kohinoor Continental Hotel - Mumbai, India
Conference Hashtag - #VI_Pharma
9th
Pharmacovigilance
2015
RAJASHRI SURVASE OJHA,
VANDANA JOLAD,
Raaj GPRAC,
VIaTAL Pharma,
Founder and MD
Director

2. ORGANIZED BY
SUPPORTED BY
FOR DELEGATE REGISTRATIONS:-
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 & enable
them to network with the industry key personnel.
Delegate Registration - delegate@virtueinsight.com
FOR 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.
Sponsorship Enquires sponsor@virtueinsight.com-
9th Pharmacovigilance 2015
2nd September 2015, Kohinoor Continental Hotel - Mumbai, India
GOLD PARTNER

3. CONFERENCE INTRODUCTION:-
After the successful journey of a series of 8 Pharmacovigilance yearly conferences, Virtue Insight is proud to announce its 9th 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. 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.
Regulatory authorities have inspected pharmaceutical companies 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 license 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 minimization efforts and comprehensive
benefit: risk analysis of drugs must lay the foundations for a strong drug safety strategy.
9th Pharmacovigilance 2015 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 9th Pharmacovigilance 2015. 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:-
• Update yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practice in PV
• Developing Pharmacovigilance into high quality management system and its components
• Audit and Inspection: Realistic steps for a fruitful consequence
• Benchmarking drug safety and pharmacovigilance
• Improving patient care and safety in relation to use of medicines and all medical and paramedical interventions
• How to use the data sources and observational research for effective safety analysis
• Training for drug safety - reporting duties, audits and expectations – risk based inspections
• Safety reporting in licensing agreement
• PV for Biologics – new legislation, new requirements
• Challenges and Opportunities in PV lifecycle management
• Good supply chain management practices for medicine distribution
• Accelerating new medicine introduction in developing world & overcoming challenges
• Developments in Pharmacovigilance, drug safety & risk management to ensure safer drug
• Determining the steps and strategies for enhancing quality in healthcare
• Emerging signal detection data gathering successful tools to highlight emerging risks
• Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
• The developing regulatory framework in advanced and developing markets
• Accelerating new medicine introduction in developing world & overcoming challenges
• Be part of a major networking opportunity
WHO WILL YOU MEET:-
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
From the following:
Pharmaceutical organizations, Generic pharmaceutical companies, Contract research organizations, Patient recruitment companies,
Government- Department of health, Non-profit organizations/ Association, Consultants
9th Pharmacovigilance 2015
2nd September 2015, Kohinoor Continental Hotel - Mumbai, India
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. 08:30 – Coffee and registration - An opportunity to meet and to
network with your conference colleagues
09:30 – Morning Chair's opening remarks
09:40 – Morning Keynote Address 1: Indian Regulations and
Patient Safety during Clinical Trials
ClinInvent Research
10:10 – Lessons to learn from management of safety data from
patient support and market research programs
10:40 – Morning Coffee/Tea & Discussion
• Patient safety perspective during clinical trials
• Indian Regulatory spectrum for protecting patient safety
• Global regulatory scenario for patient safety
• Recommendations for Indian regulatory system for patient
protection clinical trials
President,
• Overview of legal requirements
• Perspectives in handling of safety information
• Collaborations with service provider
• Revealing the true value of patient recruitment
• The evolution and implementation of patient-centered trials
• Improve Protocol Feasibility, Trial conduct and operations by
learning from a key partner in research
• Evolution of physician and patient retention in post-marketing
and real-world research – Use of Prediction and prevention
methods to optimize participation
• How pharmacists can be pivotal in helping patients
ARUN BHATT,
11:00 – Keynote Panel Discussion: Challenges and Opportunities
in PV lifecycle management
• Staying ahead in the race - Updates on PV - Current trends for
PV, and new and future guidelines
• Exploring the current and future drug safety landscape
• What can we learn from successful experiences from RoW?
• Identifying the key opportunities for biopharmaceutical
outsourcing in the area of PV
• Litigation, risk and latest developments and trends within PV
technology
• Open innovation/cross-Industry collaboration and the current
state of affairs in pharma
• How to create a proactive drug safety culture?
11:40 – Adverse event monitoring in clinical trials and post-
marketing surveillance
12:10 - Effective Pharmacovigilance: from Information to
Clinical Practice
,
Lupin
• Core and emerging challenges to monitoring adverse drug
events
• Types of ADR, Methods of ADR Monitoring including ICSR
• Formulating improvements and establishing key
performance indicators for continual quality assessment
• Timely and effective benefit-risk communication to patients
and physicians
• Combining adverse event monitoring throughout clinical
trials and post-marketing surveillance
• Establishing key performance indicators for making timely
safety reports and continuous quality improvements
• Challenges of running and reporting ADRs in India
• Total PV includes Identification, Characterization,
Management and Prevention of ADRs
• Industry Focus from compliance perspective is mainly on
identification of new ADRs
• Optimum utilization of this knowledge is desirable to
prevent ADRs or minimize the associated morbidity &
mortality
• All stakeholder should be involved in communication
Vice President- Pharmacovigilance & Global
Head- Drug Safety & Risk Management,
DEEPA ARORA
MARKET OVERVIEW & ANALYSIS
CHALLENGES & OPPORTUNITIES
9th Pharmacovigilance 2015
2nd September 2015, Kohinoor Continental Hotel - Mumbai, India
• Dissecting the challenges in vaccine safety surveillance
• Evaluating the various aspects of pharmacovigilance in
conducting trials.
Founder and MD,
Head Pharmacovigilance,
Affiliate Pharmacovigilance Head,
Manager – Clinical Affairs,
Regional Pharmacovigilance Manager, Asia,
Africa & Middle East,
Patient Safety and Regulatory Affairs
Manager,
Moderator:
Raaj GPRAC
Panellists:
Wockhardt
Sanofi
Johnson and
Johnson
Abbott
Astrazeneca
RAJASHRI SURVASE OJHA,
SHASHIDHAR SWAMY,
KARTHIK BABU,
SANDEEP SEWLIKAR,
NIPOM DEKA,
ANAND HARUGERI,

5. 12:40 – Networking luncheon
14:00 – PV for Biologics – new legislation, new requirements
14:40 – Safety surveillance and risk management lifecycle
15:10 – Afternoon Tea/Coffee
• High level overview of why biologics and their specific
characteristics which give rise to unique challenges for PV
• Importance of accurate track and trace
• Requirements of the PV legislation and what it means for
Stakeholders
• Signal detection and – management
• Alternative and lean approaches to trial planning and
execution
• Safety surveillance integrating multiple data sources
• Assessment of risks and important risks
• Risk management and risk minimization
• Identify the most important challenges towards improved
safety and monitoring of drugs.
• Capturing adverse events - best practices for dealing with
diverse types of data from multiple sources.
• Analysis of a risk management program using an innovative
claims data approach
17:00 Chairperson’s closing remarks and end of conference–
17:10 - 18:00 - Networking Drinks - Take your
discussions further & build new
relationships in a relaxed & informal setting
QUALITY – SAFETY – SIGNAL DETECTION
REGULATORY
9th Pharmacovigilance 2015
2nd September 2015, Kohinoor Continental Hotel - Mumbai, India
15:30 Panel Discussion The necessary shift of Sponsors and
CROs from adversaries to partners
– –
• In what way can the realistic expectations, clear
communications, shared understandings, practical policies,
and efficient problem resolution methods be developed
between sponsors, sites & CROs
• Patient-centric approach to clinical trials
• How will CRO's analyse the current opportunities to invest in
early stages of drug discovery or biotechnology start-ups?
• The current perspectives on the future of outsourcing in Asia
• Advantages of a collaborative clinical trial alliance for greater
efficiency and cost reduction
• Best practices for aligning critical performance and operational
data between sponsor/CRO
• An overview of realized performance gains through
partnership
• The performance impact of a shared decision making platform
• Integrating clinical trial supply by streamlining the trial set up
and managing drug inventory for successful partnerships
SPONSOR – SITE – CRO - PATIENTS
16:10 Panel Discussion The developing regulatory
framework in advanced and developing markets
Moderator:
Nishith Desai Associates
Panellists:
Bayer
Pharmaceuticals
Bristol Myers Squibb
VIaTAL Pharma
Merck
Serono
Sanofi
– –
• Keep abreast with the changing regulations of PV
• Determining where future challenges could arise
• A brief recap of recent regulatory developments. Ensuring
you comply with market requirements
• Current PV practices
• PRAC: – regulatory & industry perspective
• Regulatory considerations towards staffing and recruitments
Partner In-Charge - Pharma LifeSciences,
Senior Manager - Regulatory Affairs,
Head of Country Pharmacovigilance,
Director,
Director - Regulatory Affairs,
Director Medical Affairs,
MILIND ANTANI,
GIRISH PARHATE,
BABITA KIRODIAN,
VANDANA JOLAD,
PRIYA CHATTERJEE,
MANISH VERMA,
Moderator:
VIaTAL Pharma
Panellists:
SIRO Clinpharm
Cadila
Sanofi
Pfizer
Director,
Senior Medical Writer,
Senior Vice President,
Director & Head of Clinical Study Unit,
Country Safety Lead,
VANDANA JOLAD,
DEEPTI SANGHAVI,
BHASWAT CHAKRABORTY,
CHIRAG TRIVEDI,
MOHAMMAD SALIM,

6. FLOOR PLAN:- Book your stalls now before they run out !!!
1
2 5
3
4
CONFERENCEHALL1
CONFERENCEHALL2
CONFERENCEHALL3
1
Coffee / Tea / Networking Area
POOL
SIDE AREA
NETWORKING
LUNCHEON
4
5 6
2
3
REGISTRATION
DESK
6
9th Pharmacovigilance 2015
FLOOR PLAN - Book your stalls now before they run out !!!
7
7

7. Aark Store
Abbott
Abbott India
Abbvie
Accenture Services
Accutest Research Laboratories
Actelion Pharmacetuicals
Acton Biotech
Acunova
ADAMAS Consulting
Adcock Ingram Healthcare
Aegerion Pharmaceuticals
Afra Pharma Consultant
Agency for Medical Products & Medical
Device of The Republic of Slovenia
Agilent Technologies
Ajanta Pharma
Ajaxdotcom
Alembic Pharmaceuticals
Alkem Labs
AMCo
Amgen
Amgen Technology
Apollo Hospitals
Aprova
Aptiv Solutions
Archimed Medical Communication
Aris Global
Arklus CTSS
Astellas Pharma
Astrazeneca
Auden Mckenzie (Pharma Division)
Aurobindo
AXESS
Azin Pharma
Bagdad medical college,
Barrington James
Baxter Healthcare
Bayer
Bayer Pharma AG
Bayer Pharmaceuticals
Bharat Serums & Vaccines
Biocon
BioLinx India
Biological E
BioSpectrum India
Biosphere Clinical Research
BJ Medical college
Bluefish Pharmaceuticals
Bodhi Global
Boehringer Ingelheim
Bookmytraining.com
Boots Pharmaceuticals
Bristol Myers Squibb
Bristows
Business Vibes
Business Wire
Cadila Pharmaceuticals
Cambridge Regulatory Services
Catalyst Clinical Services
Celgene Europe
Celon Laboratories
Center for Cellular & Molecular Biology
Centre for Clinical Research and Training
Chiltern International
Cipla
Ciron Drugs & Pharmaceuticals
CISCO SYSTEMS
CKA Group
Clearight Infotech
Clinical Research & Healthcare
Clinical Research Learning and Dev
Cliniminds
Clininvent Researc
Cognizant
Cognizant Technology Solutions
Consultant Psychologist & Freelance Journalist
CSD MR UK
CSIR
Partial list of attendees from our previous Pharmacovigiliance:-
DNA India
Dr Lal Path Labs
Dr. Ebeling & Assoc
Dr. Reddy's Laboratories
Drug Safety Research Unit (DSRU)
Drug Safety Solutions
DSRU
Ecron Acunova
EGA (European Generic Medicines Association)
Ege University
Egis Pharmaceuticals
Eisai Pharmaceuticals
ELC Research
Elder Pharmaceuticals
Eli Lilly & Company
Emcure Pharmaceuticals
Ennovent
Espire Health Research
EUDRAC
European Regulatory Solutions
Express Pharma
EXTEDO
Famy Care
FDC
Flamingo Pharmaceuticals
Foresight group
Forte Research
Fresenius Kabi Oncology
Fulford
GCP QA Auditing and Consulting Inc
Generic Licensing
Genpact
German Pharmaceutical Industry Association
Gilead Sciences International
GlaxoSmithKline Pharmaceuticals
Glenmark
Global PharmaTek
Going to Meet
Good Compliance Services
Gufic Biosciences
HCL Technologies - BPO Services
Healthcare Data
Hetero Labs
Hikma Pharmaceuticals
Hydrogen Group
i3 Research
ICPC.biz
ICRI
IIHMR, Jaipur.
IMS Health
Indian Immunologicals
Innovaro
Intas Pharmaceuticals
Inventia Healthcare
Inventiv Health Clinical
IPCA Laboratories
IPPro Lifesciences
ITS-DCHRC
Janssen Infectious Diseases
JASIC Asia Bio Network
JB Chemicals & Pharmaceuticals
JensonR+ Limited
Johnson & Johnson
CSL Behring
Cytel Statistical Software & Services
Dabur Indiah
Daiichi Sankyo Development
DBMS Consulting
Deloitte Consulting
K.J Somaiya Medical College
Karmic Lifesciences
KEM Hospital
Keyrus Biopharma
Kinapse
KJ Somaiya Medical college
KPMG
Kusum Healthcare
Kuwait National Petrolium Company
Kuwait University, Faculty of Pharmacy
L.T. Medical College
Lambda Therapeutic Research
Launtech Teaching Hospital
LG Life Sciences
Lotus Labs
Lupin
Macleods Pharmaceuticals
Macro Care
Maharashtra University of Health Sciences
Manipal AcuNova
Markets&Markets
Medac UK
Medanta-The Medicity
Medical Newstoday
Medicounts Life Sciences
Medlmmune
MedZine
Mega Lifesciences
Megawecare
Merck Serono
Merck Sharp & Dohme
MHRA
Micro Therapeutic Research labs
MMS
MSD India
Mundipharma Research
Mylan Laboratories
Nanokinetik
Navitas Life Sciences
NDA
Nelsons
Netherlands Foreign Investment Agency
Nicovations
Niko Infra Licensing
Nishith Desai Associates
Norweigen Medicines Agency
Norwich Clinical Services
Novartis
Novartis Consumer Health
Novartis Pharma S.A.S.
Novo Nordisk
Oracle Corporation
Oracle Life Sciences
Orion Pharma
Orphan Europe
Otsuka Europe Dev & Commericalisation
Oviya Medsafe
OXON Epidemiology
Panacea Biotec
PAREXEL International
PCS Pharmacovigilance LTD
PDP Couriers
Pfizer
Pharma & Healthcare Insights
Pharma Asia
Pharma Focus Asia
Pharma Mirror
Pharmacosmos
pharmaphorum
PharmaVOICE
Pharmcast
Pierre Fabre Medicament
Piramal Healthcare
Piramal Life Sciences
Plethico Pharmaceuticals
PPCE Pvt. Ltd
PPD
PRA Health Sciences
Prism Ideas
ProductLife
Provenance research
Public Health Foundation of India
PVCON Pharmacovigilance Consulting Services
Quintiles
Raaj GPRAC
Ranbaxy Laboratories
Ranbaxy Research Laboratory
Rasayani Biologics
Real Staffing
RegPak BioPharma Consulting
Reliance Life Sciences
Results Healthcare
Rite-Aid Pharmacy
Roche Pharmaceuticals
Roche Products
Saffron Media
Sandoz
Sanofi
Sanofi Aventis
Sanofi-Aventis (Suisse) SA
Sciformix Technologies
Shantha Biotechnics
Shasun Pharmaceuticals
Shionogi
Sidley Austin
SIRO Clinpharm
Sitec Labs Pvt Ltd
SLARC
Springer
Sri. Devaraj URS Medical College
SRL
ST. JAMES’S PLACE
Stallergenes
Stempeutics Research
Sticares Interact
Strides Arcolab
Sun Pharmaceutical Industries
Swami Samarth Pharmatech
Symbiorph Clinical Trialogy
Symogen
Synchron Research Services
Synowledge
TAKE Solutions
Takeda Oncology: Millennium Pharma
Takeda Pharmaceuticals
TauRx Therapeutics
TCS
Tech Observer
Techsol Corporation
Techsol Systems
Teofarma S.R.L
The Medicines Company
Thinki
TN Medical College&BYL Nair Hospital
Torrent Pharmaceuticals
Torrent Research Center
Transcrip Partners LLP
UBC
UCB Celltech
UCB India
Unichem Laboratories
United BioSource Corporation
University of Hertfordshire
Until ROI
USV
Veeda Clinical Research
Vetmedico bvba
VIaTAL Pharma Consulting
Vigi Medsafe
VIVAN Life Sciences
Voisin Consulting Life Sciences
Watson Pharma
Weifa AS
Wipro
Wipro BPO
Witness
Witness Magazine
Wockhardt
World Customs Organization
World Pharma Today
Xylem Clinical research
Yes Regulatory Healthcare Services
YourStory.in
Zigzag Associates
Zydus Cadila

8. Queries:
Payment terms:
Substitutions/name changes or cancellations:
Indemnity:
Fee:
How we will contact you:
Should you have any questions on bookings,
Please feel free to contact us.
Email:
Web:
India Office: Tel: +91 044 64536444
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.
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.
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.
The conference fee includes lunch, refreshments and conference papers
provided on the day. This fee does not include travel or hotel
accommodation.
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.
Kohinoor Continental Hotel
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Tel: 91 22 66919000 / 91 22 28209999
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1 Day conference per delegate - Fee: INR 08,000 + Tax
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