8th Annual Clinical Trials Summit 2017
Offering our customers the knowledge and connections for a profitable business
Speakers
  • RAJENDRA H. JANI

    RAJENDRA H. JANI Zydus Cadila

  • ARUN BHATT

    ARUN BHATT Consultant - Clinical Research & Development

  • SUMIT MUNJAL

    SUMIT MUNJAL Takeda Pharmaceuticals (UK)

  • MANMOHAN SINGH

    MANMOHAN SINGH Pfizer

  • YASMIN SHENOY

    YASMIN SHENOY Sanofi-aventis

  • SRIRUPA DAS

    SRIRUPA DAS Abbott

  • CHIRAG TRIVEDI

    CHIRAG TRIVEDI Sanofi-aventis

  • TAPANKUMAR M. SHAH

    TAPANKUMAR M. SHAH AstraZeneca

  • MUKESH KUMAR

    MUKESH KUMAR Dr. Reddy's Laboratories

  • SHILPA RAUT

    SHILPA RAUT Novartis

  • NARESH TONDARE

    NARESH TONDARE Glenmark Pharmaceuticals

  • MILIND ANTANI

    MILIND ANTANI Nishith Desai Associates

  • JYOTSNA PATWARDHAN

    JYOTSNA PATWARDHAN Novartis

  • ABHAY PHANSALKAR

    ABHAY PHANSALKAR Cipla

  • PRAVIN GHADGE

    PRAVIN GHADGE Reliance Life Sciences

24th May 2017, Kohinoor Continental Hotel, Mumbai, India

“A critical guide for successfully conducting clinical trials”

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CONFERENCE INTRODUCTION:- 

Virtue Insight’s 8th Annual Clinical Trials Summit will bring together leaders from across pharma, biotech and academia to share case studies and best practices on effective clinical trial management and vendor oversight. The 2017 program focuses on key issues and opportunities in the clinical trial industry, including Patient Recruitment, Site Selection, Data Integration, Existing Data Sources, Mobile Tech, Project Management, Outsourcing, Vendor Management, Risk-Based Monitoring, Clinical Auditing, Regulatory Authorities, pharmaceutical industries, contract research organizations, patient associations, and academic groups are represented. This conference is known to facilitate the interaction between all stakeholders, speakers and participants, thus encouraging lively Q&A sessions without cultural barriers. In addition, as usual, this Conference represents a great opportunity to network with all players involved in drug and device development.

The fast change of our working environment - be it regulatory or scientific - requires an accurate update for those with accumulated experience wanting to gain new competencies, but in particular also for the young stakeholders who will contribute to the development of the next generation of drugs and devices.

Virtue Insight also offers comprehensive sponsorship packages, which includes presentation opportunities, exhibit space, branding and networking with specific prospects. Sponsorship allows you to achieve your objectives before, during, and long after the event. Any sponsorship can be customized to meet your company’s needs and budget. Signing on early will allow you to maximize exposure to qualified decision-makers.

It gives us immense pleasure in welcoming you to the 8th Annual Clinical Trials Summit 2017. I wish and pray that all our efforts will be beneficial to our industries and to our country at large

 

KEY THEMES DISCUSSED:-

  • Key drivers behind achieving a successful and sustainable clinical trails strategy in 2017
  • Develop faster, more effective strategies by setting up big data with the power of sophisticated analytics
  • Outsourcing early stage manufacturing
  • Benefits and challenges with using local and international vendors
  • Develop trial design and elaborate patient access
  • Span all phases of clinical and observational research
  • How we use mobile in clinical trials nowadays? What is the present barrier?
  • Integrated approaches to using digital as a clinical Tool: Real world trials and population health in the east India
  • The Impact of in-life unjust information on clinical trials execution
  • Observing operational progress and efficiency of a study or an asset in critical for drug development success
  • Strategic partnerships between Sponsor-CRO and how the industry has evolved in the past 5 years
  • DATA – Collection, Design, Storage, Execute and Manage clinical trials - an architect’s perspective
  • Possibilities for transforming data into quantifiable knowledge and growth in the quantity of clinical data collected
  • Human factors trial design and management
  • Understanding new e-clinical technologies to improve data quality and optimise clinical outcomes
  • What are the expectations of regulatory authorities and what type of regulatory structure does India currently have?
  • Updates on development for safety reporting in Indian clinical trial regulation
  • Next generations of clinical trials – How big will the market be?
  • Be part of a major networking opportunity

 

WHO SHOULD ATTEND:-

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

 

WHY SHOULD YOU ATTEND?

 
8th Annual Clinical Trials Summit 2017 - “A critical guide for successfully conducting clinical trials” - 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 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 – An opportunity to meet and to network with your conference colleagues.

09:20 – Chairperson opening remarks

MARKET OVERVIEW & ANALYSIS

09:30 – ICH GCP Integrated Addendum  2016 : Implications for India

  • Amendment objectives
  • Responsibilities of Sponsors – Quality management , Risk Based Monitoring, 
  • Responsibilities of Investigators
  • Implications for India

Arun Bhatt, Consultant – Clinical Research & Development


OUTSOURCING
 

10:00 Outsourcing early stage manufacturing

  • Logistics of using contract manufacturing organizations for early stage products
  • Pilot scale manufacturing requirements
  • GMP-grade and non-GMP grade manufacturing
  • Benefits and challenges with using local and international vendors


10:10 Topic TBC

Speaker TBC, Acceliant

 

10:30 – Morning Coffee/Tea & Discussion

CHALLENGES & OPPORTUNITIES
 

10:50 – DISCUSSION WITH EXPERTS: Develop trial design and elaborate patient access

  • Span all phases of clinical and observational research
  • Expand and influence on physician therapeutic decisions
  • Databases and clinical records, which can improve patient recruitment for clinical and observational research
  • Patients with longitudinal clinical records, which can be used for real-world evidence studies that deliver clinical, financial, and humanistic outcomes
  • Clinical trial environment where patient-specific clinical information can be easily transferred and shared within a payer system
  • Improved patient access to coverage and reimbursement for new healthcare technologies
  • Integrate value-focus across the product lifecycle
  • Identify market trends that are causing a move to a value based reimbursement and decision model
  • Explain the value of gaining payer input into clinical trial design


Moderator:
CHIRAG TRIVEDI, Director & Head of Clinical Study Unit, Sanofi-aventis
  

Panellists: 

SHILPA RAUT, Regional Training Head - Asia, Middle East and Africa Cluster, Novartis
RAJENDRA JANI, Advisor/ Independent Subject Expert, Zydus Cadila 
MUKESH KUMAR, Global Head- Clinical Management, Dr. Reddy's Laboratories

IMPACT OF TECHNOLOGY

11:40 – How we use technology in clinical trials nowadays? What is the present barrier?

  • How to enrich patient occurrence; experiences, BYOD, travel, etc.
  • How to improve data capture
  • Technical barrier - Is the technology ready?
  • Regulatory obstacle, do officials limit adoption?
  • Discuss the disconnect among hype and evidence


12:10 Integrated approaches to using digital as a clinical tool: Real world trials and population health in the east India

  • Public-private pre-competitive partnerships
  • Need to approach data analysis differently
  • Share the load, work together
  • What does this new model look like?


12:40 Networking luncheon
 

Afternoon chair person

14:00 – DISCUSSION WITH EXPERTS: Strategic partnerships between Sponsor-CRO and how the industry has evolved in the past 5 years

  • How is the partnership model trending?  Are collaborating arrangements still increasing in number and/or scope, or is the model in decline? What are the key reasons behind current trends?
  • How well do Sponsor and CRO expectations of these relationships align? Do we still see the gaps we observed in 2012? Have expectations increased or decreased due to the experiences of the past 5 years?
  • Have partnerships delivered on the prospective benefits of enhancing R&D productivity and/or efficiency? What is preventing us from accelerating progress?
  • To what extent do Sponsor/CRO relationships impact prevailing topics in clinical development such as enhanced patient engagement, leveraging big data, novel approaches to protocol design, and utilization of quality management systems?
  • What does the future hold for Sponsor/Provider relationships? Do we expect measured, incremental change, or are there disruptive paradigms that could alter the landscape?


Moderator:

Panellists:
MANMOHAN SINGH, APAC Regional Medical Director, Pfizer
TAPANKUMAR M. SHAH, Country Head – Site Management & Monitoring, AstraZeneca

SUMIT MUNJAL, Medical Director Lead, Global Medical Safety, Head of Mature Established products, Takeda Pharmaceuticals (UK)

 

DATA MANAGEMENT

14:50 – DATA – Collection, Design, Storage, Execute and Manage clinical trials - an architect’s perspective

  • Era of big data
  • Speed of data movement, accessibility of current data sources and emergence of new technology frameworks
  • Opportunities on which trials can be designed and executed faster, better and much more economically
  • Discussing used cases, accessible technologies & programs based on big data that can applied in the environment of modern clinical trials.
  • Possibilities for transforming data into quantifiable knowledge and growth in the quantity of clinical data collected
  • Clinical trial data sharing and data privacy


15:20 – Afternoon Tea/Coffee

15:40 – Differentiated clinical trial designs for a branded genetics portfolio
SRIRUPA DAS, Associate Director - Medical Affairs, Abbott

REGULATORY

16:10 – DISCUSSION WITH EXPERTS: Clinical trial regulatory challenges

  • Challenges faced by Sponsors and CROs
  • Updates on development for safety reporting in Indian clinical trial regulation
  • Overview of the regulation on risk-adapted trials and key factors
  • IMA regulations and policies - how are patients and ethics committees impacted and do the regulations meet their needs?
  • Regulatory challenges and constraints when evaluating vaccine clinical trials
  • Present situations in the regulation of vaccines and how they are being addressed
  • Improve patient safety, reporting timeliness of critical adverse events including deaths during clinical trials, and the payment of compensation to patients
  • Trial design and applicable regulatory guidance strategies to overcome
  • Regulatory considerations for a trial being run across different regions


Moderator:
MILIND ANTANI, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associates
 

Panellists:

SRIRUPA DAS, Associate Director - Medical Affairs, Abbott
NARESH TONDARE, Head– India and Nepal Regulatory Affairs, Glenmark Pharmaceuticals
JYOTSNA PATWARDHAN, Head Development QA, Novartis
ABHAY PHANSALKAR, Head Clinical Trials, Cipla
YASMIN SHENOY, Director-Regulatory Affairs, Sanofi-aventis
PRAVIN GHADGE, Head - Medical Writing & Pharmacovigilance, Reliance Life Sciences

17:00 – Chairperson’s closing remarks and end of conference

17:10 – 18:10 – Networking Drinks Session

RAJENDRA H. JANI

Advisor/ Independent Subject Expert

Zydus Cadila

ARUN BHATT

Consultant - Clinical Research & Development

SUMIT MUNJAL

Medical Director Lead, Global Medical Safety, Head of Mature Established products

Takeda Pharmaceuticals (UK)

Dr Sumit Munjal, a physician by training and an Indian by background has been associated with

Academic organizations such as London School of Hygiene & Tropical Medicine, Faculty of Pharmaceutical Medicine of the Royal College of Physicians and DSRU Southampton;

Government organizations such as NHS UK and MHRA;

And Pharmaceutical industry such as Johnson & Johnson, Millennium Oncology Pharmaceuticals Inc, Nycomed and Takeda Pharmaceuticals.

He is keen and remains committed to promote public health, patient safety and meet healthcare needs around the globe. He is currently based out of Central London.

Nov 2015, Dr Sumit Munjal

MANMOHAN SINGH

APAC Regional Medical Director

Pfizer

YASMIN SHENOY

Director-Regulatory Affairs

Sanofi-aventis

SRIRUPA DAS

Associate Director - Medical Affairs

Abbott

CHIRAG TRIVEDI

Director & Head of Clinical Study Unit

Sanofi-aventis

Chirag Trivedi is currently working in Sanofi as Director and Head of Clinical Study Unit (CSU) in India. The CSU manages the Clinical trials (for R&D and marketed Products) from Phase II-IV, Observational studies and Bioequivalence studies. It also plays a strategic and operational role in the Life Cycle Management of products.

He has been with Sanofi since May 2006 and has handled various roles and responsibilities in these years. Prior to Sanofi, he has worked in a CRO and prior to that, in a Central Lab.

He is a Ph.D. in Pharmacology from Mumbai University and is experienced in the fields of Clinical Research, Clinical Quality Assurance & Medical Excellence, Pharmacovigilance, Bioavailability & Bioequivalence Studies, and Business Development.

TAPANKUMAR M. SHAH

Country Head - Site Management & Monitoring

AstraZeneca

MUKESH KUMAR

Global Head- Clinical Management

Dr. Reddy's Laboratories

SHILPA RAUT

Regional Training Head - Asia, Middle East and Africa Cluster

Novartis

Shilpa Raut is a post-graduate in Pharmacy with Quality Assurance Program as a speciality and has a total work experience of 20 years. 6 years as a Lecturer in Pharmaceutical colleges and more than 13 years of experience in different aspects of clinical research such as Clinical Operations, Clinical Services, Quality Assurance and Training in Pharma and CRO Industry out of which completed 8 years at Novartis.

Presently, employed with Novartis India in their International Clinical Research Organization (ICRO) as a ‘Regional Training Head – Asia, Middle East and Africa Cluster & China, ’ and responsible for strategic designing of training courses and modules with hands-on experience of rolling out risk based monitoring  across countries. She is also currently an active member acting as a co-chair for the Training Council at Indian Society for Clinical Research since 2013.

She has also worked in an NGO managing Vaccine Projects conducted by ICMR, and Government of India and funded by Bill and Melinda Gates Foundation. She had a unique opportunity of working with the DCGI offices, ICMR and DBT in providing technical inputs for ‘Mapping of Indian Regulatory Systems for New Drug Approvals’. A project funded by Bill and Melinda Gates Foundation.

During her career, she has been coveted with various awards  to name a few

  • 'Best Project Manager' for the year 2009-2010 by ISCR (Indian Society For Clinical Research)
  • ‘Advancing Global Health’ award recognizing the excellence and wide spread reach of PATH as part of PATH’s Vision Awards for the Japanese Encephalitis project in the year 2008
  • ‘Innovator’s Award’ for the Indian Regulatory Systems Project as part of PATH’s Vision Awards in the year 2008


CPO Excellence awards – Gold and Silver categories for managing global audits

NARESH TONDARE

Head - India and Nepal Regulatory Affairs

Glenmark Pharmaceuticals

Dr. Naresh Tondare is a Regulatory Expert with 11 years of experience in the areas of Regulatory Affairs/strategy, Product/Formulation Development, New Drug Delivery/Technologies  and Clinical Research.

He has completed a post graduate degree (MD) in Ayurvedic/Herbal Pharmacology and Pharmaceutical from Govt. Ayurvedic Medical College in 2004.   He has also completed a PGDIM from School of Management Studies (SOMS), New Delhi in 2009 and a Black Belt in Six Sigma (BBSS) programme from Indian Statistical Institute (ISI) in 2008.

Currently, he is working with Glenmark Pharmaceuticals Ltd, Mumbai as a Head- India and Nepal Regulatory Affairs (Senior Manager) since 2011. He is responsible and accountable for regulatory strategy and regulatory submissions of New Drug, NCE, Subsequent New Drug, OTC, Food Supplements, Herbal Products and Cosmetics for India and Nepal Region. Prior to Glenmark, he has worked with several organizations such as AccuMED, SmartAnalyst etc.

MILIND ANTANI

Partner In-Charge - Pharma LifeSciences

Nishith Desai Associates

JYOTSNA PATWARDHAN

Head Development QA

Novartis

ABHAY PHANSALKAR

Head Clinical Trials

Cipla

Medical Physician with approx. 10 years of drug development experience in biopharmaceutical industry in Clinical Development, Medical Affairs, Pharmacovigilance and Medical Writing functions.

Worked across therapeutic areas including Respiratory Medicine, HIV, Cardio-metabolic, Gastroenterology, Nephrology, Oncology, Immunology, Transplantation and Infectious diseases, Vaccines, Hematology, Critical Care, Orthopedics and Pain Management, and Gynaecology.

Role in Clinical Development & Pharmacovigilance

  • Currently, responsible for the design, conduct and publication of clinical trials in India and Emerging Markets.
  • Clinical strategy for Portfolio planning and development.
  • Protocol and clinical trial documents (safety narratives, CRF, IB, Safety Management Plan) development of Biosimilars in collaboration with various stakeholders.
  • Medical review of Statistical Analysis Plan & Trial Data Analysis and development of Clinical Study Report.
  • Medical Safety Monitoring of the clinical trials including regulatory safety reporting, medical coding using MeDRA & liaison with Data Safety Monitoring Board (DSMBs) for medical safety reviews   
  • Medical Writing and review of Development Safety Update Reports (DSUR), Risk Management Plans (RMPs), and Clinical trial report database (CTRDs), and Annual Safety Update Reports (ASRs).
  • Presentation of Study results to Regulatory (DCGI) expert committees for marketing authorization approvals and in medical conferences.
  • Vendor Management & Budget Management of Phase 3 & 4 Studies

Role in Medical Affairs

  • Product Portfolio Development: Collaboration with various stakeholders for product identification, review & finalization.
  • Development of Medical Strategy for the brand life cycle management 
  • Identification & Engagement of Key Opinion Leaders & Medical Associations in India
  • Regional Medical Affairs Team management

PRAVIN GHADGE

Head - Medical Writing & Pharmacovigilance

Reliance Life Sciences

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Virtue Insight equips business professionals around the world with the latest indepth industry knowledge and provides networking opportunities in the telecom, infrastructure and pharmaceutical industry. Our aim is to provide a platform to share knowledge and insights and provide our event attendees to network effectively and deliver maximum ROI by make new business alliances. We strive to produce high quality conferences which include the latest topics which are delivered by world class leaders of the industry.

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Our highly researched conference agenda delivers all the latest information and our world-class speakers attract delegates from around the world to attend. We aim for our attendees to be equipped with knowledge of latest developments and enable them to network with the industry key personnel.


What is the format of our conference programme?
The conference programme consists of world-class keynote addresses, case study presentations and panel discussions.


What are the benefits of attending?

  • Meet your peers in an interactive, discussion-based format designed to maximize knowledge transfer and networking
  • Enjoy our informal networking at drinks and lunch
  • Meet the leading solution providers in the market to forge partnerships and discover solutions
  • Receive electronic versions of the conference documentation for use of reference post-event.
  • Get ideas for?training topics?that you might want to present as professional development sessions to others in your workplace.
  • Observe speakers from the perspective of seeing what works really well so you can learn new public speaking techniques and strategies that you can apply when doing your own presentations.
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Email - delegate@virtueinsight.com
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Early Bird Discounted Price 1 Delegate Pass - (INR 6,000 + Tax (15%) per delegate) - Book and Pay before 10th April 2017 to avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: + 91 44 64536444. Email – delegate@virtueinsight.com 

Standard Price (11th April 2017 Onwards) 1 or 2 Delegates - (INR 8,000 + Tax (15%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: + 91 44 64536444. Email – delegate@virtueinsight.com 

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Kohinoor Continental Hotel

Address: Andheri Kurla Road, Andheri ( E ), Mumbai 400059 - India
Phone:
91 22 66919000 / 91 22 28209999

Testimonials from our past Clinical Trials Summit Conferences

 

 

Over all good - Buddha Siva Kumar, Safety physician, Sciformix

It was good & interadity sessions - Shubhada Wakade, Quality lead, PV, Sciformix Tech pvt.ltd

1. Very useful to network with sponsors and CRO. 2. Good place to know the progress of competition - Basheerun sheikh, Manager - eclinical, DDi

Great conference for networking and relationship - Jaidip vyus, Officer, Spilcsun Pharma

It was great experience attending this clinical trial summit 2015. It Learned lot of new updates in clinical trial industry as well as regulatory - Shankaranarayanan. J, Sr. Manager Clinical Research, OmniActive Health Technologies

Since Pharama companies have ventured into Biologicals/ Biosimilars business, the conference could have focused on discussing case stdies in Biosimilars Clinical trails, challenges in CTS in New Biologicals& Vaccines - Tanushree Bhattacharya, Regulatory Affairs Biologicals-Cipla New Ventures, Cipla

Very interactive informative and time managed session - Kirti Ratolikar, Manager - QA &RA, Sanofi Pasteur

The sessions was informative on products and the discussions was fantastic. It has given a better idea on where the industry is heading. To start a new era of clinical trials, this seems to be a promising start for the industry. The second innings for the clinical trials seems promising technically as well as operationally - Rajesh Krishnan, Senior Business Analyst, HCL Technologies

Well Organized - Babu, Team Leader, Lotus Labs

This conference was informative. There was good exchange of information. It provided current and actual seminar in india regarding Clinical Trials would like to attend this conference in future - Satish A Gaikwad, Clinical Research Associate, Lambda Therapeutic Research

Many presentations covered were eye openers and being from a typical IT Service provider company, the conference really added value in terms of clarifying the business processer and challenges of Pharma industrials - Souvik Bit Associate Business Manager, HCL Technologies Ltd

Topic was very good huge on current seminar, Location is very good to Aelequase, Speaking was good to deliver current situation, Very on panel discussion and due and Answer session - Rajesh Telawade, Sr. CRA, Lambda Therapeutic Research

“Fen and his team from Virtue insight have done a great job in bringing everyone together to share their ideas and experiences for clinical research industry in India- the past, present and future. It was nice meeting old contacts again as well as making some new ones at the event. I wish all the very best to the scientific mind and organizing execution committee for making this conference successful with all its share of challenges.” - Dr. Deepti Sanghavi, Senior Medical Writer-Medical Writing, SIRO Clinpharm

Over all good experience and well conducted - Dr. Devas Seth, Manager Clinical Ops, Dr. Reddy's Laboratories

Summit was well organized and very interesting panel of discussion - Rituja Doiphode, Business Development Manager, Clinical Research, Metropolis Healthcare

Great administration of entire programme session by session, pleasant surprise is that 95% of speakers as planned turned up - Joe Jacob, Director Operations, GSS HR Solutions

Excellent Organisation and facilities - Jessy George, Sr. CRA, GlaxoSmithKline

Conference was informative, a great opportunity to converse and interact with esteemed and prominent delegates and speakers from renowned organisations. Being a trainee it helped me out in understanding CR industry diversely and scenario globally - Swati Jha, Trainee CRC, Trisha Trauma Centre

This is a really well managed, informative, interactive and learning event also allowing us to network together and its absolute a value for money. I wish them the “All is The Best”. Keep up the “GOOD SHOW” - Jatin Dhulla, General Manager, Accutest Research

Very Insightful.... - Dr. Arvind Gunput, CEO, EOS Medical Research

Very good forum to network and an overall good set of information shared with the attendees - Aparna Shirodka, Project Executive, SRL

Its a good conference and the approach of new ideas get a merge in single pool without any barriers - Preetam Chavan, Research Associate, Lupin Bioresearch Center

This conference gave a good insight of current challenges in running clinical trials in india – relating to regulatory, investigators, sites, training etc.... - Ritika Sugand, Business development, Karmic Life sciences

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