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DIA Medical Writing Conference

Jan 24 2014 8:30AM - Jan 24 2014 5:30PM | Sci-Tech Centre 7, Prabhatnagar Jogeshwari (W) Mumbai 400102 MH India

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Overview 

Medical Writing is a niche area, but is rapidly establishing its footprint in India. As we move up the value chain, it is increasingly critical to be aware of changing perspectives towards data transparency, ensuring ethical compliance, and the need to address regulatory requirements. This workshop will discuss the intricacies of authoring complex documents, health economics analyses, and the recognition of global trends of off shoring increasingly complex medical writing work to India. Attendees will also learn about vendor assessments and how to overcome challenges to establish effective partnerships.

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

Who Should Attend 

Professionals, researchers, and clinicians involved in drug discovery with development and regulatory affairs including:

  • Regulatory writers
  • Publication specialists
  • Clinicians
  • Ethics committee members
  • Outsourcing professionals
  • Regulatory and clinical research professionals
  • Global players looking at setting up medical writing operations in India

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

Faculty 

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Agenda  

Day 1 Friday, January 24, 2014

  • 9:30AM - 11:00AM

    Session 1: Medical Writing: Managing the Regulatory Angle


    Session Chair(s):

    • Bindu Narang
      Director
      Sciformix Corporation, India

    Session 1: Medical Writing: Managing the Regulatory Angle

    Speaker(s):

    • Responding to HAQ Questions, Response Documents: The Role of the Medical Writer
      Rajashri Ojha
      Shri J.J.T. University, India
    • The Data Transparency Initiative: Trial Disclosures and FDA8001
      Nimita Limaye, PhD
      Vice President, Biometrics and Medical Writing
      Tata Consultancy Services, India
    • The Data Transparency Initiative: Trial Disclosures and FDA8001
      Mark Barnes
      Partner
      Ropes & Gray, LLP, United States
    • Generating Evidence in Health Economic Analyses
      Sunita Nair
      Head Knowledge Services
      Capita India, India
  • 11:30AM - 1:15PM

    Session 2: Outsourcing in Medical Writing


    Session Chair(s):

    • Anupritha Sheth
      Amgen, India

    Session 2: Outsourcing in Medical Writing

    Speaker(s):

    • Challenges and Successes in Managing a Narrative Writing Partnership: The Do’s and Don’ts
      Swati Sharma
      Customer Leader
      TCS, India
    • Challenges and Successes in Managing a Narrative Writing Partnership: The Do’s and Don’ts
      Vanitha Prasad
      Group Leader, Reg. MW
      Novartis Healthcare Pvt. Ltd., India
    • Outsourcing Safety Reports: Managing Risks
      Preeti Verma
      Senior Manager
      Kinapse Ltd., India
    • Panel Discussion: Outsourcing Trends in Medical Writing – What do we see in RFPs?
      Nimita Limaye, PhD
      Vice President, Biometrics and Medical Writing
      Tata Consultancy Services, India
    • Devjani Ghosh Dasgupta
      DGM, Operations, Medical Writing & Document Publications
      Cognizant Technologies, India
    • Roopa Basrur
      Director, Medical Writing Services India
      PAREXEL International, India
  • 2:15PM - 3:45PM

    Session 3: Medical Communications


    Session Chair(s):

    • Sandeep Kamat
      Associate Vice President Medical Affairs
      Cactus Communications, India

    Session 3: Medical Communications

    Speaker(s):

    • Ethical Aspects in Document Authoring
      Nandini Kumar
      Former Deptuy Director General Sr. Grade
      Co-Investigator NIH Project, India
    • Nuances of Working with Authors in Developing Manuscripts
      Sandeep Kamat
      Associate Vice President Medical Affairs
      Cactus Communications, India
    • Responding to HCP Questions: The Role of the Medical Writer
      Bindu Narang
      Director
      Sciformix Corporation, India
  • 4:15PM - 6:00PM

    Session 4: Regulatory Writing


    Session Chair(s):

    • Sunita Nair
      Head Knowledge Services
      Capita India, India

    Session 4: Regulatory Writing

    Speaker(s):

    • Writing Robust Protocols - with the Right SPIRIT
      Payal Bharadwaj
      Subject Matter Expert and Senior Manager, Medical Writing
      Tata Consultancy Services, India
    • Writing Clinical Overviews and Summaries: A Comparative Analysis
      Rajendra Ramdas Wable
      Medical Writer
      Sciformix Technology Pvt. Ltd., India
    • Writing Clinical Overviews and Summaries: A Comparative Analysis
      Suhasini Sharma
      Director, Scientific Writing
      Sciformix Corporation, India
    • Panel Discussion: Interfaces in Medical Writing: Clinicians, Biostatisticians, Regulatory Affairs, CDM and Medical Writing
      Anish Desai
      Director Medical Writing & Clinical Affairs
      Johnson & Johnson Medical India, India

Registration Fees 

Other Fees

Charitable Nonprofit/Academia Member
Rs4000.00
Government (Full Time)
Rs4000.00
Industry
Rs5000.00
Register Online
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