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June 15 & 16, 2011

Clinical Research in India – Potential & Challenges

Speaker panel from Max Neeman International:
  • Ajoy Kumar, MD, Chief Executive Officer  Learn More
  • Renu Razdan, PhD, Chief Operating Officer   Learn More
  • Donald Swankie, MBA, Vice President, USA  Learn More
  • Clinical Research in India – Potential & Challenges

    Strategic ‘ex-US’ regions, such as Asia-Pacific, are becoming vital to Pharma and Biotech for cost effective, timely, and ICH GCP efficient research services.

    In fact, recent news out of NIH notes that from 2005-2009, over 60% of registered trials included at least one site outside of North America.

    Overseas clinical trials are becoming increasingly essential to drug development, and the leading venue, India, is becoming strategic for a host of reasons.

    This program will provide overview and key lessons in leveraging India as a strategic venue for research as well as post market approval in a country of 1.3 Billion.

    Key Takeaway Points:

    • Understanding of India’s clinical trial potential and reasons for growth
    • Updated information of India’s regulatory environment
    • Opportunities and risks of clinical research in India
    • Process of integrating India into USA based clinical trials
    THIS PROGRAM IS INTENDED FOR:

    Decision-makers involved in identifying strategic venues for clinical trial research and looking to understand better the potential of clinical research in India.

    • Pharmaceutical
    • Biotech
    • Device
    • Nutraceutical
    • Contract Research Organizations
    ABOUT OUR SPEAKERS:

    Ajoy Kumar, M.D., Chief Executive Officer, Max Neeman International

    Dr.Kumar brings with him over 19 years of experience with Apollo Hospitals, Cummins Diesel as CEO and Director and Tata Sons as GM (Group HR). Dr. Kumar was responsible for operations of the Apollo group of hospitals. His credits include initiating the Apollo Clinical Excellence model, Emergency Network and the development of common corporate database. Dr. Kumar also conceptualized and implemented the Disease Management program for Apollo group and lead of the nationwide Apollo Heart Plan.

    Dr. Kumar holds an MBBS from JIPMER, Pondichery with Master’s degree in Business Administration, Hospital Administration and Preventive and Promotional Healthcare and Medical Informatics.

    Renu Razdan, PhD, Chief Operating Officer, Max Neeman International

    Dr. Renu Razdan heads the business development team in India and looks after business in Europe and the southeast Asian regions. Dr. Renu brings in 10 years of experience. Prior to joining Max Neeman International, she worked for 6 years with Ranbaxy Laboratories Ltd.

    Dr. Renu has pursued an ICRETT Fellowship of UICC Geneva, at International Agency for Research on Cancer Lyon (France) and a G.S.F. Fellowship at German Cancer Research Centre (DKFZ), Heidelberg.

    Donald Swankie, MBA, Vice President, USA, Max Neeman International

    Mr. Swankie is responsible for the territories of North America and Latin America at Max Neeman. He has twenty years business development and consulting services experience with many in Life Sciences and Clinical Research, in both Biotechnology and U.S. Public Health care forums. Past companies he worked for include Quintiles Transnational and Science Application International [SAIC].

    Mr. Swankie holds a Masters Degree from Wake Forest University Babcock Graduate School of Business, 1995. He also holds a BSBA in Business and Economics from St. Peter’s College. He has an Executive education in Life Sciences, Duke University Associated with Max Neeman International for 4 years.

    OUR XTALKS PARTNER FOR THIS EVENT:

    Max Neeman International is a leading India-centric Contract Research Organization and wholly-owned clinical research subsidiary of Max India Limited, Life Sciences business group in India with interests in Healthcare, Clinical Research and Life Insurance. For over a decade, Max Neeman has offered customized services to the global pharmaceutical, biotech and device companies in the conduct of clinical and device trials as well as data management. Operational since 2001, Max Neeman is an ISO certified CRO for Site Management, Monitoring, Data Management and Information Security Management Systems with 6 regional offices, 175 sites across 31 cities, headquarters in New Delhi and USA office based in Cary, North Carolina.

    Max Neeman has been awarded 255 trials and 90% of 325 employees are physicians trained in ICH GCP guidelines.

    Services include:

    • Project Management
    • Regulatory Submission
    • Site Monitoring
    • Clinical Data Management
    • Biometrics and Report Writing
    • Site Management
    • Device Importation, Warehousing & Distribution

    For information about the recorded archive for this event contact Xtalks at (416) 977-6555 ext 371, or email register@xtalks.com

     
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