Clinical Research in India – Regulatory Environment

India has become an attractive destination for clinical trials, combining many of the elements western sponsors require including: a vibrant urban health care environment, English as the language of clinical trials, first rate medical credentials of CRAs and Project Managers, and an advanced clinical trial infrastructure.

Indeed, Indian based regulatory bodies cooperate fully with international agencies, to ensure regulatory standards meet the requirements of USA FDA and ICH GCP guidelines. As a result of the Indian government’s initiatives, the FDA established it’s second ‘ex-USA’ office in India in 2009.

The country’s regulatory authorities are committed to progressive review and approval of foreign clinical research requests, willing to learn from and improve upon methods when challenges are faced. They continue preparing in anticipation of increasing growth from around the world to conduct their clinical trial studies in India.

Still, with growth and change, as within any other Government regulatory body, Sponsor updates about time to approval, involvement of agencies in the approval process, and processing of import/export licenses, retain a high priority, with Sponsors.

This program will analyze the basis of India’s Regulatory environment, the regulations [both current and future] of clinical trials in India, and the challenges faced in the present scenario.

Join Max Neeman’s Regulatory experts as they present India’s Regulatory
scenario and continuous growth to meet challenges as they arise.

     Key Takeaway Points:
– Gain a comprehensive overview of the regulatory requirements in India
– Develop effective processes for obtaining clinical trials authorization
– Clarify the requirements for running clinical trials in special population
– Marketing opportunities in India and the regulatory requirements

Speakers

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.

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Vandana Pandey, Manager Regulatory Affairs, Max Neeman International

Ms. Vandana Pandey heads the Regulatory Department at Max Neeman International in India. She has seven years of experience in working in Clinical Research and Life Sciences companies.

She has been associated with Max Neeman International for last five years and is responsible for all the Regulatory related activities. Prior to joining Max Neeman International, she worked for two years with CD Pharma India Pvt. Ltd.

Ms. Vandana Pandey holds a Masters Degree in Microbiology from University of Delhi.

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