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September 26, 2014

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Clinical Trials in India: Approval Process

Speaker for this Event: 
  • Dr. Renu Razdan, Chief Operating Officer, Max Neeman International   
  • Conducting clinical trials in India is attractive because of a vibrant urban health care environment, English as the business language, first rate medical credentials of CRAs and Project Managers, and a large therapeutically diverse patient population.

    Regulatory bodies in India made strides last year strengthening drug /device regulations and clinical trial laws gaining in patient protection while increasing alignment with western regulatory authorities. Many of the changes have captured media attention and raised questions.

    Join Dr. Razdan for a live discussion to learn about the many aspects involved in conducting clinical trials in India including:

    • The current clinical trial regulatory scenario
    • How the developments are positive since critical concerns of SAE compensation have been addressed and targeted timelines issued
    • How rules are being streamlined for conducting clinical trials in India to provide higher transparency among all stakeholder groups including patients, industry, sponsor and regulators alike

    India‚Äôs regulatory authorities continue to be committed to progressive review and approval of foreign clinical research requests, having learned from and improved upon methods to ensure ethical, ICH GCP conduct. Dr. Razdan and Max Neeman International have worked closely with the Drug Controller General of India [DCGI] since 2001. During this presentation, Dr. Razdan will also discuss:

    • Targeted approval timelines issued by DCGI
    • Regulatory agencies responsible for trial approval
    • SAE Compensation requirements
    • Processing of Import / Export License
    • DCGI assurances for ethical and ICH GCP conduct by all sites
    • Why conducting clinical trials in India still makes sense for global studies
    Keywords: clinical trials in india, approval process
    THIS PROGRAM IS INTENDED FOR

    Industry decision-makers involved in identifying strategic venues for clinical research and looking to understand better the potential of clinical research in India and their Regulatory environment

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    ABOUT OUR SPEAKER

    Dr. Renu Razdan, Chief Operating Officer, Max Neeman International

    Dr. Renu Razdan is the Chief Operating Officer of the Max Neeman International, a subsidiary of the Max India Group. She has served as the COO of the company since April, 2009. Under her supervision business of Max Neeman International has grown significantly over last five years.

    She has been featured as a prominent female achiever in the Life Sciences community, in the November 2010 issue of BioSpectrum India.

    She is also the Vice Chairman of Association of Contract Research Organizations (ACRO) India

    She completed her Masters in Biochemistry from the University of Srinagar and holds a Ph.D in Biochemistry. During Her academic years she has also been bestowed upon with International Fellowships. She was awarded the ICRETT Fellowship of UICC Geneva, at International agency for Research on Cancer Lyon (France) and G.S.F. Fellowship, at German Cancer Research Centre (DKFZ), Heidelberg, Germany. She also have attended a training course on Product Policy-New Product Development at Indian Institute of management, Ahmedabad in April 2000

    Prior to joining Max Neeman Dr. Renu has worked with one of the top Pharmaceutical Companies of India. She joined Ranbaxy Laboratories Limited as Senior Manager Business Development and grew on to become the Head Exports at Ranbaxy Laboratories. She has also worked with Transasia Biomedicals and HPCL Systems

    OUR XTALKS PARTNER FOR THIS EVENT

    Max Neeman International is a full service CRO with India / S.E. Asia expertise. We offer customized, client-focused services for the successful conduct of clinical trials in India for small and mid-sized drug, device and nutraceutical companies in compliance with ICH GCP standards. Max Neeman is ISO certified for Monitoring, Site Management and Data Management operating in India since 2001.

    For more information please contact Ann Vawter, Director of Business Development at +1 919.424.3332 or ann.vawter@neeman-medical.com.

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