Conference Hashtag - #VI_Pharma

Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance,

drug safety and risk management
1st December 2016, Kohinoor Continental Hotel, Mumbai, India

Key Speakers Include

JEAN CHRISTOPHE DELUMEAU, Bayer HealthCare (Singapore),
Head of Pharmacovigilance Asia-Pacific

JESSICA THONGCHAREN, Takeda Pharmaceuticals (Singapore),

Associate Director Pharmacovigilance

V. KALAISELVAN, Indian Pharmacopoeia Commission,

Ministry of Health & Family Welfare, Govt. of India,
Principal Scientific Officer

SUDHIR PAWAR, Indian Pharmacopoeia Commission,

Coordinator - ADR monitoring Center at LTMMC & GH, Under
Pharmacovigilance Programme Of India (PvPI)

ARUN BHATT, Consultant Clinical Research & Development

BHASWAT CHAKRABORTY, Cadila,
Senior VP & Chair, Research and Development Core Committee

MANISH VERMA, Sanofi,

Director Medical Affairs

JAMAL BAIG, Merck Sharp & Dohme,

Country Head- Pharmacovigilance

SIDDHARTH DESHPANDE, KEM Hospital,

Assistant Professor Department of Clinical Pharmacology

ABHAY CHIMANKAR, Cipla,

Head, Global Drug Safety

SANDESH SAWANT, Wockhardt,

Head, Clinical Operations (India and EM)

ABHAY PHANSALKAR, Cipla,

Head Clinical Trials

GURPREET SINGH, Novartis,

Head Vendor Management, Drug Safety & Epidemiology

MILIND ANTANI, Nishith Desai Associates,

Partner In-Charge Pharma LifeSciences

PRAVIN GHADGE, Reliance Life Sciences,

Head - Medical Writing & Pharmacovigilance

PRANJAL BORDOLOI, Veeda Clinical Research,

AVP - Medical Affairs and Pharmacovigilance

PRASHANT BODHE, CliniSearch,

Director

DEEPTI SANGHAVI, Tata Consultancy Services,

Assistant Manager-Medical Writing

SANKET SAWANT, SIRO Clinpharm,

Strategy & Business Development Partner

POOJA JADHAV, Sun Pharmaceuticals,

Manager

GODHULI CHATTERJEE, Sanofi-aventis,

Senior Medical Advisor and Clinical Safety Officer

Plus many more...

Special Reasons To Attend

Updates - legislation, policies, systems, technology
Lessons to learn - Pharmacovigilance Programme of India
(PvPI)
Clinical Trial Safety: Shift from Explanatory to Pragmatic Trials
Developing pharmacovigilance into high quality management
system and its components
Adapting Risk Management Plans (RMPs) to Asia
Changing landscape of PV technologies
Integrate digital health initiative to minimize risks and enhance
patient safety
PV processes: Outsourcing vs. Capacity building
Ensuring compliance in Patient Support Program (PSP)
Mobile apps for medication adherence in pharmacovigilance
Using big data to advance drug safety
Regulatory updates and development
Accelerating new medicine introduction in developing world &
overcoming challenges
Be part of a major networking opportunity

VARSHA NARAYANAN, Wockhardt,

Head Medical Affairs

Book now...
Register now to secure your seats
Call +91 44 64536444
or
email - info@virtueinsight.com

Learn, Partner, Innovate,

Suceed

11th Pharmacovigilance 2016

1st December 2016, Kohinoor Continental Hotel, Mumbai, India
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11th Pharmacovigilance 2016

1st December 2016, Kohinoor Continental Hotel, Mumbai, India

CONFERENCE INTRODUCTION:After the successful journey of a series of 10 Pharmacovigilance conferences, Virtue Insight is proud to announce its 11th Pharmacovigilance 2016
in India.
It is our great pleasure to invite you to the 11th Pharmacovigilance 2016, in Mumbai - India on 1st of December 2016. We have a wide range of
scientific topics with something for everyone.
The past is reflected in a session about Indian traditional medicine and the future is discussed under Big Data analytics and in the research of our
young scientists. However, we must live and act in the present and debate pressing challenges that face us today in pharmacovigilance (PV). The
rates for medication errors are too high. We still struggle to communicate risk well. With the welcome drive towards transparency and respecting
human rights, legal and ethical issues in PV have come to the fore. Societys research enterprise as a whole needs to become far more aware of the
commercial reality that PV underpins safety, with its intimate links to innovation, so that safety and must be intrinsically built into successful
development and marketing. With governments round the world struggling to curb healthcare costs, the importance of integrating PV into
National Health Programmes has never been more important.
It gives me great pleasure in welcoming all of you to the virtue insights 11th Pharmacovigilance 2016. 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:

Updates - legislation, policies, systems, technology, communication strategies and best practice in PV
Lessons to learn - Pharmacovigilance Programme of India (PvPI)
Clinical Trial Safety: Shift from Explanatory to Pragmatic Trials
Developing pharmacovigilance into high quality management system and its components
Integrate digital health initiative to minimize risks and enhance patient safety
Indigenous medicines for sex selection during pregnancy: How safe is it?
Negotiating Country-Specific annexes and adapting Risk Management Plans (RMPs) to Asia
Developing a refinement of quality in people, process and technology within your PV system
Changing landscape of PV technologies
Assuring certain submission in Patient Support Programs (PSP): Leveraging organizational collaboration to enhance data capture
Understanding the Indian Medical Association (IMA) good practice guide on risk minimization and prevention of medication errors
Mobile Apps to enforce pharmacovigilance and risk minimisation interventions
Using big data to advance drug safety
Negotiating the regulatory environment
Accelerating new medicine introduction in developing world & overcoming challenges
Be part of a major networking opportunity

WHO WILL YOU MEET: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
From the following:
Pharmaceutical organizations, Generic pharmaceutical companies, Contract research organizations, Patient recruitment companies,
Government- Department of health, Non-profit organizations/ Association, Consultants

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.

11th Pharmacovigilance 2016

1st December 2016, Kohinoor Continental Hotel, Mumbai, India
08:30 Coffee and registration An opportunity to meet and to
network with your conference colleagues.

Moderator:

09:30 Chairperson opening remarks

PRANJAL BORDOLOI, AVP - Medical Affairs and

Pharmacovigilance, Veeda Clinical Research

PRANJAL BORDOLOI, AVP - Medical Affairs and

Pharmacovigilance, Veeda Clinical Research

Panellists:
ABHAY CHIMANKAR, Head, Global Drug Safety, Cipla

MARKET OVERVIEW & ANALYSIS

09:40 Clinical Trial Safety: Shift from Explanatory to
Pragmatic Trials

Pragmatism vs. explanatory trial - how different?

The need and utility of pragmatic trials
Challenges for pragmatic trials
Whither explanatory trials?

ARUN BHATT, Consultant Clinical Research & Development

10:10 Pharmacovigilance Programme of India (PvPI)
V. KALAISELVAN, Principal Scientific Officer, Indian
Pharmacopoeia Commission, Ministry of Health & Family
Welfare, Govt. of India

10:40 Morning Coffee/Tea & Discussion

CHALLENGES & OPPORTUNITIES

11:00 DISCUSSION WITH EXPERTS: Changing landscape of
PV technologies
Assessing drug safety landscape - from passive to active PV
Achieving harmonization How are we working together to
improve drug safety?
REMS and their impact on the health care delivery and
patient access
Implementing risk minimization strategies globally and
'striving' for harmonization
Benefit-risk management through drug development:
gathering evidence and making decisions
Building the continuum of pharmacovigilance across premarketing and post-marketing
Pharmacovigilance and the role of scientific literature
objections and solutions
How can cloud help life science companies deal with their
inventory of legacy validated systems?
How do you leverage mobile applications to enhance
medication adherence and patient support compliance?
Outsourcing vs. Capacity building - Strategies for developing
core PV processes in long term basis

SANDESH SAWANT, Head, Clinical Operations (India and

EM), Wockhardt
GODHULI CHATTERJEE, Senior Medical Advisor and Clinical
Safety Officer, Sanofi-aventis
GURPREET SINGH, Head Vendor Management, Drug Safety &
Epidemiology, Novartis
SANKET SAWANT, Strategy & Business Development Partner,
SIRO Clinpharm
11:40 Integrate digital health initiative to minimize risks and
enhance patient safety
Use of information technology to improve the quality of health
care.
Efficiency and accuracy in adverse event reporting while
meeting requirements
Requirements of healthcare providers and hospital
management through close collaboration
Ensuring interoperability with information systems
12:10 Topic TBC
JESSICA THONGCHAREN, Associate Director
Pharmacovigilance, Takeda Pharmaceuticals (Singapore)

12:40 Networking luncheon

Afternoon Chair person

PRASHANT BODHE, Director, CliniSearch
14:00 DISCUSSION WITH EXPERTS: Assuring certain
submission in Patient Support Programs (PSP):
Leveraging organizational collaboration to enhance data
capture
How to ensure patient adhesion and preclude off-label use
with the assistance of digital technologies?
Interface global markets research programmes to maximize
data collection
Effectively interpreting all possibilities of patient interacting
with pharmacists and healthcare providers for improved
systematic inputs of information

11th Pharmacovigilance 2016

1st December 2016, Kohinoor Continental Hotel, Mumbai, India
Verifying quality standards on conduction of PSPs and
Market Research Programmes (MRPs) in real-time
Strengthening the pharmacovigilance and medicomarketing
connect?
Moderator:
PRASHANT BODHE, Director, CliniSearch
Panellists:
DEEPTI SANGHAVI, Assistant Manager-Medical Writing, Tata
Consultancy Services
BHASWAT CHAKRABORTY, Senior VP & Chair, Research and
Development Core Committee, Cadila
SUDHIR PAWAR, Coordinator - ADR monitoring Center at
LTMMC & GH Under Pharmacovigilance Programme Of India
(PvPI), Indian Pharmacopoeia Commission
VARSHA NARAYANAN, Head Medical Affairs, Wockhardt
PRAVIN GHADGE, Head - Medical Writing &
Pharmacovigilance, Reliance Life Sciences
14:50 Mobile Apps to enforce pharmacovigilance and risk
minimisation interventions
How would you render mobile applications to raise
medication adherence and patient support compliance?
How would you evaluate a set of assessment ideals that better
for your needs?
o Product vs. Particular
o Demography profile vs. Therapeutically area
What features clinicians and patients elevate in apps and drug
databases?
Investigating effective change organization strategies

REGULATORY
16:10 DISCUSSION WITH EXPERTS: Negotiating the
regulatory environment
Offering partially or full processing and submittal of
individual case safety reports of adverse events from clinical
trial observational study or post-marketing sources
Preparation and submission of aggregate/periodic safety
reports in all formats
Preparation of risk management plans, negotiation of risk
management strategy with regulatory agencies, and execution
of risk management strategies including late phase studies
Providing medical information services
Conducting good pharmacovigilance practice inspections,
audits and gap analyses.
Preparation and maintenance of pharmacovigilance system
master files.
Assisting with the development of pharmacovigilance systems,
SOPs, and providing training in good pharmacovigilance
practices
Administering global and local searches of the medical
literature for the determination of individual case safety
reports and general safety information.
Integration of Units - start to end in clinical trials
Moderator:
MILIND ANTANI, Partner In-Charge Pharma LifeSciences,
Nishith Desai Associates
Panellists:
JAMAL BAIG, Country Head- Pharmacovigilance, Merck Sharp
& Dohme
POOJA JADHAV, Manager, Sun Pharmaceuticals
ABHAY PHANSALKAR, Head Clinical Trials, Cipla

JEAN CHRISTOPHE DELUMEAU, Head of Pharmacovigilance

Asia-Pacific, Bayer HealthCare (Singapore)

SIDDHARTH DESHPANDE, Assistant Professor Department of

Clinical Pharmacology, KEM Hospital

15:20 Afternoon Tea/Coffee

MANISH VERMA, Director Medical Affairs, Sanofi

15:40 Using big data to advance drug safety

16:50 Chairpersons closing remarks and end of conference

Advanced technology solutions to align combined reporting,

signal evaluative and data analysis challenges
Secondary use of health data
Use of big data sources in PV how far are we?
Data driven pharmacovigilance and elaborate post
authorization monitoring of benefit-risk in the market has
been conceptualized, but how are we in the industry?
Patient dataomics new innovations in safety data analysis.

17:00 - 18:00 - Networking Drinks - Take your

discussions further & build new
relationships in a relaxed & informal setting

FLOOR PLAN:- Book your stalls now before they run out !!!

11th Pharmacovigilance 2016

FLOOR PLAN - Book your stalls now before they run out !!!

4
3

POOL
SIDE AREA
NETWORKING
LUNCHEON

CONFERENCE HALL

Coffee / Tea / Networking Area

REGISTRATION
DESK

Partial list of attendees from our previous Pharmacovigilance Conference

4C Drug Safety Services LLP
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 Laboratories
Allergan
AMCo
Amgen Technology
APCER Life Sciences
Apollo Hospitals
Apotex Research
Aprova
Aptiv Solutions
Archimed Medical Communication
Aris Global
Arklus CTSS Association of the British
- Pharmaceutical Industry
Astellas Pharma
Astrazeneca
Auden Mckenzie (Pharma Division)
Aurobindo Pharma
AXESS
Azin Pharma
Bagdad medical college,
Barrington James
Baxter Healthcare
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
Bristows Business Vibes
Business Wire
Cadila Pharmaceuticals
Callisto Consulting
Cambridge Regulatory Services
Catalyst Clinical Services
Celgene
Celgene Europe
Celon Laboratories
Center for Cellular & Molecular Biology
Centre for Clinical Research and Training
Chiltern International
Christian Medical College
Cipla
Ciron Drugs & Pharmaceuticals
CISCO SYSTEMS
CKA Group
Clearight Infotech
Clinical Research & Healthcare
Clinical Research Learning and Development
Clinigene International
Cliniminds
Clininvent Research
Cmed Clinical Service
Cognizant Technology Solutions
Colgate-Palmolive
Consultant Psychologist and Freelance Journalist
CSD MR UK
CSIR
CSL Behring
Cytel Statistical Software & Services

Dabur India
Daewoong Pharmaceutical
Daiichi Sankyo Development
Danish Medicines Agency
DBMS Consulting
Deloitte Consulting
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
Emas Pharma
Emcure Pharmaceuticals
Ennovent
Espire Health Research
EUDRAC
European Regulatory Solutions
Express Pharma
EXTEDO
Famy Care
FDC
Flamingo Pharmaceuticals
Foresight group
Foresight Group International AG
Forte Research
Fresenius Kabi Oncology
Frontline Pharma Consulting
Fulford
GCP QA Auditing and Consulting Inc
Generic Licensing
Genpact
German Pharmaceutical Industry Association
Gilead Sciences International
GlaxoSmithKline Pharmaceuticals
Glenmark Pharmaceticals
Global PharmaTek
Going to Meet
Good Compliance Services
Gufic Biosciences
GW Pharmaceuticals
HCL Technologies - BPO Services
Healthcare Data
Hetero Labs
Hikma Pharmaceuticals
Hospices Civils de Lyon
Hydrogen Group
i3 Research
ICPC.biz
ICRI
IIHMR, Jaipur.
IMS Health
Indian Immunologicals
Indivior Pharma
Innovaro
Intas Pharmaceuticals
Inventia Healthcare
Inventiv Health Clinical
IPCA Laboratories
IPPro Lifesciences
ITS-DCHRC
Janssen Infectious Diseases
JASIC Asia Bio Network
JB Chemicals & Pharmaceuticals
Jeevan Scientific Technology
Jenson R+
Johnson & Johnson
K.J Somaiya Medical College
Kamani Oil Industries
Karmic Lifesciences
KEM Hospital
Kemri
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
LEO Pharma A/S
LG Life Sciences
LINK Medical Research AS
Lotus Labs
Lupin
Macleods Pharmaceuticals
Macro Care
Maharashtra University of Health Sciences
Manipal AcuNova
Markets&Markets
McCrowley and Hughes
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
Microtracers Inc
MMS
MMS Holdings
MSD India
Mundipharma Research
Mylan Laboratories
Nanokinetik
Navitas Life Sciences
Navitas LLP
NDA
Nelsons
Netherlands Foreign Investment Agency
Nicovations
Niko Infra Licensing
Nishith Desai Associates
Norweigen Medicines Agency
Norwich Clinical Services
Novartis
Novartis Consumer Health
Novartis Healthcare
Novartis Pharma S.A.S.
Novo Nordisk
NUVO Consultancy
Olexacon
Oracle Corporation
Oracle Life Sciences
Orion Pharma
Orphan Europe
Otsuka Europe Development & Commericalisation
Oviya Medsafe
OXON Epidemiology
Panacea Biotec
PAREXEL International
PCS Pharmacovigilance LTD
PDP Couriers
Pfizer
Pharma & Healthcare Insights
Pharma Asia
Pharma Focus Asia
Pharma International Company
Pharma Mirror
Pharmacosmos
Pharmacovigilance Specialist & Medical Writer
pharmaphorum
PharmaVOICE
Pharmcast
PharSafer
Pierre Fabre Medicament
Piramal Healthcare
Piramal Life Sciences
Plethico Pharmaceuticals
Povey Consultancy
PPCE Pvt. Ltd
PPD
PRA Health Sciences
Prism Ideas
ProductLife
Provenance research
PSA
PT Sanbe Farma
Public Health Foundation of India
PVCON Pharmacovigilance Consulting Services- India

Quintiles
Raaj GPRAC
Raaj GPRAC and Raaj Pharma
- eLearning
Ranbaxy Laboratories
Ranbaxy Research Laboratory
Rasayani Biologics
Real Staffing
RegPak BioPharma Consulting
Reliance Life Sciences
Results Healthcare
Rite-Aid Pharmacy
Roche Pharmaceuticals
Roche Products
Roche Products
RPM Alliance
Saffron Media
Sandoz
Sanjeevani Pharma
Sanofi
Sciformix Technologies
Shantha Biotechnics
Shasun Pharmaceuticals
Shionogi
Sidley Austin
SIRO Clinpharm
Sitec Labs Pvt Ltd
SLARC
Springer
Sri. Devaraj URS Medical College
SRL
ST. JAMESS 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 Pharmaceuticals
Tata Consultancy Services
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
TruTag Technologies
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
Virbac Animal Health
VIVAN Life Sciences
Voisin Consulting Life Sciences
Watson Pharma
Weifa AS
Wipro
Witness Magazine
Wockhardt
World Customs Organization
World Pharma Today
Xylem Clinical research
Yes Regulatory Healthcare
- Services
YourStory.in
Zigzag Associates
Zydus Cadila

REGISTRATION FORM

RESERVATION PRICING:

Queries:

Standard Rate

Should you have any questions on bookings,

Please feel free to contact us.

1 or 2 delegates - per delegate

Fee: INR 07,000 + Tax

Fee: INR 06,500 + Tax

Fee: INR 06,000 + Tax

Group Discounts
3 or 4 delegates - per delegate

Group Discounts
For 5 and above delegates - per delegate

Spot Registration:1 Day conference per delegate

Email: info@virtueinsight.com
Web: http://www.virtueinsight.com
India Office: Tel: +91 44 64536444

General information Venue:

Kohinoor Continental Hotel
Andheri Kurla Road
Andheri ( E )
Mumbai 400059 - India
Tel: 91 22 66919000 / 91 22 28209999

Payment terms:
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Fee: INR 08,000 + Tax

Registration Form Details:

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conference. Virtue Insight may refuse entry to delegates who have
not paid their invoice in full.

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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
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notes will then be sent to you. Unfortunately, we are unable to transfer
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