Regulatory Changes in India and What It Means for Clinical Research in the Country

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October 19, 2016

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After a couple of challenging years for the clinical research fraternity in India brought on by uncertainty and unpredictability in the regulatory environment, the Indian regulators have recently introduced several positive changes and modifications in existing rules and regulations. The changes have made way for a more robust patient-centric regulatory framework that is guided by science and rational thinking. This webinar will discuss the recent clinical research regulatory changes in India and what this means for those doing or interested in doing clinical research in the country.

This seminar is designed primarily for audiences in the USA and Europe but is also open to anyone interested in clinical research in India.

The webinar will address 2 key areas:

1) Overview of regulatory changes in India
Before 2015, challenges existed in India around uncertainty in the clinical research regulatory environment, particularly around compensation, audio visual recording of informed consent and the review process.

As a result of collaboration and engagement by the India regulators with stakeholders, many of these challenges have now been addressed and additional guidelines introduced to ensure a more robust and transparent regulatory environment. This session will address all the changes in the last two years.

2) The impact and implication of these changes
In a recent business magazine interview, the Drugs Controller General of India said with certainty that India is ready to do extremely good work in clinical trials now.”

This session will address the implications of the changes discussed in the earlier section, what these changes translate into from a practical standpoint and what this means for those conducting or contemplating.

Suneela Thatte
Vice President, Global Operations
QuintilesIMS India