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

    K. BANGARURAJAN CDSCO

  • RAJENDRA H. JANI

    RAJENDRA H. JANI Zydus Cadila

  • ARUN BHATT

    ARUN BHATT Consultant - Clinical Research & Development

  • VIVEK GUPTA

    VIVEK GUPTA Acceliant

  • KARIM DAMJI

    KARIM DAMJI Saama Technologies

  • NAMRATA SINGH

    NAMRATA SINGH Turacoz Healthcare Solutions

  • SRIRUPA DAS

    SRIRUPA DAS Abbott

  • CHIRAG TRIVEDI

    CHIRAG TRIVEDI Sanofi

  • EMRAN KHAN

    EMRAN KHAN Cipla

  • YASHESH MEHTA

    YASHESH MEHTA Sciformix

  • NARESH TONDARE

    NARESH TONDARE Glenmark Pharmaceuticals

  • ARUNKUMAR S

    ARUNKUMAR S Acceliant

  • MILIND ANTANI

    MILIND ANTANI Nishith Desai Associates

  • MANISH VERMA

    MANISH VERMA Sanofi

  • PRASHANT BODHE

    PRASHANT BODHE CliniSearch

  • JYOTSNA PATWARDHAN

    JYOTSNA PATWARDHAN Novartis

  • ASHWANI PANDITA

    ASHWANI PANDITA Glenmark

  • AMEY MANE

    AMEY MANE Johnson & Johnson

  • KAVYA KADAM

    KAVYA KADAM (Former - Head - Global Clinical Operations, Cipla BioTec)

  • PRAVIN GHADGE

    PRAVIN GHADGE Reliance Life Sciences

  • CHANDAN BADAPANDA

    CHANDAN BADAPANDA Xcelris Labs

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

“A critical guide for successfully conducting clinical trials”

ADD THIS EVENT TO YOUR CALENDAR
Sponsors & Exhibitors
  • Sponsors
  • Sponsors
  • Sponsors
  • Sponsors
  • Sponsors
  • Conference Info
  • Day One
  • Speakers
  • Sponsors
  • Partners
  • Sponsorship Opportunity
  • Delegates
  • Pricing
  • Venue
  • Testimonials
  • Presentations
  • Gallery

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
PRASHANT BODHE, Director,
CliniSearch

 
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


10:10 How next generation Technologies can help you take your product faster in market
 VIVEK GUPTA, Worldwide VP, Acceliant

 

10:40 – Morning Coffee/Tea & Discussion


CHALLENGES & OPPORTUNITIES

 

11:10 – 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
  

Panellists:
RAJENDRA JANI, Advisor/ Independent Subject Expert, Zydus Cadila

ARUNKUMAR S, Functional Lead, Acceliant
KAVYA KADAM, (Former - Head- Global Clinical Operations,
Cipla BioTec)
NAMRATA SINGH, Founder and Director,
Turacoz Healthcare Solutions
CHANDAN BADAPANDA, AGM-Bioinformatics,
Xcelris Labs

 
SPONSOR – SITE- CRO – PATIENT
 

12:00 – Centralizing Data to Address Imperatives in Clinical Development 

The clinical development data deluge is reaching critical mass for pharmaceuticals. Use of varied data for targeted outcomes remains difficult, despite studies that generate evidence of the risk-benefit profile of investigational products. New technologies are federating the ability to leverage analytic-ready data for innovations in clinical operations and clinical science. With the application of clinical data-as-a-service and meta-data core, centralized clinical data lakes have the power to improve data quality, evidence generation, and time-to-insights.

KARIM DAMJI, SVP - Products and Marketing, Saama Technologies

 

12:30 Networking luncheon
 

Afternoon chair person

13:40 – 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:
PRASHANT BODHE, Director, CliniSearch


Panellists:
 
EMRAN KHAN, Head-R&D Outsourcing Services Procurement, Cipla
ASHWANI PANDITA, Dy. General Manager Quality Management & Training, Global Clinical Research Operations,
Glenmark
YASHESH MEHTA, Director Delivery Partner,
Sciformix
AMEY MANE, General Manager- Medical Affairs,
Johnson & Johnson

 

14:30 – “Observational studies and ethical considerations: When and where to take them?”
NAMRATA SINGH, Founder and Director,
Turacoz Healthcare Solutions


15:00 – Afternoon Tea/Coffee

15:20 – Differentiated clinical trial designs for a branded generics portfolio
SRIRUPA DAS, Associate Director - Medical Affairs, Abbott

REGULATORY

15:50 – 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:
K. BANGARURAJAN, Deputy Drugs Controller (India), CDSCO
SRIRUPA DAS, Associate Director - Medical Affairs,
Abbott

NARESH TONDARE, Head– India and Nepal Regulatory Affairs
, Glenmark Pharmaceuticals

JYOTSNA PATWARDHAN, Head Development QA, Novartis
MANISH VERMA, Head of Medical Affairs, CHC South Asia Zone, Sanofi

PRAVIN GHADGE, Head - Medical Writing & Pharmacovigilance, Reliance Life Sciences

16:50 – Chairperson’s closing remarks and end of conference

17:00 – 18:00 – Networking Drinks Session

K. BANGARURAJAN

Deputy Drugs Controller (India)

CDSCO

Dr. K. Bangarurajan did his Degree in Pharmacy from Madras Medical College and M. Pharmacy from Banaras Hindu University, Varanasi  in the Year 1984 and was awarded Ph.D. by Tamil Nadu Dr. MGR Medical University in the Year 2000.
 
He began his career as a lecturer at J.S.S. College of Pharmacy, Ooty.

He joined the Drugs Control Department in the Year 1986 as a DRUGS INSPECTOR and served as a Senior Drugs Inspector and Assistant Director of  Drugs Controller. 

He was awarded as "Best Drugs Inspector" in the year 2005.

He joined the Central Drugs Standard Control Organization, Headquarters at New Delhi in the Year  2010 and since 24th February 2014,  he is posted at Central Drugs Standard Control Organization, West Zone, Mumbai. He has the overall charge of  the Western region and responsible for uniform implementation of the provisions of the Drugs & Cosmetics Act and rules thereunder.

He has made remarkable contributions in National and International seminars, workshops, which shows his urge for upgrading knowledge of the complex pharma spectrum which undergo rapid changes.

RAJENDRA H. JANI

Advisor/ Independent Subject Expert

Zydus Cadila

Summary

  • Presently Advisor to large pharmaceutical companies,
  • Worked for large global Pharmaceutical companies,
  • Unique blend of R&D management skills combined with business management experience,
  • More than 37 years’ experience with healthcare system of government, global companies and also possess hardware, software and networking across the globe.


Skills

  • Extensive experience in R&D system management as well as team building and negotiation. Able to motivate and move a group toward a consensus in the clinical research.
  • As a member of senior management teams of pharmaceutical companies, extensive exposure also to strategies, medico-marketing, formulation development, manufacturing, etc.
  • Detail oriented, strong analytical skills.
  • Proven history of solving complex operational problems and getting success

ARUN BHATT

Consultant - Clinical Research & Development

Dr Bhatt has extensive experience of over three decades in the Indian pharmaceutical industry in clinical research, drug development, and regulatory affairs. He has managed clinical development of novel molecular entities in diverse therapeutic areas in all clinical development phases.

Dr Bhatt has worked as a consultant in pharmaceutical medicine and clinical pharmacology. His past positions held include President, Clininvent Research Private Limited – a CRO, CEO of CMI (India) Private Limited and Medical Director of Novartis India Limited.
Dr Bhatt has been active in industry associations and was earlier the President of Indian Society for Clinical Research (ISCR). He is joint Editor-in-Chief of Perspectives in Clinical Research – the journal of ISCR.

In 2009, the Institute of Clinical Research UK nominated Dr Bhatt for the Honorary Fellowship of Institute of Clinical Research.

Dr Bhatt is the recipient of Drug Information Association outstanding Service award 2012 for his immense contributions in his field of specialization.

Dr Bhatt delivered the prestigious Prof U K Sheth Oration in 2013.

Dr Bhatt is a qualified assessor for NABH Accreditation for Clinical Trials.

Dr Bhatt has more than 100 publications in national and international journals.  He runs a regular monthly column on “Good Clinical Practice – Question Answers” and has published a book “Clinical Trials and “Good Clinical Practice in India – Questions and Answers”.

VIVEK GUPTA

Worldwide VP

Acceliant

Vivek Gupta is the worldwide VP at Acceliant. Vivek is an accomplished technology leader with demonstrated track record of driving sales organizations. At Acceliant, he is responsible for formulating sales strategy and implementing the execution plan. He focuses on increasing the existing market share and identifying new business development opportunities.

KARIM DAMJI

SVP - Products and Marketing

Saama Technologies

Karim is Senior VP, Product Management and Marketing, and joined Saama from Plantronics, where he led software strategy and product management, focusing on driving developer platforms, strategic partner integrations and contextually enabled UC solutions.

Prior to joining Plantronics, Karim served in leadership positions spanning business development, product management, sales and network engineering at Cisco, Vocera Communications, MobileIron and DiVitas. Karim spent 7 years at Cisco building global VoIP and WAN networks, eventually transitioning to product architecture positions. At Vocera Communications, Karim was the founding product manager responsible for driving product concept to market-leading solutions.

NAMRATA SINGH

Founder and Director

Turacoz Healthcare Solutions

An experienced pediatrician with intuitive and comprehensive medical communicating skills. Being on both sides of the table- pharmaceutical/biotech and healthcare professionals/hospitals, Namrata understands and comprehends the requirement and delivers spot on. Her forte initiates from being a part of the initial planning to delivering the final customized solutions. She has experience and expertise across all major medical documents (publication, regulatory and marketing) and all major therapeutics areas. As an entrepreneur and trainer, she is always ready to explore new ideas and opportunities which will impact the way scientific evidence is communicated. Turacoz Skill Development Program, a wing of Turacoz Healthcare Solutions, takes initiatives to full fil the gap between the academic curriculum and the industry requirements and have customized and specialized training solutions in the form of seminars, workshops, and e-learning modules for healthcare and pharmaceutical professional, pharmacy students, researchers and scholars.

SRIRUPA DAS

Associate Director - Medical Affairs

Abbott

Dr Srirupa Das has done her MD in Pharmacology from VSS Medical College, Burla and has a Post Graduate Diploma in Marketing Management from NMIMS, Mumbai. She started her career in the pharmaceutical industry in the year 2003 in Fresenius Kabi. Successively, she has had stints at Lupin Research Park and Sun Pharma Advanced Research Company before joining Abbott India Limited in 2011. Currently she is employed as Associate Medical Director-Medical Affairs responsible for Medical Affairs and governance for Abbott Primary Care.

CHIRAG TRIVEDI

Director & Head of Clinical Study Unit

Sanofi

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.

EMRAN KHAN

Head-R&D Outsourcing Services Procurement

Cipla

YASHESH MEHTA

Director Delivery Partner

Sciformix

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.

ARUNKUMAR S

Functional Lead

Acceliant

Arun has 13+ yrs of experience in Clinical Research Industry and predominantly spent most of tenure in CDM space.

A certified clinical data manager and having work with companies like Novartis and Jubilant Clinsys before Acceliant. At Acceliant, Arun Plays a critical role in functional assignments to understand Industry needs and act as a bridge between Domain and Technology delivery.

MILIND ANTANI

Partner In-Charge - Pharma LifeSciences

Nishith Desai Associates

Dr. Milind Antani is a Partner in charge of the Pharma & Healthcare Practice a at the multi-skilled, research-based international law firm, Nishith Desai Associates with offices in Mumbai- Nariman Point, Silicon Valley, Bangalore, Singapore, New Delhi and Mumbai – BKC, Munich and New York. He is also partner in-charge of Social Sector practice and Nanotechnology practice.

Dr. Antani represents clients on strategy matters including corporate mergers and acquisitions, investments, regulatory and transactional matters, intellectual property prosecution and litigation, collaborations including joint ventures and formation of new companies. He also advises clients in e-Health and tele-medicine on business strategy from legal and regulatory perspective.

He has authored and co-authored many articles, publications related to the pharma and healthcare industry including a book on CRAMS, and Pharma and Life science. The have also contributed a chapter on India in ‘Commercialization of Healthcare-2nd Edition Global Guide’ published by Thompson Reuters in 2015. He is a regular speaker and panelist at various national and international forums on the subjects of pharma, biotech, IP, clinical trials, healthcare, CSR, FCRA. He is also a visiting faculty at many institutions in Mumbai.

He has been included as one of the world's leading practitioners in ‘Who's Who Legal’ for Life Sciences 2014 and 2015 in the ‘Regulatory’ section as only lawyer from India.

Dr. Antani practiced as an ENT surgeon for 14 years prior to joining Nishith Desai Associates as a lawyer.

He has also successfully attended "Managing and Transforming Professional Service Firms-India” an executive training program organized by HARVARD BUSINESS SCHOOL.

MANISH VERMA

Head of Medical Affairs, CHC South Asia Zone

Sanofi

Dr Verma completed his MD in internal medicine from Gandhi Medical College, Bhopal. From 2005 to 2013, he has held several positions in medical affairs, clinical research and pharmacovigilance at Eli Lilly, Ranbaxy and Biocon. Dr Verma joined Sanofi India Limited as Director Medical Affairs for Cardiovascular Thrombosis, Internal Medicine and Hospitals in September 2013. Sanofi is a global truly diversified healthcare leader present in India since 1956. Dr Verma has published over 10 abstracts/papers in national/international journals of high repute and has been invited speakers/panelist at several national/international conferences for presenting his work. His focus area of work has been new drug development, patient support programs, public health initiatives and clinical research in the field of non-communicable disease mainly, diabetes, hypertension, dyslipidemia and cardiovascular diseases. He served as scientific committee member for the countries first ever white paper for strengthening policies on diabetes care.

PRASHANT BODHE

Director

CliniSearch

Profile Description:

Pharmacologist with 24+ years of experience in Regulatory Affairs; Quality Compliance and Systems; Global Clinical Research (Phase I-III) & Pharmacovigilance; API, Toxicology; Formulation Development; Bioavailability, Bioequivalence Studies, Pharmacokinetics

Professional Experience

Director

CliniSearch; Proprietor; Consultant, Pharmaceutical Research and Development
June 2014 - Present

Director of Operations, Medanta Duke Research Institute (MDRI)
Medanta The Medicity Sector 38, Gurgaon, Haryana, 122001, India; Aug 2013 – June 2014

Associate Director, Clinical Operations & Office Head, Sri Lanka Quintiles Research (India) Pvt. Ltd.; Feb 2011 – June 2012

Director, Clinical Development Center
Advance Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Center, Navi Mumbai; Jan 2008 - May 2010

Vice President
CliniSearch Biotechnologies, Navi Mumbai, India; Dec 2003 - Dec 2007

Deputy General Manager (Senior Clinical Pharmacologist) Lupin Research Park, Pune, India; Dec 2002 - Dec 2003

Head Regulatory Affairs (India Region) Cipla Ltd., Mumbai, India; Jul 2000 - Dec 2002

Assistant Manager, Department of Pharmacology, Toxicology, Research and Development
Cadila Pharmaceuticals Ltd., Ahmedabad, India; Since Dec. 1998 to Jul. 2000

Senior Research Fellow
Liposome Clinical Pharmacology Center, Dept. of Clinical Pharmacology, Seth G.S. Medical College and K.E.M. Hospital, Mumbai, India; Nov. 1991 - Dec. 1998

Research Fellow
Indian Institute of Toxicology, Pune, India; Apr. 1988 - Oct. 1991

Professional Memberships

  • Life member of ACTREC Alumni Association, Tata Memorial Center, Kharghar, India
  • Indian Pharmaceutical Association (Life Member)
  • Registered Pharmacist (Life)

Publications

  • 13 scientific papers in indexed International (4) and National publications (9)
  • Presentations: http://www.slideshare.net/PrashantBodhe

JYOTSNA PATWARDHAN

Head Development QA

Novartis

Pharma professional holding Masters degree in Pharmaceutical Sciences and post graduate diploma in clinical research. Have experience of over two decades in the  Indian pharmaceutical industry across different verticals like formulation development, regulatory affairs, Clinical Operations, pharmacovigilance, quality and compliance

Currently working as Head Development QA and responsible to implement and maintain the local Quality System in the areas of GCP and GPvP at Novartis

Have experience in hosting as well as auditing Pharmacogilance  as well as clinical trial activities including  sites, vendors CROs etc.  Hosted USFDA inspection Driven various Initiatives to create awareness about compliance and GxP concepts. Actively driving the initiatives to create Quality Culture within organization

ASHWANI PANDITA

Dy. General Manager Quality Management & Training, Global Clinical Research Operations

Glenmark

Ashwani Pandita is associated with the clinical research industry in India for more than 14 years. He has worked at various levels in the CRO space as well as in the sponsor companies.

Ashwani is a pharmacist by education. He has studied pharmacy at Nagpur University and also has a Master’s in Quality Management from BITS Pilani in India.

Ashwani has also earned the credentials of Registered Quality Assurance Professional in GCP from the Society of Quality Assurance, USA.

Currently, Ashwani is associated with Glenmark Pharmaceuticals Limited in India, as Dy. General Manager and Head of Clinical Quality Management & Training.

AMEY MANE

General Manager - Medical Affairs

Johnson & Johnson

Amey Mane is currently General Manager-Medical Affairs at Janssen India(Pharmaceutical companies of Johnson & Johnson). He is a clinical pharmacologist with 14 years of experience in multinational and Indian pharma.He has handled diverse responsibilities in medical affairs,clinical research, medical writing and pharmacovigilance. He has >10 international publications in diabetes,vaccine, pharmacovigilance, epidemiology and clinical research domains.

Experience

Janssen (Pharmaceutical companies of Johnson & Johnson) - (October 2014-Present) General Manager-Medical Affairs

Wockhardt Ltd.(October 2012- October 2014) DGM-Medical Affairs

Reliance Clinical Research Services (September 2011- October 2012) Head Medical writing & Pharmacovigilance

UCB India Ltd (December 2008-September 2011) Medical Advisor (Neurology) (June 2009-September 2011)

Panacea Biotec Ltd. (October 2007-December 2008)
Clinical Pharmacologist(December 2008-June 2009)

Clinical Research Manager Wockhardt Ltd. (August 2006- October 2007)

Lambda therapeutics (July 2004-July 2006) - Clinical Pharmacologist

Academic qualification

•    MD (Pharmacology) ;Mumbai University- 2006
•    MBBS ;Mumbai University- 2001

KAVYA KADAM

(Former - Head - Global Clinical Operations, Cipla BioTec)

Dr. Kavya Kadam heads Global Clinical Operations at Cipla BioTec with 15+ years of experience including CRO, Biopharmaceutical industries and Clinical Practice. She is a medical graduate from Seth G. S. Medical College, Mumbai and is presently pursuing an Executive MBA from SP Jain Global School of Management, Mumbai.

In her current profile, Dr. Kavya Kadam is responsible for Clinical Operations and Clinical Trials, globally. In her short tenure since December 2015, Dr. Kavya Kadam has already initiated the first Human trial for Cipla BioTec.

Dr. Kavya Kadam has managed Global Clinical Trials and Clinical Operations for International Clients. While doing so, she has had hands-on-experience of managing trials in various therapeutic areas including biosimilars, generics, monoclonal antibodies, stem cell, vaccine, proof-of-concept trials to name a few.

During her earlier years, Dr. Kavya Kadam has managed end to end Regulatory and Project Management in the Asia-Pac region. She also worked in the early development set-up as a Principal Investigator for early development studies including Phase I, Phase II and B.A.B.E. studies.

PRAVIN GHADGE

Head - Medical Writing & Pharmacovigilance

Reliance Life Sciences

CHANDAN BADAPANDA

AGM-Bioinformatics

Xcelris Labs

ORGANISED BY

Virtue Insight

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.

Our motto is to offer our customers the expertise and connections for a profitable business. Our events encompass an optimum chance to gain maximum value in terms of networking and an opportunity to sponsor and exhibit to attract new business alliances.

SUPPORTED BY

http://www.convergenceplus.com/

Lex Witness

LEX WITNESS – India’s 1st Magazine on Legal & Corporate Affairs

LEX WITNESS vows to be a high quality monthly magazine with the powers of fresh and original content that would deal exclusively with subjects pertaining to legality. Country's top notch practitioners and experts are being invited to contribute in WITNESS with what we feel is relevant to all stakeholders in this profession, aiming at brainstorming between the legal luminaries and hence bettering this practice in all its aspects.

Pharma Phorum

Book my training

Bookmytrainings.com is India’s leading training marketplace offering classroom, online, e-learning & in-house training to corporate & working professionals.
More than 1000 unique courses are available including on the latest technologies like Cloud, Big data, Agile, DevOps & IoT.

Benefits to Individuals:
•   Discover, Evaluate & Book training courses of your choice to suit your needs
•   User friendly Website & Policies
•   10,000+ delighted professionals benefited so far

Benefits to Corporate:
•   Bring in the right expert for any training requirement – technical, functional or      behavioural
•   Nominate to excellent public workshops or professional events
•   Trusted by more than 200 corporate HR / L&D teams

Explara

Going To Meet

Conference Locate

Clocate.com is a leading international directory for worldwide conferences and exhibitions. Clocate.com is equipped with a unique and comprehensive search that helps you find easily any event in any category or location. Each event includes detailed information, like, description, dates, location, map, prices, link to the official event's  website and more...

If you search for a conference or exhibition in areas such as Industry and manufacturing, Health and medicine, Technology and IT, Business and finance, sciences, education, services (banking, insurance, tourism, Hospitality and more), government, environment, life style and arts, you'll find it in Clocate.com.

10 Times

The Pharma Times

MEDGENERA

MEDGENERA is a leading integrated digital media and marketing platform for biotech, pharma and chemistry Industries. Join them (for free!) and stay updated for the entire perspectives on entrepreneurship, investment and true innovations in these industries.

Website: www.medgenera.com

Express Pharma

Supply Chain Brain

PV Chronicle

Life Science World

LSW LifeScienceWorld is an Online Magazine on Pharma & Biotech industry which has eminent scientists, Researchers, Industry professionals as Advisory Board Member actively involved on regular basis.

Exclusiveness:

 

•   Articles/Features on subjects not heard of, but of utmost importance in the

     industry.Interviews with eminent personalities on subjects not dealt before.
•   Guest Desk: Columns/articles by Professionals
•   Video
•   Individual sections on Pharma, Biotech, Technology and Life Science
•   Bulletin

 

LSW Forum: Objective
 
Take up issues concerning the industry to government agencies like DCGI, ICMR, DBT, Dept. of Pharmaceuticals and the Ministry of Health & Family Welfare by way of organising Roundtables between Industry personnel and Regulatory officials periodically.

JSB Conference

JSB Conference work’s globally for crafting your proposal at international level, by giving a surety that delegates land up meeting a right audience, to show-off their business skills. Embark your journey by meeting Leading Enterpernure, Bussiness tycoon, Banking & finance Leaders and Growing start-ups.

 

The conference is "All ABOUT TOGETHERNESS" and we "UNIT AS JSB CONFERENCE".

 

Website URL :

 

http://www.jsbconference.com/

BioChem Adda

BioChem Adda aims to provide the most reliable information portal related to Biotech Jobs, Biotech Internships in the USA, Biotech Internships in India, Biotech Companies Database, Careers, Education, Fellowships, News, Articles, and Events from the field of Biological and Chemical Sciences!

Pharma China

FOLLOW US

You Tube

Facebook

Linked in

Twitter

Partnering with Virtue Insight means more than making the right contacts. It means being an insider. It means being connected to the right people with the right level of influence, and it means you are allied with a globally respected organization and leaders in the industry.?


Sponsorship, exhibiting and advertising packages are designed to provide a solid platform to help you stand out and make an impact. Our programs allow you to achieve your marketing goals and deliver a maximum return on your investment. We have developed convenient and customizable packages to help your organization meet its objectives and reach your target market.


Why Sponsor / Exhibit:

PROFIT: To Maximize
MARKET SHARE: Defending and Increasing Market Share
COMPETITION: To attach and defend against competition


Benefits:

  • Generating sales leads
  • Build brand image
  • Maintaining customer relations
  • Consolidating business relationships
  • Accessing new and emerging markets
  • Obtaining technical knowledge
  • Leverages the events extensive marketing campaign to add value to your organisations marketing strategy and budget leading up to the event
  • Live product demonstration to test market responses
  • Facilitating quick market penetration
  • Reach important targeted commercial prospects face to face in a social, relaxed environment. The ideal platform to build strong business friendships Strengthen your market position


Our conferences offer not only a unique combination of benefits (as listed above) to enable the sponsor/exhibitor to communicate the message but also a major opportunity that other forms of selling or media cannot provide.


Contact Us Today

UK
Email - sponsor.uk@virtueinsight.com
Tel: +44-2036120886


INDIA
Email - sponsor@virtueinsight.com
Tel: +91 44 64536444


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.
  • Learn what not to do in presentations if you end up sitting through any sessions that fail to be engaging or informative.
  • Delegates also benefit from discounted rates onfuture event attendance


For more information or to register at the event please contact us TODAY:


Contact Us Today

UK
Email - delegate.uk@virtueinsight.com
Tel: +44-2036120886


INDIA
Email - delegate@virtueinsight.com
Tel: +91 44 64536444

Standard Price 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 

Group Discounts – 3 or 4 Delegates - (INR 7,000 + Tax (15%) per delegate) 

Group Discounts – 5 and above Delegates - (INR 6,000 + Tax (15%) per delegate) 

Spot Registration on the day of the Conference – 1 Day Conference - (INR 9,000 + Tax (15%) per delegate)

Conference Sponsor & Exhibition Stall – Should you wish to Sponsor, or purchase a Exhibiton Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to – TEL: + 91 44 64536444. Email - sponsor@virtueinsight.com

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

 

 

Great networking event – Deep Sarkar, Business Enablement & Strategy, Saama Technologies

Nice and arranged and organised well – Priya Shah, Vice President, Mascot Spincontrol

Very well structured summit. Adequate knowledge on the topic of clinical research, regulations, guidelines, amendments, etc are well discussed – Premsaikrishna R Warrier, ICRI (Institute of Clinical Research, India)

Conference was very informative and the positive of the conference is Mr. Bangarurajan sir. Regulatory perspectives were very much good and clarified. Very much happy for the conference – Krishnaswamy Maturi, Research Associate, The Himalaya Drug Company

Very informative. Good refresher on latest guidelines. Good conference for networking – Neha Joshi, Co-ordinator, CDSA-CCRE

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

DOWNLOAD Namrata Singh_Turacoz

Conference pictures can be viewed and downloaded at our official Virtue Insight facebook page

Link - Click Here

Close
Welcome
You have been registered successfully!
Close
Close
Enter Password
Submit Close