9th Annual Clinical Trials Summit 2018
Offering our customers the knowledge and connections for a profitable business

    OMPRAKASH S. SADHWANI Food and Drugs Administration (M.S.)








    JAMILA JOSEPH Reliance Life Sciences


    DEVEN V PARMAR Cadila Healthcare




    CHIRAG TRIVEDI Sanofi-aventis


    DILIP PAWAR Merck Sharp & Dohme




    BINDU AJIT Biocon Academy


    AMMAR RAZA Allergan


    KEDAR SUVARNAPATHAKI Boehringer Ingelheim




    AGAM SHAH Wockhardt




    CHIRAG TELI Alkem Laboratories




    PRANJAL BORDOLOI Veeda Clinical Research


    PRASHANT BODHE CliniSearch

22nd May 2018, Kohinoor Continental Hotel, Mumbai, India

“A critical guide for successfully conducting clinical trials”

Sponsors & Exhibitors
  • Conference Info
  • Day One
  • Speakers
  • Sponsors
  • Partners
  • Sponsorship Opportunity
  • Delegates
  • Pricing
  • Venue
  • Testimonials


With four-out-of-five clinical trials failing to meet original recruitment targets, new approaches are needed. Patients with chronic conditions or life-threatening diseases are often looking for a solution, a treatment that may help improve their quality of life or extend their life. Delays in clinical trials can cause significant problems for patients. We need to better understand the barriers and myths that deter both physicians from discussing clinical trials and patients from participating in them.

Virtue Insight welcomes you to attend the 9th Annual Clinical Trials Summit 2018, which is going to be held in Mumbai on 22nd May 2018. We cordially invite all the participants who are interested in sharing their knowledge and research in the arena of Clinical Trials.

9th Annual Clinical Trials Summit 2018 anticipates participants around the globe with thought provoking Keynote lectures, Oral Presentations and Poster Presentations. This is an excellent opportunity for the delegates from Universities and Institutes to interact with the world class Scientists. The main theme of the conference is to positively learn and educate about clinical trials is essential, if only to counter more negative perceptions.

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 9th Annual Clinical Trials Summit 2018. I wish and pray that all our efforts will be beneficial to our industries and to our country at large



  • Current challenges and regulations for clinical trials in India 
  • Having a positive impact on overall market to globalize trials and growth in new product development in emerging countries 
  • Formulating a risk-based inspection plan for advanced clinical trials 
  • New tools and technologies for data capture for clinical trials
  • Developing effective partnerships and vendor relationships
  • Dealing with the evolve business frameworks that allows third-party vendors, CROs, and sponsors to formulate traditional contracts for contemporary trials
  • Efficient administration for outsourced site contract negotiation
  • Necessary strategies to implement the maximize value of the collaboration.
  • Patient and clinical site centricity: Optimising the end users, patients and the clinical sites
  • Understanding the needs of both patients and the clinical site that should be considered
  • Encouraging data analytics for next-generation clinical trials
  • Leveraging advanced data analytics and m-health for next-gen trials
  • EHR (Electronic Health Records) for clinical research facility
  • Recent guidelines issued by FDA on the use of EHR data
  • Major roles of clinical pharmacology in drug discovery and development
  • Exhibiting and simulating the overall drug development process
  • New clinical trials rules and its impact
  • Current requirements of Indian Clinical Trial Application (CTA) and how this will change with the new clinical trial regulation
  • Regulatory considerations in India and south-east Asia
  • Be part of a major networking opportunity


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


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 time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.

08:30 – Coffee and registration – An opportunity to meet and to network with your conference colleagues.

09:20 – Chairperson opening remarks


09:30 – Topic TBC
OMPRAKASH S. SADHWANI, Joint Commissioner (Nashik Division), Food and Drugs Administration (M.S.)

10:00 – Encouraging data analytics for next-generation clinical trials

  • Constructing data analytics platform and common analytics shapes that can be employed to many types of clinical trials
  • Risk-based observation and quality to cooperate and contribute innovations based on big data and advanced analytics to clinical trials operations
  • How changing this approach using advanced data analytics and m-Health solutions can identify areas of risk much faster and more accurately
  • New and innovative way to run clinical trials by gaining more traction through remote trials

10:30 – Morning Coffee/Tea & Discussion


10:50 – DISCUSSION WITH EXPERTS: Formulating a risk-based inspection plan for advanced clinical trials

  • Conventional auditing approaches and efficiency
  • Strategies on changing regulations, intricated clinical trial structures and outsourcing
  • New tools and technologies for data capture for clinical trials
  • Auditing and necessity on risk-based approach to trials
  • Best practices and methods for developing a risk-based audit program with insight from various members of a clinical trial team.
  • Implementing RBM internally and externally, what are challenges face in major and common barriers?
  • Strategies and key concerns that need to be addressed for successful RBM


SIDDHARTH DESHPANDE, Assistant Professor Department of Clinical Pharmacology, KEM Hospital
ARUN BHATT, Consultant – Clinical Research & Development

11:30 – DISCUSSION WITH EXPERTS: Developing effective partnerships and vendor relationships

  • Establishing a team atmosphere for creative problem solving
  • Plan of success, drug development projects and a series of problems and solutions
  • Constructing an effective model early on for a successful partnership with CROs and site payment vendors
  • Investigate site payments and a view on simple line item and cost within CRO and vendor contracts
  • Dealing with the evolve business frameworks that allows third-party vendors, CROs, and sponsors to formulate traditional contracts for contemporary trials
  • Insuring efficient management and governance - appointing clear roles and obligations among sponsor and CRO to prevent duplicative attempts and set practical expectations



DEVEN PARMAR, Vice President & Head Clinical R&D, Cadila Healthcare
AGAM SHAH, Head Clinical Operations, Wockhardt
PRANJAL BORDOLOI, AVP - Medical Affairs and Pharmacovigilance, Veeda Clinical Research

12:10 – Efficient administration for outsourced site contract negotiation

  • Efficient site contract negotiation to critically support important clinical operation milestones around site activation
  • Outsourcing model to provide increased flexibility and access to industry expertise
  • Necessary strategies to implement the maximize value of the collaboration.
  • Detailed strategic views to enhance the efficiency and potency of outsourcing site contract negotiation

12:40 Networking luncheon

Afternoon Chair Person

13:50 – Creating workforce for the future - Biocon Academy a case study

BINDU AJIT, Program Director, Biocon Academy

14:10 – DISCUSSION WITH EXPERTS: Key strategies to globalizing clinical trials into emerging markets

  • Encouraging requirement for CROs to perform clinical trials and improve treatments on personalized medicine, augmenting evolution in technology
  • Having a positive impact on overall market to globalize trials and growth in new product development in emerging countries
  • Drug discovery to post-marketing surveillance
  • Increase product portfolio and drive innovation to point and further improve capabilities in clinical trial designing
  • Integrating predictive analytics that can help thrust R&D plot and perform clear ties for long-run financial impacts
  • Leveraging advanced data analytics and m-health for next-gen trials

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


JAMILA JOSEPH, Senior Vice President and Head, Clinical Research Services, Reliance Life Sciences
DILIP PAWAR, Director and Head - Clinical Development and Medical - Emerging Market including APAC, Merck Sharp & Dohme
AMMAR RAZA, Country Medical Director & Chief Medical Office, Allergan
CHIRAG TELI, Head of Medical Services, Alkem Laboratories
JYOTSNA PATWARDHAN, Head Development QA, Novartis
SUJAY SURESH KULKARNI, Senior Manager, Medical and Regulatory Affairs, GSK

14:50 – EHR (Electronic Health Records) for clinical research facility

  • Significance of evaluating sites EHR systems when used as a point in clinical trials
  • Recent guidelines issued by FDA on the use of EHR data
  • Challenges & opportunities for sponsors while evaluating these systems fundamental and elements of data quality
  • Thoughts to support sponsors in the assessment of EHR systems

15:20 – Clinical Development of Biologics- Unique Challenges and Opportunities

  • Recombinant DNA technology - changed the way medicines are discovered and developed
  • Biologics are Different
  • Biologics vs. Non biologics - Development costs and timelines
  • Opportunities and Challenges with Biologics
  • Clinical Development of Biologics – how is it different? Differences in clinical pharmacology / Development challenges etc.

AMMAR RAZA, Country Medical Director & Chief Medical Office, Allergan

15:50 – Afternoon Tea/Coffee


16:20 – DISCUSSION WITH EXPERTS: New clinical trials rules and its impact

  • Current requirements of Indian Clinical Trial Application (CTA) and how this will change with the new clinical trial regulation
  • Substantial amendments and non-substantial amendments
  • Ethical considerations for clinical trials performed in children guideline compared with adults
  • Influencing the best strategy for the different regulations across India and globally
  • Key development for sponsors and investigators to insure if they meet regulatory necessities when performing multi-country clinical trials
  • Conducting direct-to-patient trials using technologies, such as apps and wearables to report data and analyse current strategies and relevant regulations
  • Assuring the efficacy and success of clinical trials – What is a best practice for working with regulatory agencies?



K. BANGARURAJAN, Joint Drugs Controller, CDSCO (HQ)
NILIMA A. KSHIRSAGAR, National Chair Clinical Pharmacology, ICMR Govt. of India
MUZAFFAR AHMAD, Member, Strategic Advisory Board on Health Millenium Alliance (Govt of India) and Member Council of India
SHIRAZ KANDAWALLA, Associate Director - Regulatory Affairs, Abbott
KEDAR SUVARNAPATHAKI, Head - Regulatory Affairs & IP, Boehringer Ingelheim
PRASHANT BODHE, Director, CliniSearch

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


Joint Commissioner (Nashik Division)

Food and Drugs Administration (M.S.)


Joint Drugs Controller (INDIA)


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.


National Chair Clinical Pharmacology

ICMR Govt. of India


Member Strategic Advisory Board on Health Millenium Alliance (Govt of India) and Member Council of India


Senior Vice President and Head Clinical Research Services

Reliance Life Sciences


Vice President & Head Clinical R&D

Cadila Healthcare


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”.


Director & Head of Clinical Study Unit


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.


Director and Head - Clinical Development and Medical - Emerging Market including APAC

Merck Sharp & Dohme





Program Director

Biocon Academy


Country Medical Director & Chief Medical Office



Head - Regulatory Affairs & IP

Boehringer Ingelheim


Assistant Professor Department of Clinical Pharmacology

KEM Hospital


Head Clinical Operations



Head Development QA


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


Head of Medical Services

Alkem Laboratories


Senior Manager - Medical and Regulatory Affairs



AVP - Medical Affairs and Pharmacovigilance

Veeda Clinical Research




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


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)


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

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Kohinoor Continental Hotel

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

Testimonials from our past Clinical Trials Summit Conferences



Great networking event – Business Enablement & Strategy, Saama Technologies

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

Very well structured summit. Adequate knowledge on the topic of clinical research, regulations, guidelines, amendments, etc are well discussed – 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 – Research Associate, The Himalaya Drug Company

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

Over all good - Safety physician, Sciformix

It was good & interadity sessions - 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 - Manager - eclinical, DDi

Great conference for networking and relationship - 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 - 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 - Regulatory Affairs Biologicals-Cipla New Ventures, Cipla

Very interactive informative and time managed session - 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 - Senior Business Analyst, HCL Technologies

Well Organized - 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 - 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 - 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 - 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.” - Senior Medical Writer-Medical Writing, SIRO Clinpharm

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

Summit was well organized and very interesting panel of discussion - 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 - Director Operations, GSS HR Solutions

Excellent Organisation and facilities - 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 - 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” - General Manager, Accutest Research

Very Insightful.... - CEO, EOS Medical Research

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

Its a good conference and the approach of new ideas get a merge in single pool without any barriers - 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.... - Business development, Karmic Life sciences

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