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DIA Risk-based Monitoring Conference in India

May 23 2014 8:30AM - May 24 2014 6:00PM | Scitech Center 7, Prabhat Nagar Jogeshwari West Mumbai 400102 Maharashtra India

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Overview 

Risk-based Monitoring (RBM) is a niche area that is transforming the clinical trial industry. RBM involves an orchestrated interplay between core clinical domain, data management, biostatistics, analytics, quality and regulatory, and of course the sites as well and this program will touch upon all of these components. It will delve into risk assessment, the RACT tool, the monitoring plan and the complexities involved in defining risk indicators, the evolving roles of the key stake holders, the governance, implementation challenges, industry and regulatory perspectives, and how India can be a key player in this space.

The need of the pharma/biotech industry is to drive a leaner approach to drug development, while emphasizing patient safety. This conference will highlight how RBM will be a key enabler for this.

    Program Chair
Nimita Limaye
Vice President
Medical Writing Risk-based
Monitoring and CDM TCS

    Featured Topics 

    • RBM – regulatory guidances and industry perspectives, benefits, and challenges
    • Integrating Quality – QBD, the RACT tool – ensuring patient safety
    • Defining and managing risk at different levels – risk indicators
    • Strategies for developing the protocol and monitoring plans
    • Predictive Analytics
    • Roles are changing – CRA/CDM
    • Managing the sites – does anything change?
    • Technology solutions and vendor evaluation
    • Data integration and associated complexities

    Who Should Attend 

    Senior professionals driving Risk-based Monitoring initiatives within their organization, including those from:
    • Clinical Strategy
    • Business Operations
    • Clinical Operations
    • Clinical Data Management
    • Biostatistics
    • Analytics
    • IT and Technology
    • Quality
    • All clinical research professionals such as data managers, clinical research associates, site coordinators and others from the clinical space who wish to get inducted to Risk-based monitoring
    • Global players looking at setting up Risk based monitoring operations in India should also attend this event

    Contact Information 

    Manoj Trivedi, Senior Manager Marketing and Program Development, DIA India
    Mobile phone: +91-98-1977-7493
    Phone: +91-22-6765-3226
    Email: Manoj.Trivedi@diaindia.org

    Program Committee 

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    Agenda  

    Day 1 Friday, May 23, 2014

    • 10:00AM - 10:30AM

      INAUGURATION
    • 10:30AM - 11:00AM

      Keynote Address

      Speaker(s):

      • RBM – Transforming the Clinical Trial Industry
        Syed Shah
        Global Strategic Planning & Operations, Global Clinical Operations
        Novartis International AG, Switzerland
    • 11:00AM - 12:00PM

      Session 1: Risk Based Monitoring : Evolving Industry Perspectives


      Session Chair(s):

      • Chirag Trivedi
        Director, Clinical Study Unit,
        Sanofi, India

      Session 1: Risk Based Monitoring : Evolving Industry Perspectives

      Speaker(s):

      • TransCelerate BioPharma: IQRMP, RACT and QBD
        Chirag Trivedi
        Director, Clinical Study Unit,
        Sanofi, India
      • TransCelerate BioPharma: IQRMP, RACT and QBD
        Subashri Shivkumar
        Director & Hub Unit Manager
        Bristol Myers Squibb, India
      • RBM and ROW — How do we Drive RBM in Global,Multicentric Trials?
        Sumit Goyal
        Director, Clinical Research
        inVentiv Health Clinical, United States
    • 12:30PM - 1:30PM

      Session 2 -Technology As a Game Changer


      Session Chair(s):

      • No-image Nitin Kumar
        Head Technology Excellence Group, LifeSciences
        Tata Consultancy Services, United States

      Session 2 -Technology As a Game Changer

      Speaker(s):

      • Selling an RBM Solution - What Should Technology Offer?
        Nitin Kumar
        Head Technology Excellence Group, LifeSciences
        Tata Consultancy Services, United States
      • Managing Science while Integrating Technology in RBM
        Rajkumar Sinha
        Senior Director, GDS
        Quintiles Technologies (India) Private Limited, India
    • 2:30PM - 4:00PM

      Session 3: The Science of RBM


      Session Chair(s):

      • No-image Ashwini Kumar Mathur, PhD
        Head Global Clinical Operations India
        Novartis Healthcare Pvt. Ltd., India

      Session 3: The Science of RBM

      Speaker(s):

      • QBD - Integration Risk Management at the Protocol Level
        Harshad Kulkarni
        Dy. GM
        Cognizant Technology Solutions, India
      • Risk Indicators and Triggers — Getting them Right:Shifting from SDV to SDR
        Dinesh Pillaipakkamnatt
        Global Head, Central Analytics Function
        Novartis Healthcare Pvt. Ltd., India
      • Analytics and RBM — The Statistics Behind it All!
        Ashwini Kumar Mathur, PhD
        Head Global Clinical Operations India
        Novartis Healthcare Pvt. Ltd., India
    • 4:45PM - 5:30PM

      Session 4: RBM - Is it about Technology or Science?


      Session Chair(s):

      • Suresh Ramu
        Co-founder and CEO
        Cytespace, India

      Session 4: RBM - Is it about Technology or Science?

    Day 2 Saturday, May 24, 2014

    • 9:30AM - 10:30AM

      Keynote Address

      Speaker(s):

      • Keynote Address: Disruptive Innovation in Clinical Trials and Healthcare
        Nimita Limaye, PhD
        Vice President, Biometrics and Medical Writing
        Tata Consultancy Services, India
    • 10:30AM - 11:30AM

      Session 5: Change Management in RBM


      Session Chair(s):

      • Hemant Rehani
        Vice President and Head, CDS
        Quintiles, India

      Session 5: Change Management in RBM

      Speaker(s):

      • The Site’s Perspective — Like It or Not!
        Yashesh Mehta
        Sr. Director, Process Excellence
        Cytespace, India
      • Profiling the Clinical Data Monitor— A New Role in the Making
        Anita Limaye
        Director
        Quintiles Research (india) Pvt Ltd, India
    • 12:00PM - 1:30PM

      Session 6: Implementing RBM


      Session Chair(s):

      • Khalid Saifuddin
        Novartis Healthcare Pvt. Ltd., India

      Session 6: Implementing RBM

      Speaker(s):

      • Challenges and Successes in Managing an Onshore/ Offshore RBM Partnership — The Do’s and Don’ts
        Jagadeesh Rudraswamymath
        Senior Director, Centralised Data and Operational Surveillance
        Quintiles, India
      • Digital Strategy: e-Source, the eICF and e-Monitoring
        Gunjan Jain
        Solution Consultant, Oracle Health Sciences
        Oracle, India
      • Defining KPIs for the Successful Implementation of RBM
        Tapankumar Shah
        Trial Clinical Monitor
        Boehringer Ingleheim India Pvt. Ltd., India
    • 2:30PM - 4:00PM

      Session 7: RBM Strategy


      Session Chair(s):

      • Jagadeesh Rudraswamymath
        Senior Director, Centralised Data and Operational Surveillance
        Quintiles, India

      Session 7: RBM Strategy

      Speaker(s):

      • Picking the Right Study and the Right time to Pilot RBM
        Jinu Jose, MBA
        Senior Director, Clinical Operations
        Quintiles India, India
      • Organizational Health Check: RBM — Are You Ready For It?
        Veerabhadra Nayak
        Global Lead CRA
        RPS Strategic Solutions, India
      • RBM: A Steep Climb Ahead — Potential Enablers
        Y K Gupta
        Professor and Head, Department of Pharmacology
        All India Institute of Medical Sciences (AIIMS), India
    • 4:30PM - 5:15PM

      Session 8: Panel Discussion: The ROI on RBM - Is it really worth the risk?


      Session Chair(s):

      • No-image Nimita Limaye, PhD
        Vice President, Biometrics and Medical Writing
        Tata Consultancy Services, India

      Session 8: Panel Discussion: The ROI on RBM - Is it really worth the risk?

    Exhibits  

    DIA's Risk-based Monitoring Conference: Demystifying Risk-based Monitoring offers interested companies the opportunity to exhibit with a tabletop display. Other support opportunities available.

    Available Opportunities

    Platinum Supporter

    200,000 INR

    Gold Supporter

    150,000 INR

    Luncheon/Day Partner

    100,000 INR

    Tabletop

    70,000 INR

    Banner

    20,000 INR

    Useful Links

    • Lambda Therapeutic Research Private Limited
    • Quintiles Research (India) Private Ltd.

    Registration Fees 

    Member

    Charitable Nonprofit/Academia Member
    Rs3500.00
    Member Government
    Rs3500.00
    Member Standard
    Rs8000.00

    Non-Member

    Charitable Nonprofit/Academia Nonmember
    Rs4000.00
    NonMember Government
    Rs4000.00
    NonMember Standard
    Rs9000.00
    Group Discounts

    There are no group discounts for this event.


    Join DIA now to qualify to save on future events and to receive all the benefits of membership.

    A limited number of student registrations are available. A student is an undergraduate/graduate who can document enrollment in a Signature accredited, degree granting, academic program. Please send completed registration form, copy of student identification, and payment.


    CANCELLATION POLICY: On or before MAY 10, 2014

    Cancellations must be in writing and received by May 10, 2014. Registrants who do not cancel in writing by that date and do not attend the event will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations.

    DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.

    Upon cancellation, the administrative fee that will be withheld is 75% of the registration fee.

    All refunds will be issued in the currency of original payment

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