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ANKA G. EHRHARDT,
JOHN LAMBERT,
SUMIT MUNJAL,
ARUN BHATT,
BHASWAT CHAKRABORTY,
HEMA BAJAJ,
ANISH DESAI,
KAVYA KADAM,
PIYUSH GUPTA,
SAMBIT PATNAIK,
KEDAR SUVARNAPATHAKI,
CHANDRA SEKHAR,
ROHIT ARORA,
NARESH TONDARE,
MURTUZA BUGHEDIWALA,
Bristol-Myers Squibb (USA),
PAREXEL International (UK),
Takeda Pharmaceuticals (UK),
Consultant – Clinical Research & Development,
Cadila,
Sanofi Aventis,
Johnson & Johnson,
Cipla,
GNH India,
Clintech India,
Boehringer Ingelheim,
Reliance Life Sciences,
Abbott,
Glenmark Pharmaceuticals,
Sanofi,
Director Clinical Cytometry, Biomarker Technologies, ECTR
Chief Medical Officer Early Phase
Medical Director Lead, Global Medical Safety , Head of Mature
Established products
Senior VP & Chair, Research and Development Core Committee
Head of Clinical Quality & Medical Compliance - Affiliate
Quality Officer
Director Medical Affairs,Clinical Operations & Device Safety
Head - Global Clinical Operations
Associate Director
CEO & Medical Director
Head - Regulatory Affairs
Vice President Quality (Pharma)
Head - Medical & Scientific Affairs
Head– India and Nepal Regulatory Affairs
Associate Director, Project Management & Strategic Initiatives
• Risk management - Insights, Implications, Impact and Implementation
• New trends in global clinical trials and their role in India
• Conducting successful interventional oncology trials in India
• Quality by design & Data management
• Effectively incorporating GCP & GCPs – Knowing what TO-DO and what
NOT TO-DO
• Regulatory updates and Good Clinical Practice (GCP) auditing techniques
• Insight and practical tips on how to work with all payer
• Tracking returns, Reconciliation & Destruction to manage costs
• ACA, Medicare, Medicaid and state requirements regarding coverage of
clinical trials.
• Legislation, policies, systems, technology, communication strategies and
best practices
• Maintaining proper balance in relationships: Sponsor – Site – CRO &
Patients
• Margin of safety
• Next generations of clinical trials – How big will the market be?
• Be part of a major networking opportunity
Key Speakers Include
Special Reasons To Attend
Conference Hashtag - #VI_Pharma
“A critical guide for successfully conducting clinical trials”
24th May 2016, The Lalit Hotel, Mumbai, India
MILIND ANTANI,
YASHESH MEHTA,
SHILPA RAUT,
DEEPTI SANGHAVI,
UMAKANTA SAHOO,
AMEY MANE,
SANKET SAWANT,
ASHWANI PANDITA,
Nishith Desai Associates,
Sciformix,
Novartis,
Tata Consultancy Services,
Cytel,
Janssen India (Pharmaceutical companies of
Johnson & Johnson),
SIRO Clinpharm,
Glenmark Pharmaceuticals,
Partner In-Charge - Pharma LifeSciences
Director Delivery Partner
Regional Training Head - Asia, Middle East and Africa Cluster
Assistant Manager-Medical Writing
Director
General Manager - Medical Affairs
Strategy & Business Development Partner
Dy. General Manager Quality Management & Training, Global Clinical
Research Operations
Plus Many More..
Book now...
Register now to secure your seats
Call +91 44 64536444
or
email - info@virtueinsight.com
ORGANIZED BYORGANIZED BY
SUPPORTED BYSUPPORTED 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-
7th Annual Clinical Trials Summit 2016
24th May 2016, The Lalit Hotel, Mumbai, India
GOLD SPONSORGOLD SPONSOR
EXHIBITOR
CONFERENCE INTRODUCTION:-
The clinical trial market in India looks very lucrative. India has several unique features for being a hot spot for the clinical trial market. As a
signatory to the World Trade Organization agreements, India is looked upon as a favorable destination for conducting global clinical trials. There
are many opportunities and challenges for conducting global clinical trials in India. In a majority of cases, these drugs are aimed at providing
answers to unmet medical needs.
Clinical research is important not only for developing medicines for emerging health concerns (such as antibiotic resistant pathogens, H1N1,
Dengue, , etc.) also for finding safe and better medicines for entrenched diseases such as HIV, Malaria, tuberculosis (especially drug resistant TB)
Diabetes, Hypertension, Cancer, heart failure etc. India, with its large patient population, and limited resource has significant unfilled health
needs. We should make the newest and best treatment option to be avail to the population and to the patient’s globally. For this, India must
proactively take part in conducting clinical research (“Research for India”) and assume leadership role globally (“made for the world”). As we are
operating in a new regulatory and operational environment, we have a great task ahead of us – strengthening the sites, Investigators, Ethics
Committees and empowering the patient who is the center of the clinical research enterprise.
Our world is changing as we focus more on biotech, personalized medicine, biomarkers, rare diseases and orphan indications. With this comes
many challenges that we have only rarely faced in the past. As we focus more on the patient, stability and formulation hurdles arise. There is a
growing need for forecasting and planning improvements and temperature control of distribution into truly emerging markets. It is essential we
come together to learn not only how our colleagues are handling these issues, but are how they are ingeniously overcoming them.
It gives us immense pleasure in welcoming you to the 7th Annual Clinical Trials Summit 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:-
• Insights, Implications, Impact and Implementation of risk management in trial conduct
• Tracking returns, Reconciliation & Destruction to manage costs
• Reduce significant costs through successful embedding of modulation and simulation in the clinical supply chain
• Underlining the benefits and implications of drug pooling in the clinical supply chain
• Marketing for your clinical research practice
• Insurance coverage: How the ACA changed access to clinical trials
• Regulatory updates and Good Clinical Practice (GCP) auditing techniques
• Developing a standardized tool to improve patient comprehension during consent
• Insight and practical tips on how to work with all payer types to obtain coverage of clinical trial routine costs.
• ACA, Medicare, Medicaid and state requirements regarding coverage of clinical trials.
• Update yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practices
• Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients
• Overcoming challenges faced in regulatory approval processes – obtaining drug/ clinical supplies import and export licenses in Asia
• Margin of safety: Identifying ideal clinical sites and strategizing patient recruitment and clinical sites management in India to develop
appropriate clinical studies
• Next generations of clinical trials – How big will the market be?
• Be part of a major networking opportunity
WHO WILL YOU MEET:-
CEO's, CTO's, CIO's, Presidents, Vice Presidents, Directors Heads & Managers of:
Clinical Research & Development, Clinical Research Services, Clinical Operations, Clinical Data Management, Clinical IT, Clinical Trials,
Medical Affairs, Regulatory Affairs, Compliance, Quality control / Assurance/GCP, Clinical Study Design, Safety Surveillance, Subject
Recruitment, E-Clinical Systems
7th Annual Clinical Trials Summit 2016
24th May 2016, The Lalit Hotel, Mumbai, India
WHY SHOULD YOU ATTEND?
7th Annual Clinical Trials Summit 2016 -
broader scope bringing the whole communications value chain together dedicated networking drinks
time, meet the leading international vendors
“A critical guide for successfully conducting clinical trials” - Get more from the event, with a
. Enjoy and make the best out of our
expand your knowledge of the latest business models and strategies in the high-level conference.
Show casing the products of tomorrow in the co-located exhibition.
08:30 – Coffee and registration
09:20 – Chairperson opening remarks
– An opportunity to meet and to
network with your conference colleagues.
09:30 – India’s current challenge: Empowering ethics committees
Consultant – Clinical Research & Development
10:00 Comparators - The “Check Nut” in Clinical trial
GNH India
10:30 – Morning Coffee/Tea & Discussion
• Current regulatory milieu and expectations
• Quality issues in ethics committee functioning
• Paradigm shift towards accreditation
• How to empowering ethics committees
• Reverse planning - Comparator Sourcing for clinical trials
• Don’t be a victim of “Comparator Outages”
• Pedigree and Traceability - How to ensure your comparator is
actually a “Comparator"
• Difference between Comparators for SRA and ROW markets.
Associate Director,
–
ARUN BHATT,
PIYUSH GUPTA,
10:50 – DISCUSSION WITH EXPERTS: Insights, Implications,
Impact and Implementation of risk management in trial
conduct
• Operations management for Sponsors and CRO’s
• Transitioning from traditional trial planning practices to the
recommended risk-based approach to trial conduct
• Sponsors, CRO’s and Sites to understand the new model if
optimal risk management is to be attained.
• Effective, model that ensures consistent, repeatable, effective
and efficient processes
• A study life cycle if trial risks are to be identified, assessed,
optimally mitigated and managed
• Clinical trial regulations in India: Challenges, Reforms and
way forward
• Multitude of changes in market challenges and continued
focus on cost/quality
• Prioritization and execution of a structured framework if
successful implementation and management is to be attained.
11:30 – Underlining the benefits and implications of drug
pooling in the clinical supply chain
12:00 Insurance coverage: How the ACA changed access to
clinical trials
• Introducing drug pooling to your clinical supply chain: The
how to guide
• Exploring the advantages of drug pooling at various levels of
the supply chain
• Overcoming the key challenges involved with drug pooling
• Underlining the importance of assessing all levels of the
supply chain before implementation
• ACA, Medicare, Medicaid and state requirements regarding
coverage of clinical trials.
• How to determine if a trial meets coverage criteria, what
should be paid by the sponsor versus the health plan and how
to communicate with health plans including: Initial and
subsequent authorization; peer to peer consults; pre and post
service appeal of denials; claims submission / coding
requirements; and network requirements.
• Insight and practical tips on how to work with all payer types
to obtain coverage of clinical trial routine costs.
–
12:30 – Networking luncheon
Afternoon Chair person
Clintech IndiaCEO & Medical Director,SAMBIT PATNAIK,
MARKET OVERVIEW & ANALYSIS
CHALLENGES & OPPORTUNITIES
Moderator:
Janssen India
(Pharmaceutical companies of Johnson & Johnson)
Panellists:
Glenmark Pharmaceuticals
Sanofi
Takeda Pharmaceuticals
(UK)
Tata
Consultancy Services
Novartis
General Manager- Medical Affairs,
Head– India and Nepal Regulatory
Affairs,
Associate Director, Project
Management & Strategic Initiatives,
Medical Director Lead, Global Medical Safety,
Head of Mature Established products,
Assistant Manager-Medical Writing,
Regional Training Head - Asia, Middle East and
Africa Cluster,
AMEY MANE,
NARESH TONDARE,
MURTUZA BUGHEDIWALA,
SUMIT MUNJAL,
DEEPTI SANGHAVI,
SHILPA RAUT,
7th Annual Clinical Trials Summit 2016
24th May 2016, The Lalit Hotel, Mumbai, India
13:40 – Topic TBC
Bristol-Myers Squibb (USA)
Director Clinical Cytometry, Biomarker
Technologies, ECTR,
14:50 – Risk Management in Early Clinical Development - A
CRO Perspective
PAREXEL
International (UK)
Chief Medical Officer Early Phase,
ANKA G. EHRHARDT,
CHANDRA SEKHAR,
JOHN LAMBERT,
15:20 – Afternoon Tea/Coffee
15:40 – Data Integrity concepts in clinical trials
Reliance Life
Sciences
• Importance of Data Integrity
• Quality by Design (QbD) approach
• Effective CAPA (Corrective and Preventive Action)
• Role of Quality Metrics
Vice President Quality,
16:50 Chairperson’s closing remarks and end of conference–
14:10 – DISCUSSION WITH EXPERTS: Marketing for your
clinical research practice
Moderator:
Cytel
Panellists:
Johnson & Johnson
SIRO Clinpharm
Cadila
Cipla
Sciformix
• Clinical trials marketing plans, campaign development, and
performance indicators to achieve optimal campaign success.
• Basic marketing strategy; and, discuss site-marketing methods
including new media and regulations for their use
• Branding and reach to grow your site; in-house ad creation;
website analytics; conversion rates; and more.
• The cost benefit of marketing including study acquisition; ROI;
and negotiating budgets with sponsors and media vendors.
• Time-tested marketing templates and tools to drive patient,
community, and industry engagement.
Director,
Director Medical Affairs, Clinical Ops. & Device
safety,
Strategy & Business Development Partner,
Senior VP & Chair, Research and
Development,
Head - Global Clinical Operations,
Director Delivery Partner,
UMAKANTA SAHOO,
ANISH DESAI,
SANKET SAWANT,
BHASWAT CHAKRABORTY,
KAVYA KADAM,
YASHESH MEHTA,
7th Annual Clinical Trials Summit 2016
24th May 2016, The Lalit Hotel, Mumbai, India
REGULATORY
16:10 – DISCUSSION WITH EXPERTS: Regulatory updates and
Good Clinical Practice (GCP) auditing techniques
Moderator:
Nishith Desai Associates
Panellists:
Glenmark Pharmaceuticals
Sanofi
Boehringer Ingelheim
Abbott
• Good Clinical Practice (GCP) Quality Assurance (QA)
• FDA regulatory requirement, within the clinical arena
• ICH E6 GCP guidelines and ISO 14155 sections on GCP QA
and expectations that GCP auditing will occur
• Utilizing a GCP QA program
• How to build quality into a clinical trials program? Using case
studies, simulations and actual findings
• Real world evidence on clinical trials
• How to approach clinical trials compliance? What to expect
during an inspection and how to take appropriate corrective
action to avoid regulatory issues?
• GCP auditing and how to develop a GCP audit plan and GCP
audit report
Partner In-Charge - Pharma LifeSciences,
Dy. General Manager Quality
Management & Training, Global Clinical Research Operations,
Head of Clinical Quality & Medical Compliance -
Affiliate Quality Officer,
Head - Regulatory Affairs,
Head - Medical & Scientific Affairs,
MILIND ANTANI,
ASHWANI PANDITA,
HEMA BAJAJ,
KEDAR SUVARNAPATHAKI,
ROHIT ARORA,
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 !!!
1
2 5
3
4
1
4
5
2
3
REGISTRATION
DESK
7th Annual Clinical Trials Summit 2016
FLOOR PLAN - Book your stalls now before they run out !!!
CONFERENCE
HALL
Coffee / Tea / Networking Area
A. Menarini India
Abbott Healthcare
Abbott Nutrition R & D
Acceliant
Accutest
ACG Associated Capsules
ACM Global Central Laboratory
ADAMAS Consulting
AET Laboratories
Alcon - Global Clinical Site Management
Alkem Laboratories
Allergan Healthcare
Almac
Amneal Pharmaceuticals
Antara
Apotex
Ardent Research Services
Astellas Pharma
AstraZeneca
Atharva Lifesciences Consulting
Auriga Research
Aurigene Discovery Technologies
Azidus Laboratories
Bangalore Diabetes Hospital
Baxter
Bayer
Beroe Consulting India
Bilcare
Biocon Foundation
Biological E. Limited
BioSpectrum
Biotechnology Industry Research Assistance Council
Boehringer Ingelheim
Bristol Myers Squibb
Business Vibes
C.L.A.I.M.S
Cadila
Cambridge Research & Instrumentation
CanBiotech
CCRT
Chest Research Foundation
CIDP Biotech
Cipla
City X Ray & Scan Clinic
Clinical Diagnostic Centre
Clinigene Intl
Cliniminds
Clininvent Research
Clininvent Research
CliniSearch
Clinitrials Research
Clinnex
ClinOma Healthcare
Clinsoft Clinical Research
ClinTrials Research
Coffee Day
Cognizant Technologies
Crescent Scientific
CSC
Cygnus Business onsulting & research
Cytel Statistical Software and Services
Cytespace Research
Dabur India
Daewoong Pharmaceutical
Daiichi Sankyo
DBMS Consulting
DCGI
DiagnoSearch LifeSciences
Dr Lal Path Labs
Dr. Reddy's Laboratories
ECCRO India Services
Ecron Acunova
Eli Lilly
EMC Corporation
Ephicacy Lifesciences Analytics
Etyka Clinical Solutions
Expire Health Research
Express Pharma
Famy Care
Fisher BioPharma Services
Forte Research Systems
Fortis Clinical Research
Fresenius Kabi
Partial list of attendees from our previous Clinical Trials Conference
Fresenius Kabi Oncology
G7 SYNERGON
Generic Licensing
GlaxoSmithKline
Glenmark
Glenmark Pharmaceuticals
Global Data
Global Health
GNH India
Going To Meet
Government of Victoria, Australia  India office
GSK
GVK Bio
HCL Technologies
Heart Care Associates
Hinduja Hospital
Hindustan Times
Hospira Healthcare
ICRI
Image Core Lab
Inbiopro Solutions
INC Research
India Law
Indian Academy of Clinical Research
IndiPharm
Indus Biotech
Intervein laboratories
Invent Bio Med
Ipca Laboratories
ISBEC
ISBEC, Mumbai
ITS-DCHRC
JAIC Asia Holdings
Jame Jamshed Weekly
JH Bio
Johnson and Johnson
Jubilant Clinsys
KAP Computer Solutions
Karmic Lifesciences
Kinapse
Lambda Therapeutic Research
Linköping University
Lotus Labs
Lundbeck India
Lupin
Lupin Bioresearch Center
Macleods Pharmaceuticals
Marken
Mascot Spincontrol
MD Pharmacology
Medanta Duke Research Institute (MDRI)
Medi Stats Lab
Mediception Science
Medidata Solutions
Metropolis Healthcare
Microtherapeutic Research Labs
MJ Biopharm
MMSH Clinical Research
MS Clinical Research
Mylan Laboratories
Natco Pharma
National Institute of Health, U.S. Embassy
Newtronic
Nishith Desai Associates
Norwich Clinical Services
Novartis Healthcare
Novartis Healthcare- Vaccines Division
Ocasa Logistic Solutions
OmniActive Health Technologies
Oncquest Laboratories
Oracle Health Science
Oviya MedSafe
Panacea Biotec
ParadigmIT
PDP LIfe Science Logistics
Percipenz
Pfizer
Pharma Bio World
Pharma Mirror
PharmaLeaf
Pharmaniaga
Pharmaphorum PharmaVOICE
Pharmcast
PhaseON Clinical Research
Physis Learning Academy
Piramal Life Sciences
Pirmal Healthcare
PPCE
PRA Internationl
Provenance Research
Quad One Technologies
Quartesian
Quest Diagnostics
Quintiles Research
Ranbaxy Laboratories
RegPak BioPharma Consulting
Reliance Life Sciences
Roche Products
RPM Alliance
Rubicon Research
Ruby Hall Clinic
S P Software Technologies
Sahajanand Medical Technologies
Salzer Technologies Limited
Sanofi Aventis
Sanofi Pasteur
Sanofi
SAVA Healthcare
Sciformix Technologies
SenceCR
Serum Institute of India
SFS Pharma Logistics
SGD S.A Glass
Shantha A Sanofi Company
Shantha Biotechnics
SIRO
SIRO Clinpharm
Solonist Business Solutions
SP Software Technologies
Spectrum Oncology
SRL
SRL Diagnostics
Stempeutics Research
Strides
Sun Pharma Advanced Research Company
Sun Pharmaceutical Laboratories
Surat Institute of Digestive Science
Syngene International
Tata Memorial Hospital
TCS
Tech Tree
Tech-Observer
TechPharmic Consulting
Techsol
Templegate
The George Institute for Global Health
The Pharma World
Theramyt Novobiologics
Torrent Pharmaceuticals
Torrent Research Centre
Trianz Holdings
U. S. Embassy
Unichem Laboratories
Unilever
Unithink
Until Roi
VAC3 ClinicalService
Vanthys
Veeda Clincial Research
VerGo Pharma Research
VIaTAL Pharma Consulting
Virbac Animal Health
Voisin Consulting
Voisin Life Sciences
VPH
Vydehi Institute of Medical Sciences and Research Centre
Wanbury
Watson Pharma
Western Institutional Review Board
Witness Magazine
Wockhardt
World Pharma Today
YCLIN
Zifo Technologies
Zuellig Pharma Speciality Solutions
Zydus Cadila
Queries:
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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 44 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.
The Lalit Hotel
Sahar Airport Road, Andheri East,
Opp. Hotel Leela,
Mumbai 400059 - India
Tel: 91 22 6699 2222
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For 5 and above delegates - per delegate - Fee: INR 05,500 + Tax
1 Day conference per delegate - Fee: INR 08,000 + Tax
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7th annual clinical trials summit 2016

  • 1. ANKA G. EHRHARDT, JOHN LAMBERT, SUMIT MUNJAL, ARUN BHATT, BHASWAT CHAKRABORTY, HEMA BAJAJ, ANISH DESAI, KAVYA KADAM, PIYUSH GUPTA, SAMBIT PATNAIK, KEDAR SUVARNAPATHAKI, CHANDRA SEKHAR, ROHIT ARORA, NARESH TONDARE, MURTUZA BUGHEDIWALA, Bristol-Myers Squibb (USA), PAREXEL International (UK), Takeda Pharmaceuticals (UK), Consultant – Clinical Research & Development, Cadila, Sanofi Aventis, Johnson & Johnson, Cipla, GNH India, Clintech India, Boehringer Ingelheim, Reliance Life Sciences, Abbott, Glenmark Pharmaceuticals, Sanofi, Director Clinical Cytometry, Biomarker Technologies, ECTR Chief Medical Officer Early Phase Medical Director Lead, Global Medical Safety , Head of Mature Established products Senior VP & Chair, Research and Development Core Committee Head of Clinical Quality & Medical Compliance - Affiliate Quality Officer Director Medical Affairs,Clinical Operations & Device Safety Head - Global Clinical Operations Associate Director CEO & Medical Director Head - Regulatory Affairs Vice President Quality (Pharma) Head - Medical & Scientific Affairs Head– India and Nepal Regulatory Affairs Associate Director, Project Management & Strategic Initiatives • Risk management - Insights, Implications, Impact and Implementation • New trends in global clinical trials and their role in India • Conducting successful interventional oncology trials in India • Quality by design & Data management • Effectively incorporating GCP & GCPs – Knowing what TO-DO and what NOT TO-DO • Regulatory updates and Good Clinical Practice (GCP) auditing techniques • Insight and practical tips on how to work with all payer • Tracking returns, Reconciliation & Destruction to manage costs • ACA, Medicare, Medicaid and state requirements regarding coverage of clinical trials. • Legislation, policies, systems, technology, communication strategies and best practices • Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients • Margin of safety • Next generations of clinical trials – How big will the market be? • Be part of a major networking opportunity Key Speakers Include Special Reasons To Attend Conference Hashtag - #VI_Pharma “A critical guide for successfully conducting clinical trials” 24th May 2016, The Lalit Hotel, Mumbai, India MILIND ANTANI, YASHESH MEHTA, SHILPA RAUT, DEEPTI SANGHAVI, UMAKANTA SAHOO, AMEY MANE, SANKET SAWANT, ASHWANI PANDITA, Nishith Desai Associates, Sciformix, Novartis, Tata Consultancy Services, Cytel, Janssen India (Pharmaceutical companies of Johnson & Johnson), SIRO Clinpharm, Glenmark Pharmaceuticals, Partner In-Charge - Pharma LifeSciences Director Delivery Partner Regional Training Head - Asia, Middle East and Africa Cluster Assistant Manager-Medical Writing Director General Manager - Medical Affairs Strategy & Business Development Partner Dy. General Manager Quality Management & Training, Global Clinical Research Operations Plus Many More.. Book now... Register now to secure your seats Call +91 44 64536444 or email - [email protected]
  • 2. ORGANIZED BYORGANIZED BY SUPPORTED BYSUPPORTED 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 - [email protected] 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 [email protected] 7th Annual Clinical Trials Summit 2016 24th May 2016, The Lalit Hotel, Mumbai, India GOLD SPONSORGOLD SPONSOR EXHIBITOR
  • 3. CONFERENCE INTRODUCTION:- The clinical trial market in India looks very lucrative. India has several unique features for being a hot spot for the clinical trial market. As a signatory to the World Trade Organization agreements, India is looked upon as a favorable destination for conducting global clinical trials. There are many opportunities and challenges for conducting global clinical trials in India. In a majority of cases, these drugs are aimed at providing answers to unmet medical needs. Clinical research is important not only for developing medicines for emerging health concerns (such as antibiotic resistant pathogens, H1N1, Dengue, , etc.) also for finding safe and better medicines for entrenched diseases such as HIV, Malaria, tuberculosis (especially drug resistant TB) Diabetes, Hypertension, Cancer, heart failure etc. India, with its large patient population, and limited resource has significant unfilled health needs. We should make the newest and best treatment option to be avail to the population and to the patient’s globally. For this, India must proactively take part in conducting clinical research (“Research for India”) and assume leadership role globally (“made for the world”). As we are operating in a new regulatory and operational environment, we have a great task ahead of us – strengthening the sites, Investigators, Ethics Committees and empowering the patient who is the center of the clinical research enterprise. Our world is changing as we focus more on biotech, personalized medicine, biomarkers, rare diseases and orphan indications. With this comes many challenges that we have only rarely faced in the past. As we focus more on the patient, stability and formulation hurdles arise. There is a growing need for forecasting and planning improvements and temperature control of distribution into truly emerging markets. It is essential we come together to learn not only how our colleagues are handling these issues, but are how they are ingeniously overcoming them. It gives us immense pleasure in welcoming you to the 7th Annual Clinical Trials Summit 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:- • Insights, Implications, Impact and Implementation of risk management in trial conduct • Tracking returns, Reconciliation & Destruction to manage costs • Reduce significant costs through successful embedding of modulation and simulation in the clinical supply chain • Underlining the benefits and implications of drug pooling in the clinical supply chain • Marketing for your clinical research practice • Insurance coverage: How the ACA changed access to clinical trials • Regulatory updates and Good Clinical Practice (GCP) auditing techniques • Developing a standardized tool to improve patient comprehension during consent • Insight and practical tips on how to work with all payer types to obtain coverage of clinical trial routine costs. • ACA, Medicare, Medicaid and state requirements regarding coverage of clinical trials. • Update yourself with respect to terms of legislation, policies, systems, technology, communication strategies and best practices • Maintaining proper balance in relationships: Sponsor – Site – CRO & Patients • Overcoming challenges faced in regulatory approval processes – obtaining drug/ clinical supplies import and export licenses in Asia • Margin of safety: Identifying ideal clinical sites and strategizing patient recruitment and clinical sites management in India to develop appropriate clinical studies • Next generations of clinical trials – How big will the market be? • Be part of a major networking opportunity WHO WILL YOU MEET:- CEO's, CTO's, CIO's, Presidents, Vice Presidents, Directors Heads & Managers of: Clinical Research & Development, Clinical Research Services, Clinical Operations, Clinical Data Management, Clinical IT, Clinical Trials, Medical Affairs, Regulatory Affairs, Compliance, Quality control / Assurance/GCP, Clinical Study Design, Safety Surveillance, Subject Recruitment, E-Clinical Systems 7th Annual Clinical Trials Summit 2016 24th May 2016, The Lalit Hotel, Mumbai, India WHY SHOULD YOU ATTEND? 7th Annual Clinical Trials Summit 2016 - broader scope bringing the whole communications value chain together dedicated networking drinks time, meet the leading international vendors “A critical guide for successfully conducting clinical trials” - Get more from the event, with a . Enjoy and make the best out of our expand your knowledge of the latest business models and strategies in the high-level conference. Show casing the products of tomorrow in the co-located exhibition.
  • 4. 08:30 – Coffee and registration 09:20 – Chairperson opening remarks – An opportunity to meet and to network with your conference colleagues. 09:30 – India’s current challenge: Empowering ethics committees Consultant – Clinical Research & Development 10:00 Comparators - The “Check Nut” in Clinical trial GNH India 10:30 – Morning Coffee/Tea & Discussion • Current regulatory milieu and expectations • Quality issues in ethics committee functioning • Paradigm shift towards accreditation • How to empowering ethics committees • Reverse planning - Comparator Sourcing for clinical trials • Don’t be a victim of “Comparator Outages” • Pedigree and Traceability - How to ensure your comparator is actually a “Comparator" • Difference between Comparators for SRA and ROW markets. Associate Director, – ARUN BHATT, PIYUSH GUPTA, 10:50 – DISCUSSION WITH EXPERTS: Insights, Implications, Impact and Implementation of risk management in trial conduct • Operations management for Sponsors and CRO’s • Transitioning from traditional trial planning practices to the recommended risk-based approach to trial conduct • Sponsors, CRO’s and Sites to understand the new model if optimal risk management is to be attained. • Effective, model that ensures consistent, repeatable, effective and efficient processes • A study life cycle if trial risks are to be identified, assessed, optimally mitigated and managed • Clinical trial regulations in India: Challenges, Reforms and way forward • Multitude of changes in market challenges and continued focus on cost/quality • Prioritization and execution of a structured framework if successful implementation and management is to be attained. 11:30 – Underlining the benefits and implications of drug pooling in the clinical supply chain 12:00 Insurance coverage: How the ACA changed access to clinical trials • Introducing drug pooling to your clinical supply chain: The how to guide • Exploring the advantages of drug pooling at various levels of the supply chain • Overcoming the key challenges involved with drug pooling • Underlining the importance of assessing all levels of the supply chain before implementation • ACA, Medicare, Medicaid and state requirements regarding coverage of clinical trials. • How to determine if a trial meets coverage criteria, what should be paid by the sponsor versus the health plan and how to communicate with health plans including: Initial and subsequent authorization; peer to peer consults; pre and post service appeal of denials; claims submission / coding requirements; and network requirements. • Insight and practical tips on how to work with all payer types to obtain coverage of clinical trial routine costs. – 12:30 – Networking luncheon Afternoon Chair person Clintech IndiaCEO & Medical Director,SAMBIT PATNAIK, MARKET OVERVIEW & ANALYSIS CHALLENGES & OPPORTUNITIES Moderator: Janssen India (Pharmaceutical companies of Johnson & Johnson) Panellists: Glenmark Pharmaceuticals Sanofi Takeda Pharmaceuticals (UK) Tata Consultancy Services Novartis General Manager- Medical Affairs, Head– India and Nepal Regulatory Affairs, Associate Director, Project Management & Strategic Initiatives, Medical Director Lead, Global Medical Safety, Head of Mature Established products, Assistant Manager-Medical Writing, Regional Training Head - Asia, Middle East and Africa Cluster, AMEY MANE, NARESH TONDARE, MURTUZA BUGHEDIWALA, SUMIT MUNJAL, DEEPTI SANGHAVI, SHILPA RAUT, 7th Annual Clinical Trials Summit 2016 24th May 2016, The Lalit Hotel, Mumbai, India
  • 5. 13:40 – Topic TBC Bristol-Myers Squibb (USA) Director Clinical Cytometry, Biomarker Technologies, ECTR, 14:50 – Risk Management in Early Clinical Development - A CRO Perspective PAREXEL International (UK) Chief Medical Officer Early Phase, ANKA G. EHRHARDT, CHANDRA SEKHAR, JOHN LAMBERT, 15:20 – Afternoon Tea/Coffee 15:40 – Data Integrity concepts in clinical trials Reliance Life Sciences • Importance of Data Integrity • Quality by Design (QbD) approach • Effective CAPA (Corrective and Preventive Action) • Role of Quality Metrics Vice President Quality, 16:50 Chairperson’s closing remarks and end of conference– 14:10 – DISCUSSION WITH EXPERTS: Marketing for your clinical research practice Moderator: Cytel Panellists: Johnson & Johnson SIRO Clinpharm Cadila Cipla Sciformix • Clinical trials marketing plans, campaign development, and performance indicators to achieve optimal campaign success. • Basic marketing strategy; and, discuss site-marketing methods including new media and regulations for their use • Branding and reach to grow your site; in-house ad creation; website analytics; conversion rates; and more. • The cost benefit of marketing including study acquisition; ROI; and negotiating budgets with sponsors and media vendors. • Time-tested marketing templates and tools to drive patient, community, and industry engagement. Director, Director Medical Affairs, Clinical Ops. & Device safety, Strategy & Business Development Partner, Senior VP & Chair, Research and Development, Head - Global Clinical Operations, Director Delivery Partner, UMAKANTA SAHOO, ANISH DESAI, SANKET SAWANT, BHASWAT CHAKRABORTY, KAVYA KADAM, YASHESH MEHTA, 7th Annual Clinical Trials Summit 2016 24th May 2016, The Lalit Hotel, Mumbai, India REGULATORY 16:10 – DISCUSSION WITH EXPERTS: Regulatory updates and Good Clinical Practice (GCP) auditing techniques Moderator: Nishith Desai Associates Panellists: Glenmark Pharmaceuticals Sanofi Boehringer Ingelheim Abbott • Good Clinical Practice (GCP) Quality Assurance (QA) • FDA regulatory requirement, within the clinical arena • ICH E6 GCP guidelines and ISO 14155 sections on GCP QA and expectations that GCP auditing will occur • Utilizing a GCP QA program • How to build quality into a clinical trials program? Using case studies, simulations and actual findings • Real world evidence on clinical trials • How to approach clinical trials compliance? What to expect during an inspection and how to take appropriate corrective action to avoid regulatory issues? • GCP auditing and how to develop a GCP audit plan and GCP audit report Partner In-Charge - Pharma LifeSciences, Dy. General Manager Quality Management & Training, Global Clinical Research Operations, Head of Clinical Quality & Medical Compliance - Affiliate Quality Officer, Head - Regulatory Affairs, Head - Medical & Scientific Affairs, MILIND ANTANI, ASHWANI PANDITA, HEMA BAJAJ, KEDAR SUVARNAPATHAKI, ROHIT ARORA, 17:00 - 18:00 - Networking Drinks - Take your discussions further & build new relationships in a relaxed & informal setting
  • 6. FLOOR PLAN:- Book your stalls now before they run out !!! 1 2 5 3 4 1 4 5 2 3 REGISTRATION DESK 7th Annual Clinical Trials Summit 2016 FLOOR PLAN - Book your stalls now before they run out !!! CONFERENCE HALL Coffee / Tea / Networking Area
  • 7. A. Menarini India Abbott Healthcare Abbott Nutrition R & D Acceliant Accutest ACG Associated Capsules ACM Global Central Laboratory ADAMAS Consulting AET Laboratories Alcon - Global Clinical Site Management Alkem Laboratories Allergan Healthcare Almac Amneal Pharmaceuticals Antara Apotex Ardent Research Services Astellas Pharma AstraZeneca Atharva Lifesciences Consulting Auriga Research Aurigene Discovery Technologies Azidus Laboratories Bangalore Diabetes Hospital Baxter Bayer Beroe Consulting India Bilcare Biocon Foundation Biological E. Limited BioSpectrum Biotechnology Industry Research Assistance Council Boehringer Ingelheim Bristol Myers Squibb Business Vibes C.L.A.I.M.S Cadila Cambridge Research & Instrumentation CanBiotech CCRT Chest Research Foundation CIDP Biotech Cipla City X Ray & Scan Clinic Clinical Diagnostic Centre Clinigene Intl Cliniminds Clininvent Research Clininvent Research CliniSearch Clinitrials Research Clinnex ClinOma Healthcare Clinsoft Clinical Research ClinTrials Research Coffee Day Cognizant Technologies Crescent Scientific CSC Cygnus Business onsulting & research Cytel Statistical Software and Services Cytespace Research Dabur India Daewoong Pharmaceutical Daiichi Sankyo DBMS Consulting DCGI DiagnoSearch LifeSciences Dr Lal Path Labs Dr. Reddy's Laboratories ECCRO India Services Ecron Acunova Eli Lilly EMC Corporation Ephicacy Lifesciences Analytics Etyka Clinical Solutions Expire Health Research Express Pharma Famy Care Fisher BioPharma Services Forte Research Systems Fortis Clinical Research Fresenius Kabi Partial list of attendees from our previous Clinical Trials Conference Fresenius Kabi Oncology G7 SYNERGON Generic Licensing GlaxoSmithKline Glenmark Glenmark Pharmaceuticals Global Data Global Health GNH India Going To Meet Government of Victoria, Australia India office GSK GVK Bio HCL Technologies Heart Care Associates Hinduja Hospital Hindustan Times Hospira Healthcare ICRI Image Core Lab Inbiopro Solutions INC Research India Law Indian Academy of Clinical Research IndiPharm Indus Biotech Intervein laboratories Invent Bio Med Ipca Laboratories ISBEC ISBEC, Mumbai ITS-DCHRC JAIC Asia Holdings Jame Jamshed Weekly JH Bio Johnson and Johnson Jubilant Clinsys KAP Computer Solutions Karmic Lifesciences Kinapse Lambda Therapeutic Research Linköping University Lotus Labs Lundbeck India Lupin Lupin Bioresearch Center Macleods Pharmaceuticals Marken Mascot Spincontrol MD Pharmacology Medanta Duke Research Institute (MDRI) Medi Stats Lab Mediception Science Medidata Solutions Metropolis Healthcare Microtherapeutic Research Labs MJ Biopharm MMSH Clinical Research MS Clinical Research Mylan Laboratories Natco Pharma National Institute of Health, U.S. Embassy Newtronic Nishith Desai Associates Norwich Clinical Services Novartis Healthcare Novartis Healthcare- Vaccines Division Ocasa Logistic Solutions OmniActive Health Technologies Oncquest Laboratories Oracle Health Science Oviya MedSafe Panacea Biotec ParadigmIT PDP LIfe Science Logistics Percipenz Pfizer Pharma Bio World Pharma Mirror PharmaLeaf Pharmaniaga Pharmaphorum PharmaVOICE Pharmcast PhaseON Clinical Research Physis Learning Academy Piramal Life Sciences Pirmal Healthcare PPCE PRA Internationl Provenance Research Quad One Technologies Quartesian Quest Diagnostics Quintiles Research Ranbaxy Laboratories RegPak BioPharma Consulting Reliance Life Sciences Roche Products RPM Alliance Rubicon Research Ruby Hall Clinic S P Software Technologies Sahajanand Medical Technologies Salzer Technologies Limited Sanofi Aventis Sanofi Pasteur Sanofi SAVA Healthcare Sciformix Technologies SenceCR Serum Institute of India SFS Pharma Logistics SGD S.A Glass Shantha A Sanofi Company Shantha Biotechnics SIRO SIRO Clinpharm Solonist Business Solutions SP Software Technologies Spectrum Oncology SRL SRL Diagnostics Stempeutics Research Strides Sun Pharma Advanced Research Company Sun Pharmaceutical Laboratories Surat Institute of Digestive Science Syngene International Tata Memorial Hospital TCS Tech Tree Tech-Observer TechPharmic Consulting Techsol Templegate The George Institute for Global Health The Pharma World Theramyt Novobiologics Torrent Pharmaceuticals Torrent Research Centre Trianz Holdings U. S. Embassy Unichem Laboratories Unilever Unithink Until Roi VAC3 ClinicalService Vanthys Veeda Clincial Research VerGo Pharma Research VIaTAL Pharma Consulting Virbac Animal Health Voisin Consulting Voisin Life Sciences VPH Vydehi Institute of Medical Sciences and Research Centre Wanbury Watson Pharma Western Institutional Review Board Witness Magazine Wockhardt World Pharma Today YCLIN Zifo Technologies Zuellig Pharma Speciality Solutions 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 44 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. The Lalit Hotel Sahar Airport Road, Andheri East, Opp. Hotel Leela, Mumbai 400059 - India Tel: 91 22 6699 2222 General information Venue: [email protected] http://www.virtueinsight.com www.virtueinsight.com News Updates: Please tick if you do not wish to receive email updates in the future 1 or 2 delegates - per delegate - Fee: INR 07,000 + Tax 3 or 4 delegates - per delegate - Fee: INR 06,500 + Tax For 5 and above delegates - per delegate - Fee: INR 05,500 + Tax 1 Day conference per delegate - Fee: INR 08,000 + Tax Forename ............................Surname ................................ Job Title ..............................Company ................................ Official Contact Number ....................................................... Address ............................................................................. ............................................................................. Country ...............................Postcode.................................. Phone ..................................Fax ........................................ Email ................................................................................. I confirm that I have read & agree to the terms and conditions of booking..... (Please Tick) Signature ........................................................................... Complete and return the above registration form via post or email, together with your cheque payable to Virtue Insight. Standard Rate Group Discounts Group Discounts Spot Registration:- Methods of Payments: By Bank Transfer: By Cheque - Registration Form Details: Account Type - Account Number - Bank Name - Bank Address - Branch Name - Swift Code - NEFT / IFSC Code - Micro Code - Current 915020031763553 Axis Bank 2/8 LAMBERT NAGAR, 1st cross street, Virugambakkam, Chennai - 600 092 Virugambakkam, Chennai AXISINBB211 UTIB0000211 600211010 RESERVATION PRICING: REGISTRATION FORM