SOURCE: Xtalks

Xtalks Webinars

September 17, 2014 07:05 ET

Clinical Trials in India: Approval Process, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - September 17, 2014) - Join Dr. Renu Razdan, Chief Operating Officer at Max Neeman Internationals, on Friday, September 26, 2014, for a live discussion about the many aspects involved in conducting clinical trials in India. The broadcast begins at 10:30 am EDT (3:30pm BST/ UK GMT +1).

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.

India's 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

To learn more about this event visit: Clinical Trials in India: Approval Process

About Max Neeman

Max Neeman International is a full service CRO with India / S.E. Asia expertise offering customized, client-focused services to ensure the successful conduct of clinical trials 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.

About Xtalks

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com

For information about hosting a webinar visit http://xtalks.com/sponsorship.ashx

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Contact Information

  • Contact:
    Michelle Tran
    Tel: +1 (416) 977-6555 ext 352
    Email: mtran(at)xtalks(dot)com